Business and Scientific Leadership

Allen Wayne Mangel

MD
Georgetown University School of Medicine, Washington, DC

PhD, Physiology
MS, Physiology
BS, Physiology
University Of Illinois, Urbana, IL

Allen Mangel, MD, PhD, is a gastroenterologist and Executive Vice President of RTI-HS. Following completion of his medical training, Dr. Mangel did his internship and residency in internal medicine at Duke University Medical Center and then completed his gastroenterology fellowship also at Duke. Following completion of his formal training, he remained on the faculty in the Department of Medicine, Division of Gastroenterology, at Duke for 3 years. Dr. Mangel also has a PhD from the University of Illinois, where his research focused on control of electrical and mechanical activity in gastrointestinal smooth muscle.

After Dr. Mangel left Duke, he joined the gastroenterology clinical research department at Glaxo Wellcome, where he conducted numerous clinical trials and directed product development teams. After departing GlaxoWellcome, he became Vice President of Research and Development at Salix Pharmaceuticals. He joined RTI International in 2001 and currently serves as Executive Vice President of RTI-HS. Dr. Mangel has led or participated in numerous FDA interactions, advisory committee presentations, label negotiations, and new drug application submissions, and he has authored more than 100 publications.

 

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PhD, Organic Chemistry
Massachusetts Institute of Technology, Cambridge, MA

BS, Organic Chemistry
University of Delaware, Newark, DE

Lawrence Bell, PhD, is the Vice President of Business Affairs for RTI-HS. He has extensive management and hands-on experience consulting for and within the pharmaceutical industry to develop people, processes, and systems related to outcomes research, drug development, and health policy. At RTI-HS he has guided a number of business and technical functions, including Business Development, Office of Quality Assurance, Health Outcomes Strategy, and Health Economics. In addition, he has been extensively involved in the pre-IND (nonclinical) development of two novel chemical entities. He has broad experience with development strategy, including bench and scale-up chemistry, drug and dosage formulation and stability, and clinical trials.

For more than 25 years, he served as a management team member for various divisions and departments of a major pharmaceutical company, establishing and shaping the direction of a number of groups, including Project Planning (tasks and their dependencies, timelines, and costs/budgets to submit INDs and NDAs), Health Economics, Health Policy Research, Clinical Data Processing and Management, and Quality Assurance.

He has published in journals, including PharmacoEconomics, Journal of Medicinal Chemistry, International Journal of Technology Assessment in Health Care, Pharmacotherapy, Epilepsia, Journal of the American Chemical Society, and Journal of Organic Chemistry. Additionally, Dr. Bell was coauthor, coordinator, and editor for Chapter 3, “Estimating Drug Development Costs,” in the report “The Economics of TB Drug Development,” available at http://66.216.124.114/7_1_1GenericNewsArticles.asp?itemId=286

_Report.pdf.

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Josephine A. Mauskopf

PhD, Economics
MHA, Health Administration
MA, Physiology and Pharmacology
Duke University, Durham, NC

Josephine Mauskopf, PhD, MHA, is Vice President of Health Economics at RTI-HS. She has extensive experience both as a consultant and within the pharmaceutical industry designing and implementing pharmacoeconomic research strategies. She has designed pharmaco­economic research programs for drugs for bacterial infections, viral infections, psychiatric illness, and neurologic diseases. Dr. Mauskopf has estimated budget impacts for new products for schizophrenia, bipolar disease, breast cancer, and HIV infection. She has estimated the cost-effectiveness of antiretroviral drugs, as well as drugs for treating Alzheimer's disease, fungal infections, herpes zoster, epilepsy, neonatal respiratory distress syndrome, digoxin toxicity, community-acquired pneumonia, intra-abdominal infections, and primary pulmonary hypertension. Dr. Mauskopf also has estimated the impact of an antidepressant on work and social disability. Dr Mauskopf has performed many strategic literature reviews that have been published in peer-reviewed journals, including reviews of cost of care for Alzheimer's disease, cost of care for treatment-resistant depression, and cost-effectiveness of tiotropium for chronic obstructive pulmonary disease and treatments for uterine fibroids. Dr. Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed simulation models of time spent in the operating and recovery rooms and of disease progression for HIV infection.

Dr. Mauskopf was previously Vice President at MEDTAP International, Department Head of Economics Research at Burroughs Wellcome Co., and Director of Pharmacoeconomics Research for Anti-Virals and Anti-Infectives at Glaxo Wellcome Inc. Dr. Mauskopf has just completed an 8-year term as Editor-in-Chief of the journal Value in Health. She served for 4 years as a reviewer on the Health Care Technology and Decision Sciences Study Section at the Agency for Healthcare Research and Quality. She has presented her research at numerous national and international symposia. She has also published extensively in journals, including Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Value in Health, Medical Care, American Journal of Public Health, Health Services Research, American Journal of Alzheimer's Disease and Other Dementias, and Journal of Nutrition, Health, and Aging.

 

 

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Dave Obringer

JD, University of North Carolina, Chapel Hill, NC

BA, Political Science, Heidelberg College, Tiffin, OH

Dave Obringer, JD, is a member of the RTI Health Solutions (RTI-HS) Business Management Team (BMT). The BMT formulates strategic and business plans for RTI-HS and oversees implementation of those decisions. Mr. Obringer leads the contracting and procurement group supporting RTI-HS, as well as the Office of Quality Assurance within RTI-HS. He also supports the review and implementation of strategic alliances and acquisitions. Mr. Obringer also played a key role in the procurement and implementation of a strategic enterprise financial, project, and client management system for RTI-HS.

Prior to joining the RTI-HS BMT, Mr. Obringer served as the lead transactional attorney and counsel at RTI. In that role, he provided advice and counsel on corporate-wide legal and regulatory matters, reviewed and approved contractual and legal documents for the research business units, and provided counsel to RTI's administrative units. He has consulted with and managed outside counsel as needed, and managed a large legal/administrative team, including attorneys, contract professionals, and support staff, and served on the corporate steering committee overseeing the procurement and implementation of corporate-wide strategic financial systems.

 

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PhD, Biochemistry
BSc, Biochemistry
Aberdeen University, Aberdeen, Scotland

DMS, Management
Napier University, Edinburgh, Scotland

PMP, Project Management
PMI (Project Management Institute)

Derek Ross, PhD, is Vice President of Operations at RTI-HS and responsible for Project and Proposal Operations and Editorial Services. He has extensive international experience at a senior level in the pharmaceutical industry, leading technical scientific management, project management, and process improvement organizations. Previously, Dr. Ross was Vice President of Worldwide Project Planning, Strategy, and Business Re-Design at Glaxo Wellcome, and Vice President of Information Technology Portfolio and Project Management at GlaxoSmithKline. He has also founded his own management consulting business, which focuses on building high-performance organizations with emphasis on business strategy and the management of major organizational change.

 

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BA, Accounting
North Carolina State University, Raleigh, NC

Biotechology for Business Executive Education Course
Duke University, Durham, NC

CPA (Certified Public Accountant)

Chris Simmons, CPA, is Vice President of Finance at RTI-HS, heading both the finance and business development groups. He has spent more than 20 years in financial, operational, and business development roles. Mr. Simmons began his career in public accounting for 7 years, and since has worked for several technology and biotech businesses, with a particular focus on early stage companies. He has led groups spanning the support functions, including finance, IT, HR, business development, marketing, facilities, and communications.

 

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Allen Wayne Mangel

MD
Georgetown University School of Medicine, Washington, DC

PhD, Physiology
MS, Physiology
BS, Physiology
University Of Illinois, Urbana, IL

Allen Mangel, MD, PhD, is a gastroenterologist and Executive Vice President of RTI-HS. Following completion of his medical training, Dr. Mangel did his internship and residency in internal medicine at Duke University Medical Center and then completed his gastroenterology fellowship also at Duke. Following completion of his formal training, he remained on the faculty in the Department of Medicine, Division of Gastroenterology, at Duke for 3 years. Dr. Mangel also has a PhD from the University of Illinois, where his research focused on control of electrical and mechanical activity in gastrointestinal smooth muscle.

After Dr. Mangel left Duke, he joined the gastroenterology clinical research department at Glaxo Wellcome, where he conducted numerous clinical trials and directed product development teams. After departing GlaxoWellcome, he became Vice President of Research and Development at Salix Pharmaceuticals. He joined RTI International in 2001 and currently serves as Executive Vice President of RTI-HS. Dr. Mangel has led or participated in numerous FDA interactions, advisory committee presentations, label negotiations, and new drug application submissions, and he has authored more than 100 publications.

 

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Elizabeth B. Andrews

PhD, Epidemiology
MPH, Health Policy and Administration, North Carolina School of Public Health
BA
University of North Carolina, Chapel Hill, NC

Elizabeth Andrews, PhD, is the Vice President of Pharmacoepidemiology and Risk Management at RTI-HS. She provides consultation for pharmaceutical companies and the US Food and Drug Administration (FDA) on therapeutic risk management and pharmacoepidemiology, and she directs research programs that evaluate drug safety and compliance with prescribing and treatment guidelines. She oversees the conduct of large, prospective patient registries, Web-based surveys, and studies using large existing databases. Dr. Andrews currently serves as principal investigator on several large risk management studies, and serves on various study advisory boards and data safety monitoring boards. Her experience has spanned most therapeutic areas, although she has worked extensively in the areas of HIV and sexually transmitted diseases; birth defects and neonatal health; asthma and chronic obstructive pulmonary disease; and irritable bowel syndrome. Dr. Andrews is involved in the design of observational research programs within RTI-HS to assure that the methods chosen provide a robust and cost-effective approach to address the study questions and to assure appropriate linkages are forged with academic and governmental partners.

Previously, Dr. Andrews was Vice President, Worldwide Epidemiology, at GlaxoSmithKline and conducted epidemiologic research in a variety of therapeutic areas, including rheumatoid arthritis, genital herpes, HIV, asthma, migraine, and irritable bowel syndrome. She initiated the first pharmaceutical pregnancy registry, the Acyclovir Pregnancy Registry, and multiple registries for other medications. She began her career in the pharmaceutical industry at Burroughs Wellcome in 1982 and subsequently built a strong international epidemiology program at Glaxo Wellcome. Prior to joining Burroughs Wellcome, she managed the Statewide Regionalized Perinatal Care Program and directed the non-Medicaid health care reimbursement programs for the State Health Department of North Carolina.

She is a Fellow and Past President of the International Society for Pharmacoepidemiology, and coeditor of Pharmacovigilance. She is an Adjunct Associate Professor of the University of North Carolina School of Public Health and School of Pharmacy, and a member of the Scientific Advisory Board Observational Medical Outcomes Partnership.

 

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Stephen Beard

MSc (Eng), Operational Research
University of Birmingham, UK

BSc (Hons), Mathematics
University of London, UK

Stephen Beard, MSc, is Vice President of Heath Economics (Europe) and is based in RTI-HS’s UK offices in Manchester and Sheffield. He has more than 25 years of experience in the application of mathematical modeling, optimization, and decision analysis techniques to business problems gained in academic, government, and industrial organizations. He has worked specifically within the health outcomes research sector for the past 16 years, having previously held a senior project management and research position within the School of Health and Related Research (ScHARR), University of Sheffield, UK, where he headed a team producing rapid-review health technology appraisal reports for the National Institute for Health and Clinical Excellence (NICE) in the UK. His work has focused on health economics, Markov modeling, and statistical modeling techniques to explore disease progression and the impact of treatment across a range of areas, including colorectal cancer, ovarian cancer, breast cancer, schizophrenia, depression, attention-deficit/hyperactivity disorder, neuropathic pain, and infectious diseases. He is a member of the International Society of Pharmacoeconomics Outcomes Research, the Operational Research Society, and the Institute for Operations Research and the Management Sciences. He has presented his work at professional conferences and has published in several peer-reviewed journals, including European Journal of Health Economics, British Journal of Cancer, and Pharmacoeconomics.

 

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Kati Copley-Merriman

 

MBA, Marketing
Indiana University, Indianapolis, IN

 

MS, Organic Chemistry
Purdue University, Indianapolis, IN

 

BA, Chemistry and German
Smith College, Northampton, MA

 

Kati Copley-Merriman, MS, MBA, is Vice President of Market Access and Outcomes Strategy at RTI-HS. Ms. Copley-Merriman has more than 25 years of industry experience, including leadership roles in Global Outcomes Research at Eli Lilly, Parke-Davis, and Pfizer. She has experience in all aspects of outcomes research (OR), including clinical trial design with patient-reported outcomes (PRO) endpoints, economic evaluations, OR strategic plans, and regulatory strategy.

 

In her RTI-HS role, Ms. Copley-Merriman leads a team of scientists, reimbursement experts, and medical writers responsible for developing OR strategic plans, literature reviews, disease state summaries, and product value and reimbursement dossiers, and for conducting qualitative payer research. Ms. Copley-Merriman has experience in many therapeutic areas, including oncology, pain and inflammation, dermatology, respiratory, urology, and central nervous system. Ms. Copley-Merriman is an active member of International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and was elected to the ISPOR Board for 2010-2012.

 

 

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Dana Britt DiBenedetti

PhD, Clinical Psychology
MS, Clinical Psychology
Oklahoma State University, Stillwater, OK

BA, Psychology
Millsaps College, Jackson, MS

Dana Britt DiBenedetti, PhD, Head of Patient-Reported Outcomes at RTI Health Solutions, is a clinical health psychologist with extensive experience in psychosocial assessment of adults and children in numerous therapeutic areas. Her broad clinical and assessment experience includes expertise in adult and pediatric psychiatry, virology, diabetes, women's health (e.g., menopause, vaginal atrophy, endometriosis), sexual medicine (e.g., erectile dysfunction, female sexual dysfunction, Peyronie's disease), respiratory, neurology/‌neuropsychology, nicotine dependence, obesity, chronic pain, and oncology. Currently, Dr. DiBenedetti specializes in the development of questionnaires designed to measure symptom severity, quality of life, patient satisfaction, and other patient-reported outcomes. As part of the questionnaire-development process, Dr. DiBenedetti has facilitated numerous patient, caregiver, and physician focus groups, and conducted cognitive interviews with a wide variety of patient and professional populations. Dr. DiBenedetti has considerable experience in both academic and pharmaceutical settings with instrument development and validation, functional status and quality-of-life assessment, design and implementation of survey and observational studies in various patient and health care professional populations, and coordination of instrument translations. Dr. DiBenedetti has authored/coauthored numerous manuscripts and scientific presentations on instrument development, quality of life, treatment satisfaction, and other outcomes in various patient populations, and she has served as a reviewer for several journals, including Value in Health, Journal of Consulting and Clinical Psychology, Health Psychology, Annals of Behavioral Medicine, International Journal of Behavioral Medicine, Addictive Behaviors, and Medical Care.

 

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PhD, Industrial Engineering, concentrating in the areas of Operations Research and Management, Dissertation: Determining an Allocation of Trainers and Field Representatives to Training Sites and Start Times
MS, Industrial Engineering concentrating in Operations Research
North Carolina State University, Raleigh, NC

BS, Mathematical Science concentrating in Operations Research
University of North Carolina, Chapel Hill, NC

Stephanie Earnshaw, PhD, is Vice President of US Health Economics at RTI-HS. Dr. Earnshaw applies mathematical modeling, optimization, and decision-analysis techniques to industry-related issues and health care problems. Her areas of specialization include systems optimization and solving resource allocation problems. She has developed innovative mathematical models to determine pricing strategy, budget impact, and cost-effectiveness of new products. Dr. Earnshaw has developed a variety of mathematical models, including Markov models, Monte Carlo simulation models, and other state transition models, to analyze the effect of new medical drugs and devices. She has developed innovative mathematical models to determine allocations of HIV prevention interventions and trainers and field representatives to training sites. To solve these models, she has used various heuristic, linear programming, and integer programming techniques. In addition to her modeling background, Dr. Earnshaw has extensive programming experience. She has programmed cost-effectiveness, budget-impact, and allocation models along with operations research algorithms such as genetic algorithms, simulated annealing algorithms, linear and integer programming algorithms, and network algorithms. She also has led programmers in developing user interfaces for health surveys and for pharmacoeconomic models. More recently, Ms. Earnshaw provided expert guidance on the creation of an economic model predicting AIDS survival by adherence level, which was highlighted in the December 2006 issue of AIDS Alert. Dr. Earnshaw has experience in quality management, machine scheduling, linear and integer programming, network optimization, stochastic modeling, and personnel-assignment models. She is a member of the International Society of Pharmacoeconomics Outcomes Research and the Institute for Operations Research and the Management Sciences. She has presented her work at professional conferences and has published in several peer-reviewed journals, including Annuals of Internal Medicine, Medical Decision Making, Journal of American Society of Nephrology, Stroke, and Pharmacoeconomics.

 

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Sheri E. Fehnel

PhD, Quantitative Psychology
MA, Clinical Psychology
University of North Carolina, Chapel Hill, NC

BS, Mathematics and Psychology
Duke University, Durham, NC

Sheri Fehnel, PhD, is the Vice President of Patient-Reported Outcomes in RTI-HS. Since joining the RTI staff in 1988, she has combined the study of clinical psychology and psychometrics with practical research and clinical experience. She specializes in the development and evaluation of questionnaires designed to measure health-related quality of life, functional status, patient satisfaction, resource utilization, and other patient-reported outcomes. This work has involved a wide range of therapeutic areas, including dermatology (e.g., psoriasis, eczema, acne), psychiatry (e.g., depression, bipolar disorder, schizophrenia), urology (e.g., urinary incontinence, nocturia, erectile dysfunction), gastroenterology (e.g., irritable bowel syndrome, chronic constipation, gastroparesis), oncology, cardiovascular disease, women's health (e.g., endometriosis, uterine fibroids, menopause), diabetes, respiratory (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis), sexual dysfunction (male and female), obesity, chronic pain, and sexually transmitted diseases (e.g., herpes, human papillomavirus, HIV/AIDS). As part of the questionnaire-development process, Dr. Fehnel has moderated countless focus groups, conducted cognitive interviews with a wide variety of patient and professional populations, and assessed potential sources of measurement error through cognitive forms appraisal. She has also evaluated the psychometric properties of many survey and clinical instruments using techniques such as factor analysis, structural equations modeling, and item response theory.

Dr. Fehnel is a frequent presenter at annual conferences held by organizations such as the International Society for Quality of Life Research (ISOQOL) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), as well as at various Drug Information Association (DIA) symposia. She also has published a number of articles related to questionnaire development and psychometric evaluation in Quality of Life Research, Medical Care, and Pharmacoeconomics, and serves as a co-editor for Value in Health.

 

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Lynne Reynolds Hamm

BSN, Family Nurse Practitioner
Purdue University Calumet, Hammond, IN

Associate of Applied Science
Purdue University North Central, Westville, IN

Lynne Hamm is Senior Director of Clinical and Medical Services at RTI-HS. She has extensive experience in the pharmaceutical industry designing, implementing, and managing phase 2-4 clinical studies. Ms. Hamm has developed specifications for interactive voice response systems (IVRS) to facilitate the electronic capture of subject diary data and has experience using IVRS in large international studies. Ms. Hamm has been involved with multiple clinical studies in the United States, Canada, Mexico, and Europe. She has experience with national call centers and script development to assist in subject referral to study sites in response to nationwide study recruitment advertising. While working in the pharmaceutical industry, Ms. Hamm has been involved in protocol design, study report writing, preparations for Food and Drug Administration (FDA) Advisory Committees, and New Drug Application (NDA) submissions.

 

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A. Brett Hauber

PhD, Economics
MA, Economics
University of Delaware, Newark, DE

Bachelor of Business Administration (summa cum laude)
Temple University, Philadelphia, PA

A. Brett Hauber, PhD, is Senior Economist and Vice President of Health Preference Assessment at RTI-HS. He has more than 10 years of academic, research, and government experience in health and environmental economics. His primary area of specialization is discrete-choice analysis of revealed- and stated-preference data. He also has extensive experience in conducting benefit-risk analysis of patients and other health care decision makers and in estimating health-state utilities. His most recent applied work has included discrete-choice experiments of patient and physician benefit-risk preferences for treatments for conditions, including Alzheimer’s disease, HIV, vasomotor symptoms, Crohn’s disease, idiopathic thrombocytopenia purpura, type 2 diabetes, and irritable bowel syndrome. He has also studied the theoretical and empirical relationships among various health utility measures. Dr. Hauber regularly teaches courses on conjoint analysis and health-state utility estimation. Dr. Hauber’s research has been published in numerous health and medical journals, including Value in Health, Pharmacoeconomics, Quality of Life Research, Journal of Women’s Health, Medical Care, Clinical Therapeutics, ISPOR Connections, The Patient, Supportive Care in Cancer, AIDS Patient Care and STDs, and Alzheimer Disease and Associated Disorders.

 

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Kelly A. Hollis

MBA
Kenan Flagler Business School, University of North Carolina, Chapel Hill, NC

BA, Mass Communication, Minor in Zoology
North Carolina State University, Raleigh, NC

Kelly A. Hollis, MBA, is Head of Surveys and Observational Studies for RTI-HS and has a strong background in survey research and a proven track record in the successful design, implementation, and leadership of global research studies. During her 12 years at RTI International, she has provided successful leadership and oversight of research in a number of therapeutic areas, including gastroenterology, oncology, infectious disease, central nervous system, diabetes, and depression. She has particular expertise in planning and managing large-scale prospective observational studies, including health economic and epidemiologic studies, patient outcomes research, risk management programs, and patient registries. She has directed multidisciplinary international teams for large primary data collection studies in the United States and Europe. Her particular focus is in the design and leadership of Risk Evaluation and Mitigation Strategy (REMS) assessments, having led or advised more than a dozen assessments in the past several years. She has experience with all aspects of data collection, including project management, survey design and implementation, questionnaire development, patient and site recruitment, data collection and management, and reporting. Ms. Hollis is involved in the design of observational research programs within RTI-HS to assure that the methods chosen provide a robust and cost-effective approach to address the study questions. She currently co-leads a cross-functional working group of staff involved in prospective observational studies. Her results-oriented, client-focused approach to project leadership includes strategic planning, financial management, process development, and resource allocation.

 

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F. Reed Johnson

PhD, Economics
MA, Economics
State University of New York, Stony Brook, NY

BA, Economics
Occidental College, Los Angeles, CA

F. Reed Johnson, PhD, has more than 35 years of academic and research experience in health and environmental economics. He has served on the faculty of several universities in the United States, Canada, and Sweden. As a staff member in the US Environmental Protection Agency’s environmental economics research program during the 1980s, Dr. Johnson helped pioneer development of basic nonmarket valuation techniques. These techniques are now widely used for cost-benefit analysis in health and environmental economics. He has designed and analyzed numerous surveys for measuring willingness to pay for health-risk reduction and improved environmental quality. He also has developed and researched various value elicitation methods, including direct questions, discrete choice, graded pairs, and other approaches. Dr. Johnson has extensive experience in using advanced statistical techniques to analyze censored, truncated, and discrete survey data.

Dr. Johnson has over 100 publications in books and peer-reviewed journals. His research has been published in various clinical journals, the Review of Economics and Statistics, Journal of Health Economics, Medical Decision Making, Health Economics, Value in Health, Journal of Environmental Economics and Management, Journal of Policy Analysis and Management, Land Economics, and other journals. He has coauthored a book on techniques for using existing environmental and health value estimates for policy analysis. His current research involves estimating general time equivalences among health states and patients’ willingness to accept side-effect risks in return for therapeutic benefits.

 

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Josephine A. Mauskopf

PhD, Economics
MHA, Health Administration
MA, Physiology and Pharmacology
Duke University, Durham, NC

Josephine Mauskopf, PhD, MHA, is Vice President of Health Economics at RTI-HS. She has extensive experience both as a consultant and within the pharmaceutical industry designing and implementing pharmacoeconomic research strategies. She has designed pharmaco­economic research programs for drugs for bacterial infections, viral infections, psychiatric illness, and neurologic diseases. Dr. Mauskopf has estimated budget impacts for new products for schizophrenia, bipolar disease, breast cancer, and HIV infection. She has estimated the cost-effectiveness of antiretroviral drugs, as well as drugs for treating Alzheimer's disease, fungal infections, herpes zoster, epilepsy, neonatal respiratory distress syndrome, digoxin toxicity, community-acquired pneumonia, intra-abdominal infections, and primary pulmonary hypertension. Dr. Mauskopf also has estimated the impact of an antidepressant on work and social disability. Dr Mauskopf has performed many strategic literature reviews that have been published in peer-reviewed journals, including reviews of cost of care for Alzheimer's disease, cost of care for treatment-resistant depression, and cost-effectiveness of tiotropium for chronic obstructive pulmonary disease and treatments for uterine fibroids. Dr. Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed simulation models of time spent in the operating and recovery rooms and of disease progression for HIV infection.

Dr. Mauskopf was previously Vice President at MEDTAP International, Department Head of Economics Research at Burroughs Wellcome Co., and Director of Pharmacoeconomics Research for Anti-Virals and Anti-Infectives at Glaxo Wellcome Inc. Dr. Mauskopf has just completed an 8-year term as Editor-in-Chief of the journal Value in Health. She served for 4 years as a reviewer on the Health Care Technology and Decision Sciences Study Section at the Agency for Healthcare Research and Quality. She has presented her research at numerous national and international symposia. She has also published extensively in journals, including Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Value in Health, Medical Care, American Journal of Public Health, Health Services Research, American Journal of Alzheimer's Disease and Other Dementias, and Journal of Nutrition, Health, and Aging.

 

 

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Lori McLeod

PhD, Quantitative Psychology
MA, Quantitative Psychology
University of North Carolina, Chapel Hill, NC

BS, Statistics, Mathematics Education (graduated Summa Cum Laude)
North Carolina State University, Raleigh, NC

Lori McLeod, PhD, is Head of Psychometrics at RTI-HS. Dr. McLeod is a psychometrician with more than 15 years of experience in instrument development and validation, as well as experience conducting systematic assessments of clinical and economic literature and developing appropriate health outcome strategies. In her Psychometrics role, she has conducted many psychometric evaluations of both paper-and-pencil and computer-administered instruments. These investigations have included the assessment of scale reliability, validity, responsiveness, and work to identify PRO responders. Dr. McLeod has published numerous related manuscripts in Applied Psychological Measurement, Pharmacoeconomics, Journal of Educational Measurement, and Psychometrika. She has experience in a wide variety of therapeutic areas, including chronic pain, dermatology, oncology, psychiatry, respiratory, sleep disorders, urology, and sexual dysfunction. Dr. McLeod currently serves as the co-leader of the Psychometric Special Interest Group for the International Society on Quality of Life.

 

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Susana Pérez-Gutthann

MD, PhD
Universitat de Barcelona, Barcelona, Spain
MPH, Postdoctoral Fellowship
Johns Hopkins University, Baltimore, MD, USA

Susana Pérez-Gutthann, MD, MPH, PhD, FISPE, FRCP, is Vice President and Global Head of Epidemiology at RTI-HS. Dr. Pérez-Gutthann holds medical and doctoral degrees from the University of Barcelona, and a Master of Public Health with a concentration in epidemiology from Johns Hopkins University. Her prior positions include Global Head of epidemiology at Pharmacia, Novartis, and Ciba-Geigy; European Head of Epidemiology at Pfizer; and a postdoctoral fellow in the Division of Clinical Epidemiology at Johns Hopkins. Dr. Pérez-Gutthann has over 20 years of experience in the research-driven international pharmaceutical environment, developing and leading teams of epidemiologists and driving strategy and research programs for safety, pharmacovigilance, risk management, development, and regulatory activities applying public health and epidemiologic methods.

Dr. Pérez-Gutthann is an active leader and past president of the International Society of Pharmacoepidemiology (ISPE) and a member of the Steering Committee of the European Medicines Agency European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). She is a fellow of ISPE and of the Royal College of Physicians, Edinburgh. She is invited to teach in academic programs (most recently the London School of Hygiene and Public Health) and to speak and chair conferences and symposia, which have included the Drug Information Association (DIA), the Organisation for Professionals in Regulatory Affairs (TOPRA), the Australian National Prescribing Service Symposium, the Asian Pacific Regulatory Safety Sciences Meeting, the International Conference of Pharmacoepidemiology and Risk Management, and the World Congress of Pharmacology and Clinical Therapeutics. Dr. Pérez-Gutthann's roles as an advisor and in international working groups have included ENCePP research guidance, World Health Organization (WHO) research for diseases of poverty TDR Product Development and Evaluation, International Scientific Advisory Board to the Medicines and Healthcare Products Regulatory Agency (MHRA) General Practice Research Database, ISPE Working Groups on Risk Management Guidances (Food and Drug Administration, European Medicines Agency), Good Pharmacoepidemi­ology Practice, and confidentiality of patient databases in Europe. She has been on working groups on gastrointestinal complications associated with nonsteroidal anti-inflammatory drugs, the International Medical Benefit Risk Foundation (IMBRF) on drug-induced disease, and hormone replacement therapy and breast cancer risk. Currently, Dr. Pérez-Gutthann serves as a member and chair of several scientific advisory boards for studies, research programs, and strategic and regulatory risk management topics.

A list of Dr. Pérez-Gutthann's publications can be found at: http://www.rti.org/experts.cfm?objectid=5971D658-69DC-4124-99379250F1A7A84B

 

 

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DrPH
MPH
Harvard School of Public Health, Boston, MA

DMD
Harvard School of Dental Medicine, Boston, MA

AB
Colgate University, Hamilton, NY

Kenneth J. Rothman, DrPH, is a Distinguished Fellow and Vice President for Epidemiology Research at RTI-HS. He is also Professor of Epidemiology and Medicine at Boston University. His main career interest has been the development and teaching of the concepts and methods of epidemiologic research. He has authored or coauthored more than 250scholarly publications, most of which are original epidemiologic research studies. His research has spanned a wide range of health problems, including cancer, cardiovascular disease, neurologic disease, birth defects, injuries, environmental exposures, and adverse effects of pharmaceutical agents. In addition to publishing original research, he has devoted time to several other efforts related to the conduct of research. He has written extensively on ethical issues relating to the conduct of science. He regularly teaches intensive courses on epidemiologic research principles in the US and abroad. He has also dedicated a large proportion of his professional effort to editorial activities and publishing. He was the founding editor of the journal Epidemiology, and has served as Assistant Editor of the American Journal of Public Health, Editor of the American Journal of Epidemiology, a member of the Editorial Board of the New England Journal of Medicine and the International Advisory Board of the Lancet. He is a Past President of the Society for Epidemiologic Research, an Honorary Fellow of the American College of Epidemiology, Fellow and member of the Board of Directors and Fellow of the International Society for Pharmacoepidemiology. He has written two widely read epidemiologic textbooks: Modern Epidemiology, first published in 1986 by Little, Brown and Co., which is a comprehensive advanced text of epidemiologic methods, and Epidemiology: An Introduction, published in 2002 by Oxford University Press.

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Beth Sherrill

MS, Statistics
North Carolina State University, Raleigh, NC

NC Science Teacher Certification
University of North Carolina, Chapel Hill, NC

BS, Biology
Davidson College, Davidson, NC

Beth Sherrill, MS, is Global Head of Biometrics at RTI-HS. She has more than 15 years of professional experience analyzing pharmaceutical and health-related data. Ms. Sherrill brings insight and expertise to statistical issues in drug development and outcomes research to multiple clients in the pharmaceutical industry. Ms. Sherrill started her career as an industry biostatistician designing and analyzing phase 2 and phase 3 clinical trials for international submissions and is familiar with regulatory requirements for drug approval. In the past 10 years, she has broadened her experience in postmarketing studies, such as epidemiologic analyses from disease registries, econometric work with claims databases, and large patient surveys. She has extensive experience with the use of propensity scoring and proportional hazards modeling with time-dependent covariates, working in such complex disease areas as oncology and HIV. She has training from the Cochrane Collaboration for performing meta-analyses that may include indirect comparisons and network analysis. Ms. Sherrill continues to publish and represent her clients at advisory board meetings. She provides senior leadership to a team of statisticians in the US and the UK, applying advanced biostatistical techniques to issues in pharmaceutical development, epidemiology, health care resource utilization, and outcomes research. 

 

Email Beth H Sherrill

MPH, Epidemiology
University of North Carolina, School of Public Health, Chapel Hill, NC

PhD, Biology
MS, Biology
Case Western Reserve University, Cleveland, OH

BS, Zoology
University of Wisconsin, Madison, WI

Patricia Tennis, PhD, MPH, is Senior Director of Epidemiology at RTI-HS and was previously Senior Director of Safety Epidemiology at a large international pharmaceutical company, where she designed and implemented safety studies and risk management activities to evaluate medications within the therapeutic areas of neurology, psychiatry, respiratory, and metabolic diseases. Dr. Tennis was the lead epidemiologist on international pregnancy exposure registries. At RTI-HS and elsewhere, she has overseen the conduct of numerous epidemiology studies and participated in discussions of drug safety issues with regulatory agencies in the US, Canada, and Europe. She is a fellow of the International Society of Pharmacoepidemiology and has numerous publications. Dr.Tennis’s graduate education involved a minor in population genetics, and while within the pharmaceutical industry, she provided epidemiologic consultation for genetic studies. She brings to RTI-HS her decades of experience and expertise to clients facing issues of drug safety and risk management.

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Maria Alejandra Vazquez-Gragg

MD, Universidad de Buenos Aires
Buenos Aires, Argentina

MPM, UADE University
Buenos Aires, Argentina

Maria (Ale) Vazquez-Gragg, MD, MPM, is Global Head of Safety and Pharmacovigilance at RTI-HS. Following her completion of her medical training, Dr. Vazquez-Gragg worked as a pediatric surgeon in the Pediatric Hospital of San Isidro. After Dr. Vazquez-Gragg left clinical practice, she joined the regulatory affairs department at Merck, where she was responsible for safety and regulatory activities. Following this, she held positions in the areas of drug safety and pharmacovigilance throughout her career, including at Wyeth, Johnson & Johnson, and PAREXEL. Dr. Vazquez-Gragg has worked with the Global Alliance for Vaccines and Immunization (GAVI) on the Regional System Vaccine (RSV) program in Latin America (Argentina, Brazil, Chile, Colombia, Mexico, and Uruguay) since 2004 on supporting programs for vaccines and oncology vaccines.

Over her 17 years of experience, Dr. Vazquez-Gragg has authored numerous articles on a wide array of topics, including pharmacovigilance, and has given several presentations at biopharmaceutical industry conferences, as well as at meetings held by health authorities.

 

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Tony Bloise

MS, Pharmaceutical Administration and Marketing
University of North Carolina, Chapel Hill, NC

BS, Pharmacy
Albany College of Pharmacy, Albany, NY

Tony Bloise, RPH, MS, is Director of Business Development at RTI-HS. In this role, Mr. Bloise provides support for business development activities for the clinical trials, biometrics, safety, and pharmacovigilance service offerings of RTI-HS. He applies various skills based on his 20 years of pharmaceutical industry experience and is involved in developing strategic alliances that support the needs and goals of RTI-HS’s clients. Prior to joining RTI-HS, Mr. Bloise spent more than 18 years at GlaxoSmithKline, where he held a number of positions with increasing responsibility in the commercial organization. His experience includes sales, sales management, sales training, marketing, and global commercial strategy in a wide variety of therapeutic areas, including adult and pediatric vaccines, antiherpetic, HIV, migraine, gastrointestinal, oncology, anti-infective, depression, anxiety, bipolar, schizophrenia, epilepsy, respiratory, cardiovascular, smoking cessation, obesity, and diabetes.

 

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MBA, Business Administration
University of North Carolina, Chapel Hill, NC

BSc, Bachelor of Science
University of British Columbia, Vancouver, BC

BA, Business Administration
Fresno Pacific College, Fresno, CA

Graham Dyck, MBA, is a Senior Director of Marketing and Business Development at RTI-HS. He is a creative manager with 16 years of experience in product management, business development, marketing, and domestic and international sales. He is an innovative, bottom line–oriented manager with excellent strategic marketing and financial analysis skills and strong interpersonal skills. Mr. Dyck’s experience includes business plan development, profit and loss management, strategic market analysis, forecasting and budgeting, marketing communications, business to business sales, negotiating licensing agreements, and product launch planning.

 

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BS, Business Administration and Marketing
Meredith College, Raleigh, NC

Nancy Faith is a Senior Marketing Specialist at RTI-HS. She supports the business development team with the development of marketing collateral, the external Web site, trade shows, conferences, advertising, and other marketing communications. She has 15 years of experience in pharmaceutical marketing and communications and has worked on several product launches, assisted in direct-to-consumer advertising campaigns, and executed business development programs to support and optimize the marketing brands across most therapeutic classes. Before joining RTI-HS, Ms. Faith worked in the CRO industry and produced communications to support the sales efforts worldwide.

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Peter Wirth, RPH, Senior Director of Business Development at RTI-HS, provides support of the business development activities for the entire portfolio of RTI-HS services. He applies various skills based on his 22 years of pharmaceutical industry experience. He has a wide range of experience in customer relationships, people management, sales, medical and drug information, marketing support, clinical trials, and product safety. He is involved in developing strategic alliances that support the needs and goals of RTI-HS’s clients.

 

Mr. Wirth is a pharmacist who began his career in 1988 working with GSK as a pharmaceutical representative in Monterey, CA. In 1992 he relocated to North Carolina and joined Ask the Pharmacist, a nationally known leader in the provision of medical and drug information services. He served as the VP of Sales and Client Operations and became responsible for operations, training, QA, HR, IT, and sales and marketing. During this time, Mr. Wirth was involved in the launch of more than 35 products, as well as several drug recall/withdrawal projects. In 1999, PPD acquired Ask the Pharmacist and Mr. Wirth was appointed as Senior Business Development Executive for PPD Market Development. He focused on selling their late-phase suite of services, which included product safety, medical writing, marketing-support programs, patient registries, postmarket studies (phase 3b/4), and medical and drug information. He also sold their risk management, health outcomes, and Rx-to-OTC switch studies. In 2004, Mr. Wirth joined Ninaza, Inc. as Director of Business Development and marketed their electronic data collection (EDC) services

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Stephen Beard

MSc (Eng), Operational Research
University of Birmingham, UK

BSc (Hons), Mathematics
University of London, UK

Stephen Beard, MSc, is Vice President of Heath Economics (Europe) and is based in RTI-HS’s UK offices in Manchester and Sheffield. He has more than 25 years of experience in the application of mathematical modeling, optimization, and decision analysis techniques to business problems gained in academic, government, and industrial organizations. He has worked specifically within the health outcomes research sector for the past 16 years, having previously held a senior project management and research position within the School of Health and Related Research (ScHARR), University of Sheffield, UK, where he headed a team producing rapid-review health technology appraisal reports for the National Institute for Health and Clinical Excellence (NICE) in the UK. His work has focused on health economics, Markov modeling, and statistical modeling techniques to explore disease progression and the impact of treatment across a range of areas, including colorectal cancer, ovarian cancer, breast cancer, schizophrenia, depression, attention-deficit/hyperactivity disorder, neuropathic pain, and infectious diseases. He is a member of the International Society of Pharmacoeconomics Outcomes Research, the Operational Research Society, and the Institute for Operations Research and the Management Sciences. He has presented his work at professional conferences and has published in several peer-reviewed journals, including European Journal of Health Economics, British Journal of Cancer, and Pharmacoeconomics.

 

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PhD, Industrial Engineering, concentrating in the areas of Operations Research and Management, Dissertation: Determining an Allocation of Trainers and Field Representatives to Training Sites and Start Times
MS, Industrial Engineering concentrating in Operations Research
North Carolina State University, Raleigh, NC

BS, Mathematical Science concentrating in Operations Research
University of North Carolina, Chapel Hill, NC

Stephanie Earnshaw, PhD, is Vice President of US Health Economics at RTI-HS. Dr. Earnshaw applies mathematical modeling, optimization, and decision-analysis techniques to industry-related issues and health care problems. Her areas of specialization include systems optimization and solving resource allocation problems. She has developed innovative mathematical models to determine pricing strategy, budget impact, and cost-effectiveness of new products. Dr. Earnshaw has developed a variety of mathematical models, including Markov models, Monte Carlo simulation models, and other state transition models, to analyze the effect of new medical drugs and devices. She has developed innovative mathematical models to determine allocations of HIV prevention interventions and trainers and field representatives to training sites. To solve these models, she has used various heuristic, linear programming, and integer programming techniques. In addition to her modeling background, Dr. Earnshaw has extensive programming experience. She has programmed cost-effectiveness, budget-impact, and allocation models along with operations research algorithms such as genetic algorithms, simulated annealing algorithms, linear and integer programming algorithms, and network algorithms. She also has led programmers in developing user interfaces for health surveys and for pharmacoeconomic models. More recently, Ms. Earnshaw provided expert guidance on the creation of an economic model predicting AIDS survival by adherence level, which was highlighted in the December 2006 issue of AIDS Alert. Dr. Earnshaw has experience in quality management, machine scheduling, linear and integer programming, network optimization, stochastic modeling, and personnel-assignment models. She is a member of the International Society of Pharmacoeconomics Outcomes Research and the Institute for Operations Research and the Management Sciences. She has presented her work at professional conferences and has published in several peer-reviewed journals, including Annuals of Internal Medicine, Medical Decision Making, Journal of American Society of Nephrology, Stroke, and Pharmacoeconomics.

 

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Shaun Abeysinghe

PhD, Biostatistics
Certificate, JAVA Programming
Cardiff University, Cardiff, UK

BSc, Neurobiology
Sussex University, Brighton, UK

Shaun Abeysinghe, PhD, is a Senior Statistician with RTI-HS. He has 10 years of experience as a biostatistician within pharmaceutical, academic, and health care environments. Dr. Abeysinghe is experienced in the application of novel and standard statistical methodologies to large medical/biological datasets in diverse therapeutic areas. His role at RTI-HS includes planning, executing, and interpreting the analysis of a variety of studies, including epidemiology, health economics, and clinical trials. While at RTI-HS, Dr. Abeysinghe has conducted many types of statistical analyses such as mixed treatment comparison meta-analyses, The Health Improvement Network (THIN) database analyses, survival analyses, and parametric and multivariate modeling. He has provided budget estimates and contributed to proposals for a variety of studies and has been involved in submissions to the National Institute for Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC) in the United Kingdom. In addition, Dr. Abeysinghe is an experienced SAS and JAVA programmer. His previous positions have involved the statistical epidemiology of infectious disease, statistical genetics investigating human mutation in cancer and genetic disease, and an understanding of all aspects of the clinical trial process and associated International Conference on Harmonisation Good Clinical Practice (ICH GCP) requirements, attributable to 3 years of experience coordinating and managing phase 2 and 3 oncology trials.

 

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Claire Ainsworth

BSc (Hons), Mathematics
University of Manchester, Manchester, UK

Claire Ainsworth is a Trainee Health Economist at RTI-HS in the Manchester office. She graduated this year from the University of Manchester after obtaining a mathematics degree. While obtaining her degree, she largely studied statistics modules, including medical statistics and design and analysis of experiments. Ms. Ainsworth also has 3 years of experience in customer service in the retail sector.

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Bela Bapat

MA, Applied Economics
University of North Carolina at Greensboro, Greensboro, NC

MA, Economics
PGDFT, Post Graduate Diploma in Foreign Trade
BA, Economics
University of Pune, Pune, India

Bela Bapat, MA, is a research health economist at RTI-HS. Prior to joining RTI-HS, Ms. Bapat worked in the field of health services and health economic research in RTI's Public Health Economics Program. She has extensive experience in database analysis, specifically retrospective health care claims database analysis, state cancer registry data analysis, and cross-sectional and longitudinal survey analyses. Ms. Bapat has conducted research to estimate the prevalence and economic burden of contrast-induced nephropathy and chronic kidney disease. She has also worked on several high-profile cost-effectiveness evaluations for the Centers for Disease Control and Prevention (CDC), such as evaluation of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and the Colorectal Cancer Screening Demonstration Project (CRCSDP). She also has extensive knowledge and experience in data collection methodologies, including development of data collection tools, chart abstraction, and surveys. Ms. Bapat has conducted research to estimate the prevalence and economic burden of various medical conditions, including meningococcal disease, abdominal adhesiolysis, Dupuytren's contracture, adhesive capsulitis, Peyronie's disease, chronic hepatitis C, colorectal cancer, breast cancer, cervical cancer, oral cancer, chronic kidney disease, and contrast-induced nephropathy.

Ms. Bapat has coauthored research published in Applied Health Economics and Health Policy, Human Vaccine, Journal of Medical Economics, Cancer, Preventing Chronic Disease, Bulletin of the World Health Organization, and BMC Surgery. Her research has also been accepted for presentation at numerous professional conferences and workshops, including the North American Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the ISPOR 9th Annual European Congress, the Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke, the CDC's Cancer Conference, and the Academy of Health's annual meetings.

 

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Melissa Bell

BSc (Hons), Mathematics
University of Manchester, Manchester, UK

Melissa Bell is a Health Economist with RTI-HS in the Manchester, UK, office. Ms. Bell is currently undertaking an MSc in Health Economics and Decision Modelling at the University of Sheffield. She graduated from the University of Manchester after obtaining a mathematics degree. During her degree, she primarily studied statistics modules, including reliability and survival analysis and medical statistics. Ms. Bell also has more than 5 years of experience in customer service in the retail sector.

 

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Victoria Brennan

 

Currently undertaking PhD in evaluation of ePAQ: an online assessment tool for women’s health

 

MSc, Health Economics and Management
Sheffield University, Sheffield, United Kingdom

 

BSc, Physiotherapy
Coventry University, Coventry, United Kingdom

 

Victoria Brennan, MSc, is a Senior Health Economist at RTI-HS. Ms. Brennan has a broad spectrum of experience in both the clinical and academic settings. Clinically, she has 8 years of experience working as a physiotherapist specializing in elderly care, and also worked as a senior lecturer in physiotherapy at Sheffield Hallam University.

 

Ms. Brennan undertook an MSc in Health Economics and Management and is currently undertaking a PhD at Sheffield University in Health Economics. She has an Honorary Research Contract with Sheffield Teaching Hospitals in the UK. She has also worked with the University of Sheffield and the UK Department of Health on the evaluation of modernization programs for elderly care in the National Health Service. Her work has been presented at the European Respiratory Society’s annual meeting and at the International Society for Pharmacoeconomics and Outcomes Research 13th Annual International Meeting in Toronto in 2008. In addition, Ms Brennan has traveled to Mbarara Hospital in Uganda to work as a voluntary physiotherapist and lecturer.

 

Since working at RTI-HS, MS. Brennan has acted as project manager for several cost-effectiveness studies; managed and undertaken targeted literature reviews and systematic reviews of economic evaluations; supported the writing, development, and presentation of manuscripts and posters for publication; and developed cost-effectiveness, cost-utility, and budget-impact models in Microsoft Excel. Therapeutic areas include HIV, chronic obstructive pulmonary disease, rheumatoid arthritis, breast cancer, non–small cell lung cancer, malignant melanoma, and venous thromboembolism.

 

 

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James Brockbank
BSc, Neuroscience
The University of Manchester, Manchester, UK
James Brockbank is a Trainee Health Economist at RTI-HS in the Manchester office. Prior to this, he studied neuroscience at the University of Manchester, graduating in 2010. His studies focused on processes within human and mammalian nervous systems, from the molecular level to behavioural, including aspects of disease and pharmacology. In his final year of study, he collaborated with the Manchester Enterprise Centre to complete the Life Sciences Enterprise Project. The project included a literature review on disorders of cerebral development, and the creation of a full business plan and pitch for a medical diagnostic device.

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Thor-Henrik Brodtkorb

PhD, Health Technology Assessment
Linköping University, Sweden

Master in Prosthetics and Orthotics
School of Health Sciences, Jönköping University, Sweden

Thor-Henrik Brodtkorb, PhD, has a total of 8 years of experience working in the health economics area and about 7 years of experience developing health economics models in health technology and pharmaceutical products. The results of the health economic models have later been used in the company's health technology assessment submissions. Dr. Brodtkorb has a strong experience of modeling in Scandinavia and has experience in the therapeutic areas of cardiology, orthopedics, and asthma.

 

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Anita J. Brogan

PhD, Operations Research
MSc, Operations Research
University of North Carolina, Chapel Hill, NC

BS, Mathematics
Harvey Mudd College, Claremont, CA

Anita Brogan, PhD, is Head of Decision Analytic Modeling, US Health Economics at RTI-HS. Dr. Brogan uses analytical techniques to assess and present the clinical and economic value of emerging pharmaceutical and biotechnology products. She has developed cost-effectiveness, budget-impact, and population models; cost-consequence analyses; and product value dossiers. She has experience with all types of modeling procedures, including Markov and other stochastic models, simulation, regression, linear and nonlinear programming, and various types of sensitivity analysis. Dr. Brogan has extensive experience with programming models, user-friendly interfaces, and other software applications using the Visual Basic for Applications language in Excel. She is proficient with various other programming languages and mathematical and statistical software packages. Dr. Brogan has developed models and analyses in the areas of HIV, hepatitis C, influenza, diabetic nephropathy, colorectal cancer, breast cancer, non-Hodgkin's lymphoma, osteoporosis, chronic pain, age-related macular degeneration, schizophrenia, bipolar disorder, epilepsy, bone healing, hospital-acquired infection, financial portfolio optimization, and vehicle routing. Her research has been presented at various professional conferences and published in several peer-reviewed journals, including AIDS, American Journal of Health-System Pharmacy, American Journal of Preventative Medicine, European Journal of Operational Research, HIV Clinical Trials, Pharmacoeconomics, and Value in Health.

 

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Sean D. Candrilli

PhD, Pharmacy Administration
The Ohio State University, Columbus, OH

MS, Economics
BS, Economics
BS, Biological Sciences
The Florida State University, Tallahassee, FL

Sean D. Candrilli, PhD, is Head of Health Economics at RTI-HS. During his tenure at RTI-HS, Dr. Candrilli has worked extensively in the area of data management and analyses of clinical trial and commercially available and public use databases. His academic experience is heavily grounded in applied economics and econometrics, particularly as related to public health topics, and he has extensive experience in all aspects of retrospective health care claims database analyses, cross-sectional and longitudinal survey analyses, econometric modeling, and data management using a variety of statistical packages, including SAS, SUDAAN, and Stata. Dr. Candrilli has conducted research to estimate the economic burden of various diseases and conditions, including diabetic microvascular complications, constipation, ADHD, COPD, and traumatic injury. He has also conducted research to characterize patterns of medication utilization, including adherence and persistence, in patients with sickle cell disease and epilepsy. Additionally, Dr. Candrilli has analyzed numerous survey databases (including the National Health and Nutrition Examination Survey, the National Ambulatory Medical Survey, the National Hospital Ambulatory Medical Survey, the Medical Expenditure Panel Survey, and the Healthcare Cost and Utilization Project family of databases) to estimate the prevalence of various medical conditions and their associated economic burden.

Dr. Candrilli has coauthored research published in Managed Care Interface, Journal of Trauma, Journal of Diabetes and its Complications, Epilepsia, Clinical Lymphoma and Myeloma, Epilepsy and Behaviour, Ethnicity and Disease, Pediatric Critical Care Medicine, Journal of Pain & Palliative Care Pharmacotherapy, Managed Care, Epilepsy Research, Postgraduate Medicine, Child and Adolescent Psychiatry and Mental Health, American Journal of Hematology, BMC Surgery, American Journal of Obstetrics & Gynecology, and International Journal of Hematology, and has a publication forthcoming in Journal of Pediatrics. Dr. Candrilli has served as a reviewer for Journal of Dermatological Treatment, Journal of Diabetes and Its Complications, American Journal of Managed Care, Medical Decision Making, Health Outcomes Research in Medicine, Journal of Medical Economics, and BMC Gastroenterology. Dr. Candrilli's research has been presented at conferences of numerous professional organizations, including the International Society for Pharmacoeconomics and Outcomes Research, the Academy of Managed Care Pharmacy, the European Organisation for Research and Treatment of Cancer, the American Heart Association, the American College of Cardiology, the American Society of Hypertension, the American Society of Hematology, the American Evaluation Association, the American Thoracic Society, the American Association for the Surgery of Trauma, the Society for Critical Care Medicine, the American Academy of Pain Management, the European Cancer Conference, the Child Neurology Society, the National Hospice and Palliative Care Organization, the American College of Clinical Pharmacy, the Society for General Internal Medicine, the American Geriatrics Society, the Canadian Pharmacists Association, the Alzheimer's Association, the American College of Obstetricians and Gynecologists, the American Epilepsy Society, AcademyHealth, the Pediatric Academic Society, the Infectious Diseases Society of America, Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke, the European Society of Intensive Care Medicine, and the European Society for Clinical Nutrition and Metabolism.

 

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Matthew Cawson

MEnt, Master of Enterprise (Technology)
University of Salford, Salford, UK

BA (Hons), International Economics
Manchester Metropolitan University, Manchester, UK

Matthew Cawson is a Research Health Economist with RTI-HS. Mr. Cawson previously worked for the United Kingdom’s National Health Service as a Public Health Intelligence Analyst Specialist with a Primary Care Trust. He was responsible for extracting, analysing, and interpreting complex data sets in addition to producing a range of reports, reporting tools, and reporting methodologies to support commissioning decision making relating to primary and secondary care. Mr. Cawson is interested in undertaking different projects dealing with health economics modelling, cost-effectiveness analysis, and market access.

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Keith L. Davis

MA, Applied Economics
The University of North Carolina at Greensboro, Greensboro, NC

BA, Economics
BA, History
The University of North Carolina at Asheville, Asheville, NC

Keith Davis, MA, is a Senior Director of Health Economics at RTI-HS. He has extensive experience in study design and data analysis for research projects using retrospective health care claims data, electronic medical records, cross-sectional and longitudinal survey data, and data from customized retrospective medical chart abstractions. Mr. Davis has conducted research to estimate the prevalence, incidence, and economic burden of various chronic and acute medical conditions including benign prostatic hyperplasia (BPH), diabetic microvascular complications, traumatic injury, melanoma, prostate cancer, breast cancer, meningococcal disease, hepatitis C virus, respiratory diseases, and gastrointestinal disorders such as irritable bowel syndrome, constipation, ulcerative colitis, diverticulitis, and Crohn’s disease. Mr. Davis also has extensive experience in claims data and chart review analyses to evaluate patterns and cost implications of medication persistence and compliance among patients with various conditions, including Parkinson’s disease, epilepsy, ulcerative colitis, respiratory diseases, BPH, and HIV/AIDS.

Mr. Davis’ research has been published in numerous peer-reviewed journals including Applied Health Economics and Health Policy, Value in Health, Journal of Trauma, Movement Disorders, Epilepsia, Epilepsy and Behavior, Epilepsy Research, Medical Care, Diabetes Care, Journal of Diabetes and Its Complications, Journal of Studies on Alcohol, Journal of Behavioral Health Services and Research, Journal of Pain and Palliative Care Pharmacotherapy, Managed Care, Journal of Clinical Gastroenterology, The Consultant Pharmacist, Postgraduate Medicine, Human Vaccines, Managed Care, Endocrine Practice, and BMC Surgery. Additionally, Mr. Davis has a forthcoming article in Health Outcomes Research in Medicine. Mr. Davis also regularly provides peer review for journal submissions, including recent article reviews for Value in Health, Journal of Medical Economics, and Journal of Alzheimer’s Disease. Mr. Davis’ research has also been presented at numerous professional conferences and workshops.

 

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Christopher N. Graham

MSc, Clinical Epidemiology and Health Services Research
Wake Forest University, Winston-Salem, NC

BS, Biology
University of North Carolina, Chapel Hill, NC

Christopher Graham, MSc, is a Director of Health Economics at RTI-HS and provides extensive knowledge and experience in health economics and outcomes research studies, including cost-effectiveness, cost-benefit, cost-minimization, and budget-impact modeling, as well as database analyses. Mr. Graham has developed decision tree, Markov, and Monte Carlo simulation models across numerous therapeutic areas, including oncology (metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, pancreatic cancer, gastric cancer, follicular non-Hodgkin’s lymphoma), osteoporosis, age-related macular degeneration, renal transplantation, human immunodeficiency virus, asthma, chronic pain, smoking cessation, and migraine. Results of his economic analyses have been used in publications (e.g., peer-reviewed manuscripts and presentations at scientific conferences) to support submissions to health care payer and regulatory agencies, and to enhance marketing activities. Mr. Graham is an expert programmer in Microsoft Excel and Visual Basic for Applications and also has experience working in Decision Analysis by TreeAge (DATA) and SAS. Mr. Graham has used his programming skills to develop stochastic models using a Bayesian approach to model uncertainty to produce detailed sensitivity analyses around model parameters such as cost-effectiveness acceptability curves and net benefit analyses. He is a member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

 

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Jonathan B. Graham

BS, Mathematics
North Carolina State University, Raleigh, NC

Jonathan Graham is a Research Health Economist at RTI-HS. He received a Bachelor of Science in Mathematics from North Carolina State University and has experience in various mathematical applications such as Microsoft Excel, Visual Basic for Applications (VBA), MATLAB, Maple, and HTML. He has conducted literature reviews, supported the writing and development of abstracts and manuscripts, and contributed to the development of cost-effectiveness, cost-utility, and budget-impact models. He has worked on decision analytic models in numerous therapeutic areas, including schizophrenia, bipolar I disorder, multiple sclerosis, cardiovascular disease, human immunodeficiency virus, Crohn’s disease, and chronic pain.

 

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William L. Herring

PhD, Applied Mathematics (Operations Research)
MSc, Applied Mathematics
University of Maryland, College Park, MD

BSc (magna cum laude), Mathematics
Davidson College, Davidson, NC

Will Herring, PhD, is an Associate Director of Health Economics at RTI-HS and provides a strong background in probabilistic modeling and decision analysis across various components of the health care system. In particular, his most recent research experience uses dynamic programming and simulation models to study sequential decision making under uncertainty in the areas of hospital management (operating room scheduling) and public health disaster management (mass-casualty incident triage). He is a member of the Institute for Operations Research and Management Science and the Institute for Industrial Engineers’ Society for Health Systems. He has presented his work at professional conferences and has published in peer-reviewed journals, including Production and Operations Management and Operations Research Spectrum.

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Katherine A. Hicks

MS, Operations Research
BS, Public Health, Health Behavior, and Health Education
University of North Carolina, Chapel Hill, NC

Katherine A. Hicks, MS, is a Director in Health Economics at RTI-HS. Ms. Hicks' research at RTI-HS focuses on developing mathematical models for conducting cost, cost-effectiveness, cost-benefit, and risk-benefit studies. She has significant experience developing and programming analytical models and simulations for understanding and representing the dynamics involved with disease progression, disease epidemiology within populations, and the application of public health and medical interventions, including those based on Markovian structures, differential equations, and discrete event simulations. In addition, she specializes in using mathematical models for conducting resource allocation analyses and developing tools with user-friendly interfaces for distribution to decision makers at various levels. She has developed models related to breast cancer detection, diabetes, hepatitis A immunization, childhood immunization practices, HIV prevention, substance abuse treatment, rheumatoid arthritis, athlete doping, and chemical terrorism preparedness for the Centers for Disease Control and Prevention and the National Institutes of Health, as well as other nongovernmental organizations. She is proficient in programming in a variety of software environments. Before joining RTI-HS, she managed a large-scale national study evaluating an alcohol and tobacco use prevention program. Much of her graduate work at the University of North Carolina focused on the application of operations research methods to health care issues. She has published her work in the American Journal of Public Health, Medical Decision Making, Health Policy, Annals of Internal Medicine, Diabetes Care, Pediatrics, Health Care Management Science, Health Economics, and other peer-reviewed publications.

 

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Jonas Hjelmgren

MSc, Economics
BSc, Economics
Lund University, Lund, Sweden

Jonas Hjelmgren, MSc, is a Senior Health Economist at RTI-HS. Mr. Hjelmgren has 12 years of experience working with health economics, combining 5 years in industry and 7 years in consulting. He has designed and developed cost-effectiveness and budget-impact models. Mr. Hjelmgren has also been involved in health economics evaluations using real-life data, literature reviews, modeling studies, quality-of-life studies, regression modeling and conjoint studies.

Mr. Hjelmgren’s experience in the industry includes developing health economic data to support reimbursement applications for key products in Sweden; he also adapted value dossiers for the region. Mr. Hjelmgren was in direct contact with key opinion leaders, including regional stakeholders in Nordic countries, as well as with health authorities such as the Swedish Council of Health Technology Assessment (SBU) and the Swedish Dental and Pharmaceutical Benefits Agency (TLV).

Mr. Hjelmgren’s experience in the consulting business includes participating in and leading teams in the design, development, and delivery of health economics and outcomes research consulting projects. The projects included health economic modeling projects (design/development and adaptations), payer research projects (to inform about local market conditions and provide strategic advice in order to optimize the probability of successful market access in connection with product launch), and adaptation of value dossiers.

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Katherine Houghton

BSc, Psychology: Physical and Mental Health
University of Reading, Berkshire, UK

Katherine Houghton, BSc, is a Research Health Outcomes Scientist at RTI-HS. Ms. Houghton’s responsibilities include evaluation of clinical datasets to identify value-driven, post hoc subgroup analysis; examination of heterogeneity of responses in clinical trials and observational studies; retrospective analysis of clinical trials, observational studies, and registries; use of latent growth modeling techniques to support data analysis and value messages; conduct of literature reviews; conduct of interviews; and evaluation of patient-reported outcome (PRO) instrument psychometric properties. Ms. Houghton has been involved in literature reviews assessing the psychometric properties of PRO instruments in chronic obstructive pulmonary disease, psoriasis, multiple sclerosis, frequent heartburn, attention-deficit/hyperactivity disorder, posttraumatic stress disorder, women’s health, and inflammatory bowel disease. In addition, Ms. Houghton has assisted in assessing the acceptability of PRO instruments for regulatory review in oncology medications. Ms. Houghton also has experience in instrument development of respiratory-specific PROs, including PRO dossier development for Food and Drug Administration label claims. She also manages projects and assists in the development and review of protocols, reports, statistical analysis plans, abstracts, conference posters, and manuscripts. Ms. Houghton has 2 years of experience in health outcomes research in the following therapeutic areas: neurology, oncology, respiratory, dermatology, urology, pain/analgesia, women’s health, gastroenter­ology, musculoskeletal, and psychiatry. For her dissertation, she conducted a research project investigating the cognitive and parental factors involved in child anxiety.

Ms. Houghton’s work has led to articles in publications such as Quality of Life Research and Contemporary Clinical Trials, alongside presentations at conferences such as the American Thoracic Society (ATS), the International Society for Pharmacoeconomics and Outcomes (ISPOR), and the International Society for Quality of Life Research (ISOQOL).

 

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Adam Irving

BEconSc, Economics
University of Manchester, UK

MSc, Health Economics and Decision Modelling
University of Sheffield, UK
(in progress, due to graduate in 2013)

Adam Irving is a Health Economist at RTI-HS in Manchester, UK. He studied economics at the University of Manchester, graduating in 2009. During his undergraduate course, he focused on mathematical economics and econometrics. He is currently studying part-time for an MSc in Health Economics and Decision Modelling at the University of Sheffield’s School of Health and Related Research and is due to graduate in 2013.

 

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Sukhvinder Singh Johal

PhD, Optical Fibre Technology
Cranfield University, UK

MSc, Instrumentation and Analytical Science
BEng, Electrical and Electronic Engineering
University of Manchester Institute of Science and Technology, Manchester, UK

Dr. Sukhvinder Johal is a senior health economist at RTI-HS and provides extensive knowledge and experience in health economics and outcomes research studies, including cost-effectiveness, cost-benefit, cost-minimization, and budget-impact modelling. His work has involved the management of projects using health economics, Markov modelling, and statistical modelling techniques to explore disease progression and the impact of treatment across a range of areas, including, methicillin-resistant Staphylococcus aureus (MRSA) infection, endocrine disease, depression, psoriasis, Parkinson’s disease, oncology, anaemia, diabetes (diabetic retinopathy), and cardiovascular disease. He has extensive experience in Microsoft Excel and Visual Basic for Applications programming language. He has also undertaken targeted and systematic literature reviews, and developed abstracts, manuscripts, and poster presentations.

Dr. Johal has previous experience in economic and business case modeling and product development. Prior to joining RTI-HS, he worked at the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) at the University of Nottingham in the field of value assessment of medical devices. He also has more than 3 years experience in product development in the telecommunications sector. Dr. Johal is a member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

 

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Sudeep Karve

PhD, Pharmacy Administration
The Ohio State University, Columbus, OH

MS, Pharmaceutical Evaluation and Policy
The University of Arkansas for Medical Sciences, Little Rock, AR

MBA, Marketing
B. Pharmacy
The University of Pune, Pune, India

Sudeep Karve, PhD, is an Associate Director of Health Economics at RTI-HS. He has extensive experience in analyzing retrospective health care claims data, and cross-sectional and longitudinal survey data. Dr. Karve has conducted research to estimate the utilization patterns for various disease conditions, including stroke, hypertension, hyperlipidemia, and gastrointestinal disorders such as irritable bowel syndrome and constipation. He has also evaluated the impact of preferred drug policies on health care utilization and costs for various drugs classes, including nonsedating antihistamines and proton pump inhibitors. Dr. Karve's research focus has been in validating administrative claims-based adherence metrics and determining optimal adherence threshold. Dr. Karve also has extensive experience in claims-based analyses to evaluate patterns and cost implications of medication adherence among patients with various conditions, including hyperlipidemia, diabetes, schizophrenia, congestive heart failure, and hypertension. Dr. Karve has conducted research to estimate the economic burden of various medical conditions, including lung cancer, schizophrenia, systemic lupus erythematosus, inflammatory bowel disease, influenza, meningitis, and migraine.

Dr. Karve's research has been published in Medical Care, Value in Health, Journal of Human Hypertension, Journal of Stroke and Cerebrovascular Diseases, Human Vaccines, Journal of Drugs in Dermatology, Health and Quality of Life Outcomes, American Academy of Dermatology, and Neurology, and has a manuscript forthcoming in Journal of Pediatrics. Dr. Karve's research has been presented at numerous professional conferences and workshops, including the International and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research, the Academy of Managed Care Pharmacy, the International Stroke Conference, AcademyHealth, the Pediatric Academic Societies, and the Southern Pharmacy Administration Conference.

 

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MSc, Operational Research
University of Birmingham, Birmingham, UK

BS, Hons (Mathematics, Statistics & Computing) (2:1)
De Montfort University, Leicester, UK

Christopher Knight, MSc, is Director of Health Economic Modelling at RTI-HS. He has more than 15 years of experience in operational research. His work has involved the management of projects using health economics, Markov modeling, simulation modeling, and statistical modeling techniques to explore disease progression and the impact of treatment across a range of areas, including hemophilia, rheumatoid arthritis, lymphoma, depression, schizophrenia, obesity, and infectious diseases. He has presented his work at professional conferences and has a number of health economic publications in peer-reviewed journals. Mr. Knight has developed innovative mathematical models, including Markov state transition models and Monte-Carlo simulation models both at cohort and individual patient level. He has extensive experience in Microsoft Excel and Visual Basic for Applications programming language. He was previously responsible for leading a team producing rapid review health technology appraisal report for the National Institute for Clinical Excellence (NICE) in the UK and for applying cost-effective modeling to pharmaceutical companies and service planning for the NHS. Prior to joining RTI-HS, Mr. Knight held operational research analyst positions at the School of Health and Related Research (ScHARR) at the University of Sheffield and the Trent Regional Health Authority.

Mr. Knight is a member of the Operational Research Society and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

 

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Sarah Lock

BSc, Physiology
University of Manchester, Manchester, UK

Sarah Lock is a Junior Systematic Reviewer at RTI-HS in the Manchester, UK, office. Ms. Lock joined RTI-HS as a Trainee Health Economist in 2009, and in 2011 resumed a new role within the Evidence Review and Health Technology Assessment (HTA) Analysis team. Ms. Lock has experience in conducting both clinical and economic systematic reviews in a range of therapeutic areas. She has also contributed towards the development of submissions to the National Institute for Health and Clinical Excellence. Prior to this, she studied physiology at the University of Manchester, graduating in 2009. Her studies focused on aspects of human and mammalian physiology, disease, and pharmacology. In her final year of study, she collaborated with the Centre for the History of Science, Technology, and Medicine, University of Manchester, to complete a project on the organization of English hospitals in the 1950s.

 

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Josephine A. Mauskopf

PhD, Economics
MHA, Health Administration
MA, Physiology and Pharmacology
Duke University, Durham, NC

Josephine Mauskopf, PhD, MHA, is Vice President of Health Economics at RTI-HS. She has extensive experience both as a consultant and within the pharmaceutical industry designing and implementing pharmacoeconomic research strategies. She has designed pharmaco­economic research programs for drugs for bacterial infections, viral infections, psychiatric illness, and neurologic diseases. Dr. Mauskopf has estimated budget impacts for new products for schizophrenia, bipolar disease, breast cancer, and HIV infection. She has estimated the cost-effectiveness of antiretroviral drugs, as well as drugs for treating Alzheimer's disease, fungal infections, herpes zoster, epilepsy, neonatal respiratory distress syndrome, digoxin toxicity, community-acquired pneumonia, intra-abdominal infections, and primary pulmonary hypertension. Dr. Mauskopf also has estimated the impact of an antidepressant on work and social disability. Dr Mauskopf has performed many strategic literature reviews that have been published in peer-reviewed journals, including reviews of cost of care for Alzheimer's disease, cost of care for treatment-resistant depression, and cost-effectiveness of tiotropium for chronic obstructive pulmonary disease and treatments for uterine fibroids. Dr. Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed simulation models of time spent in the operating and recovery rooms and of disease progression for HIV infection.

Dr. Mauskopf was previously Vice President at MEDTAP International, Department Head of Economics Research at Burroughs Wellcome Co., and Director of Pharmacoeconomics Research for Anti-Virals and Anti-Infectives at Glaxo Wellcome Inc. Dr. Mauskopf has just completed an 8-year term as Editor-in-Chief of the journal Value in Health. She served for 4 years as a reviewer on the Health Care Technology and Decision Sciences Study Section at the Agency for Healthcare Research and Quality. She has presented her research at numerous national and international symposia. She has also published extensively in journals, including Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Value in Health, Medical Care, American Journal of Public Health, Health Services Research, American Journal of Alzheimer's Disease and Other Dementias, and Journal of Nutrition, Health, and Aging.

 

 

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Louise McCrink

MSc, Economic Evaluation in Health Care: Distinction
City University, London, UK

BA, Economics
Manchester University, Manchester, UK

Louise McCrink, MSc, is a Senior Health Economist at RTI-HS. She has more than 10 years of professional experience conducting health economics and health outcomes research. During this time, she has contributed to the development of cost-effectiveness, cost-utility, and budget-impact models in Microsoft Excel; undertaken targeted and systematic literature reviews; developed abstracts, manuscripts, and poster presentations; and lead a number of health economics and market access projects. She also has extensive experience in conducting health resource costing studies for European countries and has also been involved in conducting a time trade-off study and the analysis of health-related quality of life data, including a published regression analysis of SF-36. Therapeutic areas include vascular disease, depression/anxiety, non–small cell lung cancer, restless leg syndrome, fibromyalgia, and diabetic neuropathic pain.

 

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Computer Programming
Accounting
Technical College of Alamance, Haw River, NC

Cheryl McDade is a Programmer Analyst at RTI-HS and provides knowledge and experience in health economics and outcomes research studies, including cost-effectiveness, cost-benefit, cost-utility, and benefit-risk, as well as budget-impact modeling. Ms. McDade has developed decision tree, Markov, and Monte Carlo simulation models across numerous therapeutic areas, including fungal infections; pediatric asthma; bipolar disorder; angiography technology; breast, colorectal, and prostate cancer; chronic idiopathic constipation; and ulcerative colitis. Ms. McDade is an expert programmer in Microsoft Excel and Visual Basic for Applications and also has experience working in Decision Analysis by TreeAge (DATA). Ms. McDade also provides extensive experience in programming graphical user interfaces (GUIs) for health economic models. Ms. McDade has developed GUIs for pediatric asthma, angiography technologies, HIV, and stroke models.

 

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Juliana Meyers

MA, Economics
BS, Biomedical Engineering
Boston University, Boston, MA

Juliana Meyers, MA, is an Associate Director of Health Economics at RTI-HS. Prior to joining RTI-HS, Ms. Meyers worked as a research manager at Boston Health Economics. She has extensive experience in the design and analysis of studies involving retrospective health care claims data, cross-sectional and longitudinal survey data, data from prospective clinical studies, data from customized retrospective medical chart abstractions, and inpatient and long-term care data. Ms. Meyers has conducted research to estimate the prevalence and economic burden of various medical conditions, including acute myeloid leukemia, non–small cell lung cancer, chronic obstructive lung disease, attention-deficit/hyperactivity disorder, Parkinson's disease, HIV, restless legs syndrome, diabetes, hypertension, ovarian cancer, renal disease, acute coronary syndromes, invasive fungal infections, and complicated skin and skin structure infections. Ms. Meyers also has extensive experience in claims-based analyses to evaluate patterns and utilization implications of medication adherence among patients with HIV, hypertension, non–small cell lung cancer, chronic obstructive lung disease, diabetes, Parkinson's disease, restless legs syndrome, and schizophrenia.

Ms. Meyers has coauthored research published in numerous peer-reviewed journals, including Postgraduate Medicine, Child and Adolescent Psychiatry and Mental Health, Psychiatric Services, American Journal of Health Systems Pharmacy, American Journal of Infection Control, and Current Medical Research and Opinion. Additionally, Ms. Meyers has a forthcoming article in Managed Care.

Ms. Meyers also provides peer review for journal submissions in Current Medical Research and Opinion. Additionally, her research has been presented at numerous professional conferences and workshops, including the meetings of the American Society of Hematology (ASH); the European Society for Patient Adherence, Compliance, and Persistence (ESPACOMP); the Academy of Managed Care Pharmacy (AMCP); Bone Marrow Transplantation (BMT); the Society of Gynecologic Oncologists (SGO); the American Society of Consultant Pharmacists (ASCP); the National Association of Directors of Nursing Administration in Long Term Care (NAMDA-LTC); the American Society of Nephrology; the North American and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR); the International Congress on Drug Therapy in HIV Infection; the European AIDS conference; and the Intersciences Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

 

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LaStella Miles
MS, Industrial Engineering, Health Systems Engineering Certificate
BS, Industrial Engineering
North Carolina State University, Raleigh, NC
LaStella Miles, MS, is a Research Health Economist at RTI-HS. She assists in the development of cost-effectiveness and budget-impact models, literature reviews, modeling reports, and manuscripts. Ms. Miles also has experience developing computer integrated database systems and simulation models.

 

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Debanjali Mitra

MA, Applied Economics
The University of North Carolina at Greensboro, Greensboro, NC

Postgraduate Diploma in Management (MBA)
The Institute of Management Development and Research, Pune, India

BA, Economics
The University of Pune, Pune, India

Debanjali Mitra, MA, MBA, is a Director of Health Economics at RTI-HS. She is a highly experienced health economist with expertise in many areas of health services research. She has extensive knowledge of health care claims database analysis, cross-sectional and longitudinal survey analysis, analysis of data from prospective clinical studies with patient-reported outcomes, analysis of data from retrospective chart abstractions, econometric modeling, and data management using a variety of statistical packages, including SAS and Stata. Ms. Mitra has conducted research to estimate the economic burden of various diseases and conditions, including hepatitis C, chronic constipation, Crohn’s disease, and irritable bowel syndrome. Ms. Mitra also has conducted research to characterize patterns of medication utilization, including adherence and persistence, titration, switching, and discontinuation in various therapeutic areas, including chronic myeloid leukemia, attention-deficit/hyperactivity disorder, melanoma, kidney disease, hepatitis C, and ulcerative colitis. In addition, Ms. Mitra has assisted in the development of cost-effectiveness and budget-impact models for various medical conditions. In the past, she worked with the Behavioral Health Economics Program at RTI International where she conducted economic evaluations of substance abuse and mental health interventions for the federal government. She served as the project manager and economist for the cost-effectiveness study of COMBINE, a large multisite, randomized clinical trial sponsored by NIAAA for therapies for alcohol dependence. As part of this project, she wrote the analysis plan, designed data collection questionnaires, conducted data analyses, and coauthored manuscripts using the COMBINE trial data. She also has conducted research to estimate the effect of brief interventions for alcohol use on the health care utilization of problem drinkers.

Ms. Mitra has coauthored research published in Value in Health, Journal of Clinical Gastroenterology, Postgraduate Medicine, Medical Care, Journal of Studies on Alcohol and Drugs, Archives of General Psychiatry, Applied Health Economics and Health Policy, and International Journal of Hematology. Her research has also been accepted for presentation at numerous professional conferences and workshops, including the Research Society on Alcoholism, the Academy of Health’s annual meetings, the Society for Prevention Research, the American Society of Health Economists, the North American and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research, Digestive Disease Week, the American College of Gastroenterology, the Academy of Managed Care Pharmacy, the Society for Medical Decision Making, the American Society of Clinical Oncology, the European College of Neuropsychopharma­cology, and the American Society of Nephrology.

 

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Deirdre (Dee Dee) M. Mladsi

Graduate coursework (24 hours), Master of Health Sciences
Duke University School of Medicine, Durham, NC

BA, Economics
University of North Carolina, Charlotte, NC

Deirdre Mladsi is Head of Health Economics and Market Access at RTI-HS, applying methods and experience to support development and commercialization of pharmaceuticals, medical devices, and diagnostics. She has over 20 years of experience conducting health economics and outcomes research, including 5 years in the Global Health Outcomes group of a leading research-based pharmaceutical company. As a consultant, Ms. Mladsi, one of the founding senior members of RTI-HS, formed and led several teams within the organization; she served as one of the first Directors of Health Economics and as the first Global Head of Health Outcomes Strategy and the first Global Head of Pricing and Reimbursement, before returning to organize the Health Economics and Market Access service offering.

As Head of Health Economics and Market Access, Ms. Mladsi blends her technical skills in health economics with her experience conducting strategic pricing, reimbursement, and market access projects, both with a global focus and with local pricing and reimbursement experts in markets around the world. Areas of specialization that blend health economics and market access include threshold analysis to estimate value-based price opportunity, given an expected product profile; valuation modeling to inform clinical development prioritization efforts; and decision support modeling targeted at payers and other health care market access decision makers.

Ms. Mladsi also serves as a senior RTI-HS resource, bringing a market-oriented perspective to health economics and outcomes research projects, ensuring that they are conducted with an appreciation of the value messages that will result. She provides senior expertise to a team of health outcomes scientists and medical writers that specialize in designing and communicating the results of value-driven research. The team does this by developing and testing value messages, designing value-driven research strategies and plans, creating value dossiers, and preparing pricing and reimbursement dossiers for major markets. In addition to health economics, her interest is in bringing together scientists and marketing professionals to ensure that clear, concise, and relevant information is placed in the hands of marketplace decision makers, facilitating patient access to valuable new health care technologies.

Ms. Mladsi’s training is in economics and applied biostatistics, with an emphasis on clinical research. Although she has worked in all primary therapeutic areas, for several years her primary focus was oncology. She has published (also under the name Neighbors) in the Journal of Clinical Oncology, Journal of Pain and Symptom Management, Journal of Health Economics, Pharmacoeconomics, and Current Medical Research and Opinion, and has presented at numerous professional conferences. She has served as an adjunct faculty of Campbell University, responsible for their Health Economics course, offered as part of their Master’s in Clinical Research program.

 

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Hediyyih Narula

MA, Applied Economics
BS, Economics
University of North Carolina at Greensboro, Greensboro, NC

Hediyyih Narula, MA, is a Research Health Economist for the Health Economics group at RTI-HS. She assists in the development of cost-effectiveness and budget-impact models, literature reviews, modeling reports, and manuscripts. She also has experience developing various value and formulary submission dossiers and burden-of-illness reports, as well as conducting literature searches and data extractions. Additionally, she has extensive experience with the RTI-HS quality-control processes that are performed to ensure the accuracy of information presented in deliverables. Ms. Narula graduated magna cum laude, with a BS in economics, followed by a master’s degree in applied economics at the University of North Carolina at Greensboro.

 

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Pedro Oliveira

MSc, Health Economics and Decision Modeling
University of Sheffield, UK

Diploma, Economic Evaluation of Pharmaceuticals
ISEG, Lisbon, Portugal

MPhil, Industrial Economics
University of Nottingham, UK

DEA, Quantitative Economics
Université de Toulouse 1, France

BSc, Economics
Portuguese Catholic University, Lisbon, Portugal

Pedro Oliveira, MSc, MPhil, is a Health Economist, having joined RTI-HS in 2010. Having undertaken extensive academic training in health economics, economic evaluation of health care interventions, and decision analytic modeling, Mr. Oliveira has participated in a variety of professional projects in health economics. These included advice on long-term capital investment decisions for a Portuguese tertiary care institution; quantification of the budgetary impact of Portuguese Primary Care services’ reorganization; comparison of international data on the burden of illness of diabetes; adaptation of pharmaceuticals’ cost-effectiveness studies to the Portuguese regulatory setting in the therapeutic areas of immunology and endocrinology; advice on pricing and reimbursement strategies for an oncology medicine, taking into account the Portuguese market regulatory setting; and benefit-risk analysis modeling applied to CNS medicines.

Mr. Oliveira is interested in undertaking different projects dealing with health economics modeling, cost-effectiveness analysis, and market access.

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Isobel Pearson

DPhil, Molecular Biology and Biochemistry
University of Oxford, UK

BSc (Hons), Biochemistry with Intercalated Year
University of Warwick, UK

Isobel Pearson, DPhil, is a Senior Health Economist at RTI-HS. After gaining a DPhil at the University of Oxford, Dr. Pearson worked at Complete Market Access (formerly the Evidence Research Unit), a division of the Complete Medical Group. Dr. Pearson focused on projects where she was able to develop a detailed and in-depth understanding of the technology in question and its place in therapy.

Dr. Pearson’s experience both as Technical Lead and Senior Research Associate, included the development of health technology assessment submissions, core value dossiers, objection handling materials, cost-minimization and budget impact analyses, key opinion leader interviews, and publications.

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Naoko Akashi-Ronquest

PhD, Economics
MA, Economics
University of Virginia, Charlottesville, VA

BA, Business and Commerce
Keio University, Tokyo, Japan

Naoko Akashi-Ronquest, PhD, is an Associate Director of Health Economics at RTI-HS. Her experience at RTI-HS includes developing cost-effectiveness, cost-utility, cost-benefit, and budget-impact models using Microsoft Excel and Visual Basic for Applications. She has experience in the therapeutic areas of pain, schizophrenia, systemic lupus erythematosus, atopic dermatitis, HIV, female hypoactive sexual desire disorder, acute coronary syndrome,  non-small cell lung cancer, hepatitis B, and rheumatoid arthritis. In addition to disease modeling,  Dr. Akashi-Ronquest has experience in developing models to support the value of diagnostic testing strategies that guide treatments for various diseases.

Prior to joining RTI-HS, Dr. Akashi-Ronquest taught microeconomic theory, econometrics, and applied econometrics at California State University, Fullerton. She has conducted numerous empirical health and labor economics studies, including her doctoral thesis on the effects of managed care organizations’ restrictions on patients’ well-being. She has published in the Review of Economics of the Household, as well as Applied Economics Letters, and has presented at numerous professional conferences and meetings. She has developed various advanced economic models, including discrete choice models with simulations, and is proficient with various programming languages and statistical software packages such as FORTRAN, MATLAB, SAS, STATA, and SPSS.

 

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Neil S. Roskell

MSc, Medical Statistics
London School of Hygiene & Tropical Medicine, London, UK

BSc, Mathematics and Statistics
University of Newcastle upon Tyne, UK

Neil Roskell, MSc, is Director of Biostatistics, UK, at RTI-HS. Mr. Roskell has more than 15 years of professional experience analyzing pharmaceutical and health-related data. Mr. Roskell has extensive experience in the application of statistical analyses to pharmaceutical development and epidemiologic projects. As an International Project Statistician in the pharmaceutical industry, Mr. Roskell was responsible for all statistical input to a clinical dossier and accountable for statistical integrity, timelines, and quality of output for individual studies and regulatory submissions. Mr. Roskell has been responsible for data analysis planning and execution, and protocol and study report development. His experience spans an array of complex therapeutic areas such as HIV, cardiovascular diseases, metabolic diseases, musculoskeletal and connective tissue disorders, oncology, psychiatric disorders, central nervous systemic disorders, cerebrovascular disease, and urologic diseases. Mr. Roskell has managed clinical databases and SAS programming efforts on multiple computing platforms. He provides budget estimates and contributes to proposals for large-scale complex studies. Mr. Roskell has a wealth of experience in the use of the General Practice Research Database (GPRD) and The Health Improvement Network (THIN) in support of large-scale epidemiologic studies. Mr. Roskell has experience in different meta-analysis techniques, including meta-regression and mixed treatment comparisons. He has experience in many statistical aspects related to economic evaluations for medical compounds and has been involved in successful submissions to the National Institute for Health and Clinical Excellence and the Scottish Medicines Consortium in the UK.

 

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Miny Samuel

MS, Immunology
National University of Singapore, Singapore

PhD, Biological Sciences
MS, Zoology
Maharshi Dayanand University, India

BS (Hons.), Zoology
University of Madras, India

Miny Samuel, PhD, MS, is a Health Technology Appraisal Systematic and Evidence Reviewer at RTI-HS. Dr. Samuel has more than 14 years of experience in the field of systematic reviews. Prior to RTI-HS, Dr. Samuel was an evidence-based medicine analyst at the Clinical Trials and Epidemiology Research Unit at the National Medical Research Council in Singapore. She also served as codirector of the Australasian Cochrane Center in Singapore, where she supported Cochrane reviewers by providing consultation on reviews and meta-analyses, as well as methodologic help and statistical analysis and support in writing systemic reviews. Her work includes development of evidence-based clinical practice guidelines for Singapore’s Ministry of Health and increasing the awareness of evidence-based medicine practices among the medical community in Singapore. She has presented her research at numerous international symposia. She also has published extensively in journals and research publications, including The Cochrane Library (Systematic Reviews) and BMJ Clinical Evidence.

 

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BSc, Applied Statistics
Sheffield Hallam University, Sheffield, UK

Paul Shannon is a Senior Statistical Programmer for RTI-HS with more than 5 years of experience in the pharmaceutical industry. In this time, he has worked in pharmaceutical market research specializing in the development of quantitative research projects, in particular conjoint and multivariate analyses, providing critical input to study design and analysis methods. His programming expertise has been applied to creating advanced Excel models as key deliverables for such studies. He has also worked as a biostatistician and SAS programmer in clinical trial design and analysis as part of a respiratory team.

Mr. Shannon has worked in several therapeutic areas, including oncology, rheumatology, and respiratory, as well as cardiovascular and metabolic diseases.

Since joining RTI-HS, Mr. Shannon has qualified as a certified base SAS programmer while working on general practice database studies and trial-based economic analyses. He also has worked with various teams within RTI-HS do develop advanced graphical interfaces for Excel-based models, as well as creating online surveys for data collection.

 

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Donald E. Stull

PhD, Sociology
MA, Sociology
BA, Sociology
University of Washington, Seattle, WA

Donald E. Stull, PhD, is Director of Retrospective Data Analysis at RTI-HS. Dr. Stull’s responsibilities include analysis of clinical trial, observational, and registry data for studies focused on patient-reported, economic, and clinical outcomes. These analyses focus on instrument development and validation, and heterogeneous response data for identifying differential responders to treatment. He holds adjunct positions at the University of Maryland (Baltimore) School of Medicine and Touro University College of Medicine. Dr. Stull has over 25 years of health outcomes and health services research experience, including studies of the measurement of physical and mental health; the validity of patient-reported health; and studies of health outcomes, such as mortality, hospitalization, and physician visits. In addition, Dr. Stull specializes in psychometrics and the analysis of longitudinal and heterogeneous data using latent growth models and factor mixture models.

Dr. Stull’s work has led to articles in publications such as Journals of Gerontology: Psychology Sciences, Journals of Gerontology: Social Sciences, Heart and Lung, Research in Nursing and Health, Journal of Applied Gerontology, Value in Health, Quality of Life Research, Current Medical Research and Opinion, and Contemporary Clinical Trials. In addition, he was a coeditor of an award-winning book, Ethnic Elderly and Long-Term Care (Springer). He is Editor-in-Chief of Health Outcomes Research in Medicine, published by Elsevier.

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Sandra Talbird

MSPH
University of North Carolina, Chapel Hill, NC

BA, Bachelor of Business Administration (Finance)
University of Notre Dame, Notre Dame, IN

Sandra Talbird, MSPH, is an Associate Director of Health Economics at RTI-HS. Her experience at RTI-HS includes developing advanced economic models, such as cost-effectiveness, cost-utility, cost-benefit, and budget-impact models, using Microsoft Excel and Visual Basic for Applications. Her primary research focus has been in infectious disease, including both treatment and prevention strategies. Her experience at GlaxoSmithKline included conducting detailed literature reviews and supporting the writing and development of abstracts and manuscripts. Ms. Talbird's academic experience is grounded in finance, economics, and public health. Therapeutic areas include influenza, malaria, HIV, hepatitis C, pneumococcal disease, and women's health, including leiomyoma (uterine fibroids) and reproductive health.

Ms. Talbird is a member of the American Statistical Association and the International Society of Pharmacoeconomics and Outcomes Research. Her research has been presented at various professional conferences and published in several peer-reviewed journals, including AIDS, Vaccine, American Journal of Preventative Medicine, American Journal of Health-System Pharmacy, and Value in Health.

 

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Birgitta von Schéele

MS, Pharmacy Policy and Evaluative Science
University of North Carolina, Chapel Hill, NC

MSc, Pharmacy
School of Pharmacy, Uppsala University, Sweden

Birgitta von Schéele, MS, MSc, is a Director of Health Science (Nordic Countries) at RTI-HS. She has 10 years of professional experience applying health outcomes research of pharmaceutical and health data, and more than 10 years of professional experience managing international clinical research projects, ranging from phase 1 to phase 4 trials, in the pharmaceutical industry. She has experience in developing product-specific health economic and outcome research (HEOR) analysis plans for core markets, and application letters for pricing and reimbursement in Sweden and the United Kingdom, as well as in preparing several meta-analytic and cost-economic reports comparing different drugs within therapeutic areas. Ms. von Schéele also has prepared product value assessment documents and worked on epidemiologic projects since joining RTI-HS. Her experience includes depression, analgesics, oncology, hyperlipidemia, obstetrics, wound care, and cardiovascular disease. She has designed and managed international phase 3 and phase 4 clinical programs according to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) standards, including study designs, study protocols, case record forms, clinical report writing, cost-economic modeling, and decision analysis.

 

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Chi-Chuan (Emma) Wang

PHD, Pharmaceutical Outcomes and Policy
University of North Carolina, Chapel Hill, NC

MS, Health Policy and Administration
Washington State University, Spokane, WA

BS, Pharmacy
National Taiwan University, Taipei, Taiwan

Chi-Chuan (Emma) Wang, PhD, is a Senior Research Health Economist at RTI-HS. Dr. Wang has particular expertise in study design and has extensive experience working on large databases, including both administrative claims and national survey data. Her research focuses on utilization patterns and costs associated with prescription drug use. She has also conducted several studies to evaluate the influences of pharmaceutical policies on medication adherence and utilization.

Dr. Wang’s research has been published in several peer-reviewed journals, including Psychiatric Services, American Journal of Pharmaceutical Education, Research in Social and Administrative Pharmacy, Primary Care Companion to the Journal of Clinical Psychiatry, and Evidence-based Complementary and Alternative Medicine. Dr. Wang has also presented at professional conferences, including the International Society for Pharmacoeconomics and Outcomes Research and the American Pharmacists Association Annual Meeting and Exposition.

 

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Henry Wildey

BSc, Mathematics, Operational Research & Statistics (2 of 3 years completed)
Cardiff University, Cardiff, UK

AAA, Mathematics, Further Mathematics, Physics A-Levels
Salesian College, Farnborough, UK

Henry Wildey is a Health Economic Researcher at RTI-HS. Mr. Wildey is currently undertaking a BSc in Mathematics at Cardiff University. During 2 years of his degree so far, he has primarily studied operational research and statistics-related modules. Mr. Wildey also has more than three years of customer service experience in various retail sectors.

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Michele Wilson

PhD in progress, Health Policy and Management
University of North Carolina, Chapel Hill, NC

MSPH, Health Policy and Administration
University of North Carolina, Chapel Hill, NC

BSE, Biomedical Engineering (BS Economics)
Duke University, Durham, NC

Michele Wilson, MSPH, is an Associate Director of Health economics at RTI-HS. During his tenure at RTI-HS, Mr. Wilson has worked extensively in the development of advanced economic models, such as cost-effectiveness, cost-benefit, cost-utility, and budget-impact models, using Microsoft Excel and Visual Basic for Applications. Other experience at RTI-HS includes conducting detailed literature reviews and supporting the writing and development of abstracts and manuscripts. Mr. Wilson also has experience in health economic research in a government research setting, including econometric analysis. Mr. Wilson's academic experience is grounded in applied health economics and public health policy. Mr. Wilson's experience includes research in therapeutic areas such as bipolar disorder, pain management, diabetes, chronic obstructive pulmonary disease, schizophrenia, stroke, cardiovascular disease, cancer, myelofibrosis, Parkinson's disease, Alzheimer's disease and dementia, and HIV.

Mr. Wilson has coauthored research published in Stroke, Managed Care Interface, Review of Economics of the Household, Value in Health, Respiratory Medicine, Journal of Opioid Management, and Journal of Health and Economic Issues. Mr. Wilson's work has also been presented at the International Society for Pharmacoeconomics and Outcomes Research, Chest, the Winter Workshop on Schizophrenia and Bipolar Disorders, the American Academy of Managed Care Pharmacy, the International Stroke Conference, the American Thoracic Society, the World Congress on Parkinson's Disease and Related Disorders, International Congress of Parkinson's Disease and Movement Disorders, and AcademyHealth.

 

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Sorrel E. Wolowacz

PhD, Biotechnology
Cambridge University, Cambridge, UK

BSc, Biochemistry
Birmingham University, Birmingham, UK

Sorrel Wolowacz, PhD, is a Director of Health Economics at RTI-HS with 10 years of experience in heath economics consulting and more than 20 years of experience in the health care industry, including health outcomes, clinical research, and product development. She has researched in the areas of modeling, analysis of resource use and cost data (collected alongside trials, by medical record abstraction, surveys, or within databases), formal health technology appraisal submissions, systematic reviews, and compilation of value dossiers. She has experience in various therapeutic areas, including oncology (specifically lung, breast, ovarian, skin, and hematological cancers), cardiology, venous thromboembolism, arthritis, chronic pain, ophthalmology, and dermatology, She has participated in health technology appraisals in several markets, including the UK (NICE and SMC), Ireland (NCPE), Australia (PBAC), and Canada (CADTH). Dr. Wolowacz acts as peer reviewer for Pharmacoeconomics, European Journal of Health Economics, American Journal of Clinical Oncology, Value in Health and Therapeutics, and Clinical Risk Management.

 

 

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Evelina Zimovetz

MSc, Operational Research and Applied Statistics
University of Salford, UK
BSc (Hons), Management Science with Economics
University of Northampton, UK
Evelina Zimovetz, MSc, is a Senior Health Economist with RTI-HS. She has more than 4 years of experience conducting health economics and outcomes research. During this time, she has contributed to the development of cost-effectiveness, cost-utility, and budget-impact models in Microsoft Excel; undertaken targeted and systematic literature reviews; developed abstracts, manuscripts, and poster presentations; and lead a number of health economics and market access projects. Her experience includes the therapeutic areas of major depressive disorder, attention-deficit hyperactivity disorder, generalised anxiety disorder, multiple sclerosis, rheumatoid arthritis, osteoporosis, neuropathic pain, lung cancer, and human immunodeficiency virus.
Prior to joining RTI-HS, Ms. Zimovetz worked as an Economic Analyst within the United Kingdom’s Strategy Directorate of the Commission for Social Care Inspection, where she was responsible for extracting, analyzing, and interpreting complex data and information relevant to the social care market; writing briefings and reports on social care provision; and conducting ad hoc studies on the social care sector in England.

 

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Diane Whalley

PhD, Medicine
MPhil, Psychology
BSc, Psychology
University of Manchester, UK

Diane Whalley, PhD, is a Senior Director of Patient-Reported Outcomes (PRO) at RTI-HS and has over 16 years experience in PRO and related research. Before joining RTI-HS, she has been involved in research relating to health outcome and psychological measurement in the pharmaceutical, clinical, and academic sectors. She has developed, culturally adapted, and validated PROs in a number of different therapeutic areas. In her latest role at the University of Manchester, she conducted and advised on a range of policy-related studies in primary care, including large-scale surveys, discrete choice experiments, and questionnaire development. Dr. Whalley has extensive experience in a number of different research methodologies. Her particular area of expertise is in the development, psychometric evaluation, and interpretation of PRO measures, using traditional psychometrics, structural equation modelling, and item response theory techniques.

Dr. Whalley has published widely in peer-reviewed journals and presented her research at professional, scientific, and academic conferences. She has served as peer reviewer for Cancer Research UK, and for various journals, including Value in Health, Quality of Life Research, Health and Quality of Life Outcomes, British Journal of General Practice, International Journal for Quality in Health Care, Family Practice, Quality in Primary Care, Psychosomatics, and Health Policy. She has also been an advisor to a large-scale international study of depression outcomes involving the World Health Organization.

 

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Sheri E. Fehnel

PhD, Quantitative Psychology
MA, Clinical Psychology
University of North Carolina, Chapel Hill, NC

BS, Mathematics and Psychology
Duke University, Durham, NC

Sheri Fehnel, PhD, is the Vice President of Patient-Reported Outcomes in RTI-HS. Since joining the RTI staff in 1988, she has combined the study of clinical psychology and psychometrics with practical research and clinical experience. She specializes in the development and evaluation of questionnaires designed to measure health-related quality of life, functional status, patient satisfaction, resource utilization, and other patient-reported outcomes. This work has involved a wide range of therapeutic areas, including dermatology (e.g., psoriasis, eczema, acne), psychiatry (e.g., depression, bipolar disorder, schizophrenia), urology (e.g., urinary incontinence, nocturia, erectile dysfunction), gastroenterology (e.g., irritable bowel syndrome, chronic constipation, gastroparesis), oncology, cardiovascular disease, women's health (e.g., endometriosis, uterine fibroids, menopause), diabetes, respiratory (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis), sexual dysfunction (male and female), obesity, chronic pain, and sexually transmitted diseases (e.g., herpes, human papillomavirus, HIV/AIDS). As part of the questionnaire-development process, Dr. Fehnel has moderated countless focus groups, conducted cognitive interviews with a wide variety of patient and professional populations, and assessed potential sources of measurement error through cognitive forms appraisal. She has also evaluated the psychometric properties of many survey and clinical instruments using techniques such as factor analysis, structural equations modeling, and item response theory.

Dr. Fehnel is a frequent presenter at annual conferences held by organizations such as the International Society for Quality of Life Research (ISOQOL) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), as well as at various Drug Information Association (DIA) symposia. She also has published a number of articles related to questionnaire development and psychometric evaluation in Quality of Life Research, Medical Care, and Pharmacoeconomics, and serves as a co-editor for Value in Health.

 

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Amy Barrett

MSPH, Health Policy and Administration
University of Alabama, Birmingham, AL

MA, English
University of North Carolina at Chapel Hill, Chapel Hill, NC

BA, English and Pre-medicine
University of Alabama, Tuscaloosa, AL

Amy Barrett, MA, MSPH, is a Director of Patient-Reported Outcomes with RTI-HS. She has more than 10 years of health outcomes research experience. Ms. Barrett's experience in performing PRO research includes assisting in developing questionnaires and conducting focus group and cognitive interviews. She also has experience leading literature reviews of PRO instruments by disease area. She has conducted PRO instrument reviews in areas such as rheumatoid arthritis, obesity, pediatric asthma, and gastroesophageal reflux disease. She has extensive experience in comprehensive burden of illness literature reviews, systematic literature reviews, global value dossiers, and strategic value messaging. She offers knowledge in multiple therapeutic areas, including rheumatoid arthritis, cardiovascular disease, Alzheimer's disease, Parkinson's disease, mood disorders, bipolar disorder, benign prostatic hyperplasia, obesity, non–small cell lung cancer, and endometrial cancer.

 

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T. Michelle Brown

PhD, Counseling Psychology
University of Missouri, Kansas City

BA, Psychology
University of Tennessee, Chattanooga

Michelle Brown, PhD, is a Director of Patient-Reported Outcomes at RTI-HS. Dr. Brown has more than 15 years of experience in consumer, patient, and physician primary research. She comes to RTI-HS with considerable experience in both qualitative and quantitative research design and implementation, instrument development, and analysis. Dr. Brown has extensive experience moderating focus groups and conducting in-depth interviews among a broad range of patient populations, physician types, and therapeutic areas such as fibromyalgia, multiple sclerosis, lupus, hemophilia, and rheumatoid arthritis. She also has conducted patient studies in the assessment of treatment preference and satisfaction, symptom burden, health-related quality of life, and productivity. Some of her recent work has been published in Gynecologic Oncology, Haemophilia, and the Journal of Occupational and Environmental Medicine.

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Marci Clark

Pharmacoeconomic and Outcomes Research Fellowship
PharmD
University of Michigan, Ann Arbor, MI

Marci Clark, PharmD, is a Director of Patient-Reported Outcomes at RTI-HS. Dr. Clark is an established scientist with more than 10 years of experience in the field of health outcomes research. Dr. Clark joined RTI-HS after 7 years of working in clinical drug development and global health outcomes research at Pfizer. She is skilled at developing outcomes research strategy and key value messages/claims to differentiate developmental products in phases 1-3B. Dr. Clark has expertise in the evaluation, selection, development, and validation of patient-reported outcome (PRO) questionnaires, specifically assessment of quality of life, disease symptoms, treatment satisfaction, and inhaler device preference. She is also skilled at developing evidence dossiers to support product labeling claims based on PRO endpoints consistent with the Food and Drug Administration PRO guidance. Over the course of her career, Dr. Clark has worked in several disease areas, including respiratory, oncology, dermatology, osteoarthritis, women's health, stuttering, diabetes, insomnia, Parkinson's disease, and Cushing's disease. She has built strong positive relationships with key clinical experts and instrument developers in several therapeutic areas. Dr. Clark has presented research at both clinical and outcomes research-related national meetings.

 

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Theresa M. Coles

MS, Analytics
North Carolina State University, Raleigh, NC

BS, Psychology
Appalachian State University, Boone, NC

Theresa Coles, MS, is a Senior Health Outcomes Analyst in the Patient-Reported Outcomes group within RTI-HS. Ms. Coles has collaborated with colleagues on questionnaire instrument development, validation and instrument quantitative analyses related to health outcomes, psychometrics, biometrics, and drug risk mitigation strategies. She has also had the opportunity to moderate qualitative focus groups and conduct patient interviews.

Ms. Coles has over 8 years of professional experience in statistical analysis and data management. Her responsibilities include the development of statistical analysis plans, production of analysis tables and graphical data visualizations, data cleaning, and data manipulation. More specifically, her professional analysis experience covers prevalence estimates, psychometric analyses, response rate analyses, and interview burden analyses. Ms. Coles' experience with SAS over the past 8 years includes a Base Programming Certification for SAS 9, expertise in advanced SAS programming techniques, and training in SAS Enterprise Miner, SAS Text Miner, and JMP.

Her health outcomes experience has been applied to a variety of therapeutic areas, such as depression, anxiety, exercise, fibromyalgia, Cushing's, asthma, diabetes, rhinitis, hepatitis C virus, chronic obstructive pulmonary disease, irritable bowel syndrome, chronic pain, HIV, and bone fractures. In addition, she has studied influenza vaccination programs, postsecondary education, and customer behaviors in the marketing field.

 

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PhD, Quantitative Psychology

PhD, Quantitative Psychology
MA, Quantitative Psychology
BA, Psychology and French
University of North Carolina, Chapel Hill, NC

 

 

Cheryl Coon, PhD, is a Director of Psychometrics in RTI-HS. She has several years of experience in psychometric research, with particular concentration in item response theory and factor analysis. She has applied these and other statistical techniques to a variety of therapeutic areas, including respiratory and reproductive disorders, anxiety, schizophrenia, mood disorders, overactive bladder, and movement disorders. Much of her project experience involves the assessment of reliability, validity, factor structure, responsiveness, and minimal important difference. Dr. Coon has used these methods in the development and psychometric evaluation of scales measuring a number of outcomes such as health-related quality of life, treatment satisfaction and efficacy, patient preference, and symptom severity. She has several publications and presentations in the fields of quantitative psychology and patient-reported outcomes, including manuscripts in Medical Care, the Journal of Clinical Epidemiology, and the Journal of Psychiatric Research and presentations at the International Society for Quality of Life Research and the International Society for Pharmacoeconomics and Outcomes Research.

 

 

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S. Rebecca Crawford

MA Research Methods (Anthropology)
Durham University, United Kingdom

BA (honors) Anthropology/Archaeology
Durham University, United Kingdom

S. Rebecca Crawford is a Research Health Outcomes Scientist in the RTI-HS Patient-Reported Outcomes (PRO) group. Ms. Crawford has over 3 years of experience providing consultative support to pharmaceutical companies with a focus on the development of PRO measurement strategies to best meet the needs of their clinical trial programs. Her experience includes conducting literature reviews to evaluate the quality of PRO scales and their suitability for inclusion in clinical trials, and conducting qualitative research to assess the content validity of scales for specific patient groups. She has also collaborated on the development of new PRO measures and assessed the impact of medical conditions and treatments by conducting patient interviews and focus groups, applying qualitative analysis techniques, and developing associated documentation.

Ms. Crawford is also highly experienced in quantitative techniques pertinent to PRO research, including classical techniques and the application of item response theory (Rasch analysis) to investigate the psychometric properties of PRO measures. Specifically, she has been involved in the development and evaluation of PRO measures for Dupuytren's contracture, ankylosing spondylitis, systemic lupus erythematosus, psoriatic arthritis, chronic obstructive pulmonary disease, asthma, and atopic dermatitis. She has also designed and led the development of a new PRO measure for Crohn's disease.

Ms. Crawford has a firm understanding of the challenges involved in selecting PRO measures for use in international studies and specifically, of the challenges involved in ensuring the cultural acceptability of PRO scales. She has managed the adaptation and validation of multiple new language versions of existing PRO measures for use in Europe, South and Central America, and East Asia. Many of these have been large-scale parallel adaptation studies, with Ms. Crawford acting as both as a project manager and as a scientific researcher conducting translation panels and ensuring cross-cultural comparability of new language versions. As a project manager, Ms. Crawford has been responsible for identifying, and establishing contracts with international investigators and ensuring that all activities are kept on track in terms of both budget and timelines.

Ms. Crawford's work has led to articles in publications such as Journal of Medical Economics, Health and Quality of Life Outcomes, Journal of Investigative Dermatology, and Value in Health. She has also presented at conferences such as the International Society for Quality of Life Research.

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Carla DeMuro

PhD Candidate, Public Health
Walden University

MS, Community Health and Education
Arcadia University, Glenside, PA

BS, Applied Computer Science/Communications
Chestnut Hill College, Philadelphia, PA

Carla DeMuro, MS, is a Senior Director of Patient-Reported Outcomes in RTI-HS. Ms. DeMuro has extensive experience in the rigorous development and validation of patient-reported outcome measures for use in clinical trials, as well as large scale epidemiologic and population-based studies. She joined RTI-HS after 15 years of working in the pharmaceutical industry and brings her experience with and understanding of the newly drafted FDA Guidance for Patient Reported Measures. Ms. DeMuro has worked to developed measures across a wide span of therapeutic areas, including but not limited to respiratory illness (asthma, COPD, allergic rhinitis, influenza), oncology (non-small cell and small cell lung cancer), Alzheimer’s disease, infectious disease (including sexually transmitted disease), sleep disorders, hair loss (male and female), menopausal symptoms, cognition, acne, benign prostatic hyperplasia, diabetes, and migraine. Measures have included multiple types of patient-reported outcomes, including quality of life, treatment satisfaction, symptom severity, daily event logs, patient diaries, and utility measures. She has specialized in both the qualitative and quantitative aspects of instrument design and has worked toward creating a clear path from measure development to interpretation.

 

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Dana Britt DiBenedetti

PhD, Clinical Psychology
MS, Clinical Psychology
Oklahoma State University, Stillwater, OK

BA, Psychology
Millsaps College, Jackson, MS

Dana Britt DiBenedetti, PhD, Head of Patient-Reported Outcomes at RTI Health Solutions, is a clinical health psychologist with extensive experience in psychosocial assessment of adults and children in numerous therapeutic areas. Her broad clinical and assessment experience includes expertise in adult and pediatric psychiatry, virology, diabetes, women's health (e.g., menopause, vaginal atrophy, endometriosis), sexual medicine (e.g., erectile dysfunction, female sexual dysfunction, Peyronie's disease), respiratory, neurology/‌neuropsychology, nicotine dependence, obesity, chronic pain, and oncology. Currently, Dr. DiBenedetti specializes in the development of questionnaires designed to measure symptom severity, quality of life, patient satisfaction, and other patient-reported outcomes. As part of the questionnaire-development process, Dr. DiBenedetti has facilitated numerous patient, caregiver, and physician focus groups, and conducted cognitive interviews with a wide variety of patient and professional populations. Dr. DiBenedetti has considerable experience in both academic and pharmaceutical settings with instrument development and validation, functional status and quality-of-life assessment, design and implementation of survey and observational studies in various patient and health care professional populations, and coordination of instrument translations. Dr. DiBenedetti has authored/coauthored numerous manuscripts and scientific presentations on instrument development, quality of life, treatment satisfaction, and other outcomes in various patient populations, and she has served as a reviewer for several journals, including Value in Health, Journal of Consulting and Clinical Psychology, Health Psychology, Annals of Behavioral Medicine, International Journal of Behavioral Medicine, Addictive Behaviors, and Medical Care.

 

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Lynda C. Doward

MRes, Psychology
University of Manchester, Manchester, UK
Thesis: Exploring the impact of bipolar disorder on the quality of life of individuals

BSc, Geography/Biology
University of Lancaster, Lancaster, UK

Lynda Doward is the European Head of Patient-Reported Outcomes (PRO) at RTI-HS. Ms. Doward has over 20 years experience in PRO research. She provides advice and guidance to pharmaceutical companies, medical personnel, and academic researchers on the incorporation of PRO measurement into pharmaceutical product development strategies, clinical trial design and questionnaire development, translation, adaptation, and validation. Ms. Doward has particular expertise in research design and in the application of both traditional and innovative qualitative and quantitative research methods. She has extensive experience managing large-scale international projects involving a broad range of therapeutic areas, including multiple sclerosis, Alzheimer’s disease (patients and caregivers), depression, oncology, recurrent genital herpes, diabetic foot ulcers, venous leg ulcers, ankylosing spondylitis, systemic lupus erythematosus, psoriatic arthritis, osteoarthritis, osteoporosis, lipoatrophy, HIV/AIDS, COPD, asthma, atopic dermatitis, psoriasis, ostomy, and bowel cleansing.

 

Ms. Doward has acted as a member of several international task forces and working groups. She was a lead member of an International Benefit Assessment Taskforce for Outcome Measurement in Multiple Sclerosis from 2004 to 2009, has acted as a consultant to the World Health Organization, and has served as a research advisor to the UK Department of Health and the Arthritis Research Campaign. She also has been an active member of the International Society for Pharmacoeconomic Outcomes Research since 2000, regularly acting as a scientific reviewer and judge at international conferences. Ms. Doward has published widely in peer-reviewed journals and has presented her research at numerous international symposia. She also acts as peer reviewer for Value in Health, Pharmacoeconomics, Quality of Life Research, Rheumatology, Social Science & Medicine, Annals of Rheumatic Diseases, Journal of Investigative Dermatology, and BMC Health Services Research.

 

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Claire M. Ervin

MPH, Public Health Leadership
University of North Carolina, Chapel Hill, NC

BA, Communications
College of Wooster, Wooster, OH

Claire Ervin, MPH, is a Director in the Patient-Reported Outcomes division with RTI-HS. Ms. Ervin has more than 8 years of health care experience, including project management, patient and site recruitment, survey design and implementation, literature reviews, investigator and interviewer training, data collection and management/auditing, and analysis and reporting. Therapeutic areas in which she has worked include irritable bowel syndrome, women’s sexual/reproductive health, obesity, stroke, heart disease, anxiety disorders, depression, and autism.

Ms. Ervin also specializes in the development, evaluation, and validation of questionnaires designed to measure health-related quality of life, patient satisfaction, and other patient-reported outcomes. As part of the questionnaire-development process, Ms. Ervin has led and assisted with the moderation of both focus groups and cognitive interviews with a variety of patient populations.

Prior to her role at RTI-HS, Ms. Ervin served as the project manager for a multicenter, Center for Disease Control and Prevention (CDC)–funded continuous quality-improvement initiative focused on improving stroke care in North Carolina. Her work has been presented at national conferences.

 

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Barbara Forsyth

Postdoctoral Research Fellow in Cognitive Psychology
University of Michigan, Ann Arbor, MI

PhD, Quantitative Psychology
University of North Carolina, Chapel Hill, NC

MA, Cognitive and Experimental Psychology
University of South Carolina, Columbia, SC

BA, Psychology
College of Wooster, Wooster, OH

Barbara Forsyth, PhD, is a Senior Director of Patient-Reported Outcomes at RTI-HS and a cognitive and quantitative psychologist with over 25 years research experience in academic and private sectors. She is an effective project leader and technical consultant with strong skills in qualitative and quantitative research design, analysis, and reporting. Dr. Forsyth has special expertise in questionnaire design, instrument development and testing, and survey methods. She is accomplished with a range of data collection methodologies, including qualitative interviews, key opinion leader interviews, focus groups, case study methods, cognitive interviews, survey interviews, and cognitive behavioral laboratory methods.

Dr. Forsyth is particularly adept working with clients and research teams to specify research goals, articulate design priorities, and select approaches for addressing them efficiently. She is proficient in oral and written communication and has notable abilities building and supervising multidisciplinary research teams. She is effective in a variety of team roles, including program director, project director, task leader, analyst, technical writer, and methodological consultant.

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Shelly L. Harris

ScD (candidate), Health Systems Management
Tulane University, New Orleans, LA

MPH, Health Behavior and Health Education
University of North Carolina, Chapel Hill, NC

BA, Psychology
University of North Carolina, Chapel Hill, NC

Shelly Harris, MPH, is a Senior Health Outcomes Scientist in Patient-Reported Outcomes at RTI-HS. Ms. Harris has more than 15 years of experience in health policy, health communication, and other public health–related research. She comes to RTI-HS with considerable experience in qualitative data collection and analysis, program evaluation, project management, patient and site recruitment, and research design and implementation. Ms. Harris has extensive experience moderating focus groups and conducting in-depth and cognitive interviews among a broad range of populations. Ms. Harris has worked in various topic areas, including maternal and child health, infectious diseases (tuberculosis, HIV/AIDS and sexually transmitted diseases, and influenza), oral health, health disparities, gastrointestinal diseases, and chronic diseases (asthma, diabetes, and cancer).

 

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Sandra Lewis

BSN
Gwynedd-Mercy College, Gwynedd Valley, PA

Sandy Lewis is a Director of Patient-Reported Outcomes at RTI-HS. She has more than 15 years of experience in the pharmaceutical industry, half of which has been focused on the development and validation of patient-reported outcome (PRO) measures and implementation of PROs within clinical trial programs. Ms. Lewis has assisted with the development of PRO evidence dossiers for submission to the FDA to support label claims. Throughout the span of her career, Ms. Lewis has worked in numerous therapeutic areas, including gastroenterology, neuropsychology, infectious diseases, respiratory, endocrinology, orthopedics, urology, and vaccines. Ms. Lewis has a strong interest in pediatric patient populations and has conducted numerous interviews with children and adolescents between the ages of 6 and 17. Additionally, Ms. Lewis has extensive experience in the standardization and development of training materials and instruction for the administration of multiple instruments, including, but not limited to, the HAMD, HAMA, and MADRS in psychiatry and the BDI/TDI in respiratory disease. Ms. Lewis has strong project management skills and has experience in all aspects of data collection from protocol development through report writing.

While at Merck, Ms. Lewis supported 12 clinical trials that used electronic (ePRO) technology and was part of the Business Process Implementation team, which developed the guidance documents, working instructions, joint validation plan, and business processes for incorporation of ePRO technology at the company. Prior to entering the pharmaceutical arena, Ms. Lewis received her BSN from Gwynedd-Mercy College and worked for 3 years in a step-down critical care unit as a primary care nurse.

 

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Susan Martin

MSPH, Health Policy and Administration
University of North Carolina, Chapel Hill, NC

BS, Political Science
College of Charleston, Charleston, SC

Susan Martin, MSPH, is a Senior Director of Patient-Reported Outcomes at RTI-HS. Ms. Martin has more than 17 years of experience in the health care sector. Before joining RTI-HS, Ms. Martin held various posts at Pfizer, Parke Davis, Henry Ford Health System, Burroughs Wellcome, and the South Carolina Department of Health and Environmental Control. Most recently, she was a Director at Pfizer Global Outcomes Research where she was responsible for the pain and inflammation therapy areas, including designing and implementing product- and therapy-level strategies. Ms. Martin has extensive outcomes research experience in numerous types of conditions, including fibromyalgia, rheumatoid arthritis, osteoarthritis, low back pain, postherpetic neuralgia, diabetic painful neuropathy, atopic dermatitis, obesity, ophthalmology, and Alzheimer's disease. She has been an active participant in pain research collaborations spanning industry, academia, and regulatory agencies, including the IMMPACT group—which has published recommendations in the area of pain clinical research—as well as leading the first OMERACT workshop held on fibromyalgia.

 

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Lori McLeod

PhD, Quantitative Psychology
MA, Quantitative Psychology
University of North Carolina, Chapel Hill, NC

BS, Statistics, Mathematics Education (graduated Summa Cum Laude)
North Carolina State University, Raleigh, NC

Lori McLeod, PhD, is Head of Psychometrics at RTI-HS. Dr. McLeod is a psychometrician with more than 15 years of experience in instrument development and validation, as well as experience conducting systematic assessments of clinical and economic literature and developing appropriate health outcome strategies. In her Psychometrics role, she has conducted many psychometric evaluations of both paper-and-pencil and computer-administered instruments. These investigations have included the assessment of scale reliability, validity, responsiveness, and work to identify PRO responders. Dr. McLeod has published numerous related manuscripts in Applied Psychological Measurement, Pharmacoeconomics, Journal of Educational Measurement, and Psychometrika. She has experience in a wide variety of therapeutic areas, including chronic pain, dermatology, oncology, psychiatry, respiratory, sleep disorders, urology, and sexual dysfunction. Dr. McLeod currently serves as the co-leader of the Psychometric Special Interest Group for the International Society on Quality of Life.

 

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Lauren Nelson

PhD, Quantitative Psychology
MA, Quantitative Psychology
MS, Physics
BS, Physics
University of North Carolina, Chapel Hill, NC

BS, Psychology
University of North Carolina at Charlotte, Charlotte, NC

Lauren Nelson, PhD, is a Director of Psychometrics. She has over 15 years of experience applying psychometric and statistical methods to address research questions. At RTI-HS, Dr. Nelson has conducted the psychometric evaluation of patient-reported outcome instruments for a variety of therapeutic areas, including irritable bowel syndrome, chronic constipation, Cushing's disease, diabetes, gynecological disorders, chronic sinusitis, asthma, and chronic obstructive pulmonary disease. She has expertise in applying modern psychometric methodology such as item response theory, factor analysis, structural equation modeling, latent growth modeling, and growth mixture modeling. Dr. Nelson has several publications and presentations in the fields of psychology and patient-reported outcomes, including manuscripts in Diabetes Research and Clinical Practice, Pediatrics, American Journal of Mental Health, and Developmental Psychology and papers and posters presented to the International Society for Quality of Life Research and the International Society of Pharmacoeconomics and Outcomes Research.

 

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Bimpe Olanrewaju

PharmD
University of Michigan College of Pharmacy, Ann Arbor, MI

MPH, Epidemiology
Indiana University-Purdue University Indianapolis (IUPUI), Indianapolis, IN

BS, Human Biology
Michigan State University, East Lansing, MI

Bimpe Olanrewaju, PharmD, MPH, is a Health Outcomes Scientist at RTI-HS. Dr. Olanrewaju has both clinical and research expertise, including experience with patient screening efforts, data collection, data entry, and study design in areas such as walkability, obesity, and care giver issues. Her research activities have included reviewing literature, conducting interviews and focus groups, analyzing statistical data, interpreting study results, creating abstracts and posters, and presenting study results at multiple meetings.

 

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PhD, coursework in Educational Research Methodology (with Statistics minor)
MEd, Educational Research Methodology (with Statistics minor)
MA, French
University of North Carolina at Greensboro, Greensboro, NC

BA, English and French
Emory and Henry College, Emory, VA

Mark Price, MEd, MA, is a Director of Psychometrics in the Patient-Reported Outcomes group, where he works on both qualitative and quantitative tasks supporting questionnaire development. Mr. Price has more than 15 years of experience in the design, collection, analysis, interpretation, and reporting of high-stakes data. In the past, Mr. Price was a senior psychometrician for the New York Stock Exchange, where he provided expertise for the development and enhancement of examination programs. In addition, Mr. Price has designed, coordinated, and analyzed data for qualitative studies in the specific disease areas of male sexual dysfunction, HIV, prostate cancer, obesity, diabetes, schizophrenia, gastrointestinal disorders, cardiovascular disorders, multiple sclerosis, and asthma. Mr. Price’s areas of expertise include both qualitative and quantitative research design and implementation (focus groups, patient interviews, surveys, online data collection), statistical analysis, item response theory, factor analysis, and technical writing and editing. He has experience with major statistical analysis, qualitative data analysis, and database programs. His language skills include fluency in French and an intermediate knowledge of Spanish, and he has designed parallel bilingual data collection protocols.

 

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Carolyn Sweeney

MPH, Epidemiology
Eastern Virginia Medical School, Norfolk, VA

BS, Health Sciences
James Madison University, Harrisonburg, VA

Carolyn Sweeney, MPH, is a Health Outcomes Scientist in the Patient-Reported Outcomes group at RTI-HS. Ms. Sweeney has more than 6 years of health care experience, including project management, survey design and implementation, development of protocols and claims-based research, patient and site recruitment, investigator and study coordinator training, data collection and management, review of documentation for quality-control purposes, literature reviews, and analysis and reporting.

Prior to joining RTI-HS, Ms. Sweeney worked in the pharmaceutical industry, where she provided strategy support for both marketed products and products in development within the gastrointestinal, metabolic, and cardiovascular disease areas. She also has several years of experience working in local health departments in environmental health services and epidemiology.

 

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Valerie S. L. Williams

PhD, Quantitative Psychology
BA, Psychology
University of North Carolina, Chapel Hill, NC

MA (summa cum laude), Psychology
North Carolina Central University, Durham, NC

Valerie Williams, PhD, is a Senior Director of Psychometrics at RTI-HS. She has 25 years of experience applying psychometric and statistical methods to topics in measurement. Her work at RTI-HS has involved a number of therapeutic areas, including respiratory, gastrointestinal, and gynecological disorders, obesity, sexual dysfunction, bipolar disorder, anxiety, depression, and chronic pain. Dr. Williams has developed scales and surveys for a range of applications, including substance abuse, health care utilization, and various psychological disorders; she has designed and directed the psychometric evaluation and statistical analysis of instruments related to health care, quality of life, educational achievement, and a variety of psychological constructs, using specialized techniques such as factor analysis, structural equations modeling, hierarchical modeling, and item response theory. She has published and presented widely on topics related to measurement and quantitative psychology.

 

 

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Brian Clark

MM, Masters Management-International Business
Aquinas College, Grand Rapids, MI

BSBA, Marketing
Aquinas College, Grand Rapids, MI

Brian Clark is a Senior Director of Market Access and Outcomes Strategy at RTI-HS. Mr. Clark has over 15 years of pharmaceutical experience with Merck and GlaxoSmithKline (GSK). He held positions within managed care strategy and contract and performance analytics. He has expertise in the respiratory area, where he spent over 5 years in a managed care marketing strategy role supporting the respiratory franchise (i.e., Advair and Flovent). He most recently worked on the US market access team at GSK, where he was involved with evaluating business development opportunities. He also provided US payer insights into Research and Development on assets in development. Lastly, he managed a unique process of scoring pipeline assets, based on the perceived value to the payers. Prior to joining GSK, he worked in the Health Management Services department at Merck, where he had account responsibility for 12 regional payers. He also worked on the Marketing Integration Team, where he led the tactical implementation of strategies to support brand objectives for Zocor and Singulair. In addition, he was part of the core team that launched Merck's Patient Assistance Program. Mr. Clark also developed and implemented over 15 comprehensive disease management programs. Prior to joining Merck and GSK, Mr. Clark worked for Priority Health Plan, where he held positions of increasing responsibility in marketing, pharmacy, and medical departments.

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Kati Copley-Merriman

 

MBA, Marketing
Indiana University, Indianapolis, IN

 

MS, Organic Chemistry
Purdue University, Indianapolis, IN

 

BA, Chemistry and German
Smith College, Northampton, MA

 

Kati Copley-Merriman, MS, MBA, is Vice President of Market Access and Outcomes Strategy at RTI-HS. Ms. Copley-Merriman has more than 25 years of industry experience, including leadership roles in Global Outcomes Research at Eli Lilly, Parke-Davis, and Pfizer. She has experience in all aspects of outcomes research (OR), including clinical trial design with patient-reported outcomes (PRO) endpoints, economic evaluations, OR strategic plans, and regulatory strategy.

 

In her RTI-HS role, Ms. Copley-Merriman leads a team of scientists, reimbursement experts, and medical writers responsible for developing OR strategic plans, literature reviews, disease state summaries, and product value and reimbursement dossiers, and for conducting qualitative payer research. Ms. Copley-Merriman has experience in many therapeutic areas, including oncology, pain and inflammation, dermatology, respiratory, urology, and central nervous system. Ms. Copley-Merriman is an active member of International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and was elected to the ISPOR Board for 2010-2012.

 

 

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Stephanie Barrows

MPH, Health Management and Policy
University of Michigan, Ann Arbor, MI

MA, Health Promotion and Program Management
BS, Health Education
Central Michigan University, Mt. Pleasant, MI

Stephanie Barrows, MA, MPH, is a Senior Director in the Market Access and Outcomes Strategy group at RTI-HS. Ms. Barrows has several years of industry experience in outcomes research (OR) with Pharmacia and Pfizer, including clinical trials with patient-reported outcome (PRO) endpoints, development of PROs, creating OR strategic plans, and collecting health resource utilization data. Her expertise includes work in several areas of psychiatry, including schizophrenia, bipolar disorder, attention-deficit/hyperactivity disorder, and depression; oncology; infectious diseases; pain; inflammation; migraine; movement disorders; and dermatology. In her role at RTI-HS, Ms. Barrows has responsibility for developing OR strategic plans for phase 2/3 compounds, value positioning of new products, conducting literature reviews, creating global value dossiers, and conducting competitive overviews.

 

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LeeAnn Braun

MPH, Epidemiology
University of North Texas Health Science Center, Ft. Worth, TX

Certificates, Secondary Education, Biology, and Health Education
University of Texas at Arlington, Arlington, TX

BS, Community Health Education
Texas A&M University, College Station, TX

LeeAnn Braun, MPH, is an Associate Director of Market Access and Outcomes Strategy at RTI-HS. For nearly 10 years, Ms. Braun successfully led research, writing, and strategy for many US- and globally-focused clinical and health outcomes research projects within the pharmaceutical and biotechnology industry. Her project experience is wide and varied across functions. Examples of her clinical work include international clinical trial management and supplementary new drug application submissions to the European Medicines Agency and the US Food and Drug Administration, leadership and management for all investigator-initiated trials requesting growth hormone or insulin products, development and writing of an orphan drug application which received orphan status, and epidemiological consultation and writing for pediatric investigational and risk management plans. Examples of her Health Outcomes and Economic Research work include the development and execution of strategic research plans for multiple products and indications across each product’s lifecycle (phase 2 through post-launch phase 4). Such plans included but were not limited to literature review, descriptive and epidemiological research, selection and recommendation of patient-reported outcomes instruments and economic endpoints for inclusion in clinical trials, US and European Union label strategy, economic research, and model development. Resulting value-based deliverables led by Ms. Braun include value propositions, global value dossiers, formulary submission dossiers, clinical and managed market detail aids, outcomes liaison field training, and payer slide development. Additionally, she led and coauthored several abstracts and publications in peer-reviewed journals.

In her role as an Outcomes Liaison, Ms. Braun had the opportunity to gain customer-facing experience through research presentations to managed-market payers upon unsolicited requests. Throughout Ms. Braun’s career, she worked on more than 15 products (small and large [biological] molecules) and devices, with experience in neuroscience (major depressive disorder, bipolar disorder, multiple sclerosis), skeletal science (osteoporosis, bone and tendon repair, rheumatoid arthritis), critical care (severe sepsis, cardiovascular disease), endocrine (growth disorders, orphan indication, short stature homeobox-containing gene (SHOX) deficiency, Turner syndrome, growth hormone deficiency, and diabetes), gastroenterology (Crohn’s disease, ulcerative colitis, diverticulitis), infectious disease (hepatitis C virus, human immunodeficiency virus and acquired immune deficiency), and oncology (multiple tumor types).

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Ann Colosia

PhD, Molecular Physiology and Biophysics
BS, General Biology
Vanderbilt University, Nashville, TN

Ann Colosia, PhD, is a Senior Associate in the Market Access and Outcomes Strategy group. She has more than 10 years of experience in communicating pharmaceutical drug value to payers and physicians. She has experience conducting literature reviews, including systematic literature reviews, and developing product value dossiers and Academy of Managed Care Pharmacy (AMCP) dossiers. Before joining RTI-HS, she developed science and business materials with an educational focus for sales training programs. Prior to beginning her career in health care communications, her laboratory research dealt with glucoregulatory mechanisms affected by diabetes and autoimmune mechanisms causing autoantibody development. Dr. Colosia’s writing experience includes the therapeutic areas of diabetes, cancers, gastrointestinal diseases, hypercholesterolemia, cardiovascular disease, Parkinson’s disease, pulmonary diseases, hematoproliferative disorders, and autoimmune diseases.

 

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Eleanor Croft

PhD, Genetics
University of Cambridge, Cambridge, UK

BSc, Biochemistry
University of Birmingham, Birmingham, UK

Eleanor Croft, PhD, is Associate Director of Market Access and Outcomes Strategy and is based in RTI-HS’s office in Manchester, UK. Dr. Croft has more than 5 years of experience in strategic pharmaceutical pricing, reimbursement, and market access in a broad range of therapeutic areas. She has performed qualitative and quantitative stakeholder research, and modeling and case study reviews. Her experience includes developing pricing and reimbursement strategies and global value dossiers; developing value messages (including payer validation); performing systematic literature reviews, utility studies, and mixed treatment comparisons; and developing health technology assessment models to support successful market access.

 

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Maria M. Fernandez

MBA, Health Sector Management
Fuqua School of Business, Duke University, Durham, NC

PhD, Organic Medicinal Chemistry
BS, Chemistry
University of Alcala, Madrid, Spain

 

Maria Fernandez, PhD, MBA, is an Associate Director of Market Access and Outcomes Strategy at RTI-HS. Dr. Fernandez has extensive experience in health care market research, including research in the field of reproductive health. She has conducted primary and secondary market research on pharmaceutical and medical device products, developed cost-analyses, break-even analyses, and market segmentation. She has also developed competitive and market strategies to create demand for new products, as well as recommended pricing strategies. In addition to the US market, Dr. Fernandez has much experience conducting market assessments in international markets, including Argentina, Brazil, France, Italy, Germany, Mexico, Spain, and the UK. She has a doctorate in organic medicinal chemistry and has worked as a senior research scientist for 10 years in the pharmaceutical industry and academia. She also has an MBA and has worked for nearly 5 years in health care companies, like Johnson & Johnson in Madrid, and not-for-profits, like Ipas and WomanCare Global. She is coauthor of a patent and has published 12 peer-reviewed articles in top science journals.

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Anne Heyes

MBA
Health Economics Diploma
University of Keele, Keele, UK

BSc, Plant Sciences
University of Sheffield, Sheffield, UK

Anne Heyes, MBA, is Head of Market Access and Outcomes Strategy, Europe, and is based in RTI-HS’s office in Manchester, UK. Ms. Heyes has more than 20 years of industry and consultancy experience, including leadership roles in Global Health Economics and Outcomes Research at AstraZeneca, where she was responsible for the development and implementation of market access strategies and evidence generation to support new products. She then led the UK-based market access team within an international consultancy. She has experience in drug development and market access in the clinical and commercial arenas in both global and local settings. Ms. Heyes has experience in all aspects of market access evidence development and implementation, including development of global value dossiers, payer research, health economic analyses, value communication, trial design, and health technology assessment submissions. She leads a team of specialists responsible for providing clients with effective, tailored solutions to support market access for new products. Ms. Heyes has experience in a wide range of therapeutic areas, including oncology, pain, diabetes, immunosuppression, urology, central nervous system, and hematological disorders. She is a member of the International Society for Pharmacoeconomics and Outcomes Research and the International Health Economics Association.

 

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Kristen Hinson

BA, Journalism
University of Kentucky, Lexington, KY

Kristen Hinson is a Quality Assurance Specialist in the RTI-HS Office of Quality Assurance. Ms. Hinson conducts internal project and process audits, hosts external client audits, qualifies subcontractors, and provides project support. Ms. Hinson has knowledge of US Food and Drug Administration regulations, Good Clinical Practices, regulatory compliance applications, and regulatory affairs. In her previous role, Ms. Hinson performed quality-control tasks and assisted with project management responsibilities. She also has experience managing budgets, consultant contracts, and invoicing, both to clients and consultants or subcontractors. She has more than 3 years of experience working in medical communications and has earned a certificate in medical writing from the American Medical Writers Association.

 

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Susan L. Hogue

MPH, Health Policy and Administration
The University of North Carolina, Chapel Hill, NC

PharmD
The University of Kentucky, Lexington, KY

BS, Pharmacy
The University of North Carolina, Chapel Hill, NC

Susan Hogue is a Senior Director in the Market Access and Outcomes Strategy group at RTI-HS. Dr. Hogue has more than 18 years of industry experience including leadership roles in both Global Health Outcomes and US Health Outcomes at GlaxoSmithKline. Dr. Hogue’s considerable experience encompasses all aspects of outcomes research and market access evidence generation, including health economic and outcomes strategy development, value proposition development and value communication, endpoint determination in clinical trial design (both PRO and economic), health economic evaluations, and value dossier development. Dr. Hogue has broad therapeutic expertise, including in the areas of neuroscience (e.g., depression, migraine, smoking cessation, restless legs syndrome, epilepsy, bipolar disorder), urology, pediatrics, and osteoporosis. In her RTI-HS role, she leads a team of specialists responsible for providing clients with effective, tailored solutions to support market access for medicines and devices. Additionally, Dr. Hogue serves as an adjunct Assistant Professor at the School of Public Health at the University of North Carolina, Chapel Hill.

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Melissa D. Juniper

MS, Developmental Psychology
North Carolina State University, Raleigh, NC

BA, Psychology
Susquehanna University, Selinsgrove, PA

Certificate, Core Public Health Concepts
University of North Carolina, Chapel Hill, NC

Melissa Juniper, MS, is a Senior Director of Market Access and Outcomes Strategy at RTI-HS. In more than 7 years with RTI-HS, Ms. Juniper has successfully led a number of large, multifaceted projects for leading pharmaceutical companies. She has focused on developing formulary submission dossiers to help ensure pharmaceutical access and reimbursement; she has also prepared value dossiers and literature reviews. She has completed a certificate in Core Public Health Concepts at the University of North Carolina, as well as an Expert Workshop at the Centre for Health Economics at the University of York, training sponsored by the Academy of Managed Care Pharmacy (AMCP) on formulary submission dossier preparation, and training sponsored by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). She offers knowledge in a variety of therapeutic areas, including cardiovascular disease (e.g., acute coronary syndrome, atrial fibrillation, atherosclerosis, and hypercholesterolemia), diabetes (type 1 and type 2), oncology (e.g., non–small cell lung cancer, renal cell carcinoma, and glioblastoma multiforme), psychiatric disorders (e.g., depression, major depressive disorder, generalized anxiety disorder, and schizophrenia), musculoskeletal and connective tissue disorders (e.g., osteoporosis, fibromyalgia, chronic low back pain, and rheumatoid arthritis), and respiratory disorders (e.g., asthma and chronic obstructive pulmonary disease), as well as age-related macular degeneration, hypoactive sexual desire disorder, hepatitis B, opioid-inducted constipation, and Parkinson’s disease.

 

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Shahnaz B. Khan

 

MPH, Maternal and Child Health
BS, Clinical Laboratory Science
University of North Carolina, Chapel Hill, NC

 

Shahnaz Khan, MPH, is a Senior Director of Market Access and Outcomes Strategy. Ms. Khan is responsible for the development of pricing and reimbursement dossiers. She has more than 12 years of experience working in medical communications and has earned a certificate in medical writing from the American Medical Writers Association. Prior to joining RTI-HS, she served as a Medical Writer for a contract research organization. Her extensive clinical writing experience includes preparation of protocols, clinical study reports, and manuscripts in the areas of ophthalmology, infectious diseases, cardiovascular disease, endocrinology, urology, gynecology, oncology, hematology, and neurology. In addition to her focus on pricing and reimbursement dossiers, she has considerable experience in the production of corporate health economics and outcomes research communication materials. Ms. Khan attends Academy of Managed Care Pharmacy (AMCP) meetings and AMCP / Foundation for Managed Care Pharmacy (FMCP)–sponsored seminars on a regular basis in order to remain up-to-date on the latest news regarding AMCP dossiers.

 

 

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Anne Kilburg

MSc
Human Nutrition Sciences and Economics
Friedrich-Wilhelms-University, Bonn, Germany

Anne Kilburg, MSc, is Senior Director of Market Access and Outcomes Strategy, Europe, and is based in Weil am Rhein, Germany. In more than 15 years of professional life, Ms. Kilburg has gained deep experience and knowledge in health economic methods, health technology assessment, international health care policy and individual health care systems, the design and management of health economic evaluations, and the development of pricing and market access strategies for major disease areas, including cardiovascular diseases, diabetes, immunosuppression, and infectious diseases. Anne started her career as a health economist and consultant at the Institute of Empirical Health Economics in Germany. Since 2001, Anne has held corporate manager positions in health care strategy, health economics, and strategic pricing at Boston Scientific GmbH, Novartis Pharma GmbH, and Novartis Pharma AG. Her expertise encompasses not only the perspective of a global pharmaceutical player but also of the German health care market. This specifically includes collaboration with representatives of all important stakeholders and decision makers of the German health care system as well as international universities and health care institutions. She has authored scientific papers and acted as an editor for the German journal Gesundheitsökonomie & Qualitätsmanagement. She is a member of the International Society for Pharmacoeconomics and Outcomes Research and the International Health Economics Association.

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Jake Lebiecki

PhD, Neuroscience
University of Manchester, Manchester UK

BSc, Biochemistry with Industrial Experience
University of Manchester, Manchester UK

Jake Lebiecki, PhD, is a Senior Associate in Market Access and Outcomes Strategy and is based in RTI-HS’s office in Manchester, UK. Prior to joining RTI-HS in August 2010, Dr. Lebiecki held an associate management consultant position at a London-based market access consultancy where he gained 3 years’ experience in coordinating and leading on a wide range of strategic, European-based market access, clinical writing, and commercial effectiveness projects in a broad range of therapeutic areas. Dr. Lebiecki was particularly involved in projects which involved direct contact with payers/payer influencers and clinical decision makers to undertake qualitative and quantitative stakeholder research, willingness-to-pay research, value message development and testing, and budget and service impact modeling.

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Mary Levine

BA, Zoology
University of California, Santa Barbara, CA

Mary Levine is a Project Manager in the Market Access and Outcomes Strategy (MAOS) group at RTI-HS. Ms. Levine is responsible for preparing the project kickoff, organizing the project meeting schedule, maintaining project timelines, and ensuring that team members stay on budget. She also is responsible for setting up consultant contracts and invoicing, both to clients and consultants or subcontractors. Ms. Levine also serves in a project administrative capacity internally to the MAOS team to draft proposals. In addition, she assists in writing, conducting literature reviews, data entry, and coordinating research materials for various groups in RTI-HS. She graduated from the University of California, Santa Barbara, with a BA in zoology. She developed her skills in leadership and client management as a pension consultant and human resources/office manager. Ms. Levine is also fluent in Mandarin Chinese.

 

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Caroline Ling

PhD, Genetics
BSc, Biology
University of Nottingham, Nottingham, United Kingdom

Caroline Ling, PhD, is a Director in the Market Access and Outcomes Strategy group and is based in RTI-HS’s office in Manchester, UK. Dr. Ling has over 10 years of experience with market access and health economic consultancies and is able to deliver a broad spectrum of strategic and tactical market access projects for both global and local clients. In her previous roles at Evidence Research Unit and Cardiff Research Consortium, she contributed to a broad range of projects, including systematic and pragmatic literature reviews, global value dossiers, health technology assessment (HTA) submissions, interactive payer tools, database analyses, and microcosting studies. Dr. Ling has experience in a wide range of therapeutic areas, including mental health, oncology, renal disease, diabetes, and cardiovascular disorders.

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Catherine Masaquel

MPH, Health Policy and Administration
Yale University, New Haven, CT

BS, Psychobiology
University of California, Los Angeles, CA

Catherine Masaquel, MPH, is an Associate Director in the Market Access and Outcomes Strategy group at RTI-HS. Ms. Masaquel has several years of industry experience in outcomes research and health economics with Pfizer and Amgen. She has extensive experience with health care claims database analysis, managed care communication plans, pharmacoeconomics, and patient-reported outcomes. Her previous work has focused on therapeutic areas such as cardiovascular disease, nephrology, movement disorders, diabetes, osteoarthritis, depression, cancer, and infectious diseases. Ms. Masaquel is responsible for the development of health economic and outcomes research strategic plans for phase 2/3 compounds, conducting literature reviews, creation of global value and Academy of Managed Care Pharmacy dossiers, and value message positioning.

 

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Margaret Mordin

MS, Public Policy
BA, Political Science
University of Rochester, Rochester, NY

Margaret Mordin, MS, is a Senior Director of Market Access and Outcomes Strategy at RTI-HS. Ms. Mordin has nearly 20 years of experience in conducting and managing outcomes research, including designing and implementing outcomes assessments in prospective trials for regulatory submission and as postmarketing studies. Her areas of expertise include study design (e.g., observational postmarketing studies, patient-reported outcomes for use in clinical development programs, and patient health-related quality of life and satisfaction surveys), analysis of outcomes data, publication development, and outcomes-related regulatory submission strategies. Her experience also includes directing health economic evaluations (prospective economic trials and billing studies). In addition, Ms. Mordin has conducted outcomes research for multiple medical devices, including drug/device combination products, transdermal delivery systems, blood glucose monitoring systems, intravenous patient-controlled analgesia, multiple medication inhalation devices, photodynamic therapy, and digital mammography.

Ms. Mordin regularly presents at conferences and has numerous publications in peer-reviewed journals, including the Journal of Managed Care Pharmacy, American Journal of Clinical Dermatology, Clinical Cardiology, Quality of Life Research, Transplantation, Oncology, and New England Journal of Medicine. Ms. Mordin’s therapeutic expertise includes age-related macular degeneration, asthma, cardiology, chronic pain, diabetes, Gaucher disease, HIV/AIDS, kidney transplantation, oncology, ophthalmology, orthopedics, Parkinson’s disease, psoriasis, and schizophrenia.

 

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Annete Njue, PhD

PhD, Molecular Biology
McGill University, Canada

MSc, Applied Parasitology and Medical Entomology
Liverpool University, England

BVM
University of Nairobi, Kenya

Annete Njue is a Senior Research Associate in the RTI-HS Market Access and Outcomes Strategy group in Manchester, UK. Before joining RTI-HS, Dr. Njue was a Senior Medical Writer at Prime Medica Ltd., where she gained experience in communicating scientific information in a broad range of therapy areas, including oncology, anaemia, cardiovascular disease, fertility, virology (influenza, cytomegalovirus), transplantation, depression, hypertension, diabetes, and angioedema. Prior to her career in medical communications, Dr. Njue worked in veterinary research in Canada and Kenya, and published her work in Journal of Neurochemistry, Parasitology, and Parasitology Research.

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Rachel Police

MPH, Health Management and Policy
University of Michigan, Ann Arbor, MI

BA, English
University of Pennsylvania, Philadelphia, PA

Rachel Police, MPH, is an Associate Director in the Market Access and Outcomes Strategy group at RTI-HS. Ms. Police primarily focuses on writing and developing systematic and targeted literature reviews, manuscripts, Academy of Managed Care Pharmacy (AMCP) dossiers and global value dossiers (GVDs), health technology assessments, physician and patient surveys, and time-and-motion studies. She also has experience moderating focus groups and conducting in-depth interviews among a broad range of physician types and health care payer organizations. Her therapeutic area background includes work in multiple sclerosis, metastatic breast cancer, anemia, fibromyalgia, osteoarthritis, HIV/AIDS, hypertension, chronic obstructive pulmonary disease, prostate cancer, chronic leukemia, bladder cancer, women's health issues, myelofibrosis, advanced macular degeneration, chronic pain, and health information technology. Prior to her career in outcomes research, Ms. Police worked as a health care consultant advising hospitals and health systems on strategic, clinical, and operational issues. She has also spent time as a health policy analyst at a nonprofit research group in Washington, DC. Ms. Police's work has been recently published in Informatics in Primary Care, and recent work has been presented at the American Academy of Pain Management and the American Pain Society.

 

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Catherine Rycroft

PhD, Microbiology
BSc, Food Science
University of Reading, Reading, UK

Catherine Rycroft, PhD, is an Associate Director in the Market Access and Outcomes Strategy group at RTI-HS involved in preparing value dossiers; submissions for the National Institute for Health and Clinical Excellence (NICE), the Scottish Medicines Consortium (SMC), and the National Centre for Pharmacoeconomics (NCPE); systematic literature reviews; burden of illness reviews; and gap analyses. Dr. Rycroft has 10 years of experience in scientific research, medical communications, and health outcomes. She has experience in a range of disease areas, including cardiovascular disease, depression, anxiety, multiple sclerosis, osteoporosis, chronic obstructive pulmonary disease, Crohn’s disease, breast cancer, diabetes, and influenza. Before joining RTI-HS, Dr. Rycroft was a medical writer at Prime Medica Limited, where her responsibilities included the communication of scientific information in a range of therapy areas through primary manuscripts, reviews, meeting reports, abstracts, posters, slide sets, competitor monitor reports, and newsletters. Previously, she was a senior research scientist at a biotechnology company, where she studied novel antifungal drug targets. In addition, Dr. Rycroft has published her work in several books and journals, including Current Medical Research and Opinion, the Journal of Applied Microbiology, and the Journal of Medical Economics.

 

 

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Allan Scott

MSc (in progress)
London School of Economics and Political Science, London, UK

MHA
BA, Economics
University of North Carolina at Chapel Hill, Chapel Hill, NC

Allan Scott, MHA, is Director of Market Access and Outcomes Strategy at RTI-HS. In this role, he assists clients with developing and implementing market access strategies for their pharmaceutical product offerings in Australia, Europe, and the United States. Prior to joining RTI-HS, Mr. Scott led pricing and reimbursement research for the boutique consulting firm Thought Leader Select, LLC. Mr. Scott’s in-depth understanding of health insurance and the role that third-party payers play in the global health care system grows out of his years of experience in the Blue Cross Blue Shield system, most recently as a Senior Manager at Blue Cross Blue Shield of Tennessee. Mr. Scott is a Certified Health Consultant (CHC) by the Blue Cross and Blue Shield Association and holds the “Professional” designation from the Academy for Healthcare Management (AHM).

 

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Catherine Siersma

Master Certificate in Applied Project Management
Villanova University, Philadelphia, PA

BS, Zoology
Michigan State University, East Lansing, MI

Catherine Siersma is a Project Manager in the Market Access and Outcomes Strategy (MAOS) group at RTI-HS. Ms. Siersma is responsible for preparing for the project kickoff, organizing the project meeting schedule, maintaining project timelines, and ensuring team members stay on budget. She also is responsible for setting up consultant contracts and invoicing, both to clients and consultants or subcontractors. In addition, Ms. Siersma serves in a project administrative capacity internally to the MAOS team to draft proposals and track workload capacity. She also has experience working on projects with the Patient-Reported Outcomes team within RTI-HS.

Ms. Siersma came to RTI-HS from Pfizer, where she was a Project Manager and Scientist, with the responsibilities of maintaining project plans, templates, and departmental resource data, and acting as a liaison between scientists and project management.

 

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A. Brett Hauber

PhD, Economics
MA, Economics
University of Delaware, Newark, DE

Bachelor of Business Administration (summa cum laude)
Temple University, Philadelphia, PA

A. Brett Hauber, PhD, is Senior Economist and Vice President of Health Preference Assessment at RTI-HS. He has more than 10 years of academic, research, and government experience in health and environmental economics. His primary area of specialization is discrete-choice analysis of revealed- and stated-preference data. He also has extensive experience in conducting benefit-risk analysis of patients and other health care decision makers and in estimating health-state utilities. His most recent applied work has included discrete-choice experiments of patient and physician benefit-risk preferences for treatments for conditions, including Alzheimer’s disease, HIV, vasomotor symptoms, Crohn’s disease, idiopathic thrombocytopenia purpura, type 2 diabetes, and irritable bowel syndrome. He has also studied the theoretical and empirical relationships among various health utility measures. Dr. Hauber regularly teaches courses on conjoint analysis and health-state utility estimation. Dr. Hauber’s research has been published in numerous health and medical journals, including Value in Health, Pharmacoeconomics, Quality of Life Research, Journal of Women’s Health, Medical Care, Clinical Therapeutics, ISPOR Connections, The Patient, Supportive Care in Cancer, AIDS Patient Care and STDs, and Alzheimer Disease and Associated Disorders.

 

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Angelyn Otteson Fairchild

BA with University Honors, Economics
Brigham Young University, UT

Angelyn Fairchild is an Associate Research Economist with RTI-HS. Ms. Fairchild assists in developing and analyzing models to elicit patients’ preferences for health interventions. Ms. Fairchild has previously worked as a country director for HELP International in Uganda, and subsequently served as the organization’s evaluation supervisor. Ms. Fairchild was a teaching assistant for health economics, public economics, and introductory economics at Brigham Young University. As a research assistant at Brigham Young University, she studied the impact of insurance regulations on birth outcomes, and she conducted a study of community-based health insurance in rural Cambodia that was later published as an undergraduate thesis as required for graduation with University Honors.

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PhD, Agricultural and Resource Economics
Colorado State University, Fort Collins, CO

MS, Resource Economics
University of Nevada, Reno, NV

BA, Economics and Finance
Universidad de Puerto Rico, Río Piedras, Puerto Rico

Juan Marcos Gonzalez, PhD, is a Research Economist at RTI-HS. Dr. Gonzalez has developed valuation models that bring together revealed- and stated-preference methods to deal with shortcomings of each data type. His models have been used to assess the value of access to recreational sites in El Yunque National Forest (formerly Caribbean National Forest), Puerto Rico. They have been used for similar valuation efforts along the Snake River area in Jackson Hole, Wyoming, and Off-Highway Vehicles Parks in North Carolina.

As part of the Puerto Rico Biocomplexity Project, sponsored by the National Science Foundation, Dr.Gonzalez helped develop recreational visitors’ behavioral rules. These rules were used in the creation of a regional SWORM model designed to look at interactions among humans, forest biota, and hydrologic components of two river basins in the northeastern part of Puerto Rico.

In the past, Dr. Gonzalez worked for the Tourism Development Fund (TDF), a branch of the Puerto Rico Government Development Bank. During his time there, he helped in the creation of the fund’s private financing credit ranking system.

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F. Reed Johnson

PhD, Economics
MA, Economics
State University of New York, Stony Brook, NY

BA, Economics
Occidental College, Los Angeles, CA

F. Reed Johnson, PhD, has more than 35 years of academic and research experience in health and environmental economics. He has served on the faculty of several universities in the United States, Canada, and Sweden. As a staff member in the US Environmental Protection Agency’s environmental economics research program during the 1980s, Dr. Johnson helped pioneer development of basic nonmarket valuation techniques. These techniques are now widely used for cost-benefit analysis in health and environmental economics. He has designed and analyzed numerous surveys for measuring willingness to pay for health-risk reduction and improved environmental quality. He also has developed and researched various value elicitation methods, including direct questions, discrete choice, graded pairs, and other approaches. Dr. Johnson has extensive experience in using advanced statistical techniques to analyze censored, truncated, and discrete survey data.

Dr. Johnson has over 100 publications in books and peer-reviewed journals. His research has been published in various clinical journals, the Review of Economics and Statistics, Journal of Health Economics, Medical Decision Making, Health Economics, Value in Health, Journal of Environmental Economics and Management, Journal of Policy Analysis and Management, Land Economics, and other journals. He has coauthored a book on techniques for using existing environmental and health value estimates for policy analysis. His current research involves estimating general time equivalences among health states and patients’ willingness to accept side-effect risks in return for therapeutic benefits.

 

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BA, Economics
BS, Mathematics
The University of Chicago, Chicago, IL

Vikram Kilambi is an Associate Research Economist at RTI-HS. Mr. Kilambi assists with developing and analyzing models to elicit patients’ preferences for health interventions.

In the past, Mr. Kilambi worked in economic consulting and helped model market structures for antitrust litigation in the Internet services, telecommunications, and insurance industries. He also served as a Research Assistant and helped conduct economics research about HIV in sub-Saharan Africa.

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Ateesha Farah Mohamed

MA, Applied Economics & Policy Analysis
North Carolina State University, Raleigh, NC

BA, Business Economics
College of Wooster, Wooster, OH

Ateesha Mohamed, MA, Senior Research Economist at RTI-HS, has 12 years of experience in research economics. She was invited as a Visiting Scholar to the Johns Hopkins Bloomberg School of Public Health in 2012. With respect to health economics, she has worked on discrete-choice experiments to investigate patients' and physicians' treatment preferences in several therapeutic areas, including Alzheimer's disease, HIV, type 2 diabetes, cancer, osteoporosis, osteoarthritis, hepatitis B, hepatitis C, asthma, obesity, migraines, hemophilia, antiplatelet therapies, genetic testing, kidney transplants, and vaccine-preventable diseases. She has experience in survey development, experimental design, data analysis, and report writing. With respect to environmental economics, she specialized in natural resource damage assessment, property value diminution, and travel cost models of recreation demand. Ms. Mohamed's research has been published in Health Economics, Pharmacoeconomics, AIDS Patient Care and STDs, Quality of Life Research, The Patient, Haemophilia, Journal of Viral Hepatitis, Vaccine, Journal of Rheumatology, Diabetic Medicine, European Journal of Gastroenterology & Hepatology, Lung Cancer, Alzheimer's Disease and Associated Disorders, Supportive Care in Cancer, and Land Economics. Her research has been presented at various professional conferences, including the International Society for Pharmacoeconomics and Outcomes Research, American Society of Health Economists, Conjoint Analysis in Health, American Society of Clinical Oncology, Hemophilia World Congress, European AIDs Conference, American Academy of Allergy, Asthma, and Immunology, and American Academy of Neurology meetings.

 

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PhD, Public Policy
University of North Carolina, Chapel Hill, NC

BA, Environmental Studies
University of Rochester, Rochester, NY

Christine Poulos, PhD, is a Senior Research Economist in RTI-HS. Dr. Poulos has more than 10 years of academic, government, donor, and commercial experience in health and environmental economics. Her area of expertise is survey research to support the assessment of preferences, willingness to pay and demand for products and services, cost-benefit analyses, and impact evaluation studies to support health and environmental policy decision making. She has directed research projects funded by the World Bank, the Acumen Fund, PATH, the International Vaccine Institute, the US Environmental Protection Agency, and the Coastal Response Research Center. She has led or participated in survey research in the United States, Ethiopia, Bangladesh, Vietnam, China (Hebei and Guangxi provinces), Indonesia, and India (in the city of New Delhi and the states of Andhra Pradesh, Maharashtra, and Orissa). Her most recent work has included conjoint studies of preferences for HPV vaccines in the United States and Vietnam, and for household water treatment products in India. Dr. Poulos has published her research in peer-reviewed journals, including Health Policy and Planning; Value in Health; Bulletin of the World Health Organization; Journal of Development Economics; Environmental Science and Technology; Resource and Energy Economics; Journal of Health, Nutrition, and Population; and the Journal of Water and Health.

 

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MEM, Resource Economics and Policy
Duke University, Durham, NC

BS, Environmental Science (summa cum laude)
Tunghai University, Taichung, Taiwan

Jui-Chen Yang, MEM, is a Research Economist in the Health Preference Assessment group at RTI-HS. She has 9 years of experience in conducting socioeconomic evaluation of health, environmental, and resource programs and policies for various federal government agencies, Acumen Fund, Inc., the Asian Development Bank (ADB), PATH, and the World Bank. Her most recent work has included (1) assessing household demand for HPV vaccines in Vietnam, for water treatment and storage products in India, and for improved water and sanitation services in Nepal and Sri Lanka using stated preference methods; and (2) estimating health and socioeconomic impacts of improvements in water and sanitation sector in India. Ms. Yang also coauthored a guideline paper to assist ADB project officers in implementing stated preference studies (i.e., contingent valuation and conjoint analysis) in preparation of rolling out large-scale water supply and sanitation projects. She has been involved in several program evaluation studies using randomized and quasi-experimental research designs in the water and sanitation sector, and has played instrumental roles in the design and implementation of large-scale surveys, including extensive fieldwork in India, Sri Lanka, and Vietnam. In the past, she conducted analyses for EPA-funded studies on children’s asthma and ground-level ozone exposure in the United States, as well as several meta-analyses of valuation of water quality improvements, valuation of avoided morbidity events, and forestry and agroforestry technology adoption. In addition, Ms. Yang has reviewed manuscripts using contingent valuation on environmental health and environmental services in Asia, and has published her work in Health Economics, Bulletin of the World Health Organization, Journal of Water and Health, Water Resources Research, Water Policy, Land Economics, Forest Policy and Economics, and Agroforestry Systems.

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Jing Zhang

PhD, Agricultural and Resource Economics
University of Alberta, Canada

MSc, Natural Resource Management
University of Western Australia, Australia

MA, Management
BA, Economics
Huazhong Agricultural University, China

Jing Zhang, PhD, is a Research Economist at RTI-HS and an adjunct professor at the Department of Bioresource Policy and Business and Economics at the University of Saskatchewan in Canada. Dr. Zhang has nearly 10 years of research experience using stated preference methods to elicit individuals’ preferences for nonmarket goods and services. She has developed expertise in choice-experiment design and discrete-choice modeling. She worked as an assistant professor for 3 years at the Department of Bioresource Policy and Business and Economics before she joined the Health Preference Assessment unit at RTI-HS. Her previous work has been focusing on investigating consumer preferences for novel food, and her future research will involve estimating patient preferences for alternative medications or treatments using conjoint analysis. Dr. Zhang has published papers at Land Economics, Journal of Environmental Economics and Management, Journal of Agricultural Economics, and Empirical Economics.

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Susana Pérez-Gutthann

MD, PhD
Universitat de Barcelona, Barcelona, Spain
MPH, Postdoctoral Fellowship
Johns Hopkins University, Baltimore, MD, USA

Susana Pérez-Gutthann, MD, MPH, PhD, FISPE, FRCP, is Vice President and Global Head of Epidemiology at RTI-HS. Dr. Pérez-Gutthann holds medical and doctoral degrees from the University of Barcelona, and a Master of Public Health with a concentration in epidemiology from Johns Hopkins University. Her prior positions include Global Head of epidemiology at Pharmacia, Novartis, and Ciba-Geigy; European Head of Epidemiology at Pfizer; and a postdoctoral fellow in the Division of Clinical Epidemiology at Johns Hopkins. Dr. Pérez-Gutthann has over 20 years of experience in the research-driven international pharmaceutical environment, developing and leading teams of epidemiologists and driving strategy and research programs for safety, pharmacovigilance, risk management, development, and regulatory activities applying public health and epidemiologic methods.

Dr. Pérez-Gutthann is an active leader and past president of the International Society of Pharmacoepidemiology (ISPE) and a member of the Steering Committee of the European Medicines Agency European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). She is a fellow of ISPE and of the Royal College of Physicians, Edinburgh. She is invited to teach in academic programs (most recently the London School of Hygiene and Public Health) and to speak and chair conferences and symposia, which have included the Drug Information Association (DIA), the Organisation for Professionals in Regulatory Affairs (TOPRA), the Australian National Prescribing Service Symposium, the Asian Pacific Regulatory Safety Sciences Meeting, the International Conference of Pharmacoepidemiology and Risk Management, and the World Congress of Pharmacology and Clinical Therapeutics. Dr. Pérez-Gutthann's roles as an advisor and in international working groups have included ENCePP research guidance, World Health Organization (WHO) research for diseases of poverty TDR Product Development and Evaluation, International Scientific Advisory Board to the Medicines and Healthcare Products Regulatory Agency (MHRA) General Practice Research Database, ISPE Working Groups on Risk Management Guidances (Food and Drug Administration, European Medicines Agency), Good Pharmacoepidemi­ology Practice, and confidentiality of patient databases in Europe. She has been on working groups on gastrointestinal complications associated with nonsteroidal anti-inflammatory drugs, the International Medical Benefit Risk Foundation (IMBRF) on drug-induced disease, and hormone replacement therapy and breast cancer risk. Currently, Dr. Pérez-Gutthann serves as a member and chair of several scientific advisory boards for studies, research programs, and strategic and regulatory risk management topics.

A list of Dr. Pérez-Gutthann's publications can be found at: http://www.rti.org/experts.cfm?objectid=5971D658-69DC-4124-99379250F1A7A84B

 

 

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Elizabeth B. Andrews

PhD, Epidemiology
MPH, Health Policy and Administration, North Carolina School of Public Health
BA
University of North Carolina, Chapel Hill, NC

Elizabeth Andrews, PhD, is the Vice President of Pharmacoepidemiology and Risk Management at RTI-HS. She provides consultation for pharmaceutical companies and the US Food and Drug Administration (FDA) on therapeutic risk management and pharmacoepidemiology, and she directs research programs that evaluate drug safety and compliance with prescribing and treatment guidelines. She oversees the conduct of large, prospective patient registries, Web-based surveys, and studies using large existing databases. Dr. Andrews currently serves as principal investigator on several large risk management studies, and serves on various study advisory boards and data safety monitoring boards. Her experience has spanned most therapeutic areas, although she has worked extensively in the areas of HIV and sexually transmitted diseases; birth defects and neonatal health; asthma and chronic obstructive pulmonary disease; and irritable bowel syndrome. Dr. Andrews is involved in the design of observational research programs within RTI-HS to assure that the methods chosen provide a robust and cost-effective approach to address the study questions and to assure appropriate linkages are forged with academic and governmental partners.

Previously, Dr. Andrews was Vice President, Worldwide Epidemiology, at GlaxoSmithKline and conducted epidemiologic research in a variety of therapeutic areas, including rheumatoid arthritis, genital herpes, HIV, asthma, migraine, and irritable bowel syndrome. She initiated the first pharmaceutical pregnancy registry, the Acyclovir Pregnancy Registry, and multiple registries for other medications. She began her career in the pharmaceutical industry at Burroughs Wellcome in 1982 and subsequently built a strong international epidemiology program at Glaxo Wellcome. Prior to joining Burroughs Wellcome, she managed the Statewide Regionalized Perinatal Care Program and directed the non-Medicaid health care reimbursement programs for the State Health Department of North Carolina.

She is a Fellow and Past President of the International Society for Pharmacoepidemiology, and coeditor of Pharmacovigilance. She is an Adjunct Associate Professor of the University of North Carolina School of Public Health and School of Pharmacy, and a member of the Scientific Advisory Board Observational Medical Outcomes Partnership.

 

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Christine L. Bui, MPH
MPH
Yale University School of Medicine, New Haven, CT
BS, Biology and Society
Cornell University, Ithaca, NY
Christine L. Bui, MPH, is a Research Epidemiologist within the Epidemiology Research Group at RTI HS. She has experience as a clinical research coordinator and project manager for a variety of large clinical and epidemiologic research projects, both domestically and internationally. Her primary areas of interest are cancer epidemiology and behavioral/social epidemiology. Ms. Bui has managed large, multiyear, multisite prospective cohort studies funded by the National Cancer Institute and Department of Defense. She also has experience working in a quality improvement and research setting, providing her with practical knowledge of quality assurance, clinical intervention studies, and disease management programs.
Ms. Bui has experience supervising multidisciplinary teams involved in complex study designs. She has considerable experience in assuring the protection of human subjects. In addition, she has experience coordinating information across multiple research collaborators. She has provided oversight for the operational direction of large study components and their implementation in the field, and for the development of field procedures and data collection tools.

 

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Brian Calingaert

MS, Biostatistics
University of North Carolina, Chapel Hill, NC

Master of Biomath
North Carolina State University, Raleigh, NC

BA, Economics
University of North Carolina, Chapel Hill, NC

Brian Calingaert, MS, MBMA, is an Epidemiology Analyst in the Pharmacoepidemiology and Risk Management division of RTI-HS. His principal area of therapeutic experience is oncology, but he has worked in several other therapeutic areas, including osteoporosis, asthma, and cardiovascular disease. He has experience in data management and analysis, creation of statistical analysis plans, and production of tables, listings, reports, and manuscripts for numerous epidemiologic studies. He has also worked extensively in the analysis of observational studies, including building statistical models using logistic regression and proportional hazards regression. Another area of specialty is Risk Evaluation and Mitigation Strategy (REMS) surveys for which he regularly develops statistical analysis plans and serves as lead analyst. Mr. Calingaert has been involved in large multisite data collaborations, including managing the epidemiologic data for 18 studies that comprise the international Ovarian Cancer Consortium (OCAC). Mr. Calingaert’s research experience covers a broad range of topics, and he has published extensively, with articles appearing in 25 different peer-reviewed journals.

Prior to joining RTI-HS, Mr. Calingaert was a Senior Statistician in the Epidemiology Program at the Duke Comprehensive Cancer Center, where he worked for 9 years. He also previously worked at RTI International as a Research Economist in pharmacoeconomics.

 

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Jordi Castellsague

MPH
Yale University School of Medicine, Department of Epidemiology and Public Health, New Haven, CT, USA

MD
School of Medicine, Autonomous University, Barcelona, Spain

Jordi Castellsague, MD, MPH, is a Director of Epidemiology at RTI-HS. Dr. Castellsague has 11 years of research experience in pharmacoepidemiology in the international pharmaceutical setting, 4 years in respiratory and environmental epidemiology, and 7 years of clinical practice. Dr. Castellsague has led safety research and strategy for products in development and marketed drugs driving epidemiologic, pharmacovigilance, and risk management plans; he has conducted pharmacoepidemiologic studies on the natural history of disease, and the use and safety of medications in the general population. He has coordinated regulatory safety epidemiologic activities in the area of COX-2 inhibitors, including the preparation of the Food and Drug Administration advisory committee and the European Medicines Agency oral hearings. Dr. Castellsague has produced epidemiologic research in the areas of asthma and chronic obstructive pulmonary disease, allergic rhinitis, liver injury, renal failure, serious skin disorders, gastroenterology, and cardiology related to a variety of products, including COX-2 inhibitors and nonsteroidal anti-inflammatory drugs, monoclonal antibodies, inhaled bronchodilators, oral antifungals, and hormone replacement therapy. He has coordinated and participated as an investigator in several international, multicenter epidemiologic field studies in the areas of asthma and chronic obstructive pulmonary disease.

 

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Carla Franzoni

BS, Biology
Universitat Autònoma de Barcelona, Barcelona, Spain

Carla Franzoni is a Senior Project Administration Specialist at RTI-HS. Ms. Franzoni holds a bachelor’s degree in Biology with a specialty in microbiology from the Autonomous University of Barcelona, and a certificate in Computer Information Systems from Portland Community College. Prior to joining RTI-HS, she worked as a project and team coordinator at Pfizer Global Epidemiology, coordinating the legal and financial aspects of epidemiological studies, analyzing cost data to support business decisions, and monitoring compliance functions in key areas such as Good Epidemiological Practice, Patient Data Privacy and Confidentiality, and Inspection Readiness. Former positions include laboratory technologist at Wheat Marketing Center, sales administrator at ASGA, and research assistant at the microbiology department at the University of Barcelona.

 

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PhD, Epidemiology
MS, Pharmacy Administration
BS, Pharmacy
University of North Carolina, Chapel Hill, NC

Alicia Gilsenan, PhD, is a Senior Director of Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management. Since joining RTI in 1997, she has applied state-of-the-art approaches to the design, conduct, and analysis of both retrospective and prospective epidemiologic studies focused on evaluating disease natural history and incidence of and risk factors for adverse outcomes potentially associated with use of medications. She has directed multidisciplinary international teams for large primary data collection studies in the United States and Europe. Currently she leads an international safety surveillance study and a US-based patient registry that are both part of a mandated risk management program and is involved in several Risk Evaluation and Mitigation Strategy (REMs) projects. Dr. Gilsenan has also led retrospective database studies designed to examine differences in risk factors and health care resource utilization between subgroups. She has led and conducted systematic reviews of the literature. Dr. Gilsenan has published within multiple therapeutic areas, including mental health, oncology, sexual functioning, cardiovascular health, respiratory health, and smoking cessation.

 

 

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MPH
University of Texas School of Public Health, Houston, TX

BSc
School of Nursing, Universidad Nacional de Colombia, Bogotá, Colombia

Lia Gutiérrez, MPH, BSc, is a Director of Epidemiology at RTI-HS. Ms. Gutiérrez has more than 10 years of clinical and epidemiologic research experience in various epidemiology departments of multinational pharmaceutical companies. Prior to joining the pharmaceutical industry, she held clinical and research positions at MD Anderson Cancer Center in Houston. Her focus in epidemiology research has encompassed various therapeutic areas, including oncology, endocrinology, and bone metabolism. She has expertise in the design and implementation of registry studies involving several international sites and in leading communications with health authorities for regulatory mandated studies. Ms. Gutiérrez has been in charge of the preparation of epidemiologic reports for orphan drug applications and other key regulatory submissions and for the implementation of safety evaluations and risk management activities during the pre- and postapproval phases of drug development.

Her primary research areas of interest include studies on disease natural history, evaluation of cancer-related outcomes associated with the use of drugs, and drug-safety epidemiology in general.

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Abenah Harding

MPH, Maternal & Child Health
BA, Sociology
University of North Carolina, Chapel Hill, NC

Abenah Harding, MPH, is a Research Epidemiologist with the Epidemiology Research Group within RTI-HS. Ms. Harding has expert project management, data management, and data analysis skills. She has over 8 years of research experience focusing on data management and epidemiological research. Ms. Harding has experience managing numerous types of data such as survey, vital statistics, and biochemical data. Her data management skills encompass all stages of the data management process from receipting of completed survey forms to analysis of the final analytical data file. Ms. Harding has experience with a variety of research areas, including maternal, perinatal, and child health; Native American health; occupational health; and asthma. She also has experience with literature reviews and preparing manuscripts for publication.

 

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David Harris

MPH, Epidemiology
San Diego State University, San Diego, CA

 

BS, Biology
California State University Sacramento, Sacramento, CA

 

Certificate of Advanced Business Studies
California State University Sacramento, Sacramento, CA

 

David H. Harris, a Research Epidemiologist II within the Epidemiology Research Group of RTI-HS, has approximately 12 years of experience in the public health field, mainly in the field of cancer and cancer registration. He has experience in probabilistic data linkage design and execution, database production, data manipulation, statistical analysis, and report and publication editing and writing. Additionally, Mr. Harris has experience in the areas of health information exchange and health information technology, specifically in the areas of privacy and security of electronic data. Mr. Harris also has experience collaborating with external investigators on numerous projects, managing multiple subcontractors and their deliverables for a research project, and working with state cancer registries. Mr. Harris has significant experience in all aspects of proposal development and has also prepared several study training manuals and implementation guides. He has presented both oral and poster presentations at a variety of national and international conferences and has traveled extensively for project work.

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Catherine B. Johannes

PhD, Epidemiology
Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD

MS, Microbiology
Harvard University School of Public Health, Boston, MA

BS, Biology
Florida State University, Tallahassee, FL

Catherine (Kay) Johannes, PhD, is a Director of Epidemiology at RTI-HS. She has considerable experience in the design, conduct, analysis, and reporting of epidemiologic studies and has over 9 years of experience in the field pharmacoepidemiology.

Dr. Johannes has experience with the use of large health care claims databases to conduct drug safety and background epidemiological research, including the development of claims-based disease algorithms and validation of outcomes using medical records. She has experience in a number of clinical areas, including rheumatoid arthritis, fracture, diabetes, cardiovascular disease, chronic pain, and sexual function. She also is experienced with the conduct of targeted literature reviews and primary data collection, including telephone, mailed, in-person, and Web-based surveys.

Before joining RTI-HS, Dr. Johannes worked as a pharmacoepidemiologist for a large health insurance company. She also worked for a research organization and was involved with the design, analysis, reporting, and management of several population-based longitudinal studies of aging men and women funded by the National Institutes of Health. Her areas of expertise included the menopausal transition, erectile dysfunction, sexuality in aging adults, and hormone therapy, and the development of data collection software for recording daily information about headache and menstrual cycle symptoms. Before receiving her PhD, Dr. Johannes worked for a number of years in the field of hospital infectious disease epidemiology.

 

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MD Stanford University Schoolof Medicine, Stanford, CA DrPH (Epidemiology)
Harvard School of Public Health, Boston, MA

James Kaye, MD, DrPH, is a medical oncologist/hematologist, epidemiologist, and Director of Epidemiology at RTI-HS. After graduating from medical school, Dr. Kaye completed an internship and residency in internal medicine at the Beth Israel Hospital in Boston and a fellowship in medical oncology/hematology at the Dana-Farber Cancer Institute. Dr. Kaye remained on the faculty in the Department of Medicine at Harvard Medical School for the next 5 years while practicing medical oncology/hematology and coordinating the clinical research program at Harvard Community Health Plan.

In 1991, Dr. Kaye joined the clinical development group at Genetics Institute, Inc. (later Wyeth, now Pfizer) where he directed clinical trials on several hematology/oncology products, two of which were approved for marketing, and participated in numerous Food and Drug Administration interactions, including investigational new drug (IND) and biologic license application (BLA) submissions, advisory committee presentations, and label negotiations.

Dr. Kaye subsequently completed doctoral training in epidemiology, where his research focused on pharmaceuticals and cancer risk. During the following decade, he was senior epidemiologist at the Boston Collaborative Drug Surveillance Program and a faculty member at Boston University School of Public Health, where he continues to serve as adjunct associate professor of epidemiology. Dr. Kaye joined RTI-HS in 2009, where he conducts pharmacoepidemiology research on a variety of postmarketing safety issues. He has chaired or participated in numerous independent data monitoring committees for clinical trials of drugs with cancer or hematologic diseases as target indications and consults on the development and evaluation of new pharmaceuticals in these areas as well as on the assessment of cancer-related safety issues for drugs with other indications. Dr. Kaye has authored more than 50 articles in the peer-reviewed medical literature.

 

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MPH, Epidemiology
Emory University, Atlanta, GA

BS, Mathematics
Salem College, Winston-Salem, NC

Amy Ladner, MPH, is a Senior Research Epidemiologist within the Epidemiology Research Group at RTI-HS. She has experience as a project director and manager for epidemiologic research projects domestically and internationally. Her primary area of interest is cancer epidemiology. Ms. Ladner has managed large longitudinal studies for the National Institute of Child Health and Human Development and National Institute of Aging. She also has experience working on a variety of safety studies ranging from active surveillance approaches for signal detection to retrospective database analyses. Ms. Ladner also has been involved in risk evaluation and mitigation strategy (REMS) projects.

Ms. Ladner has broad experience supervising multidisciplinary teams involved in complex study designs. She has experience developing study protocols and with all aspects of data collection, including questionnaire development, patient and site recruitment, investigator and interviewer training, biospecimen collection, data management and data quality control, and reporting. She has provided oversight for the technical direction of large study components and their implementation in the field, and for the development of field procedures manuals.

 

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ScD, Epidemiology & Biostatistics
MPH, Epidemiology & Biostatistics
Boston University School of Public Health, Boston, MA

BA, Psychology, cum laude
Brandeis University, Waltham, MA

Lee Lanza, MPH, ScD, is a Director in Epidemiology at RTI-HS. She has more than 25 years of experience in designing, conducting, analyzing, and reporting epidemiologic studies. Dr. Lanza is particularly experienced in postmarketing drug safety surveillance and use of large automated insurance claims databases for safety studies.

Dr. Lanza worked for 2 years at Ingenix, Epidemiology Division in studies describing health care utilization for overactive bladder, atopic dermatitis, and erectile dysfunction. At Decision Resources Inc., she developed and led a team of epidemiologists who produced more than 50 reports per year describing major drug indications and estimating incidence, prevalence, and trends in the United States, Europe, and Japan. There she focused on the descriptive epidemiology of cognitive disorders such as anxiety, depression, bipolar disorder, insomnia, and mild cognitive impairment. Prior to this, she worked for 12 years at Epidemiology Resources Inc. in occupational and drug safety epidemiology. There she conducted and authored reports from a study of gastrointestinal safety of nonsteroidal anti-inflammatory drugs and a study of mortality and suicide risk in users of clozapine.

Dr. Lanza entered the field of epidemiology working at the Vincent Memorial Hospital and Massachusetts General Hospital in three studies of cancer risk following prenatal exposure to the drug diethylstilbestrol. She coauthored a study of breast cancer risk in mothers who received this drug during pregnancy. Published reports of Dr. Lanza’s work appeared in the Archives of Internal Medicine, Epidemiology, and New England Journal of Medicine.

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Andrea V. Margulis, MD ScD

ScD, Epidemiology
ScM, Epidemiology
Harvard University, Boston, MA, USA

Summer Institute in Reproductive and Perinatal Epidemiology
National Institute of Child Health and Human Development (USA) and Institute of Human Development, Child and Youth Health (Canada), Montreal, Canada

Specialist in Pediatrics
MD
Universidad de Buenos Aires, Buenos Aires, Argentina

Andrea V. Margulis, MD ScD, is a specialist in pediatrics and a Senior Research Epidemiologist at RTI-HS, located in Barcelona, Spain. During her residency in pediatrics at the Children's Hospital Ricardo Gutierrez in Buenos Aires, Argentina, she conducted research on the effectiveness of medical training for specific common procedures among residents, and joined the Division of Epidemiology to work on clinical epidemiology. After completing her clinical training, she moved to Boston, Massachusetts, USA, to pursue a doctoral degree in epidemiology with focus on pharmacoepidemi­ology at Harvard School of Public Health. There, she was a teaching fellow in several graduate-level epidemiology and biostatistics courses; she also worked as a research fellow at the Brigham and Women's Hospital's Division of Pharmacoepidemiology and Pharmacoeconomics. She did her postdoctoral training at the Center for Drug Evaluation and Research in the US Food and Drug Administration. Dr. Margulis has conducted research using claims, electronic medical record, and registry data from North America and Europe. She has experience in meta-analysis, case-control, and cohort studies and has worked on drug utilization and drug safety in pregnancy, methodological aspects of drug safety in pregnancy, validation of gastrointestinal and neonatal outcomes, and physicians' prescribing preferences in acute myocardial infarction.

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Lisa J. McQuay

Master of Bioinformatics
North Carolina State University, Raleigh, NC
Phi Kappa Phi, Golden Key International Honour Society

BS, Biology
University of North Carolina, Chapel Hill, NC
Degree awarded with distinction, with highest honors in biology
Phi Eta Sigma, Phi Beta Kappa

Associate Degree, Computer Programming
North Carolina State University, Raleigh, NC

C/C++ Programming Language Certificate, Durham Technical Community College, Durham, NC

Lisa McQuay is a Senior Research Epidemiologist who assists in the design and conduct of epidemiologic and health outcomes studies for the Pharmacoepidemiology and Risk Management division of RTI-HS. Her primary responsibilities include database management and statistical analysis, as well as protocol and analysis plan development, project management, and report/manuscript writing. Prior to joining RTI-HS, she was a Principal Programmer/Analyst in the Worldwide Epidemiology department at GlaxoSmithKline (GSK), where she provided analytic support for studies that utilized data from clinical trials, population-based survey databases (e.g., NHIS and NHANES III) and large observational databases (e.g., LNEI administrative claims and the UK’s General Practice Research Database [GPRD]).

Over the course of more than 20 years of health care–related research experience, Ms. McQuay has gained a particular expertise in the management and analysis of large longitudinal databases. She has acquired expert SAS skills on multiple platforms, and has a strong background in computer science and systems management. Many of the projects on which she has worked at both GSK and RTI-HS were focused on the respiratory therapeutic area; however, she has worked within a wide range of clinical/therapeutic areas, including infectious disease (HIV/AIDS, influenza), rheumatology/immunology, orthopedics (TKR), gastrointestinal disease (IBS), cardiovascular disease (stroke, severe arrhythmia, sudden cardiac death), metabolic disease (diabetes, hyperlipidemia), mental health, and substance abuse.

 

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Kirk Midkiff

MPH, Epidemiology
University of New Mexico, Albuquerque, NM

BA, Human Biology
University of Kansas, Lawrence, KS

Kirk Midkiff, MPH, is a Director of Epidemiology within RTI-HS. He has experience as a project director and manager for a variety of clinical and epidemiologic research projects domestically and internationally. His primary area of interest is cancer epidemiology. Mr. Midkiff has managed and contributed to the technical direction of large multiyear, multisite prospective cohort studies for the National Cancer Institute. He also has experience working on a variety of safety studies ranging from active surveillance approaches for signal detection to retrospective database analyses.

Mr. Midkiff has considerable experience supervising large multidisciplinary teams involved in complex study designs. He has broad experience developing study components while harmonizing the information received from multiple stakeholders. He has provided oversight for the development of various research pieces, including study protocols, statistical analysis plans, and study reports, and played a key role in dissemination of the research findings. Mr. Midkiff has also provided oversight for field research implementation and the development of field procedures manuals and technical users’ guides. Mr. Midkiff has traveled extensively in order to coordinate and participate in national and international trainings and meetings, and for study initiation and auditing visits.

 

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Alejandro Arana

MD
School of Medicine, University of Zaragoza, Zaragoza, Spain

Specialist in Preventive Medicine and Public Health
University Hospital of Zaragoza and Department of Public Health, Government of Aragón, Zaragoza, Spain

MPH
Institute of Studies in Public Health, University of Valencia, Spain

MSc, Epidemiology
School of Medicine, Erasmus University, Rotterdam, The Netherlands

Alejandro Arana, MD, MPH, MSc, FISPE, is a Director of Epidemiology at RTI-HS. Dr. Arana has 16 years of experience in research in pharmacoepidemiology. He has strong experience in regulatory observational studies using different data collection methods in multiple therapeutic areas, including automated health databases. He has authored numerous articles and publications in scientific journals. Particular areas of expertise are neurosciences and epidemiology methods. He also has expertise applying preventive medicine and public health methods to risk management, developing risk minimization strategies, and providing risk minimization assessment evaluation.

Dr. Arana has lectured at the London School of Hygiene & Tropical Medicine, UK; the Universidad de Barcelona, Spain; the Universidad de Zaragoza, Spain; and the Université Saint Antoine, Paris, France. He has participated in several multinational projects addressing epidemiologic and pharmacoepidemiologic issues, including the EURODEM and EURODEP (European Community Concerted Action on the Epidemiology and Prevention of Dementia or Depression Group), the UN-AIDS (United Nations Project on Acquired Immunodeficiency Syndrome), and the North American Registry of Epileptic Pregnancies.

Dr. Arana is Fellow of the International Society for Pharmacoepidemiology (ISPE). From 2001 to 2011, he was member of the board of directors of the ISPE and cochair of the Industry Council of the Society. He currently chairs the methods working group of the European Network of Centers of Pharmacovigilance and Pharmacoepidemiology.

 

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Manel Pladevall-Vila

MS
School of Public Health, University of Texas, Health Science Center, Houston, TX, USA

 

MD
School of Medicine, Autonomous University, Barcelona, Spain

 

Manel Pladevall-Vila, MD, MS, is a Director of Epidemiology at RTI-HS. Dr. Pladevall-Vila has almost two decades of research experience. He has worked in the area of cardiovascular diseases with a focus on hypertension, diabetes, and medication adherence. He is been involved both in epidemiological studies and clinical trials as well as systematic reviews. He has worked with population-based surveys, registries, and field and automated databases studies. Completed research includes grants from National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Heart, Lung, and Blood Institute (NHLBI), the Spanish and Catalan governments, and several pharmaceutical companies. He has clinical experience as a hypertension specialist.

 

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Nuria Riera

PhD, Epidemiology
Heidelberg University, Germany

BS, Pharmacy
Barcelona University, Barcelona, Spain

Nuria Riera, PhD, is a Research Epidemiologist at RTI-HS. During her years as a pharmacy student, she conducted a student research project at the University of Bonn in the Department of Pharmaceutical Microbiology, gaining experience in different laboratory methods. Dr. Riera has experience in clinical pharmacy, including drug distribution, central cytostatic preparation, compounding of total parenteral nutrition, and therapeutic drug monitoring.

During her PhD, Dr. Riera acquired experience in the epidemiology of cardiovascular diseases and diabetes, as well as in the development of study protocols, data analysis, and laboratory methods. She has experience with large longitudinal studies from the German Cancer Research Center. She also has experience with literature reviews and preparing manuscripts for publication.

 

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DrPH
MPH
Harvard School of Public Health, Boston, MA

DMD
Harvard School of Dental Medicine, Boston, MA

AB
Colgate University, Hamilton, NY

Kenneth J. Rothman, DrPH, is a Distinguished Fellow and Vice President for Epidemiology Research at RTI-HS. He is also Professor of Epidemiology and Medicine at Boston University. His main career interest has been the development and teaching of the concepts and methods of epidemiologic research. He has authored or coauthored more than 250scholarly publications, most of which are original epidemiologic research studies. His research has spanned a wide range of health problems, including cancer, cardiovascular disease, neurologic disease, birth defects, injuries, environmental exposures, and adverse effects of pharmaceutical agents. In addition to publishing original research, he has devoted time to several other efforts related to the conduct of research. He has written extensively on ethical issues relating to the conduct of science. He regularly teaches intensive courses on epidemiologic research principles in the US and abroad. He has also dedicated a large proportion of his professional effort to editorial activities and publishing. He was the founding editor of the journal Epidemiology, and has served as Assistant Editor of the American Journal of Public Health, Editor of the American Journal of Epidemiology, a member of the Editorial Board of the New England Journal of Medicine and the International Advisory Board of the Lancet. He is a Past President of the Society for Epidemiologic Research, an Honorary Fellow of the American College of Epidemiology, Fellow and member of the Board of Directors and Fellow of the International Society for Pharmacoepidemiology. He has written two widely read epidemiologic textbooks: Modern Epidemiology, first published in 1986 by Little, Brown and Co., which is a comprehensive advanced text of epidemiologic methods, and Epidemiology: An Introduction, published in 2002 by Oxford University Press.

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MA, Medical Science
Boston University School of Medicine, Boston, MA

MPH, Epidemiology
Boston University School of Public Health, Boston, MA

BS, Behavioral Neuroscience
Northeastern University, Boston, MA

Catherine (Kate) Saltus, MA, MPH, is a Research Epidemiologist at RTI-HS. Ms. Saltus has clinical experience as a medical assistant and training as an EMT-Basic. In addition, she has worked in the hospital setting both to provide patient care and to conduct studies of clinical effectiveness. Her previous work as a data analyst for the Boston Public Health Commission’s Research and Evaluation Office included analysis, interpretation, and dissemination of local public health data. Ms. Saltus has been responsible for managing the daily operation of the Massachusetts Center for Birth Defects Research and Prevention, which includes a multistate birth defects surveillance network, and participation in the National Birth Defects Prevention Study (NBDPS).

Ms. Saltus’ prior research includes studies of cocaine addiction, chronic inflammatory disease and experimental treatments, and gender-based differences in health and disease.

 

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MPH, Epidemiology
University of North Carolina, School of Public Health, Chapel Hill, NC

PhD, Biology
MS, Biology
Case Western Reserve University, Cleveland, OH

BS, Zoology
University of Wisconsin, Madison, WI

Patricia Tennis, PhD, MPH, is Senior Director of Epidemiology at RTI-HS and was previously Senior Director of Safety Epidemiology at a large international pharmaceutical company, where she designed and implemented safety studies and risk management activities to evaluate medications within the therapeutic areas of neurology, psychiatry, respiratory, and metabolic diseases. Dr. Tennis was the lead epidemiologist on international pregnancy exposure registries. At RTI-HS and elsewhere, she has overseen the conduct of numerous epidemiology studies and participated in discussions of drug safety issues with regulatory agencies in the US, Canada, and Europe. She is a fellow of the International Society of Pharmacoepidemiology and has numerous publications. Dr.Tennis’s graduate education involved a minor in population genetics, and while within the pharmaceutical industry, she provided epidemiologic consultation for genetic studies. She brings to RTI-HS her decades of experience and expertise to clients facing issues of drug safety and risk management.

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PhD, Medicine, Cardiology Department
MD
Bachelor in Nursing, School of Nursing Santa Madrona
University of Barcelona, Barcelona, Spain

MS, School of Public Health
University of Texas, Health Science Center, Houston, TX

Cristina Varas-Lorenzo, PhD, MD, is a Director of Epidemiology at RTI-HS. Dr. Varas-Lorenzo has almost 20 years of experience in research focused on the epidemiology and prevention of cardiovascular diseases. She has worked with population-based surveys, registries, and field and automated databases studies. This experience includes 10 years in multinational pharmaceutical companies where she conducted and evaluated research programs for safety, risk management, development, and regulatory activities applying public health and epidemiological methods; developed and mentored team epidemiology members; and led cardiovascular safety and epidemiology strategy.

 

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Kelly A. Hollis

MBA
Kenan Flagler Business School, University of North Carolina, Chapel Hill, NC

BA, Mass Communication, Minor in Zoology
North Carolina State University, Raleigh, NC

Kelly A. Hollis, MBA, is Head of Surveys and Observational Studies for RTI-HS and has a strong background in survey research and a proven track record in the successful design, implementation, and leadership of global research studies. During her 12 years at RTI International, she has provided successful leadership and oversight of research in a number of therapeutic areas, including gastroenterology, oncology, infectious disease, central nervous system, diabetes, and depression. She has particular expertise in planning and managing large-scale prospective observational studies, including health economic and epidemiologic studies, patient outcomes research, risk management programs, and patient registries. She has directed multidisciplinary international teams for large primary data collection studies in the United States and Europe. Her particular focus is in the design and leadership of Risk Evaluation and Mitigation Strategy (REMS) assessments, having led or advised more than a dozen assessments in the past several years. She has experience with all aspects of data collection, including project management, survey design and implementation, questionnaire development, patient and site recruitment, data collection and management, and reporting. Ms. Hollis is involved in the design of observational research programs within RTI-HS to assure that the methods chosen provide a robust and cost-effective approach to address the study questions. She currently co-leads a cross-functional working group of staff involved in prospective observational studies. Her results-oriented, client-focused approach to project leadership includes strategic planning, financial management, process development, and resource allocation.

 

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Christina M. Darden, CQA

BS, Chemistry
North Carolina State University, Raleigh, NC

American Society for Quality - Certified Quality Auditor (CQA)

Christina M. Darden is a Project Manager in the Surveys and Observational Studies (SOS) group at RTI-HS. Ms. Darden has over 6 years of experience in the pharmaceutical industry and currently supports a range of studies, including risk evaluation and mitigation strategy (REMS) assessment studies. Ms. Darden has experience with both electronic and paper-and-pencil-based data collection efforts and has worked on numerous data collection projects involving multidisciplinary teams. Prior to joining the SOS group, Ms. Darden worked as a Quality Assurance Supervisor in the RTI-HS Office of Quality Assurance (OQA). Ms. Darden conducted internal project and process audits, managed the corrective and preventive action (CAPA) process, hosted external client audits, qualified subcontractors, and provided project support as a QA Lead for multiple studies. Ms. Darden has experience with several quality initiatives, including collaboration across multiple groups within RTI-HS to achieve consistency regarding record management activities. She has supported project teams with the creation and implementation of work practice documents, and authored several standard operating procedures.

 

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Kimberly Hunt Davis

MS, Pharmaceutical Policy and Evaluative Sciences
BS, Pharmacy
University of North Carolina, Chapel Hill, NC

Kim Davis, MS, is a Director of Surveys and Observational Studies at RTI-HS. She worked in the pharmaceutical industry for 4 years as a Global Health Outcomes manager before joining RTI-HS in 2003. In her current role at RTI-HS, she combines clinical experience as a pharmacist, industry experience, and study of pharmaceutical policy with practical research. She has worked with various multidisciplinary teams in the pharmaceutical industry, including commercial, clinical, global pricing, epidemiology, biomedical data sciences, international product development, and clinical trial project teams. She has excellent interpersonal skills and is highly motivated, organized, and efficient, with strong oral and written communication skills that allow her to build and maintain rapport with team members, key opinion leaders, and experts.

Ms. Davis has extensive experience leading and serving as a project manager for multiple types of projects, including large international data collection studies. Ms. Davis' project experience includes study design and implementation, patient and site recruitment, and investigator training. In addition, she has assisted with the development of protocols and physician and patient surveys for risk evaluation and mitigation strategy (REMS) plans to support new drugs in development for the treatment of pain and arthritis as required by the Food and Drug Administration (FDA). She also specializes in the development and evaluation of questionnaires designed to measure health-related quality of life, patient satisfaction, resource utilization, and other patient-reported outcomes. As part of the questionnaire-development process, Ms. Davis has assisted with the moderation of focus groups and cognitive interviews with a variety of patient populations and with physicians. Ms. Davis has also served as a consultant for various health outcomes projects (e.g., large data collection, literature reviews, clinical trials) across a number of therapeutic areas, including attention-deficit/hyperactivity disorder, allergic rhinitis, asthma, bipolar disorder, blood disorders, cancer, depression, diabetes, gastrointestinal disorders, insomnia, migraine, obesity, and women's health portfolios. She has also developed economic models and value proposition dossiers to assist international operating companies with reimbursement submissions to assure optimal reimbursement of products at launch.

 

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Diana S. Goss

AS, Medical Secretarial Science
Hardbarger Junior College, Raleigh, NC

SAS Institute courses - 2000: SAS Fundamentals: A Programming Approach, SAS Macro Language

Diana Goss is a Senior Project Manager with 20 years of experience in data collection and health-related research. Her project management experience includes designing and producing case report forms, editing and producing study protocols, supervising data collection staff to ensure compliance with study procedures, tracking site visits, and producing study progress reports. She also has conducted focus groups and cognitive interviews with a variety of populations to inform the development of survey instruments, as well as the refinement of item wording, formatting, and response scales. Ms. Goss currently plays a key role in nationwide data collection efforts, performing daily activities such as monitoring survey distribution and receipt, supervising data collection staff, site management, data abstraction management, and reporting spontaneous adverse events with an emphasis on confidentiality and participants’ rights.

 

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Laurin Jackson

MA, Sociology
BA, Psychology, minor in Sociology
East Carolina University, Greenville, NC

Laurin Jackson, MA, is a Senior Project Manager in the Surveys and Observational Studies division of RTI-HS. Ms. Jackson has more than 10 years of professional experience in survey research methodology, data reporting, and field management. She has been involved in survey design, instrument development, data collection, data tabulation, and data analysis. Since joining RTI in 1999, Ms. Jackson has been responsible for data collection tasks, including field interviewer training, field staff recruiting, and managing field interviewing staff for a large national study.

 

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Patrick Murphy

BS, Chemical Engineering
Northwestern University, Evanston, IL

Patrick Murphy is Senior Director of Data Management at RTI-HS. He has extensive experience developing and maintaining clinical database management environments that are compliant with 21 CFR Part 11 and Good Clinical Practices. Mr. Murphy has personally led the 21 CFR Part 11 validation of many clinical database systems, including Clintrial, OpenClinica, and systems developed by contractors under his supervision. In addition to maintaining a regulated clinical database management environment, he has provided on-site data management support to observational studies and clinical trials implemented in Mexico, Peru, Brazil, Argentina, Mali, Kenya, Tanzania, Rwanda, South Africa, India, Viet Nam, China, Thailand, and Indonesia.

Mr. Murphy has served as the Data Management Manager of three National Institutes of Health (NIH) Division of Microbiology and Infectious Diseases (DMID) networks: the International Clinical Support Services Center, the Sexually Transmitted Disease Clinical Trials Group, and the South East Asia Influenza Clinical Research Network. He has developed and delivered comprehensive data management trainings to over 100 data managers worldwide. Mr. Murphy has a total of 17 years of health-based research data management experience, plus 10 years of experience as a chemical engineer supporting the development of US Environmental Protection Agency regulations. Mr. Murphy has been responsible over 100 clinical trials and behavioral/survey studies, including many multicountry HIV phase 2/3 clinical trials.

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Michelle A. Therrien

MPH
University of Connecticut, Storrs, CT

PMP
Project Management Institute, Newtown Square, PA

BA, Microbiology
University of New Hampshire, Durham, NH

Michelle Therrien, MPH, PMP, is a Director of Project Management in the Surveys and Observational Studies group at RTI-HS. Ms. Therrien worked in the pharmaceutical industry as a microbiologist for 12 years prior to joining RTI-HS. She has combined her industry experience and study of public health with practical research, placing a strong emphasis on project management.

As a project manager, Ms. Therrien supports a wide range of studies, including risk evaluation and mitigation strategy (REMS) assessment studies, prospective epidemiological studies, patient-reported outcomes studies, and database studies. Ms. Therrien has experience managing both electronic and paper-and-pencil-based data collection efforts and has worked on several data collection projects involving multidisciplinary teams. Ms. Therrien’s project experience includes study design and implementation, questionnaire development and pretesting, patient and site recruitment, investigator training, and management of data collection activities. As part of the questionnaire development process, Ms. Therrien has assisted with moderating focus groups and has conducted cognitive interviews with a variety of patient populations. Her industry experience includes providing health outcomes support for a melanoma clinical trial and coordinating and managing timelines for technical projects.

 

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Megan Thomas

Master of Technical and Scientific Communication
Miami University, Oxford, OH

BS, Biological Science, Honors Program/Cum Laude
North Carolina State University, Raleigh, NC

Megan Thomas, MTSC, is a Health Outcomes Scientist in the Survey and Observational Studies group within RTI-HS. Ms. Thomas has 5 years of health care research experience working across several research areas, including epidemiology, clinical, patient-reported outcomes, and regulatory health outcomes strategy. At RTI-HS, Ms. Thomas currently has two primary roles. In epidemiology, she is the Assistant Data Collection Manager for a national patient registry. In clinical, she reviews central and local institutional review board (IRB) materials for physician sites for a phase 3 clinical trial. Ms. Thomas has also been a project manager for focus group facility recruitment and has assisted with IRB document development, graphic design, literature reviews, white papers, cognitive interviews, patient and physician surveys, and dossiers across a number of therapeutic areas, including allergic rhinitis, blood disorders, cardiology, cancer, depression, gastroenterology, and women's health.

Prior to joining RTI-HS, Ms. Thomas worked in the pharmaceutical industry for 4 years. In the Procedures Associate role, Ms. Thomas managed a multiyear project to revise laboratory data documents and implemented a controlled process for distributing documents to manufacturing testing laboratories in accordance with Good Manufacturing Practices. She also coordinated the revision of laboratory standard operating procedures and equipment operating procedures. In her scientific communications role, she developed clinical trial abstracts and posters that were presented at worldwide conferences. Prior to working in the pharmaceutical industry, she had also developed marketing materials and conducted laboratory bench research. Ms. Thomas is a member of the American Medical Writers Association (AMWA) and attends local AMWA conferences.

 

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Daniel Wolin

BS, Biology
Indiana University, Bloomington, IN

Daniel Wolin is a Director of Project Management in the Surveys and Observational Studies group at RTI-HS where he supports a variety of projects, including clinical trials, safety, and various training initiatives. Prior to joining RTI-HS, Mr. Wolin spent 10 years in the pharmaceutical industry in drug safety and regulatory affairs. He has worked in a variety of therapy areas, including ophthalmology, pain/inflammation, central nervous system, and metabolic and cell therapy (autologous). Mr. Wolin has led numerous Food and Drug Administration meetings (pre-IND, end of phase 2, and labeling discussions) and has been involved with early development projects through approval and postmarketing programs. While at Pfizer, Mr. Wolin acted as a global regulatory lead and was responsible for coordinating and progressing global regulatory projects in the United States, Japan, and the European Union.

 

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Laurie Zografos
BS, Psychology
University of North Carolina, Chapel Hill, NC
Semester Abroad at the University of Sussex, Brighton, England
Laurie Zografos is a Senior Director of Survey Research in the Surveys and Observational Studies division of RTI-HS. Ms. Zografos has a strong background in survey research, both in the public and private sector. She has extensive experience designing and managing Web, telephone, mail, field, and mixed-method studies. Her experience includes the design and conduct of patient-reported outcome studies, prospective epidemiologic studies, risk management studies, and consumer use studies. While at RTI, she has worked on several large longitudinal studies involving multidisciplinary teams with primary data collection in the United States. Ms. Zografos has experience with all aspects of data collection, including project management, survey design and implementation, questionnaire development, patient and site recruitment, investigator and interviewer training, biospecimen collection, data collection and management, and reporting. Ms. Zografos also has experience in the development and evaluation of questionnaires designed to measure patient-reported outcomes. As part of the questionnaire development process, Ms. Zografos has conducted cognitive interviews with a variety of patient populations.

 

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Maria Alejandra Vazquez-Gragg

MD, Universidad de Buenos Aires
Buenos Aires, Argentina

MPM, UADE University
Buenos Aires, Argentina

Maria (Ale) Vazquez-Gragg, MD, MPM, is Global Head of Safety and Pharmacovigilance at RTI-HS. Following her completion of her medical training, Dr. Vazquez-Gragg worked as a pediatric surgeon in the Pediatric Hospital of San Isidro. After Dr. Vazquez-Gragg left clinical practice, she joined the regulatory affairs department at Merck, where she was responsible for safety and regulatory activities. Following this, she held positions in the areas of drug safety and pharmacovigilance throughout her career, including at Wyeth, Johnson & Johnson, and PAREXEL. Dr. Vazquez-Gragg has worked with the Global Alliance for Vaccines and Immunization (GAVI) on the Regional System Vaccine (RSV) program in Latin America (Argentina, Brazil, Chile, Colombia, Mexico, and Uruguay) since 2004 on supporting programs for vaccines and oncology vaccines.

Over her 17 years of experience, Dr. Vazquez-Gragg has authored numerous articles on a wide array of topics, including pharmacovigilance, and has given several presentations at biopharmaceutical industry conferences, as well as at meetings held by health authorities.

 

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Tim Cartwright

BS, Math and Computer Science
McGill University, Montreal, Canada

Tim Cartwright is a Director of Pharmacovigilance Operations at RTI-HS. He has 20 years of experience as an IT business analyst working within the pharmaceutical industry. His primary areas of experience are toxicology systems, GxP validation, and drug safety systems. For the last 10 years, Mr. Cartwright has focused on pharmacovigilance, working initially with the Argus software vendor, Relsys, followed by consulting work with drug safety departments at several companies before joining RTI-HS.

 

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Linda Godfrey

AD, Nursing
Wake Community College, Raleigh, NC

Linda Godfrey, RN, is a Medical Product Safety Specialist at RTI-HS. She has 5 years of experience in clinical and postmarketing drug safety activities, including serious adverse event processing, narrative writing, case queries, safety data entry, tracking cases, preliminary coding, preparation and submission of regulatory reports, quality control of case reports, and quality assurance of case reports. Her safety project experience includes dermatology disorders, degenerative joint disease (osteoarthritis), infectious disease (HIV and Clostridium difficile infection), exocrinopathy disease (cystic fibrosis), ophthalmology disorders (vitreomacular adhesions and conjunctivitis), and immunization studies. Additional industry experience includes 10 years of coordinating clinical research trials. She also has 12 years of nursing experience in neuropsychiatry.

 

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Lisa C. Keith

BFA, Commercial Design
Barton College, Wilson, NC

AA, Commercial Design
Chowan College, Murfreesboro, NC

Certified MedDRA Coder (Certificate #437323)
Northrop Grumman Information Systems

Lisa Keith has 15 years of experience in the pharmaceutical industry. She has 13 years of experience directly related to working in the areas of drug safety and pharmacovigilance, with 11 of those years specializing in safety database administration and support. Prior to joining RTI-HS, she assisted in the design, development, and implementation of tracking and drug safety database systems at two pharmaceutical companies. At RTI-HS, Ms. Keith manages technology used within the Drug Safety and Pharmacovigilance group and is responsible for managing system validation activities in compliance with domestic and foreign regulations. As the Argus Safety Administrator, she manages system implementation, administration, troubleshooting, data migration, database queries, and end user training. As part of database management, Ms. Keith is responsible for configuration and testing of electronic reporting with domestic and foreign regulatory agencies/competent authorities.

 

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Carmela A. Skillman

PhD, Pharmacology and Toxicology
MS, Pharmacology and Toxicology
Purdue University, West Lafayette, Indiana

BS, Pharmacy, Rutgers, The State University of New Jersey, New Brunswick, NJ

Carmela Skillman, RPh, PhD, has 25 years of professional experience in the pharmaceutical industry encompassing the areas of clinical research, safety reporting, and medical writing. She has experience in clinical research, including cardiovascular, neurology, diabetes, and infectious diseases (antifungals). Her consulting experience includes the clinical areas of women’s health, gastrointestinal disorders, hemophilia, depression, schizophrenia, oncology, infectious diseases (antibiotics and antiretrovirals), cardiovascular, neurology, ophthalmology, obesity, gout, and insomnia. Her responsibilities have included consulting with clients in various aspects of safety such as in developing, writing, or coordinating integrated clinical summaries (e.g., Clinical Safety Summary, Clinical Efficacy Summary, Clinical Pharmacology) of the New Drug Application (NDA) or Common Technical Document (CTD); reviewing and advising on coding for safety integration; developing templates and writing, and reviewing clinical study reports, periodic safety update reports (PSURs), Investigational New Drug (IND) annual reports, subject narratives, and other safety-related documents; writing manuscripts for journal publications; and presenting at training workshops for industry personnel on preparing safety reports, clinical study reports, and integrated safety summaries.

Dr. Skillman’s earlier pharmaceutical experience included the management of clinical research associate (CRA) staff involved in the conduct of clinical studies and work with an international project team in the clinical development of compounds. Her responsibilities included developing clinical plans, protocols, and budgets; recruiting appropriate investigators; managing CRA activities in the progression of the studies; reviewing, editing, or writing reports; preparing abstracts for presentations; and reviewing and/or preparing manuscripts for publication.

 

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Donna Ward

BS, Health Information Management
East Carolina University, Greenville, NC

Donna Ward, RHIA, is a Medical Product Safety Specialist at RTI-HS. She has 7 years of experience in the pharmaceutical industry specific to safety and pharmacovigilance activities, including serious adverse event (SAE) handling, data entry of SAEs, and quality control and quality assurance of SAEs, periodic reports, and other safety-related reports. She also has 17 years of experience in an acute care hospital setting, fulfilling diagnostic/procedural data requests for physicians, hospital administration, and outside agencies.

 

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Beth Sherrill

MS, Statistics
North Carolina State University, Raleigh, NC

NC Science Teacher Certification
University of North Carolina, Chapel Hill, NC

BS, Biology
Davidson College, Davidson, NC

Beth Sherrill, MS, is Global Head of Biometrics at RTI-HS. She has more than 15 years of professional experience analyzing pharmaceutical and health-related data. Ms. Sherrill brings insight and expertise to statistical issues in drug development and outcomes research to multiple clients in the pharmaceutical industry. Ms. Sherrill started her career as an industry biostatistician designing and analyzing phase 2 and phase 3 clinical trials for international submissions and is familiar with regulatory requirements for drug approval. In the past 10 years, she has broadened her experience in postmarketing studies, such as epidemiologic analyses from disease registries, econometric work with claims databases, and large patient surveys. She has extensive experience with the use of propensity scoring and proportional hazards modeling with time-dependent covariates, working in such complex disease areas as oncology and HIV. She has training from the Cochrane Collaboration for performing meta-analyses that may include indirect comparisons and network analysis. Ms. Sherrill continues to publish and represent her clients at advisory board meetings. She provides senior leadership to a team of statisticians in the US and the UK, applying advanced biostatistical techniques to issues in pharmaceutical development, epidemiology, health care resource utilization, and outcomes research. 

 

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Lee Bennett

DrPH (in progress), Biostatistics
University of North Carolina, Chapel Hill, NC

MS, Statistics
University of Georgia, Athens, GA

BS, Chemistry
Georgia Institute of Technology

Lee Bennett, MS, is a Senior Statistician in the Biostatistics group. He has 10 years of experience in statistical planning and analysis, and has worked in many therapeutic areas, including oncology, gastroenterology, and neurology. Mr. Bennett has provided statistical expertise for a large breast cancer registry, a regulated comprehensive pharmaceutical risk management program, quality of life studies in clinical trials, and numerous surveys. His duties have included the creation of statistical analysis plans and study reports, as well as the development of programs to manage data and produce study tables, listings, and figures. His experience in statistical modeling includes linear and logistic regression, mixed effects models, pattern mixture models, and proportional hazards models. He has extensive experience with statistical programming in SAS.

 

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Costel Chirila

PhD, Statistics
MS, Statistics
University of Kentucky, Lexington, KY

BA, Economics
BS, Mathematics
"Al. I. Cuza" University, Iasi, Romania

Costel Chirila, PhD, is a Senior Statistician in RTI-HS. Dr. Chirila worked for several years as a statistician with pharmaceutical companies designing and analyzing clinical trials (including phase 1) and writing statistical analysis plans and statistical reports. More recently, he provided biostatistical support for the development of diagnostic products (biomarker identification) and cost-effectiveness, budget-impact, and Risk Evaluation and Mitigation Strategy (REMS) analyses. Dr. Chirila has experience with various statistical methods, including linear and logistic regression, variable and model selection using resampling techniques (e.g., cross-validation, bootstrapping), nonparametric modeling, mixed modeling, meta-analyses, and receiver operating characteristic (ROC) curves. He also has programming experience with SAS and R/S-Plus. He has worked cross-functionally and has exposure to numerous disease areas, including amyotrophic lateral sclerosis (ALS), diabetes, and prostate cancer.

 

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Diana Hall

MS, Statistics
University of North Carolina at Chapel Hill, Chapel Hill, NC

BA, Mathematics
University of Chicago, Chicago, IL

Diana Hall, MS, is a Statistician at RTI-HS. As a graduate student at the University of North Carolina, she worked with statistical genetic data and developed a linear model to determine significant difference in genetic expression. As a statistician at RTI-HS, Ms. Hall has conducted analysis on various types of data, including registry, clinical trial, and observational study data. Her analytical research experience consists of statistical modeling, including logistic regression and random effects models, Quality-Adjusted Time Without Symptoms of Disease or Toxicity of Treatment (Q-TWiST) survival analysis, and meta-analysis. She has experience with the SAS programming language as well as MATLAB, STATA, R, and C++.

 

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Dawn M. Odom

MS, Biostatistics
BSPH, Biostatistics
University of North Carolina, Chapel Hill, NC

Dawn Odom, MS, is a Director of Biostatistics, US. She has over 10 years of professional experience working with public health and clinical trial data. During this time, she has worked as a clinical statistician in numerous therapeutic areas, including pregnancy registries, respiratory, oncology, gastroenterology, medical devices, and HIV. Her responsibilities include protocol development, creation of statistical analysis plans, and production of analysis tables and listings. She has designed and implemented randomization plans for clinical trials. She has extensive experience in the analysis of both randomized and observational studies, including building statistical models using logistic regression, Cox's regression, and linear mixed models. She has also led numerous meta-analysis projects where she has applied statistical techniques such as meta-regression and adjusted indirect and mixed-treatment comparisons. In addition, Ms. Odom has worked as a survey statistician on a large national household survey where she was responsible for sample selection, item imputation, analysis tables, and report writing. She has experience with the SAS programming language, including the macro language, as well as SUDAAN. Ms. Odom is a member of the American Statistical Association and the International Society of Pharmacoeconomics and Outcomes Research.

 

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Jianmin Wang

PhD, Biostatistics
MPH, Biostatistics
University of North Carolina, Chapel Hill, NC

MS, Biostatistics
Chinese Academy of Preventive Medicine, Beijing, China

MD
Xinjiang Medical College, Xinjiang, China

Jianmin Wang, PhD, MD, is a Director of Biostatistics, US, in RTI-HS. He began his career in statistics in 1983, and has used SAS software since 1987. He accumulated extensive collaborative research experience with medical and public health professionals. Before joining RTI-HS, Dr. Wang was the Senior Biostatistician at the Gynecological Oncology Group (GOG), where he developed the statistical sections for numerous research protocols and analyzed data from clinical trials and experimental medicine studies. He was a research assistant professor in the Department of Biostatistics at the University of Buffalo from 2004 to 2005. In GOG, Dr. Wang developed an extensive background in clinical trials while participating in the development of protocols and statistical analysis plans for clinical trials. Dr. Wang’s widely published work covers topics such as the risk of development of advanced prostate cancer, radiation and chemotherapy after radical hysterectomy, disease progression in patients with epithelial ovarian cancer, and patient survival in lung cancer.

 

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MAS, Applied Statistics
Pennsylvania State University, University Park, PA

BS, Biology
NanKai University, Tianjin, China

 

Yun Wu, MAS, is a Senior Statistician with RTI-HS. She has experience with different types of projects, including traditional clinical trial, epidemiological analyses from surveillance study, meta-analyses and psychometric analysis involving health-related survey data, public payor claims databases, and SEER-Medicare data. She has conducted analyses involving regression, structure equation model, and factor analysis and is adept with a number of statistical programming languages, including SAS, SPSS, S+, and WinBUGS. Ms. Wu works as a contributing partner on research teams involving physicians, epidemiologists, physiologists, and biologists.

 

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Jie Zhang

MSPH, Biostatistics
University of South Carolina, Columbia, SC

MS, Biochemistry
Beijing Forestry University, Beijing, China

BS, Chemistry
Beijing University of Chemical Technology, Beijing, China

Jie Zhang, MSPH, MS, is a Statistician in Biometrics at RTI-HS. She has been involved in analysis for a wide range of projects, including clinical trials, longitudinal epidemiology studies, health-related surveys, SEER-Medicare data, and meta-analyses. She has experience in prevalence and incidence estimation, development of predictive models, longitudinal data analysis, analysis involving missing data (including random effect pattern-mixture models), survival analysis, and sample size calculations. Ms. Zhang has valuable experience with the SAS programming language, including MACRO and IML. In addition, she is familiar with R, REVMAN, STATA, WINBUGS, and MINITAB.

 

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Xiaolei Zhou

PhD Candidate, Biostatistics
MS, Biostatistics
University of North Carolina, Chapel Hill, NC

MS, Chemistry
BS, Chemistry
Peking University, Beijing, China
Xiaolei Zhou, MS, is a Senior Statistician in the Biometrics group at RTI-HS. She has led statistical analysis for a wide range of projects, including health-related surveys; longitudinal epidemiology studies on smoking cessation and obesity; quality of life data analysis in clinical trials on breast cancer, colorectal cancer, gastric cancer, kidney cancer, follicular lymphoma, and myelofibrosis; and post-hoc analysis of pooled data from multiple clinical trials on chronic hepatitis C and other exploratory data analyses. Ms. Zhou has been responsible for writing statistical analysis plans, performing or overseeing statistical programming and validation, and developing statistical reports, abstracts, and manuscripts. She managed databases for several large, multinational, Web-based longitudinal studies and was involved in medical database studies. Her experience includes analysis of patient-reported outcomes, prevalence and incidence estimation, development of predictive models using observational or clinical trial data, longitudinal data analysis, analysis involving missing data (including random effect pattern-mixture models), survival analysis, factor analysis, sample size calculations, and programming in SAS and SUDAAN. Ms. Zhou has authored/coauthored numerous scientific presentations and manuscripts in peer-reviewed journals.

 

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Ryan Ziemiecki

MS, Statistics
University of North Carolina, Chapel Hill, NC

BS, Statistics
BS, Mathematics–Operations Research
University of North Carolina Wilmington, Wilmington, NC

Ryan Ziemiecki, MS, is a Statistician at RTI-HS. Mr. Ziemiecki is a graduate of the University of North Carolina (UNC) where he conducted research in evolutionary game theory. While at UNC, he also assisted in developing an outlier detection procedure for real-time quantitative PCR analysis. As a statistician at RTI-HS, he has been able to use his statistical knowledge while performing analyses relating to various practice areas, such as patient-reported outcomes, epidemiology, health preference assessment, health economics, and drug safety. His responsibilities have included writing statistical analysis plans and statistical sections of study reports, as well as the development of programs to manage data and produce study tables, listings, and figures. Mr. Ziemiecki is experienced in statistical modeling, including linear and logistic regression, mixed effects models, pattern mixture models, general-additive models, and survival models. He has experience with the SAS programming language, including the macro and IML languages, as well as the R-statistical package, Matlab, Limdep, and GAUSS.

 

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Allen Wayne Mangel

MD
Georgetown University School of Medicine, Washington, DC

PhD, Physiology
MS, Physiology
BS, Physiology
University Of Illinois, Urbana, IL

Allen Mangel, MD, PhD, is a gastroenterologist and Executive Vice President of RTI-HS. Following completion of his medical training, Dr. Mangel did his internship and residency in internal medicine at Duke University Medical Center and then completed his gastroenterology fellowship also at Duke. Following completion of his formal training, he remained on the faculty in the Department of Medicine, Division of Gastroenterology, at Duke for 3 years. Dr. Mangel also has a PhD from the University of Illinois, where his research focused on control of electrical and mechanical activity in gastrointestinal smooth muscle.

After Dr. Mangel left Duke, he joined the gastroenterology clinical research department at Glaxo Wellcome, where he conducted numerous clinical trials and directed product development teams. After departing GlaxoWellcome, he became Vice President of Research and Development at Salix Pharmaceuticals. He joined RTI International in 2001 and currently serves as Executive Vice President of RTI-HS. Dr. Mangel has led or participated in numerous FDA interactions, advisory committee presentations, label negotiations, and new drug application submissions, and he has authored more than 100 publications.

 

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Lynne Reynolds Hamm

BSN, Family Nurse Practitioner
Purdue University Calumet, Hammond, IN

Associate of Applied Science
Purdue University North Central, Westville, IN

Lynne Hamm is Senior Director of Clinical and Medical Services at RTI-HS. She has extensive experience in the pharmaceutical industry designing, implementing, and managing phase 2-4 clinical studies. Ms. Hamm has developed specifications for interactive voice response systems (IVRS) to facilitate the electronic capture of subject diary data and has experience using IVRS in large international studies. Ms. Hamm has been involved with multiple clinical studies in the United States, Canada, Mexico, and Europe. She has experience with national call centers and script development to assist in subject referral to study sites in response to nationwide study recruitment advertising. While working in the pharmaceutical industry, Ms. Hamm has been involved in protocol design, study report writing, preparations for Food and Drug Administration (FDA) Advisory Committees, and New Drug Application (NDA) submissions.

 

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Jeffrey J. Buda

BA, Biology
SUNY College, Buffalo, NY

Jeffrey Buda is a Director of Clinical and medical Services with RTI-HS. Mr. Buda has helped design and has personally managed phase 1-4 clinical research trials in the therapeutic areas of gastroenterology, oncology, virology, and endocrinology. His experience in the field of clinical research included development of clinical protocols, design of interactive voice response systems (IVRS) to capture patient symptom data, development of data collection forms, interaction with key opinion leaders in various disciplines, operationalization of complex multicenter studies, and clinical monitoring.

Mr. Buda has extensive experience in managing projects that involve multiple vendors and subcontractors, as well as an array of scientific and technical disciplines.

 

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Chad L. Downey

BS, Electrical Engineering
North Carolina State University, Raleigh, NC

Chad L. Downey is a Clinical Research Associate in the Clinical and Medical Services Division of RTI-HS. Mr. Downey has played a role in a number of clinical research therapeutic areas, including hypertension, rheumatoid arthritis, and colorectal cancer. He has experience in clinical trial monitoring, regulatory review, data management, Food and Drug Administration (FDA) regulation and International Conference on Harmonization – Good Clinical Practice (ICH-GCP) guideline application, study form design, and literary authorship and review. He has conducted international training on topics that include the Applications of the Belmont Report to Research in Humans and the Challenges of Cross-Cultural Training in Clinical Research. Mr. Downey has received certifications from such entities as the National Institutes of Health (NIH), the Coaches Training Institute (CTI), and Caligeo Clinical, LLC Fundamentals of Pharmaceutical Research for clinical research associates and clinical research coordinators. He is a member of Toastmasters International, Caligeo Clinical Trials Initiative (CCTI), and the Society of Clinical Research Associates (SoCRA).

 

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Jodi Tipper

MS, Clinical Research
Campbell University, Buies Creek, NC

BS, Medical Technology
West Virginia University, Morgantown, WV

Jodi Tipper, MS, is a Lead Clinical Research Associate at RTI-HS. Ms. Tipper has extensive experience in the pharmaceutical industry, including study management overseeing the conduct of clinical trials (including phase 2-4 and postmarketing) and management of regional monitors, various vendors, investigational sites, and contract research organizations (CROs). Her experience in the field of clinical research includes protocol design, development, and implementation as well as authorship of many clinical research documents, including clinical study reports, Investigational New Drug (IND) and New Drug Application (NDA) submissions, investigator brochures, and safety updates. Her therapeutic areas of experience include respiratory, metabolic (diabetes), HIV, oncology, cardiology, and gastroenterology.  Ms. Tipper’s experience also included clinical monitoring, clinical data management, and clinical safety.

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