Business and Scientific Leadership

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 Glaxo Wellcome, he became Vice-President of Research and Development at Salix Pharmaceuticals. Dr. Mangel has led or participated in numerous FDA interactions, Advisory Committee Presentations, label negotiations, and NDA submissions, and he has authored more than 80 publications.

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.

PhD, Economics
MHA, Health Administration
MA, Physiology/Pharmacology
Duke University

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 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. Additionally, she has managed projects to develop or culturally adapt psychometrically valid quality of life measures for migraine, genital herpes, and epilepsy. Dr.Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed a simulation model of time spent in the operating and recovery rooms.

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 is 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 the Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Medical Care, American Journal of Public Health, Health Services Research, and the American Journal of Cardiology.

Dave Obringer, JD, is a member of RTI-HS’s Business Management Team (BMT). He also directs the contracting group supporting RTI-HS and leads review and implementation of strategic alliances and acquisitions. In these roles, he has led or overseen resolution of numerous contract issues in collaboration and/or negotiation with clients and third-party vendors, led or participated in the development and implementation of contracting and procurement processes, and served key roles in the opening of two new RTI-HS offices, one in the United States and one in Spain. He has also served key roles in due diligence activities in two acquisitions in which RTI-HS expanded its service offerings, one in the United States and one in Canada.

Prior to joining RTI-HS, Mr. Obringer served as the lead transactional attorney and counsel for three of the four research divisions at RTI International (RTI-HS, Social & Statistical Sciences, Science & Engineering). In that role, he managed a large legal/administrative team including attorneys, contract professionals, and support staff. Mr. Obringer provided support, advice and counsel to the research business units on corporate-wide legal and regulatory matters including both governmental and commercial transactions, and created, reviewed, and approved contractual and legal documentsin support of their businesses. He also provided counsel to RTI’s administrative units andconsulted with and managed outside counsel as needed. Mr. Obringer has developed and presented training to contract and research staff on various topics, and served on the corporate steering committee overseeing the procurement and implementation of corporate-wide strategic financial systems.

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.

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. Mr. Simmons has spent 20years in financial and operational roles, with particular focus on early stage, rapidly growing technology and biotech businesses. Mr. Simmons began his career at KPMG Peat Marwick and moved to other public accounting firms whose focus was more on early stage businesses. During his 7 years in public accounting, he gained significant experience with building business plans and forecasts for start-ups. Mr. Simmons then moved into corporate finance as controller for Mitsubishi Semiconductor America, Inc., a semiconductor manufacturer. Upon leaving Mitsubishi, Mr. Simmons served 4 years as corporate controller and then vice president of finance for a start-up biotech company, Cogent Neuroscience, Inc. Just prior to joining RTI-HS, Mr Simmons consulted for several other early stage biotech and high-tech businesses as leader of finance

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 Glaxo Wellcome, he became Vice-President of Research and Development at Salix Pharmaceuticals. Dr. Mangel has led or participated in numerous FDA interactions, Advisory Committee Presentations, label negotiations, and NDA submissions, and he has authored more than 80 publications.

PhD, Epidemiology
MPH, Health Policy and Administration
University of North Carolina at Chapel Hill

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 on therapeutic risk management, 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 prospective databases. Dr. Andrews currently serves as principal investigator on two large risk management programs. Her primary research focus has been on studies of disease natural history, treatment patterns, and drug safety. Her experience has spanned most therapeutic areas, though she has worked extensively in the areas of HIV and sexually transmitted diseases; reproductive health, birth defects, and neonatal health; asthma and COPD; 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, a member of the editorial board of the Journal of Pharmacoepidemiology and Drug Safety, and co-editor of Pharmacovigilance. She is an Adjunct Associate Professor of the University of North Carolina School of Public Health and School of Pharmacy, a senior consultant and investigator with the UNC Center for Education and Research on Therapeutics, and a consultant to the FDA in epidemiology and risk management.

MSc, Operational Research
University of Birmingham, UK

BSc, Mathematics
University of London, UK

Stephen Beard, MSc, is Global Head of Heath Economics Europe and is based in RTI HS’s UK office in Manchester. He has more than 20 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 research sector for the past 11 years, having previously held a senior project management and research position within the 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 involved the management of projects using 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, and infectious diseases. He is a member of the International Society of Pharmacoeconomics Outcomes Research 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.

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 Regulatory and Health 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 PRO endpoints, economic evaluations, OR strategic plans, and regulatory strategy. In her outcomes research and regulatory role, she leads a team of scientists responsible for developing OR strategic plans for phase 2/3 compounds, developing PRO dossiers for the FDA for Label Claims, and designing clinical trials with OR endpoints. Ms. Copley-Merriman has experience in many therapeutic areas, including oncology, pain and inflammation, dermatology, respiratory, urology, and CNS.

Janice D’Angelo is the Global Head of Pricing and Reimbursement in RTI-HS’s Canadian Office. She is the co-founder of Palmer D’Angelo Consulting Inc. (PDCI), which was acquired by RTI-HS in January 2007. She provides expert advice to clients with respect to the Guidelines and Regulations of the Canadian Patented Medicine Prices Review Board (PMPRB) and coordinates RTI-HS’s pricing and reimbursement research projects. She has over 20 years of regulatory experience with the federal government of Canada. From 1991 to 1996, she was employed by the PMPRB and was responsible for operational policy development, the resolution of non-standard reviews, and a wide range of compliance activities. As Chief of Compliance, she oversaw the application of the Excessive Price Guidelines by the Board’s Compliance Officers. Prior to 1991, Janice D’Angelo conducted economic and statistical analysis for the National Energy Board (NEB) relating to Canada’s oil supply and demand and was responsible for various regulatory activities including the advancement of export application through the NEB’s public hearing process.

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.

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 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 depression, attention-deficit disorder, bipolar disorder, schizophrenia, insomnia, incontinence, irritable bowel syndrome, oncology, cardiovascular disease, women’s health, diabetes, asthma, COPD, sexual dysfunction, obesity, cystic fibrosis, chronic pain, and sexually transmitted diseases such as herpes, HPV, and 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.

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 II-IV 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 FDA Advisory Committees, and NDA submissions.

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 Global Head of Health Preference Assessment at RTI Health Solutions. 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, Alzheimer Disease and Associated Disorders.

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 more than 85 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 recent book on various 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.

PhD, Economics
MHA, Health Administration
MA, Physiology/Pharmacology
Duke University

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 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. Additionally, she has managed projects to develop or culturally adapt psychometrically valid quality of life measures for migraine, genital herpes, and epilepsy. Dr.Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed a simulation model of time spent in the operating and recovery rooms.

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 is 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 the Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Medical Care, American Journal of Public Health, Health Services Research, and the American Journal of Cardiology.

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 trained psychometrician with over 10 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 define minimal important differences. 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.

Neil Palmer is Vice President of Pricing and Reimbursement at RTI-HS. Formerly Principal Consultant of Palmer D’Angelo Consulting Inc., Canada’s leading pricing and reimbursement consultancy, Mr. Palmer is responsible for leading RTI-HS’s pricing, reimbursement, and policy research assignments. Mr. Palmer worked with the Canadian Patented Medicine Prices Review Board, where his responsibilities included policy development, overseeing the price review of patented medicines, and conducting economic research. Prior to this, he worked with the Health Division of Statistics Canada, where he was responsible for economic and statistical analysis of health care costs and utilization. After completing his studies at the University of Western Ontario, Mr. Palmer began his career in Montreal with the research group of the Kellogg Centre for Advanced Studies in Primary Care. He has written extensively on pharmaceutical pricing and reimbursement issues and is a frequent speaker at pharmaceutical conferences in North America and Europe.

Susana Perez-Gutthann, MD, MPH, PhD, FISPE, FRCP, is Vice President and Global Head of Epidemiology at RTI HS. Dr. Perez-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. Perez-Gutthann has 19 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. Perez-Gutthann is an active leader and Past President of the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of ISPE and of the Royal College of Physicians, Edinburgh. She is invited to teach in several programs, to speak and chair conferences and symposia, which have included DIA, TOPRA, Australian National Prescribing Service Symposium, Asian Pacific Regulatory Safety Sciences Meeting, International Conference of Pharmacoepidemiology & Risk Management, and World Congress of Pharmacology and Clinical Therapeutics. Dr. Perez-Gutthann’s roles as an advisor and in international working groups have included WHO TRD Product Development and Evaluation, International Scientific Advisory Board to MHRA General Practice Research Database,  ISPE Working Groups on Risk Management Guidances (FDA, EMEA), Good Pharmacoepidemiology Practice, and confidentiality of patient databases in Europe; working groups on gastrointestinal complications associated with NSAIDs, IMBRF on drug-induced disease, and HRT and breast cancer risk. Currently, Dr. Perez-Gutthann serves as a member and chair of several scientific advisory boards for studies, research programs, strategic, and regulatory risk management topics.

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.

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.

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.

BSc, Nutrition and Dietetics
University of Saskatchewan, Saskatoon, Saskatchewan, Canada

Elizabeth Resch is a Manager of Business Development at RTI-HS and has an emphasis on business development initiatives for the pricing and reimbursement group. She is also responsible for managing the group’s Canadian market access publications, including the “Canadian Drug Benefit Plans Reference Guide.” She studied at McGill University and received a Bachelor of Science from the University of Saskatchewan with a major in Nutrition and Dietetics. Ms. Resch has worked in the pharmaceutical industry, clinical research, and the public and private health care sectors.

BS, Pharmacy
Albany College of Pharmacy, Albany, NY

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 20 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.

PhD, Economics
MHA, Health Administration
MA, Physiology/Pharmacology
Duke University

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 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. Additionally, she has managed projects to develop or culturally adapt psychometrically valid quality of life measures for migraine, genital herpes, and epilepsy. Dr.Mauskopf has developed Markov models of disease progression for lung cancer and HIV infection and has developed a simulation model of time spent in the operating and recovery rooms.

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 is 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 the Journal of the American Medical Association, Journal of Pediatrics, PharmacoEconomics, Medical Care, American Journal of Public Health, Health Services Research, and the American Journal of Cardiology.

MSc, Operational Research
University of Birmingham, UK

BSc, Mathematics
University of London, UK

Stephen Beard, MSc, is Global Head of Heath Economics Europe and is based in RTI HS’s UK office in Manchester. He has more than 20 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 research sector for the past 11 years, having previously held a senior project management and research position within the 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 involved the management of projects using 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, and infectious diseases. He is a member of the International Society of Pharmacoeconomics Outcomes Research 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.

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.

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 HIV, schizophrenia, systemic lupus erythematosus, and rheumatoid arthritis.

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 economics studies, including her doctoral thesis on the effects of managed care organizations’ restrictions on patients’ well-being. 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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MA, Applied Economics
University of North Carolina, 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 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 the Journal of Medical Economics, Cancer, Preventing Chronic Disease, and Bulletin of the World Health Organization. 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, International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 9th Annual European Congress, 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.

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 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.

She undertook an MSc in Health Economics and Management and is currently undertaking a PhD at Sheffield University in Health Economics. She has also worked with The University of Sheffield and UK Department of Health on the evaluation of modernization programs for elderly care in the NHS. Her work has been presented at the European Respiratory Society’s annual meeting and at the ISPOR 13th Annual International Meeting in Toronto in 2008. In addition to this, 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 undertaken targeted literature reviews and systematic reviews of economic evaluations; supported the writing, development, and presentation of manuscripts and posters for publication; and contributed to the development of cost-effectiveness, cost-utility, and budget-impact models in Microsoft Excel, as well as project managing cost-effectiveness studies. Therapeutic areas include rheumatoid arthritis, breast cancer, NSCLC, and VTE.

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

BS, Mathematics
Harvey Mudd College, Claremont, CA

Anita Brogan, PhD, is a Senior Director of 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, 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 Value in Health, European Journal of Operational Research, American Journal of Health-System Pharmacy, IIE Transactions, and Journal of Parenteral and Enteral Nutrition.

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

BA, Economics
University of North Carolina, Asheville, NC

Keith Davis, MA, is a Director of Health Economics at RTI-HS. Prior to joining RTI-HS, Mr. Davis served as a Research Economist in RTI’s Behavioral Health Economics Program. He has extensive experience in analyzing retrospective health care claims data, electronic medical records, cross-sectional and longitudinal survey data, and data from prospective clinical studies. Mr. Davis has conducted research to estimate the prevalence and economic burden of various medical conditions, including benign prostatic hyperplasia, diabetic microvascular complications, traumatic injury, melanoma, meningococcal disease, hepatitis C virus, respiratory diseases, and gastrointestinal disorders such as irritable bowel syndrome, constipation, ulcerative colitis, and Crohn’s disease. Mr. Davis also has extensive experience in claims-based 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, and benign prostatic hyperplasia. Mr. Davis’ research has been published in Epilepsia, Journal of Trauma, Medical Care, Journal of Diabetes and Its Complications, Journal of Studies on Alcohol, Journal of Behavioral Health Services and Research, and Epilepsy and Behavior. Mr. Davis also coauthored a forthcoming article in Applied Health Economics and Health Policy. Mr. Davis’ research has been presented at numerous professional conferences and workshops, including the North American and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR); Academy of Managed Care Pharmacy (AMCP); American Public Health Association (APHA); European Federation of Neurological Societies (EFNS); Child Neurology Society (CNS); American Association for the Surgery of Trauma (AAST); Society for Critical Care Medicine (SCCM); Digestive Disease Week (DDW); American College of Gastroenterology (ACG); American Academy of Pain Management (AAPM); European Cancer Conference (ECCO); National Hospice and Palliative Care Organization (NHPCO); American Epilepsy Society (AES); American Society of Clinical Oncology (ASCO); the Canadian Pharmacists Association (CPhA); the Infectious Diseases Society of America (IDSA); and the American Association for the Study of Liver Diseases (AASLD).

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 an Associate 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 metastatic colorectal cancer, 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) 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), SAS, and Stata. 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).

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. He is a member of the International Society for Pharmacoeconomics and Outcomes Research.

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 Global Head of Health Preference Assessment at RTI Health Solutions. 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, Alzheimer Disease and Associated Disorders.

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

Juliana Jackel, MA, is a Research Health Economist at RTI-HS. Prior to joining RTI-HS, Ms. Jackel worked as a research manager at Boston Health Economics. She has extensive experience analyzing retrospective health care claims data, cross-sectional and longitudinal survey data, and data from prospective clinical studies. Ms. Jackel has conducted research to estimate the prevalence and economic burden of various medical conditions, including acute coronary syndromes, invasive fungal infections, and complicated skin and skin structure infections. Ms. Jackel also has extensive experience in claims-based analyses to evaluate patterns and utilization implications of medication adherence among patients with schizophrenia.

Ms. Jackel has coauthored research published in the American Journal of Health Systems Pharmacy and Current Medical Research and Opinions. Additionally, her research has been presented at numerous professional conferences and workshops, including the North American and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Academy of Managed Care Pharmacy (AMCP), Bone Marrow Transplantation (BMT), and the Intersciences Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

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

Sukhvinder Singh Johal, PhD, is a Health Economist at RTI-HS. 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. At MATCH, he was engaged in developing a generic Excel-based health economics tool for medical device companies wishing to evaluate products primarily in the early stages of development to ascertain their feasibility for the marketplace. This included an element of training managers in the basics of health economics, and providing advice and guidance on the use of concepts such as the incremental cost-effectiveness ratio and quality-adjusted life years in evaluations of medical devices. Dr. Johal has carried out various consultancy projects for MATCH industrial partners to aid with their product development. His experience also covers more traditional approaches to business modeling such as net present value modeling, as well as a more innovative financial modeling approach called “real options” analysis. He also has more than 3 years of experience in product development in the telecommunications sector.

Since working at RTI-HS, Dr Johal has developed cost-effectiveness, cost-utility, budget-impact, and capacity planning models in Excel, as well as project managing cost-effectiveness studies. He has also undertaken targeted reviews of economic evaluations. Therapeutic areas include diabetes, contraception, infectious diseases, and Parkinson’s disease.

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

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

MBA, Marketing
B. Pharmacy
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’s research has been published in Medical Care, Value in Health, Journal of Human Hypertension, Journal of Drugs in Dermatology, and Health and Quality of Life Outcomes. Dr. Karve also coauthored a forthcoming article in Journal of the American Academy of Dermatology. Dr. Karve’s research has been presented at numerous professional conferences and workshops, including the North American Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Academy of Managed Care Pharmacy (AMCP), International Stroke Conference (ISC), Academy Health; Pediatric Academic Societies (PAS), and Southern Pharmacy Administration Conference (SPAC).

MSc, Operational Research
University of Birmingham, Birmingham, UK

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

Christopher Knight, MSc, is a Director of Health Economics 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).

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 8 years of professional experience applying health outcomes research of pharmaceutical and health data. She has conducted detailed literature reviews; supported the writing and development of abstracts, manuscripts, and poster presentations; and developed cost-effectiveness, cost-utility, and cost-minimization economic models in Microsoft Excel. 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 lunch cancer, restless leg syndrome, fibromyalgia, and diabetic neuropathic pain.

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

Cheryl McDade is a Research Health Economist at RTI-HS and provides knowledge and experience in health economics and outcomes research studies, including cost-effectiveness, cost-benefit, and cost-utility, 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, angiography technology, breast and colorectal 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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MA, Applied Economics
University of North Carolina, Greensboro, NC

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

BA, Economics
University of Pune, India

Debanjali Mitra, MA, MBA, is an Associate 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, 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 has also conducted research to characterize patterns of medication utilization, including adherence and persistence, titration, switching, and discontinuation in various therapeutic areas, including melanoma, 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 has also 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 Medical Care and the Journal of Studies on Alcohol and Drugs and has a forthcoming publication in the Archives of General Psychiatry. Her research has also been accepted for presentation at numerous professional conferences and workshops, including the Research Society on Alcoholism (RSA), Academy of Health’s annual meetings, the Society for Prevention Research (SPR), North American and European Congresses of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Digestive Disease Week (DDW), American College of Gastroenterology (ACG), Academy of Managed Care Pharmacy (AMCP), and the American Society of Health Economists (ASHE).

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

Miny Samuel, PhD, MS, is Health Technology Appraisal Systematic and Evidence Reviewer at RTI HS. Dr. Samuel has more than 10 years of experience in the field of epidemiology. 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.

PhD, Industrial and Operations Engineering
University of Michigan, Ann Arbor, MI

MS, Industrial Engineering
University of Houston, University Park, Houston, TX

BEng, Chemical Engineering
Chulalongkorn University, Bangkok, Thailand

Sada Soorapanth, PhD, is a Director in Health Economics at RTI-HS. Her research and work experiences include epidemic modeling (e.g., Markov model, population dynamic model, or compartmental model using ordinary differential equations), probabilistic sensitivity analysis, discrete-event simulation, decision analysis and Bayesian inference, and health economic analyses (e.g., cost-utility, cost-effectiveness, cost-benefit, and budget-impact analyses). Prior to joining RTI-HS, Dr. Soorapanth taught statistics and operations management courses at the Department of Decision Sciences at San Francisco State University.

Dr. Soorapanth has conducted numerous studies in disease modeling and cost-effectiveness analyses of public health policy and new medical technology. Her PhD thesis, funded by the Environmental Protection Agency, involved developing mathematical models (deterministic and probabilistic) to quantify risk of waterborne disease and to provide useful information for water treatment policy decision making. As a Prevention Effectiveness Fellow, she has worked in various projects with the Centers for Disease Control and Prevention to develop the cost-effectiveness models for HIV/AIDS prevention interventions. She has also worked with major pharmaceutical companies to perform economic modeling and analyses in various diagnostic and therapeutic areas. Her research has been presented at various professional conferences and published in academic journals such as the Journal of Acquired Immune Deficiency Syndrome (JAIDS), Management Science, and Handbook of Operations Research/Management Science Applications in Health Care.

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 experience at GlaxoSmithKline included conducting detailed literature reviews and supporting the writing and development of abstracts and manuscripts. Ms. Talbird also has experience in health policy in the public sector, working directly with state Medicaid departments on developing 1915(c) waivers, conducting cost surveys, setting reimbursement rates for services, and working on an independent evaluation of a State Children’s Health Insurance Program. Ms. Talbird has experience with SAS statistical programming software and data analysis in Microsoft Excel. Ms. Talbird’s academic experience is grounded in finance, economics, and public health. Therapeutic areas include prostate cancer, benign prostatic hyperplasia, influenza, malaria, HIV, and reproductive health.

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

MSc, Pharmacy
School of Pharmacy, Uppsala University, Sweden

Birgitta von Scheele, MS, MSc, is a Senior Health Economist at RTI-HS. She has 7 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 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 Scheele has also 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 GCP standards and ICH harmonization, including study designs, study protocols, case record forms, clinical report writing, cost-economic modeling, and decision analysis.

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

MSPH
University of North Carolina, Chapel Hill, NC

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

Michele Wilson, MSPH, is a Research Health Economist 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, diabetes, COPD, schizophrenia, stroke, cardiovascular disease, lupus, Alzheimer’s disease and dementia, and HIV.

Mr. Wilson has coauthored research published in Stroke, Managed Care Interface, Review of Economics of the Household, and the Journal of Health and Economic Issues. Mr. Wilson’s work has also been presented at the International Society for Pharmacoeconomics and Outcomes Research, Chest, Winter Workshop on Schizophrenia and Bipolar Disorders, the American Academy of Managed Care Pharmacy, International Stroke Conference, the American Thoracic Society, and AcademyHealth.

PhD, Biotechnology
Cambridge University, Cambridge, UK
Dissertation: Novel Immobilisation Techniques in Amperometric Biosensors

BSc, Biochemistry
Birmingham University, Birmingham, UK

Sorrel Wolowacz, PhD, is a Director of Health Economics at RTI-HS with 8 years of experience in heath economics consulting and more than 18 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, 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, and hematological cancers), cardiology, VTE, arthritis, chronic pain, ophthalmology, and dermatology, She has participated in health technology appraisals in several markets, including the UK (NICE and SMC), 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.

MSc, Operational Research and Applied Statistics
University of Salford, Salford, UK

BSc (Hons), Management Science with Economics
University of Northampton, Northampton, UK

Evelina Zimovetz, MSc, has more than 2 years of experience working as a Health Economist at RTI-HS. During this time, she has contributed to the development of cost-effectiveness, cost-utility, and budget-impact models in Microsoft Excel; undertaken systematic literature reviews; supported the writing and development of abstracts, manuscripts, and poster presentations; and managed a number of health economics and pricing and reimbursement projects. Her experience includes the therapeutic areas of rheumatoid arthritis, neuropathic pain, fibromyalgia, hemophilia, prostate cancer, 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.

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 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 depression, attention-deficit disorder, bipolar disorder, schizophrenia, insomnia, incontinence, irritable bowel syndrome, oncology, cardiovascular disease, women’s health, diabetes, asthma, COPD, sexual dysfunction, obesity, cystic fibrosis, chronic pain, and sexually transmitted diseases such as herpes, HPV, and 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.

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 7 years of industry experience in clinical drug development and global health outcomes research with Pfizer. She is skilled at developing outcomes research strategy and key value messages/claims to differentiate developmental compounds in phases 1-3B for women’s health, oncology, dermatology, and respiratory indications. Dr. Clark also has expertise in the evaluation, selection, development, and validation of patient-reported outcome questionnaires, specifically quality of life, treatment satisfaction, and symptom assessment; and the development of FDA evidence dossiers to support labeling claims for patient-reported outcome endpoints. She also 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.

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

Kim Davis, MS, is a Director of Patient-Reported Outcomes 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 her 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. 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 ADHD, 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.

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-Mercon, MS, is a Senior Director of Patient-Reported Outcomes in RTI-HS. Ms. DeMuro-Mercon 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-Mercon 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.

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.

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

Cheryl Hill, 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. Hill 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 Clinical Therapeutics and Medical Care and posters presented to the International Society for Quality of Life Research and the American Psychiatric Association.

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, Senior Director of Survey Research for RTI-HS, has a strong background in project management and a proven track record in the successful design, implementation, and leadership of global research studies. During her 10 years at RTI International, she has provided successful leadership and oversight of research in a number of therapeutic areas, including IBS, oncology, 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. Her results-oriented, client-focused approach to project management includes strategic planning, financial management, process development, and resource allocation.

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 between the ages of 6 and 18. 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.

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 16 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, postherpetic neuralgia, diabetic painful neuropathy, Alzheimer’s disease, low back pain, and arthritis. 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.

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 trained psychometrician with over 10 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 define minimal important differences. 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.

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

BS, Psychology
University of North Carolina, Charlotte, NC

Lauren Nelson, PhD, is a Director of Psychometrics at RTI-HS. She has more than 10 years of experience in quantitative methods research with a specific focus in psychometrics. Most recently, she has applied these methods in the areas of child development and early childhood education research. Dr. Nelson has served as statistical consultant in a variety of areas, including substance abuse, speech and communication of typically developing children and children with Fragile-X and Down syndrome, evaluation of statewide prekindergarten programs, and nationwide early intervention services. She has several publications and presentations in the fields of childhood development and early education, including Pediatrics, American Journal of Mental Health, and Developmental Psychology

MEd, Educational Research and Evaluation
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 Senior Psychometrician 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 helped design, coordinate, and analyze data for qualitative studies in the specific disease areas of male sexual dysfunction, HIV, prostate cancer, obesity, 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, 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.

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. Her background is in epidemiology and includes a history in study design and project management. She has experience conducting literature searches, developing concept protocols and analytic plans for survey and claims-based research, reviewing documentation for quality control purposes, and preparing abstracts and manuscripts for submission/publication.

Prior to joining RTI-HS, Ms. Sweeney worked in the pharmaceutical industry where she provided strategy support for both marketed 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.

MPH
University of Connecticut, Storrs, CT

PMP
Project Management Institute, Newtown Square, PA

BA, Microbiology
University of New Hampshire, Durham, NH

Michelle Thompson, MPH, PMP, is a Senior Project Manager in the Patient-Reported Outcomes group at RTI-HS. Ms. Thompson 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, she supports a wide range of studies, including patient-reported outcomes studies, prospective epidemiological studies, and database studies. Ms. Thompson 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.Thompson’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. Thompson 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.

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 20 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 and gynecological disorders, obesity, sexual dysfunction, bipolar disorder, anxiety, 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.

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

Semester Abroad at the University of Sussex, Brighton, England

Laurie Zografos is a Director of Survey Research in the Patient-Reported Outcomes 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.

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 Regulatory and Health 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 PRO endpoints, economic evaluations, OR strategic plans, and regulatory strategy. In her outcomes research and regulatory role, she leads a team of scientists responsible for developing OR strategic plans for phase 2/3 compounds, developing PRO dossiers for the FDA for Label Claims, and designing clinical trials with OR endpoints. Ms. Copley-Merriman has experience in many therapeutic areas, including oncology, pain and inflammation, dermatology, respiratory, urology, and CNS.

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

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

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

Amy Barrett, MA, MSPH, is a Director of Regulatory and Health Outcomes Strategy with RTI-HS. She has more than 10 years of experience analyzing and writing about issues related to health care delivery. Ms. Barrett has developed global value dossiers and has led large, multicountry burden-of-illness literature reviews. She also has experience in payer research, including designing interview guides, conducting interviews with payers, and analyzing results for their impact on pricing and reimbursement strategy. Her experience in performing patient-reported outcomes research includes developing questionnaires and conducting focus group and cognitive interviews. She offers knowledge in several therapeutic areas, including Alzheimer’s disease, Parkinson’s disease, anxiety disorders, depression, schizophrenia, bipolar disorder, epilepsy, stress urinary incontinence, and reproductive health. Prior to joining RTI-HS, Ms. Barrett served as an editor-in-chief for a health care publisher. She wrote a national newsletter for the assisted living industry, which required analysis of federal, state, and local regulations, as well as compliance, liability, and long-term care delivery models. She also wrote about topics related to the provision of skilled nursing and rehabilitation.

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 an Associate Director in the Regulatory and Health Outcomes Strategy group at RTI-HS. Ms. Barrows has several years of industry experience in outcomes research 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, ADHD, and depression, migraine, pain, inflammation, 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, conducting competitive overviews, and developing FDA dossiers for PRO endpoints.

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

Ann Colosia, PhD, is a Health Outcomes Scientist in the Regulatory and Health 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 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.

BA, Journalism
University of Kentucky, Lexington, KY

Kristen Hinson is a Research Coordinator at RTI-HS. Ms. Hinson assists in writing, conducting literature reviews, data entry, and the coordination of research materials for various groups in RTI-HS. She graduated from the University of Kentucky with a BA in Journalism and a minor in political science.

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

BA, Psychology
Susquehanna University, Selinsgrove, PA

Certificate (in process), Core Public Health Concepts
University of North Carolina, Chapel Hill, NC

Melissa Juniper, MS, is a Director of Regulatory and Health Outcomes Strategy at RTI-HS. Ms. Juniper develops Value Strategies and Value Dossiers to help ensure pharmaceutical access and reimbursement and successful product commercialization. She has completed an Expert Workshop at the Centre for Health Economics at the University of York, as well as 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 is currently completing coursework toward her certificate in Core Public Health Concepts through the University of North Carolina. Ms. Juniper’s research and writing experience has been in the areas of cardiovascular disease, diabetes, osteoporosis, fibromyalgia, non-small cell lung cancer, glioblastoma multiforme, macular degeneration, hepatitis B, psoriasis, opioid-induced bowel dysfunction, major depressive disorder, and generalized anxiety disorder.

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

Shahnaz Khan, MPH, is a Senior Director of Regulatory and Health Outcomes Strategy. Ms. Khan is responsible for the development of pricing and reimbursement dossiers. She has more than 9 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 AMCP meetings and AMCP/FMCP-sponsored seminars on a regular basis in order to remain up-to-date on the latest news regarding AMCP dossiers

BA, Zoology
University of California, Santa Barbara, CA

Mary Levine is a Research Resource Specialist at RTI-HS. 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.

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 Regulatory and Health Outcomes Strategy group at RTI-HS. Ms. Masaquel has 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 primarily focused on therapeutic areas such as cardiology and nephrology. Ms. Masaquel is responsible for the development of outcome research strategic plans for phase 2/3 compounds, PRO evidence dossiers for drug label claims, competitive overviews, and value message positioning.

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

Margaret Mordin, MS, is a Senior Director of Regulatory and Health Outcomes Strategy at RTI HS. Ms. Mordin has more than 16 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, including designing observational postmarketing studies, designing patient-reported outcomes for use in clinical development programs, patient health-related quality of life and satisfaction surveys, analyses 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.

MA (in progress), Applied Economics
BS, Economics
University of North Carolina, Greensboro, NC

Hediyyih Narula is a Health Outcomes Scientist for the Regulatory and Health Outcomes Strategy group at RTI-HS. She assists in the development of various dossiers, burden of illness reports, and manuscripts, and she thoroughly reviews documentation for the purpose of ensuring quality control. She also has experience conducting literature searches and data abstractions (the process of extracting relevant information from articles that have been selected through a targeted literature search and inputting the data into detailed data abstraction forms).  Ms. Narula graduated magna cum laude, with a BS in economics, and is currently pursuing her Master’s in applied economics at the University of North Carolina at Greensboro.

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

Catherine Rycroft, PhD, is a Health Outcomes Scientist in the Regulatory and Health Outcomes Strategy group at RTI-HS, involved in preparing value dossiers, SMC submissions, and burden of disease reviews. Dr. Rycroft has more than 7 years of experience in scientific research, medical communications, and health outcomes. She has experience in selecting and interpreting critical data from various sources, such as clinical study reports, questionnaires, and published manuscripts, and presenting them in a clear, appropriate format to convey key messages in line with client needs. Dr. Rycroft has experience in a range of disease areas, including cardiovascular disease, Crohn’s disease, breast cancer, diabetes, gout, and overactive bladder disorder. Before joining RTI-HS, Dr. Rycroft was a medical writer at Prime Medica Limited, where her responsibilities included the communication of scientific information through primary manuscripts, reviews, meeting reports, abstracts, posters, slide sets, competitor monitor reports, and newsletters, in a range of therapy areas. 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 World Journal of Microbiology and Biotechnology.

BS, Zoology
Michigan State University, East Lansing, MI

Catherine Siersma is a Project Manager at 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. In her scientist role, she performed pharmacokinetic studies in animals and in vitro metabolism studies. Prior to Pfizer, her work focused primarily on pharmacokinetic and oral absorption studies, with an emphasis on animal use regulations, resulting in a strong knowledge of NIH and USDA guidelines.

PhD, Genetics
Duke University, Durham, NC

BS, Biotechnology
Rochester Institute of Technology, Rochester, NY

Jeffrey Walter, PhD, is a Health Outcomes Scientist at RTI-HS. Dr. Walter develops formulary submission dossiers, product value dossiers, and other health outcomes documents, and also contributes to strategic planning services on behalf of pharmaceutical industry clients. Dr. Walter’s graduate and postgraduate research dealt with the genetics underlying diverse disorders, including Parkinson’s disease, glaucoma, and vascular tumors. Following his postdoctoral training, Dr. Walter became involved with scientific writing and has implemented publication planning on behalf of numerous pharmaceutical industry clients. Dr. Walter’s areas of professional writing expertise include genetics, neurologic disorders, gastrointestinal disease, cardiovascular disease, autoimmune disorders, and cancer biology.

Neil Palmer is Vice President of Pricing and Reimbursement at RTI-HS. Formerly Principal Consultant of Palmer D’Angelo Consulting Inc., Canada’s leading pricing and reimbursement consultancy, Mr. Palmer is responsible for leading RTI-HS’s pricing, reimbursement, and policy research assignments. Mr. Palmer worked with the Canadian Patented Medicine Prices Review Board, where his responsibilities included policy development, overseeing the price review of patented medicines, and conducting economic research. Prior to this, he worked with the Health Division of Statistics Canada, where he was responsible for economic and statistical analysis of health care costs and utilization. After completing his studies at the University of Western Ontario, Mr. Palmer began his career in Montreal with the research group of the Kellogg Centre for Advanced Studies in Primary Care. He has written extensively on pharmaceutical pricing and reimbursement issues and is a frequent speaker at pharmaceutical conferences in North America and Europe.

Janice D’Angelo is the Global Head of Pricing and Reimbursement in RTI-HS’s Canadian Office. She is the co-founder of Palmer D’Angelo Consulting Inc. (PDCI), which was acquired by RTI-HS in January 2007. She provides expert advice to clients with respect to the Guidelines and Regulations of the Canadian Patented Medicine Prices Review Board (PMPRB) and coordinates RTI-HS’s pricing and reimbursement research projects. She has over 20 years of regulatory experience with the federal government of Canada. From 1991 to 1996, she was employed by the PMPRB and was responsible for operational policy development, the resolution of non-standard reviews, and a wide range of compliance activities. As Chief of Compliance, she oversaw the application of the Excessive Price Guidelines by the Board’s Compliance Officers. Prior to 1991, Janice D’Angelo conducted economic and statistical analysis for the National Energy Board (NEB) relating to Canada’s oil supply and demand and was responsible for various regulatory activities including the advancement of export application through the NEB’s public hearing process.

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 US Pricing and Commercial Strategy at RTI-HS. In this role, he assists clients with their pricing and reimbursement optimization strategies for their pharmaceutical, biological, and medical device brands. 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.

MD
Universidad Autónoma de Barcelona, Barcelona, Spain

MIR (Medical Internal Resident), Specialization in Preventive Medicine and Public Health
Board of Specializations, Ministry of Health, Spain

MBA
Columbia University, New York, New York

Salomé de Cambra, MD, MBA, is a Senior Consultant for European Pricing and Reimbursement at RTI-HS in the Barcelona office. Dr. de Cambra holds a Medical Degree, specializing in public health and preventive medicine, and an MBA. She has 17 years of experience in the health care industry and health public administration. Her most recent position was at Esteve (Spanish pharmaceutical company) where she was responsible for drug price negotiation with the Ministry of Health and promoting institutional projects focused on patients and health management. During her professional career, Dr. de Cambra has collaborated with major pharmaceutical companies and governmental agencies through internal positions and as an external consultant.

Her main areas of expertise are health management and policy, health promotion, and vaccines, although she has been involved in many other areas, including depression, Alzheimer disease, pain and analgesia, workplace health promotion, and health communication. Dr. de Cambra participated in developing and writing the first Health Plan and the Year 2000 Health Objectives of the Catalan Ministry of Health. While at Diversified (Smithkline Beecham), she started a disease management program on depression (achieving a reduction of 40 days on the average sick leave), a patient management project for primary health care, and a pharmacy benefit project for primary health care. At Esteve, Dr. de Cambra supported and defended the pharmaceutical company interests against the new Medicines Law and the Autonomous Governments cost control policies.

While working the in the Catalan Government, Dr. de Cambra began the Physical Activity Promotion Program and participated as a consultant in various WHO workshops. She has designed and implemented programs in the workplace that focus on smoking cessation, and the prevention of effects of psychosocial factors on workers.

As a resident, Dr. de Cambra participated in the first hepatitis B clinical trial performed in Spain. In Pasteru Mérieux, she conducted the marketing and epidemiologic studies to introduce the Haemophilus influenzae B vaccine in Spain, and identified potential opinion leaders. She has also conducted market research on adult vaccines. At GSK, she was responsible for vaccine sales in Catalonia, Andorra, and Aragon. In addition, she has promoted the development of an On-line Patient Immunizations Database.

MPH
University of North Carolina, Chapel Hill, NC

BS, Biology
Radford University, Radford, VA

Eric C. Faulkner, MPH, is Senior Director of US Market Access and Reimbursement at RTI-HS. He has approximately 12 years of experience focusing on health technology assessment, product reimbursement and commercialization, health care management, and health policy analysis. Prior to joining RTI-HS, Mr. Faulkner was a senior consultant at the Littell Group and The Lewin Group. In these positions, he managed a portfolio of consulting projects, including reimbursement strategy analysis, evaluation of the clinical and economic impact of the in vitro diagnostics industry, design of clinical trials to meet requirements of third-party health decision makers, life sciences stakeholder surveys, burden of illness studies, and analysis of key health policy initiatives. In previous positions, he provided intellectual property consulting services and managed a variety of genomic and molecular research initiatives for the NIH and Duke University. Additional responsibilities have included participation in a number of expert advisory groups addressing ethical, legal, policy, and commercial/operational issues relevant to the life sciences industry. Mr. Faulkner holds a bachelor’s in biology from Radford University and a master of public health in health policy and administration from the University of North Carolina at Chapel Hill.

Mr. Faulkner has recently served as an expert advisor to the Personalized Medicine Subcommittee of the President’s Council of Advisors on Science and Technology and is serving as a lead editor for an upcoming book entitled Medical Device and Diagnostics Outcomes Research: Issues and Good Research Practices, sponsored by the US Medical Device and Diagnostics Council of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).

Mr. Faulkner has significant experience in evidence-based practice and policy. He has served as a project manager for the AHRQ Evidence-Based Practice Center program and US Preventive Services Task Force (USPSTF) initiatives, including process management, stakeholder communications, systematic literature assessment, meeting planning and thought leader recruitment, and development of a novel horizon scanning approach. Mr. Faulkner has managed multiple public and commercial health technology assessments of drugs, medical devices, and diagnostics, including cognitive and neurodegenerative disorders, stem cell transplantation, oncology, cardiovascular disease, diabetes and metabolic syndrome, hypertension, depression and psychological disorders, dermatological disease, sexually transmitted and infectious disease, and health care management issues. He has also led health policy assessments, including CMS’s Coverage with Evidence Development (CED) and Clinical Trial Policy, value-based purchasing, competitive bidding, cost-effectiveness, comparative effectiveness, pharmacogenomics, and health care transparency for life sciences manufacturers, industry and medical professional associations, and government agencies, including HHS, NIH, FDA, CDC, and ASPE.

Mr. Faulkner also serves as Director of the Genomics Biotech Institute (GBI) of the National Association of Managed Care Physicians and Editor-in-Chief of the GBI section of the Journal of Managed Care Medicine. He has significant experience in evaluating novel molecular diagnostics, targeted therapeutics, and personalized medicine approaches and how these advances influence medicine and health policy and enable new paradigms of health care delivery. Mr. Faulkner also has a strong commitment to helping payers, providers, employers, patients, policy makers, and other health stakeholders work collaboratively to address opportunities and challenges associated with adoption and diffusion of emerging genomic, biotechnological, and other technological innovations.

Linda Laframboise is a Research Assistant at RTI-HS located in the Ottawa office. She began work as a research assistant of international prescription drug prices with Palmer D’Angelo Consulting Inc. in 2001.

MBA
University of Ottawa, Ottawa, ON, Canada

MA, International Affairs
University of Carleton, Ottawa, ON, Canada

BA, Economics
University of Waterloo, Waterloo, ON, Canada

Arvind Mani, MBA, MA, is the Director of International Pricing and Policy with RTI-HS’s Pricing and Reimbursement group in Ottawa, Canada. Mr. Mani is responsible for furthering the development and dissemination of the international price database, as well as contributing to pricing and reimbursement policy and analysis projects. Before joining RTI HS, Mr. Mani spent several years as the director of corporate affairs at the National Association of Pharmacy Regulatory Authorities (NAPRA) in Ottawa. Prior to NAPRA, he worked for 8years at Canada’s Research-Based Pharmaceutical Companies (Rx&D), an association that represents the interests of innovative pharmaceutical companies in Canada. Mr. Mani held various positions at Rx&D, including research analyst, director of regulatory affairs, and director of policy development. In his policy development role, Mr. Mani provided expert knowledge to companies, governments, and international associations on pharmaceutical pricing, regulatory, market access, and patent issues. He also coauthored a number of industry submissions responding to significant government policy initiatives such as the (Romanow) Commission on the Future of Health Care in Canada and the Government of Canada’s Innovation Strategy. In his role as director of regulatory affairs, Mr. Mani monitored government policy activities and participated in the development of industry responses on regulatory issues. As research analyst, he provided high-level analytical expertise through the provision of accurate, timely, and reliable information on key industry issues affecting the pharmaceutical industry. Prior to joining Rx&D, Mr. Mani was a market analyst with Novartis Pharmaceuticals Canada Inc.

BA, Psychology (Minor in Economics)
Carleton University, Ottawa, Ontario, Canada

Dana Mills is an Analyst in RTI-HS’s Market Access team, assisting in the preparation of reimbursement submissions, preparing PMPRB Form 2 filings, PMPRB submissions, and pricing analyses. He also assists in writing the C-MAP Canadian Drug Benefit Plans Reference Guide and is in charge of keeping the Reference Guide updated throughout the year. He was previously employed at Rx&D and PRA Int’l. Mr. Mills holds a Bachelor of Arts in Psychology with a Minor in Economics from Carleton University.

MBA
York University, Toronto, Ontario

BA, Psychology
University of Toronto, Toronto, Ontario

Susan Neale is a Senior Policy Analyst with RTI-HS’s Pricing and Reimbursement group located in Ottawa, Canada. Ms. Neale manages international and Canadian research projects and provides expertise on market access and pricing/reimbursement of new and existing therapies in Canada, the United States, and Europe. She coordinates research carried out by a network of international consultants and consolidates findings for global projects. Ms. Neale has written numerous reports and articles including several Spectrum reports published by Decision Resources Inc.: Successful Pricing Strategies, The Outlook for Parallel Trade in North America, and Pharmaceutical Pricing and Reimbursement in Canada. Ms. Neale has an MBA from York University in Toronto and a background in group health administration. Ms.Neale has written numerous reports and articles including several Spectrum reports published by Decision Resources Inc.: Successful Pricing Strategies, The Outlook for Parallel Trade in North America and Pharmaceutical Pricing and Reimbursement in Canada.

MSc, Drug Development Options in Pharmacoeconomy and Pharmacoepidemiology
BSc, Microbiology and Immunology
University of Montreal, Montreal, Canada

Nancy Paul Roc, MSc, is a Pricing Associate at RTI-HS. She provides assistance in the areas of pricing and reimbursement. She recently completed her Master’s degree by doing an 8-month internship at sanofi-aventis Canada in the Health Economics and Health Outcomes (HE & HO) department. Previously, she had completed 30 units in Drug Development at the University of Montreal.

During her internship at sanofi-aventis Canada, she helped in the creation of market access and reimbursement documents and analyzed costs for economic evaluations. She also has reviewed literature to assist the HE & HO team in finding relevant publications to support their Canadian products.

BSc, Nutrition and Dietetics
University of Saskatchewan, Saskatoon, Saskatchewan, Canada

Elizabeth Resch is a Manager of Business Development at RTI-HS and has an emphasis on business development initiatives for the pricing and reimbursement group. She is also responsible for managing the group’s Canadian market access publications, including the “Canadian Drug Benefit Plans Reference Guide.” She studied at McGill University and received a Bachelor of Science from the University of Saskatchewan with a major in Nutrition and Dietetics. Ms. Resch has worked in the pharmaceutical industry, clinical research, and the public and private health care sectors.

Ara Salazar is a Market Access Associate in the Pricing and Reimbursement group at RTI-HS. She assists in the preparation of reimbursement submissions, including budget impact analyses and reports, to the provincial and federal drug plans in Canada, as well as to private payers. Ara Salazar conducts statistical and economic research on the Canadian pharmaceutical industry. She has assisted in writing articles and reports on Canadian pharmaceutical care, pricing trends, market exclusivity, and economic trends in the pharmaceutical industry. Ara Salazar is also responsible for the research, writing, and updating of the Canadian Drug Benefit Plans Reference Guide.

MBA
St. John’s University, New York, NY

BS, Biology
Siena College, Loudonville, NY

Barbara Rivera, MBA, is Director of Commercial Services at RTI-HS. She is a senior-level marketing professional with a track record of managing the development and execution of strategic marketing and product launch plans for pharmaceutical product portfolios. Ms. Rivera has led cross-functional, multidisciplinary teams in navigating regulatory, patent, business development, and manufacturing issues to achieve business objectives. She has experience developing and deploying branding, professional/consumer marketing, and sales training programs. This experience includes strategic and tactical planning, market research, forecasting, P&L management, and budgeting.

Ms. Rivera’s recent projects include leading the United States team in the early commercialization stage for the monoclonal antibody Bosatria (mepolizumab), the first GlaxoSmithKline-developed biologic, and participating as a core team member in bringing Lotronex (alosetron HCl) back to the market. In that endeavor, she established first-of-kind risk management, physician education, sales programs, and a corresponding Web site. Ms. Rivera also led a first-of-its-kind multidiversity marketing initiative that included designing a targeted marketing plan exclusively for the Asian American population that is a predominant population for hepatitis B. In addition, she was a key member of the team that implemented a distribution agreement for Ceftin (cefuroxime axetil) with LifeCycle Ventures, allowing GlaxoSmithKline to move resources from this mature product to other growth products.

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 more than 85 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 recent book on various 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.

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 Global Head of Health Preference Assessment at RTI Health Solutions. 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, Alzheimer Disease and Associated Disorders.

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.

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.

Susana Perez-Gutthann, MD, MPH, PhD, FISPE, FRCP, is Vice President and Global Head of Epidemiology at RTI HS. Dr. Perez-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. Perez-Gutthann has 19 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. Perez-Gutthann is an active leader and Past President of the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of ISPE and of the Royal College of Physicians, Edinburgh. She is invited to teach in several programs, to speak and chair conferences and symposia, which have included DIA, TOPRA, Australian National Prescribing Service Symposium, Asian Pacific Regulatory Safety Sciences Meeting, International Conference of Pharmacoepidemiology & Risk Management, and World Congress of Pharmacology and Clinical Therapeutics. Dr. Perez-Gutthann’s roles as an advisor and in international working groups have included WHO TRD Product Development and Evaluation, International Scientific Advisory Board to MHRA General Practice Research Database,  ISPE Working Groups on Risk Management Guidances (FDA, EMEA), Good Pharmacoepidemiology Practice, and confidentiality of patient databases in Europe; working groups on gastrointestinal complications associated with NSAIDs, IMBRF on drug-induced disease, and HRT and breast cancer risk. Currently, Dr. Perez-Gutthann serves as a member and chair of several scientific advisory boards for studies, research programs, strategic, and regulatory risk management topics.

PhD, Epidemiology
MPH, Health Policy and Administration
University of North Carolina at Chapel Hill

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 on therapeutic risk management, 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 prospective databases. Dr. Andrews currently serves as principal investigator on two large risk management programs. Her primary research focus has been on studies of disease natural history, treatment patterns, and drug safety. Her experience has spanned most therapeutic areas, though she has worked extensively in the areas of HIV and sexually transmitted diseases; reproductive health, birth defects, and neonatal health; asthma and COPD; 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, a member of the editorial board of the Journal of Pharmacoepidemiology and Drug Safety, and co-editor of Pharmacovigilance. She is an Adjunct Associate Professor of the University of North Carolina School of Public Health and School of Pharmacy, a senior consultant and investigator with the UNC Center for Education and Research on Therapeutics, and a consultant to the FDA in epidemiology and risk management.

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.

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 for 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 developing study protocols and 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.

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 FDA advisory committee and EMEA oral hearings. Dr. Castellsague has produced epidemiologic research in the areas of asthma and COPD, allergic rhinitis, liver injury, renal failure, serious skin disorders, gastroenterology, and cardiology related to a variety of products, including COX-2 inhibitors and NSAIDs, monoclonal antibodies, inhaled bronchodilators, oral antifungals, and HRT. He has coordinated and participated as an investigator in several international, multicenter epidemiologic field studies in the areas of asthma and COPD.

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

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.

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

MS, Microbiology
Harvard University School of Public Health, Cambridge, 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. Her most recent and primary area of interest is pharmacoepidemiology, particularly postmarketing drug safety.

Dr. Johannes worked for 4 years at Ingenix, Epidemiology Division (now i3 Drug Safety) conducting drug safety studies using a large health care claims database. Her primary areas of research included estimating the incidence of hematologic malignancy and neurological conditions in rheumatoid arthritis patients; describing the epidemiology of treated rheumatoid arthritis and patterns of use of biologic therapeutic agents; examining the risk of fracture associated with inhaled corticosteroids; comparing various antidiabetic agents with respect to cardiovascular disease risk; and describing the off label use of antihypertensive agents in children. Before joining Ingenix, Dr. Johannes worked for 7 years at New England Research Institutes with the design, analysis, and reporting 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. In addition, she obtained several grants to develop data collection software using hand-held computers for recording daily information about headache and menstrual cycle symptoms.

MD
Stanford University School of Medicine, Stanford, CA

DrPH
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 did his internship and residency at the Beth Israel Hospital and his fellowship in medical oncology/hematology at the Dana-Farber Cancer Center. Following completion of his training, Dr. Kaye remained on the faculty in the Department of Medicine at Harvard Medical School while practicing medical oncology/hematology and coordinating the clinical research program at Harvard Community Health Plan.

After leaving Harvard, Dr. Kaye joined the clinical development group at Genetics Institute, Inc. (later Wyeth) where he directed clinical studies on several hematology/oncology products, two of which were approved for marketing, and participated in numerous FDA interactions, including IND and 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. For the past decade he has been a senior epidemiologist at the Boston Collaborative Drug Surveillance Program and served on the faculty of the epidemiology department at Boston University School of Public Health. In addition to conducting his own epidemiology research on a broad array of drug safety issues, Dr. Kaye has chaired or participated in numerous independent data monitoring committees for advance phase clinical trials of oncology drugs in development. He has authored approximately 50 articles in the peer-reviewed medical literature.

MPH, Epidemiology
Emory University, Atlanta, GA

BS, Mathematics
Salem College, Winston-Salem, NC

Amy Ladner, MPH, is a 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 a strong background in survey research and has extensive experience designing and managing telephone, mail, field, and mixed-method studies.

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.

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.

PhD, Epidemiology
University of Texas-Health Science Center Houston, Houston, TX

MSW, Medical Social Work
University of Houston, Houston, TX

BA, Sociology
University of Florida, Gainesville, FL

Covenant College, Lookout Mountain, GA

College of the Mainland, Texas City, TX

Rebecca Martin, PhD, MSW, is a Director of Epidemiology at RTI-HS. Previously, Dr.Martin was a Senior Research Epidemiologist at RTI International with skills in field implementation, biospecimen collection, and analysis of epidemiologic cancer studies. She is familiar with central cancer registries, having formerly been the Director of the North Carolina Central Cancer Registry. She is currently conducting research with a number of state cancer registries and is an active member of the North American Association of Central Cancer Registries. She is an expert in designing and conducting epidemiologic surveys, etiologic research, and population-based studies and in gathering primary data. She has experience in all modes of data collection, including record abstraction, mail surveys, household screening and interviewing, telephone interviewing, biological specimen collection, and clinical interviews and exams. Dr. Martin has developed field implementation strategies for the collection, processing, and management of biologic and epidemiologic information, including tissue specimens, blood, and buccal cells. Dr. Martin has experience with a variety of research areas, including cancer, maternal and child health, preterm birth, reproductive epidemiology, adolescents, substance abuse, patient outcome studies, mental health, health services evaluation, dental health, and health status of the homeless.

Currently enrolled in Master’s program in Bioinformatics
North Carolina State University, Raleigh,NC

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 in the Epidemiology division of RTI-HS. She assists in the design and conduct of epidemiologic and health outcomes studies, with her particular expertise being longitudinal database analysis. Some of the projects on which she has worked include the following:

§ Characterization of Users of Antihypertensive Medications Used in the Management of Heart Failure

§ The Impact of Influenza Vaccination on Household Members of Vaccinated Children in the United Kingdom: A Study of Herd Immunity

§ Study of the Epidemiology of Pain and Development of a Chronic Pain Screening Tool for Use in a Primary Care Setting

§ Prevalence of Type 2 Diabetes Mellitus in the United States (includes projection models of the prevalence of diagnosed and undiagnosed T2DM for years 2001 through 2021)

§ Study of Male Attitudes Regarding Sexual Health

§ Dyslipidemia in HIV/AIDS Patients: Impact of Protease Inhibitor Therapy

Prior to joining RTI-HS, she was a Principal Programmer/Analyst in the Worldwide Epidemiology department at GlaxoSmithKline (GSK), where she worked on epidemiologic studies that utilized large longitudinal databases (e.g., LNEI administrative claims or GPRD medical records) or population-based survey databases (e.g., NHANES III). Her responsibilities include database management and analysis, as well as protocol development, project management, and report/manuscript writing.

In recent years, her work has been focused primarily in the respiratory therapeutic area. However, over the course of more than 15 years in health care–related research, she has worked in a wide range of clinical/therapeutic areas, including infectious disease (HIV/AIDS, influenza), rheumatology/immunology, orthopedics (TKR), gastrointestinal disease (IBS), cardiovascular disease (stroke), metabolic disease (diabetes, hyperlipidemia), mental health, and substance abuse. She has acquired expert SAS skills on multiple platforms, and has a strong background in computer science and systems management.

MPH, Epidemiology
University of New Mexico, Albuquerque, NM

BA, Human Biology
University of Kansas, Lawrence, KS

Kirk Midkiff, MPH, is a Senior Research Epidemiologist within the Epidemiology Research Group at 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 participated 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.

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.

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

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

Abenah Vanderpuije, MPH, is a Research Epidemiologist with the Epidemiology Research Group within RTI-HS. Ms. Vanderpuije has expert project management, data management, and data analysis skills. She has over eight years of research experience focusing on data management and epidemiological research. Ms. Vanderpuije 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. Vanderpuije has experience with a variety of research areas including maternal, perinatal and child health; Native American health; occupational health; and asthma. She has experience with literature reviews and preparing manuscripts for publication.

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.

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 Glaxo Wellcome, he became Vice-President of Research and Development at Salix Pharmaceuticals. Dr. Mangel has led or participated in numerous FDA interactions, Advisory Committee Presentations, label negotiations, and NDA submissions, and he has authored more than 80 publications.

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

MD
University of Miami School of Medicine, Miami, FL

MS, Organic Chemistry
BS, Organic Chemistry
Emory University, Atlanta, GA

Wendy Painter, MD, MPH, MS, is Vice President of Safety and Pharmacovigilance at RTI-HS. Dr. Painter also serves on RTI International’s institutional review board. She has worked for more than 20 years at clinical and pharmaceutical institutions in positions including chief medical officer, drug safety physician, director of occupational health, and in a variety of consulting roles. Her research interests include clinical drug development and drug safety.

MS, Nursing, Minor in Information Science
University of North Carolina, Chapel Hill, NC

BS, Nursing
Nazareth College, Kalamazoo MI

Susan Bartone, MSN, RN, is a Medical Product Safety Specialist at RTI-HS. She has 7 years of industry experience, all in the area of drug safety and pharmacovigilance. Prior to joining this industry in 2002, Ms. Bartone was a pediatric staff nurse for 15 years, first in a children’s hospital and subsequently in a pediatric intensive care unit. As a staff nurse, Ms. Bartone’s specialties included pediatric medical and surgical nursing, and a strong background in pediatric hematology and oncology. Since joining the pharmaceutical industry in 2001, Ms. Bartone has been responsible for managing the daily activities of adverse event/serious adverse event case processing for both clinical and postmarketing clients. Additionally, she has experience in quality-control processing, writing narratives, and preparation of client-specific management plans. She has extensive expertise using a validated safety database, including data entry, query searches, and creating client-specific CIOMS line listings from the database. Ms. Bartone is well versed and skilled in using MedDRA and has participated in the coordination of pharmacovigilance activities with other departments. She has mentored and trained other personnel in the roles and processes within the area of pharmacovigilance

DVM
Louisiana State University School of Veterinary Medicine, Baton Rouge, LA

BS, Biology Major, Chemistry Minor
Nicholls State University, Thibodaux, LA

Cecile “Skippy” Berner, DVM, is Director, Medical Services, for the Safety and Pharmacovigilance group at RTI-HS. Since 1988, she has participated in the global development of cardiovascular, antiobesity, antidepressant, immunomodulatory, and genitourinary pharmaceutical agents. She has held several clinical research and managerial positions with Boots Pharmaceuticals, Inc. (BPI), La Jolla Pharmaceutical Company (LJPC), PPD Pharmaco (PPD), and Integrated Safety Systems, Inc. (ISS, Inc.). Dr. Berner has consulted on, managed the production of, and written clinical protocols, Investigators’ Brochures, clinical study reports, subject narratives, INDs, IND annual reports, Periodic Safety Update Reports, and major nonclinical and clinical summaries (including the Common Technical Document Sections 2.7.3 and 2.7.4) for regulatory submissions worldwide. Dr. Berner also consulted and trained on effective coding practices and data standards and performed coding of adverse events and medical histories (MedDRA, WHO-ART, Costart) and concomitant medications (WHO-Drug). At PPD, she advised development teams on scientific/regulatory and clinical aspects relating to product development, prepared strategic plans, and participated in meetings and discussions with staff of multinational regulatory affairs departments. At LJPC, Dr. Berner developed and directed the toxicology and clinical research programs for an oligonucleotide B cell toleragen for systemic lupus erythematosus, and represented the clinical research department to the Board of Directors, corporate partners, and the investment community. She also managed a Senior CRA and a full-service CRO; prepared, filed, and maintained an IND; managed communications with the US Food and Drug Administration; and participated in regulatory and corporate strategic planning. At BPI, she performed routine monitoring of clinical research studies, wrote study reports, and integrated safety summaries for the United States and Europe and managed a staff of nine medical writers and all writing projects. She also managed a team and project activities for a cardiorenal advisory committee presentation. Prior to joining the pharmaceutical industry, she was a staff veterinarian responsible for health care of patients, routine surgery, and general veterinary office management.

MS, Nursing
Duke University, Durham, NC

BS, Nursing
Lenoir-Rhyne College, Hickory, NC

Cristy Burnette, RN, MSN, has a total of 12 years of industry experience, including 9 years in drug safety and pharmacovigilance and 5 years of nursing experience in cardiology. In her position at RTI-HS, she is responsible for managing the daily activities of Medical Product Safety, including direct supervision of Medical Product Safety Specialists and general management and administrative duties. Additional duties include assistance with AE/SAE case processing, QC, oversight of Safety Management Project Plan development, assistance with/preparation of proposals and contracts, and coordination of pharmacovigilance activities with other departments. Ms. Burnette’s experience also includes postmarketing pharmacovigilance and a knowledge of foreign regulatory reporting requirements. Her disease state experience includes cardiology, peripheral vascular disease, oncology, central nervous system disorders, and endocrinology.

BA, Public Policy
North Carolina Wesleyan College, Rocky Mount, NC

Cindy Heffner is a Medical Product Safety Specialist at RTI-HS. Ms. Heffner has 15 years of industry experience, including postmarketing and clinical pharmacovigilance. The majority of her industry years were spent at GlaxoSmithKline (GSK) where, in addition to performing pharmacovigilance tasks, she provided safety monitoring for pregnancy registries and worked with international coding systems teams, and international safety database validation teams. Outside of GSK, she has experience as a Medical Product Safety Narrative/Medical Writer. Her therapeutic experience includes the areas of antiviral, anti-infective, respiratory, cardiovascular, neurological, and gastroenterology.

BSN
North Carolina Central University, Durham, NC

BFA, Commercial Design
Barton College, Wilson, NC

AA, Commercial Design
Chowan College, Murfreesboro, NC

Lisa Keith has more than 12 years of experience in the pharmaceutical industry. She has 10 years of experience directly related to working in the areas of drug safety/pharmacovigilance, with 8 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 global implementation, administration, troubleshooting, data migration, and end user training for both internal personnel and external clients. As part of database management, Ms. Keith is responsible for configuration and testing of electronic reporting with domestic and foreign regulatory agencies/competent authorities

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 22 years of professional experience in the pharmaceutical industry encompassing the areas of clinical research, safety reporting, and medical writing. She has experience in clinical programs, including cardiovascular, neurology, diabetes, women’s health, gastrointestinal disorders, hemophilia, depression, schizophrenia, oncology, and infectious diseases (antibiotics, antifungals, and antiretrovirals). 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 NDA; reviewing and advising on coding for safety integration; developing a template, writing, and reviewing clinical study reports, periodic safety update reports (PSURs), 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 the Integrated Summary of Safety section of an NDA.

Dr. Skillman’s earlier pharmaceutical experience included the management of 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.

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 had 17 years of experience in an acute care hospital setting fulfilling diagnostic/procedural data requests for physicians, hospital administration, and outside agencies.

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/biologic 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 meta-analyses, database and survival analyses, bootstrapping, and parametric and multivariate modeling. 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 ICH GCP requirements, attributable to 3 years of experience coordinating and managing phase 2 and 3 oncology trials.

PhD (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 Statistician in the Biostatistics group at RTI-HS. He has provided support for a wide range of projects, including a large breast cancer registry, observational studies, surveys, and a comprehensive pharmaceutical risk management program. He has developed statistical analysis plans, written study reports, and created and managed datasets for large studies. His experience includes linear and logistic regression modeling, pattern mixture models, survival analysis, and programming in SAS, S-Plus, and SUDAAN.

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

BA, Economics
BA, Mathematics
“Al. I. Cuza” University, Iasi, Romania

Costel Chirila, PhD, is a Research 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 from biomarker identification to FDA submission. 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 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 ALS, diabetes, and prostate cancer.

BA, History, Reed College
Portland, OR

Graduate coursework in Archaeology and Anthropology
University of New Mexico, Albuquerque,NM

Peter Hickman is a Data Manager at RTI-HS. He has more than 15 years of professional experience in programming and analyzing pharmaceutical and health-related data. He has worked on many types of applications, including health insurance analyses, and in a number of therapeutic areas, including cardiology, CNS, cancer, and HIV. Study types include traditional clinical trials, risk management programs, and genetic data analysis. He has been the lead programmer for programming teams and has headed the validation and introduction of new computing methods, systems, and servers.

MBA
Meredith College, Raleigh, NC

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

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 has also worked with the health economic team to develop graphical interfaces for Excel-based economic models.

MS, Biostatistics
BS, Interdisciplinary Studies
University of Pittsburgh, Pittsburgh, PA

Bintu Sherif, MS, is a Statistician at RTI-HS. She has experience with different types of projects, including observational studies, clinical trials, and meta-analyses, as well as analyses of health-related outcome data. Ms. Sherif has developed statistical analysis plans and written study reports. Her experience includes longitudinal data analysis, survival analysis, and programming in SAS and R.

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 has more than 19 years of experience in research and in the use of applied statistics, including 18 years of experience using SAS software and 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. Dr. Wang developed an extensive background in clinical trials while participating in the China Health and Nutrition Study, which collected data from approximately 16,000 individuals of 3,800 households in 190 communities. Dr. Wang conducted the training sessions of interviewers, cleaned data, and calculated the sample weights. Dr. Wang’s work on the risk of development of advanced prostate cancer, on radiation and chemotherapy after radical hysterectomy, on disease progression in patients with epithelial ovarian cancer, and on patient survival in lung cancer has been widely published.

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

Yun Wu, MAS, is a 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.

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 “Jessica” Zhang, MSPH, MS, is a Statistician at RTI-HS. Ms. Zhang is a recent graduate of the University of South Carolina (USC). At USC, she worked as a research assistant and also as a teaching assistant in the Department of Epidemiology and Biostatistics. As a research assistant, she was involved in several health-related projects, doing data management and statistical analysis. She has experience with the SAS programming language, including the macro and iml languages. In addition, she is familiar with R, Stata, Winbugs, and Minitab.

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

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

Ryan Ziemiecki, MS, is a Statistician at RTI-HS. Mr. Ziemiecki is a recent graduate of the University of North Carolina where he conducted research in evolutionary game theory. While at UNC, he also assisted in developing an outlier detection procedure for real-time QPCR analysis during a summer appointment as a research assistant in the Lineberger Comprehensive Cancer Center. He has experience with the SAS programming language, including the macro and iml languages, as well as the R-statistical package and Matlab.

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 Glaxo Wellcome, he became Vice-President of Research and Development at Salix Pharmaceuticals. Dr. Mangel has led or participated in numerous FDA interactions, Advisory Committee Presentations, label negotiations, and NDA submissions, and he has authored more than 80 publications.

PhD, Anatomy and Embryology
University of London, London, UK

MD
Harvard Medical School/Massachusetts Institute of Technology Division of Health Sciences and Technology, Cambridge, MA

MBA
University of North Carolina, Chapel Hill, NC

AB, Chemistry and Physics
Harvard College, Cambridge, MA

Brad Walters, MD, PhD, MBA, is a Senior Director of Clinical and Medical Services at RTI-HS and Chief Medical Officer of RTI International. After completing his PhD at University College London and his MD at Harvard Medical School, Dr.Walters did a surgical internship at Johns Hopkins Hospital and a neurological surgery residency at the Massachusetts General Hospital. He then joined the faculty of the University of North Carolina (UNC) at Chapel Hill School of Medicine, where he established the radiosurgery program (with colleagues from radiation oncology) and epilepsy surgery program (with colleagues from neurology). His basic research focused on central nervous system trauma.

While at UNC, Dr. Walters enrolled in the Kenan-Flagler Business School, and after completion of his MBA joined Academy Funds, a pre-seed and seed stage venture capital firm specializing in the commercialization (via spin-outs) of intellectual property based on university research. As Principal and then Partner, he served on the Boards of Directors of Kucera Pharmaceutical Company, ParinGenix, and Curry Pharmaceuticals. While at Academy, Dr. Walters was appointed a member of the Building Entrepreneurial Companies Work Group of the North Carolina Biotechnology Center Strategic Plan, and also to the Governor’s Task Force on Nanotechnology and North Carolina’s Economy. From 1999 through 2006, he served as a member of the Board of Directors of NCHICA.

For the 2 years prior to joining RTI-HS, Dr. Walters was an independent life sciences consultant. Most recently he focused on phase 1 and phase 2 projects, where he performed clinical trial design, data analysis, data interpretation, and medical writing. He has been involved with regulatory submissions to the FDA and European Competent Authorities for clinical trials running in the United States, Belgium, Germany, Switzerland, and Canada. He continues to serve on the Science Advisory Board of UNC-Greensboro, and the Committee for the Protection of the Rights of Human Subjects at UNC-Chapel Hill.

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 II-IV 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 FDA Advisory Committees, and NDA submissions.

BA, Psychology
University of Maryland Baltimore County, Baltimore, MD

MBA (in progress)
Pfeiffer University, Research Triangle Park, NC

Colleen Hudimac is a Clinical Research Associate in the Clinical and Medical Services Division of RTI-HS. Ms. Hudimac has worked on research projects in numerous disease areas, including gastrointestinal disorders, psychiatry, and diabetes. She has experience in clinical monitoring, safety and pharmacovigilance, document creation/review, file auditing, literature reviews, and data management. She is proficient with the Oracle Adverse Event Reporting System (AERS) database and the Global Product Complaint Management Systems (GPCMS) database. Her background also includes an extensive history in data entry (including MEDRA coding), quality control, and other various administrative duties such as file maintenance, training, and customer service. Ms. Hudimac is a member of the North Carolina Chapter of the Society of Quality Assurance (NCCSQA).