RTI-HS - Key Persons
Job Titles:
- Fellow of the International Society for Pharmacoepidemiology
- Research Team
- Senior Director, Epidemiology
Dr. Arana is a Fellow of the International Society for Pharmacoepidemiology (ISPE) and chair of the Spanish Chapter of ISPE (Farmaco EpiEnRed). From 2001 to 2011, he was a member of the board of directors of the ISPE and co-chair of the Industry Council of the Society. He currently chairs the methods working group of the European Network of Centers of Pharmacovigilance and Pharmacoepidemiology.
Job Titles:
- Research Epidemiologist
- Research Team
Alicia Abellan, MSc, PhD, is a Research Epidemiologist in the Pharmacoepidemiology and Risk Management group with RTI-HS. Dr. Abellan has a background in Biomedicine and Public Health. She has academic research experience in early life determinants of health and disease, environmental exposures, pregnancy exposures and outcomes, paediatrics, and respiratory health. Dr. Abellan has participated in multiple international collaborative networks and has experience in designing and performing epidemiologic studies using diverse study designs and data sources, including multidatabase studies in longitudinal birth cohorts, large electronic health records, and registry databases.
Job Titles:
- Director of Epidemiology at RTI
- Director, Epidemiology
- Research Team
Alison Kawai is a Director of Epidemiology at RTI-HS where she provides scientific leadership and epidemiology expertise in the planning, design, and execution of studies. Dr. Kawai has 13 years' experience as a pharmacoepidemiologist, with extensive experience in using secondary data to assess the utilization and safety of medications and vaccines, including post-authorization safety and other regulatory studies. She has worked extensively in multi-site collaborations with data from electronic health records and claims, medical records and public health registries. She is experienced in conducting feasibility assessments and validation studies. Dr. Kawai has worked in a range of therapeutic and disease areas, including cancer, type 2 diabetes, multiple sclerosis, and vaccines, with substantial expertise in vaccine safety studies and in pregnancy safety studies.
Before joining RTI-HS, Dr. Kawai was a Research Scientist and Principal Associate in the Department of Population Medicine at Harvard Pilgrim Health Care Institute and Harvard Medical School, where she was an investigator within the Sentinel Program and the Vaccine Safety Datalink Project, two federally-funded postmarket safety surveillance systems that incorporate data from several health insurers across the US with the use of distributed databases. While there, she worked primarily on studies to evaluate vaccine safety in pregnant women and pediatric populations, as well as on infrastructure activities to develop methods and data capabilities to conduct these and other postmarketing safety studies. Dr. Kawai received her master's and doctorate degrees from the Harvard Chan School of Public Health.
Job Titles:
- Associate Director of Medical
- Director, Medical Writing, Editing, and Design Services
- Research Team
Alyssa Dallas is the Associate Director of Medical Writing, Editing, and Design Services at RTI-HS, where she leads a team of five medical editors and oversees the proposal editing process. She has more than 17 years of experience as an editor in professional and academic environments. Ms. Dallas provides editorial support for deliverables, marketing materials, and proposals, as well as technical writing support. She has developed many of the company's standard proposal and deliverable templates for branding consistency and efficient formatting, and she oversees the tracking, updating, and implementation of these templates. Ms. Dallas led the editing group in creating company-specific and deliverable-specific style guides; developing editor, reviewer, and transcriptionist guidelines for recorded interviews; and generating an Excel-based system of capturing editorial process metrics. Prior to joining RTI- HS, Ms. Dallas served as a medical writer/editor at a contract research organization, where in addition to editing, she assisted in the development of a variety of documents, including protocols, clinical study reports, new drug applications, case report and informed consent forms, and patient brochures for many different therapeutic areas.
Job Titles:
- Director of Epidemiology at RTI
- Director, Epidemiology
- Research Team
Amy Ladner, MPH, is a Director of Epidemiology at RTI-HS. Ms. Ladner has more than 20 years of project and portfolio management experience . Since joining RTI-HS in 2007, she has focused on large primary and secondary data-collection studies, including multidatabase studies , patient registries and site-based studies in the United States and Europe. Ms. Ladner has led and conducted systematic reviews of literature; developed study protocols, questionnaires, and reports; recruited investigators and sites for primary data collection; conducted investigator and interviewer training; planned biospecimen collection; and performed data management activities. She has worked within a wide-range of therapeutic areas including oncology, gastrointestinal disease, depression and cardiovascular and respiratory health.
Job Titles:
- Research Team
- Senior Director of Patient
- Senior Director, Patient - Centered Outcomes Assessment
Amy Barrett, MSPH, MA, is a Senior Director of Patient-Centered Outcomes Assessment with RTI-HS. She has more than 20 years of health outcomes research experience. Ms. Barrett has expertise in the evaluation, selection, and development of clinical outcome assessments (COAs), particularly those assessing disease symptoms, physical functioning, and adaptive behavior. She has extensive experience designing and conducting qualitative and survey research studies involving patients, caregivers, and clinicians and developing patient- and caregiver-completed measures. She is skilled in developing COA measurement strategies for clinical trials in alignment with regulatory guidelines. Ms. Barrett also has extensive experience developing COA evidence dossiers and briefing books to support product indications and labeling from regulatory agencies. She offers knowledge of patient-centered outcomes assessment in several areas, including multiple cancer types and autoimmune, cardiovascular, and neurometabolic conditions, cellular and gene therapies, and study endpoints based on digital health technology data.
Job Titles:
- Research Team
- Vice President, Medical Writing, Editing, and Design Services
Job Titles:
- Research Team
- Senior Director, Epidemiology
- Specialist
Andrea V. Margulis, MD, ScD, is a specialist in pediatrics and Senior Director of Epidemiology at RTI-HS, located in Berlin, Germany, and working remotely as a member of the RTI-HS Barcelona, Spain, office. Dr. Margulis studied medicine and completed her residency in pediatrics in Buenos Aires, Argentina, and obtained her doctoral degree in epidemiology (with a focus on pharmacoepidemiology) at Harvard's TH Chan School of Public Health. She did her postdoctoral training at the Center for Drug Evaluation and Research in the United States Food and Drug Administration. Dr. Margulis has conducted research using claims, electronic medical records, and registry data from North America and Europe in single-database and multi-database studies. She has experience in literature reviews; meta-analyses; drug utilization, case-control and cohort studies; methods research; and outcome and covariate validation, as well as in developing various types of regulatory documents for the Food and Drug Administration and the European Medicines Agency. Dr. Margulis has worked in several therapeutic and disease areas and has a special interest in pediatrics and drug safety in pregnancy.
Job Titles:
- Research Epidemiologist
- Research Team
Anita Tormos, MPH, is a Research Epidemiologist at RTI-HS. As a graduate student, she participated as a field researcher for the French Red Cross delegation in Congo-Brazzaville on a project to evaluate health system improvements. Ms. Tormos also gained experience in statistical analysis and programming at Brunel University when she was working during her gap year at PAREXEL. After graduating from École des Hautes Études en Santé Publique, Ms. Tormos acquired experience in the epidemiology of infectious respiratory diseases while working as an Epidemiologist Coordinator for Sanofi Pasteur for the Global Influenza Hospital Surveillance Network project. During these two years, she gained experience in the coordination and development of all study-specific documents, site and data management, data analysis, literature reviews, and manuscripts for publication. Ms. Tormos also has experience coordinating projects as a Senior Clinical Project Coordinator in the Real World Late Phase Department at Quintiles. She has more than 5 years of experience in managing and coordinating epidemiologic studies and projects including regulatory driven literature reviews with multiple contributors. She has been involved in multiple types of epidemiology projects conducted both in the United States and in Europe, including multicounty collaborative research projects, database studies, and feasibility evaluations. In her current position, Ms. Tormos coordinates and manages study implementation; site and patient recruitment; investigator training; and data collection, management, and quality control. She also assists with reporting study progress both to clients and to regulatory agencies and contributes to dissemination activities.
Job Titles:
- Research Team
- Senior Director of Market Access
- Senior Director, Market Access and Outcomes Strategy
Annete Njue, PhD, is a Senior Director of Market Access and Outcomes Strategy in Manchester, United Kingdom at RTI-HS. She has over 13 years of experience working in market access and medical communications. Dr. Njue is involved in leading and writing systematic and targeted literature reviews and value dossiers to support products in a variety of therapy areas. She is also involved in preparing health technology assessment (HTA) submissions for the National Institute for Health and Clinical Excellence (NICE), the Scottish Medicines Consortium (SMC), and the National Centre for Pharmacoeconomics (NCPE). She has experience in a broad range of therapy areas, including cardiovascular disease, diabetes, hematological disorders, infectious diseases, oncology (breast, lung, prostate, colorectal cancer, myeloma), mental health, ocular conditions, renal disease, reproductive disorders, and respiratory disorders. Before joining RTI HS, Dr. Njue was a Senior Medical Writer at Prime Medica Ltd. Dr. Njue previously worked in veterinary research in Canada and Kenya, and published her work in Journal of Neurochemistry, Parasitology, and Parasitology Research.
Job Titles:
- Principal Scientist in Patient
- Principal Scientist, Patient - Centered Outcomes Assessment
- Research Team
Ari Gnanasakthy, MBA, MSc, is a Principal Scientist in Patient-Centered Outcomes Assessment at RTI-HS, Mr. Gnanasakthy was the Executive Director and Head of the Patient-Reported Outcomes Center of Excellence at Novartis Pharmaceuticals. He has almost 25 years of experience in the pharmaceutical industry. At Novartis, he worked in several departments, including Biostatistics, Health Economics, Pricing, and Outcomes Research. After receiving his bachelor's degree in mathematics, statistics, and computing, Mr. Gnanasakthy joined Rothamsted Experimental Station (UK), where he was responsible for the statistical analysis of survey data of agricultural soil in England and Wales. He then joined the Milk Marketing Board (UK), where he was a part of the team responsible for modeling lactation curves of dairy cows. Mr. Gnanasakthy's extensive experience in the field of statistics and outcome research has resulted in numerous abstracts and almost 40 publications. Throughout his career, Mr. Gnanasakthy has developed and validated over a dozen patient-reported outcomes instruments and currently serves in the editorial board of Cancer Clinical Trials and a reviewer for many professional journals, including Value in Health.
Job Titles:
- Research Team
- Vice President of Project and Proposal
- Vice President, Project and Proposal Operations
Art Granger is the Vice President of Project and Proposal Operations at RTI-HS. He has over 20 years of pharmaceutical industry experience. In his current capacity, Mr. Granger oversees a team of operations staff responsible for central project management, internal portfolio review, the development and implementation of high-quality proposal and project management processes and practices as well as training for RTI-HS. Mr. Granger also leads the team of proposal managers within RTI-HS, ensuring that high-quality proposals are developed and delivered in an efficient and timely manner to our clients. The Project & Proposal Operations team manages the client satisfaction surveys program and is also home to RTI-HS's Library Services group.
Prior to taking on his operational position, Mr. Granger gained valuable experience managing research projects in the health outcomes space across a number of therapeutic areas. He has played key roles in the development of PRO instruments, has extensive experience conducting cognitive interviews and moderating focus groups with a variety of patient and physician populations and has experience managing large data collection efforts.
Job Titles:
- Senior Associate in the Market Access
- Senior Associate, Market Access and Outcomes Strategy
Bidur Banjara, MS, is a Senior Associate in the Market Access and Outcomes Strategy group with RTI-HS. In this role, Mr. Banjara provides research and medical writing support for evidence-based dossiers, systematic and targeted literature reviews, slide sets, abstracts, posters, and manuscripts. Additionally, he has conducted research for concept and preference elicitation, patient-reported outcome instrument development and reviews, and clinical outcome assessment measurement strategies. Mr. Banjara has conducted research in various therapeutic areas, including oncology, neurology, dermatology, endocrinology, and lung and cardiovascular diseases. In his past roles, he worked in market access, real-world evidence, patient-reported outcomes, and patient-preference studies.
Job Titles:
- Senior Research Scientist, Patient - Centered Outcomes Assessment
Job Titles:
- Head of Patient
- Research Team
- Vice President, Patient - Centered Outcomes Assessment
Carla DeMuro, MS, is Head of Patient-Centered Outcomes Assessment in RTI-HS. Ms. DeMuro has extensive experience in the rigorous development and validation of patient-reported outcome measures for use in clinical trials, as well as large-scale epidemiologic and population-based studies. She joined RTI-HS after 15 years of working in the pharmaceutical industry and brings her experience with and understanding of the FDA Guidance for Patient-Reported Measures. Ms. DeMuro has worked to developed measures across a wide span of therapeutic areas, including but not limited to respiratory illness (asthma, chronic obstructive pulmonary disease, 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, osteoarthritis, rheumatoid arthritis, 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, utility measures, and other patient-reported outcomes. 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.
Job Titles:
- Director, Health Economics
Job Titles:
- Co - Chair of the ISPOR Health Preference Research Special Interest Group
- Research Team
- Senior Economist and Vice President of Health Preference Assessment at RTI HS
- Senior Economist and Vice President, Health Preference Assessment
Dr. Poulos is Senior Economist and Vice President of Health Preference Assessment at RTI HS. She has more than 25 years of academic, consulting, and government experience in stated preference research in health and environmental economics applications. She is an expert in the design of stated preference surveys and has extensive experience in applying stated preference methods to measuring the benefit-risk preferences of patients and other health care decision-makers. She has been principal investigator for numerous vaccine preference projects, as well as studies focused on measuring preferences for treatments including drugs and devices. Her most recent work has applied these studies to support ACIP's Evidence to Recommendation framework, structured benefit-risk assessment, regulatory decisions, and decision making throughout the clinical product development cycle for tick-borne encephalitis vaccination, pneumococcal vaccination, and treatments for hypertension, severe emphysema, Alzheimers' disease, multiple sclerosis, endometriosis, and diabetes, among others.
Dr. Poulos is co-chair of the ISPOR Health Preference Research Special Interest Group (SIG) and co-chair of the ISPE BRACE special interest group. Dr. Poulos has been an invited speaker at multiple industry-sponsored and FDA-sponsored meetings, including the ISPOR FDA summit. She has over 50 peer-reviewed publications in journals that include The Patient, Value in Health, Journal of Choice Modeling, and Vaccine.
Job Titles:
- Senior Vice President
- Senior Vice President of RTI - HS
Chris Simmons is Senior Vice President of RTI-HS and leads the organization. In this role, he works closely with the leadership team to ensure staff have the resources and support to deliver high-quality solutions our clients have come to expect from us.
Mr. Simmons holds an MS in Clinical Research Management from Wake Forest University, where he concentrated on the unique design, analysis, data management, quality, ethical, and regulatory aspects of clinical and real-world studies. In addition, he is a CPA with more than 30 years of experience in financial and operational positions, with particular focus on early-stage, rapidly growing technology and biotech businesses.
After beginning his career at KPMG, Mr. Simmons moved to other public accounting firms with a focus on early-stage businesses. He transitioned 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. Since joining RTI-HS, he has moved from a finance executive role, to managing all the operations functions, to now leading the RTI-HS business unit.
Job Titles:
- Director of Biostatistics in RTI
- Director, Biostatistics
- Research Team
Costel Chirila, PhD, is a Director of Biostatistics in RTI-HS with more than 10 years of experience as a biostatistician in the pharmaceutical industry. Dr. Chirila worked for several years as a statistician with pharmaceutical companies designing and analyzing clinical trials (including phase 1), providing biostatistical support for the discovery and development of diagnostic products (biomarker identification), and writing statistical analysis plans and statistical reports. In his role at RTI-HS, he manages various projects in which he plans, implements, and interprets the analysis of a variety of studies, including health economics (within-trial health care resource use and cost-effectiveness), epidemiology (burden of illness, risk evaluation, treatment patterns, and mitigation strategy), meta-analyses (direct, indirect, and mixed treatment comparisons), patient-reported outcomes (quality-of-life, mapping health-state utility scores), and phase 1 clinical trial analyses. Dr. Chirila has experience with various statistical methods, including generalized linear mixed modeling, survival-analysis, nonparametric modeling, receiver operating characteristic curves, statistical (i.e., machine) learning including variable and model selection using resampling techniques (e.g., cross-validation, bootstrapping). He also has programming experience with SAS and R/S-Plus. He has worked cross-functionally and has exposure to numerous disease areas, including amyotrophic lateral sclerosis, asthma, diabetes, insomnia, schizophrenia, plaque psoriasis, and various oncology areas (i.e., prostate cancer, colorectal cancer, breast cancer, myelofibrosis).
Job Titles:
- Research Team
- Vice President of Biostatistics at RTI
- Vice President, Biostatistics
Dawn Odom, MS, is the Vice President of Biostatistics at RTI-HS. She has 25 years of professional experience working with real world and clinical trial data. During this time, she has worked as a statistician in numerous therapeutic areas, with a focus on oncology and gastroenterology. She has key regulatory experience, having participated in numerous FDA meetings. Her responsibilities at RTI-HS include statistical consulting, protocol development, creation of statistical analysis plans, production of analysis tables and listings, and report and publication development. She has extensive experience planning and conducting analysis of patient-reported outcomes particularly in oncology studies, with numerous publications in this area. Her experience spans both the analysis of randomized and observational studies, with in-depth experience analyzing data with informative missing data. She has also led numerous meta-analysis projects where she has applied statistical techniques such as meta-regression, mixed-treatment comparisons, and matching-adjusted indirect comparisons. In addition, Ms. Odom has worked as a survey statistician on a large national household survey where she was responsible for sample selection, item imputation, analysis tables, and report writing. She has extensive experience with the SAS programming language. Ms. Odom is a member of the American Statistical Association and the International Society of Pharmacoeconomics and Outcomes Research.
Job Titles:
- Senior Director, Health Economics
Job Titles:
- Research Team
- Vice President for Legal & Regulatory
- Vice President, Legal & Regulatory Affairs
Jennifer Luebke, JD, is Vice President for Legal & Regulatory Affairs at RTI-HS. Ms. Luebke oversees the negotiation and administration of all contracts between RTI-HS and its clients, research partners, and third-party suppliers. She is also responsible for regulatory compliance at RTI HS, leading a team that provides training, guidance and project support, primarily related to data protection. Ms. Luebke works closely with the research, finance, quality assurance, proposal, and project management teams to support RTI-HS's operational processes and compliance, and is a member of the organization's management team.
Prior to joining RTI-HS, Ms. Luebke was in private law practice, representing clients in corporate matters, including mergers and acquisitions, succession planning, commercial leases, employment and independent contractor agreements, post termination issues, tax matters, landlord/tenant matters, and construction disputes. At Allscripts, Ms. Luebke was responsible for client support, software deployment, and technical services for clients using practice management and electronic medical records software products.
Prior to attending law school in 2003, Ms. Luebke was employed at Misys Healthcare Systems (formerly Medic Computer Systems) in various roles including software implementation, research and development, oversight of several acquired business units, operational launch of a new medical office management software product, and HIPAA privacy and security compliance.
Job Titles:
- Senior Associate, Market Access and Outcomes Strategy
Job Titles:
- Practice Area: Biostatistics
- Senior Statistician
Job Titles:
- Distinguished Fellow, Health Economics
Job Titles:
- Senior Evidence - Based Medicine Specialist / Practice Area: Health Economics
Job Titles:
- Research Team
- Vice President of Market Access
- Vice President, Market Access and Outcomes Strategy
Kati Copley-Merriman, MS, MBA, is Vice President of Market Access and Outcomes Strategy at RTI-HS. Ms. Copley-Merriman has more than 35 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. In her RTI-HS role, Ms. Copley-Merriman leads a team of outcomes research scientists, medical writers, and reimbursement experts responsible for developing outcomes research strategic plans, literature reviews, disease-state summaries, global value dossiers, and reimbursement dossiers. Ms. Copley-Merriman has experience in many therapeutic areas, including oncology, pain and inflammation, dermatology, respiratory, urology, and central nervous system. Ms. Copley-Merriman is an active member of International Society for Pharmacoeconomics and Outcomes Research and served on its Board of Directors from 2010 to 2012. Ms. Copley-Merriman also was appointed as a member of the editorial advisory board of the journal Value in Health for November 2014 to November 2022.
Job Titles:
- Research Team
- Vice President of Surveys and Observational
- Vice President, Surveys and Observational Studies
Kelly A. Hollis, MBA, is the Vice President of Surveys and Observational Studies for RTI-HS and has a strong background in survey research and a proven track record in the successful design, implementation, and leadership in global research studies. During her 20 years at RTI International and RTI-HS, she has provided successful leadership and oversight of research in a number of therapeutic areas, including allergy, autoimmune disease, gastroenterology, oncology, infectious disease, respiratory, central nervous system, diabetes, and dermatology. She has particular expertise in planning and managing large-scale prospective observational studies, including health economic and burden-of-illness studies, epidemiologic studies, patient outcomes research, risk-management program evaluations, and patient registries. She has directed multidisciplinary international teams for large primary data-collection studies in the United States and Europe. She has experience with all aspects of data collection, including project management, survey design and implementation, questionnaire development, patient and site recruitment, data collection and management, and reporting. Ms. Hollis is involved in the design of observational research programs to ensure that the methods chosen provide a robust and cost-effective approach to address the study questions. Her results-oriented, client-focused approach to project leadership includes strategic planning, financial management, process development, and resource allocation.
Job Titles:
- Distinguished Fellow and Vice President for Epidemiology Research at RTI
- Distinguished Fellow Emeritus
- Research Team
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 300 scholarly 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, 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., now in its 3rd edition, is a comprehensive advanced text of epidemiologic methods; and Epidemiology: An Introduction, published in 2002 by Oxford University Press, is now in its 2nd edition.
Job Titles:
- Research Team
- Vice President of Patient
- Vice President, Patient - Centered Outcomes Assessment
Lori McLeod, PhD, is Vice President of Patient-Centered Outcomes Assessment at RTI-HS. Dr. McLeod is a psychometrician with more than 25 years of measurement experience, including expertise in instrument development and validation, as well as experience supporting the regulatory review of clinical outcome assessments. In her Psychometrics role, she has conducted many psychometric evaluations including the assessment of scale reliability, validity, responsiveness, and work to define meaningful change. Dr. McLeod has expertise in classical and modern psychometric methods such as factor analysis, Rasch analysis, and item response theory. In addition, Dr. McLeod has experience conducting and analyzing data from clinical trials and observational studies, including data to document burden of disease and treatment benefit. Dr. McLeod has published numerous related manuscripts in Quality of Life Research, Value in Health, Pharmacoeconomics, Mayo Clinic Proceedings, and Psychometrika, and currently serves on the editorial advisory board for Value in Health. She has substantial experience specific to dermatology and rare diseases, including the support of PRO labeling claims and psychometric evaluations of disease-specific measures. Dr. McLeod routinely provides consulting and psychometric assistance in a wide variety of therapeutic areas, including chronic pain, neurology, oncology, psychiatry, respiratory, sleep disorders, urology, gastroenterology, and sexual dysfunction. Dr. McLeod also serves as an adjunct faculty in the Department of Health Policy and Management at the University of North Carolina at Chapel Hill.
Job Titles:
- Research Team
- Vice President of Market Access
- Vice President, Market Access and Outcomes Strategy
Margaret Mordin, MS, is Vice President of Market Access and Outcomes Strategy at RTI-HS. Ms. Mordin has over 25 years of experience in conducting and managing outcomes research, including designing and implementing outcomes assessments in prospective trials for regulatory submission and as postmarketing studies. Her areas of expertise include study design (e.g., observational postmarketing studies, patient-reported outcomes for use in clinical development programs, and patient health-related quality of life and satisfaction surveys), analysis of outcomes data, publication development, and outcomes-related regulatory submission strategies. Her experience also includes directing health economic evaluations (prospective economic trials and billing studies).
Job Titles:
- Senior Director, Epidemiology
Job Titles:
- Associate Director, Market Access and Outcomes Strategy
Nicholas Rockwood, PhD, is a Senior Psychometrician in the Patient-Centered Outcomes Assessment group with RTI Heath Solutions and has been working on psychometric evaluations of clinical outcome assessments. Prior to joining RTI-HS, Dr. Rockwood was an assistant professor within the School of Behavioral Health at Loma Linda University, where he conducted quantitative research, taught doctoral-level statistics courses, and provided statistical consulting services to medical and behavioral health faculty and researchers. His statistics and psychometrics research, which has been published in top psychometrics journals such as Psychometrika and Multivariate Behavioral Research, broadly focuses on the development and evaluation of generalized latent variable modeling methods (e.g., item response theory, multilevel modeling, structural equation modeling).
Job Titles:
- Pharmacist
- Vice President, Business Development
- Research Team
- Vice President of Business Development at RTI
Peter Wirth is Vice President of Business Development at RTI-HS and leads the business development team and activities for the entire portfolio of RTI-HS services. He applies various skills based on his 30 years of pharmaceutical industry experience. He has a wide range of experience in customer relationships, people management, sales, health economics and outcomes research, 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 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.
Job Titles:
- Associate Director, Health Economics
Job Titles:
- Human Resources Business Partner
- Research Team
- Senior Director, Human Resources
Shannon Poirier is the Human Resources Business Partner for RTI Health Solutions.
Job Titles:
- Senior Director, Data Analytics and Design Strategy
Job Titles:
- Research Team
- Vice President of Patient
- Vice President, Patient - Centered Outcomes Assessment
Sheri Fehnel, PhD, is a Vice President of Patient-Centered Outcomes Assessment in RTI-HS. Since joining the Health Solutions staff in 1988, she has combined the study of clinical psychology and psychometrics with practical research and clinical experience. She specializes in the development, psychometric evaluation, and regulatory support of patient-reported outcome measures and other types of clinical outcome assessments used in clinical trials. This work has involved a wide range of therapeutic areas, including dermatology (e.g., psoriasis, eczema, acne), psychiatry (e.g., depression, bipolar disorder, schizophrenia), urology (e.g., urinary incontinence, nocturia, erectile dysfunction), gastroenterology (e.g., irritable bowel syndrome, chronic constipation, gastroparesis), oncology, cardiovascular disease, women's health (e.g., endometriosis, uterine fibroids, menopause), diabetes, respiratory (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis), sexual dysfunction (male and female), obesity, chronic pain, and sexually transmitted diseases (e.g., herpes, human papillomavirus, HIV/AIDS). An expert in qualitative research, Dr. Fehnel has conducted countless focus groups and interviews with patients, caregivers, health care providers, and key opinion leaders. She has also evaluated the psychometric properties of many survey and clinical outcome measures using techniques such as factor analysis, structural equations modeling, and item response theory.
Dr. Fehnel routinely develops briefing documents and supports clients through negotiations with the Food and Drug Administration's Division of Clinical Outcomes Assessment and various medical reviewing divisions. She frequently publishes in both clinical and methodologically oriented journals, completed a 4-year term as a co-editor for Value in Health, and serves as a peer-reviewer for numerous scientific journals.
Job Titles:
- Executive Director, Market Access and Outcomes Strategy
Job Titles:
- Senior Vice President, Health Economics
Job Titles:
- Senior Director, Marketing & Communications
Job Titles:
- Leader and past President of the International Society of Pharmacoepidemiology
- Vice President, Global Head of Epidemiology
Dr. Perez-Gutthann is an active leader and past president of the International Society of Pharmacoepidemiology (ISPE) and past Vice-Chair of the Steering Committee of the European Medicines Agency European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). She is a fellow of ISPE and of the Royal College of Physicians, Edinburgh. She is invited to teach in academic programs (most recently the London School of Hygiene and Public Health, Oxford University, and University of North Carolina at Chapel Hill) and to speak and chair conferences and symposia. Dr. Perez-Gutthann's roles as an advisor and in international working groups have included ENCePP research guidance, International Scientific Advisory Board to the Medicines and Healthcare Products Regulatory Agency (MHRA) General Practice Research Database, ISPE Working Groups on Risk Management Guidances (Food and Drug Administration, European Medicines Agency), Good Pharmacoepidemiology Practice, and confidentiality of patient databases in Europe. Currently, Dr. Perez-Gutthann serves as a member and chair of several scientific advisory boards for studies, research programs, and strategic and regulatory risk management, real world evidence topics.
Job Titles:
- Research Team
- Senior Director, Technology Leader
Tim Farris, MS, has more than 15 years of progressive experience in Information Technology. In his current role, he is responsible for the overall direction of technology to support RTI International's Health Solutions, Health Advance, and laboratory business units.
Mr. Farris manages a team of technology professionals that provide operations, implementation, compliance/regulatory support of technology platforms to enable the success of business units in his portfolio. In addition to providing the strategic direction and management for technology, he guides executive and research leaders on awareness and mitigation of technology-related risk and change management. His current role reports directly to the CIO.
Prior to joining RTI, Mr. Farris served in various information technology roles including systems administration, security and compliance, programming, and information technology management across academic and commercial enterprises.
Job Titles:
- Director, European Operations
- Operations Director for Europe at RTI
- Research Team
Tracy Walker, ACMA, CGMA, is the Operations Director for Europe at RTI-HS. A large proportion of Ms. Walker's 20-year career was spent in senior finance roles for a listed leisure sector group in the United Kingdom. Ms. Walker joined RTI-HS from a biometric technology business where she was Head of Finance with additional responsibility for the human resources and information technology functions. She is a financial professional with more than 20 years of experience in finance, accounting, and decision support.
Job Titles:
- Vice President, Finance
- Research Team
- Senior Director of Finance for RTI
Troy Young, CPA, is Senior Director of Finance for RTI-HS. In this role, he is responsible for RTI-HS's financial and project accounting functions. Prior to joining RTI-HS, Mr. Young spent 25 years in various financial and operational roles within the pharmaceutical and health care industry. Most recently, he was responsible for global project management of the pharmaceutical development business of Catalent Pharma Solutions, one of the largest contract development and manufacturing organizations in the world. Prior to that, Mr. Young directed the business operations group for the Catalent Pharma Solutions' Research Triangle Park, North Carolina site, which included oversight of the finance, proposals, and procurement organizations. Prior to joining Catalent Pharma Solutions, he worked as the Controller for ClinTrials Research, a publicly held global clinical research organization. Mr. Young started his career in the health care industry working in accounting and finance roles at a number of primary care facilities and physician practice management organizations.