Advancing the Science of Study Endpoints
René Allard, PhD
- Public Disclosure Lead
- Grünenthal GmbH, Germany
René Allard graduated from the University of the Witwatersrand in 1991 and completed reading for his doctorate at the Ruhr-University Bochum, Graduation College of Biogensis and Mechanism of Complex Cellular Functions, in 1995. Since 2012 René has been Public Disclosure Lead at Grünenthal after serving in various positions in Research and Development in the Pharmaceutical Industry in the past 20 years. Interests include trial designs, outcomes research, genetic biomarkers, data collection methods, and pharmaco-economics.
- Director, Patient-Reported Outcomes
- AstraZeneca, United States
Emuella Flood is co-chair of the DIA Study Endpoints Community and has been working in the field of patient-centered outcomes for over 20 years. She recently joined AstraZeneca as PRO Director, with a focus on PRO strategy and implementation in women's cancer. Prior to joining AstraZeneca, Emuella was Senior Principal of Patient-Centered Outcomes (PCO) for ICON Clinical Research, where she led the US East Coast PCO research team, providing strategy and guidance to capture the patient experience.
- Head of Value, Evidence and Portfolio Strategy – EUCAN
- Takeda Pharmaceuticals International GmbH, Switzerland
Michael is the Head of Value, Evidence and Portfolio Strategy at Takeda EUCAN. He is responsible for ensuring that evidence generated in support of Takeda's medicines meets the needs of HTA and access decision makers in Europe and Canada, and therefore supports patient access to medicines. Prior to joining Takeda in September 2017, Michael led the HEOR Europe and Canada Oncology team at Bristol-Myers Squibb for seven years.
J. Jason Lundy, PhD
- Outcometrix, United States
J. Jason Lundy, PhD is a measurement scientist specializing in the development and analysis of COAs. Before co-founding Outcometrix, Jason was the Director of the ePRO Consortium and the Associate Director of the PRO Consortium at C-Path. In these roles, Jason worked on numerous COA qualification projects in collaboration with FDA and industry colleagues. His experience navigating the DDT Qualification process provided the opportunity to engage in frequent FDA discussions on the evidence needed for the regulatory review of COA measures.
Matthew Reaney, MSc
- Head of Clinical Outcomes
- Sanofi, United Kingdom
Matt is a Chartered and Practitioner Health Psychologist, a Chartered Scientist, a Fellow of both the Royal Societies of Medicine and Public Health, and an Associate Fellow of the British Psychological Society. Matt is the Global Head of Clinical Outcomes at Sanofi, focusing on understanding and measuring patient-relevant outcomes and experiences in a scientifically sound way. This includes both outcome evaluation for clinical drug development and the support of patients in routine clinical practice. Matt is particularly interested in understanding and embracing patient heterogeneity in defining outcome measures such as benefit-risk and patient perception and preference.
Ashley F. Slagle, PhD, MS
- Principal, Scientific and Regulatory Consulting
- Aspen Consulting, LLC, United States
Ashley Slagle, Principal of Aspen Consulting, LLC, provides strategic regulatory and scientific advice to drug product developers on matters related to patient-focused drug development, with a particular focus on patient-relevant endpoints and Clinical Outcome Assessments (COAs). Previously, she served as Scientific Coordinator for the FDA/CDER Drug Development Tool COA qualification program. She also provided recommendations on COAs submitted to FDA/CDER through the IND/NDA/BLA pathways across all therapeutic review divisions, and participated in FDA policy and guidance development. Dr. Slagle received her PhD in Pharmaceutical Health Services Research from the University of Maryland, Baltimore.
Keith W. Wenzel
- Senior Director, Solution Incubator
- PAREXEL, United States
Mr. Wenzel holds the position of Senior Director within PAREXEL Informatics’ Solution Incubator, a team that brings innovation to clinical trials. He is responsible for advising clinical trial sponsors and consults with regulatory authorities and industry organizations to advance the knowledge of eClinical, electronic clinical outcome assessments (eCOA), sensors/remote medical devices and their application in clinical trials. Mr. Wenzel is a member of core committee for the Drug information Association’s (DIA) Study Endpoints Community. He was a member of the program committee for the DIA’s Annual Meeting from 2012-2015 and has been on the program committee for all three of the DIA’s Study Endpoints-centric conferences.
Theresa Mullin, PhD
- Associate Director for Strategic Initiatives, OCD, CDER
- FDA, United States
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002, 2007, 2012 and 2017 cycles of reauthorization of the Prescription Drug User Fee Act, providing nearly $1B in annual funding for new drug review.
Sudip Parikh, PhD
- Senior Vice President and Managing Director, DIA Americas
- DIA, United States
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute
Elise Berliner, PhD
- Director, Technology Assessment Program
- Agency For Healthcare Research and Quality (AHRQ), United States
Dr. Berliner is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment Program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions and other policy issues. Prior to joining AHRQ, Dr. Berliner worked as a consultant to pharmaceutical and medical device companies. Dr. Berliner also has several years of experience in research and development at a number of innovative medical technology companies. She was a Congressional Fellow at the Office of Technology Assessment. Dr. Berliner received her Ph.D. in biophysics from Brandeis University.
Robyn Carson, MPH
- Head, Patient-Centered Outcomes Research, Global Evidence and Value Development
- Allergan, United States
Robyn has worked in the pharmaceutical industry for 12 years and has recently transitioned to a new role, leading the establishment of the new Patient Centered Outcomes Research (PCOR) function. In this role, Robyn will be responsible for the development of innovative strategies to evaluate meaningful outcomes to patients and consumers in Allergan product development programs and real-world research. In her previous role at Allergan, as the GHEOR-Strategy Therapeutic Area Lead for Gastroenterology & Liver, Robyn made significant contributions with respect to major product approvals, launches and strategic development for multiple patient-reported outcome (PRO) instruments and real-world research platforms.
Cheryl D. Coon, PhD
- Outcometrix, United States
Cheryl D. Coon, PhD is a psychometrician with 15 years of experience as a consultant in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments, with particular interest in score interpretation, and leads the statistical analysis of clinical trial PRO data. Her psychometric and statistical expertise has allowed her to support regulatory communication across a broad range of therapeutic areas. Dr. Coon earned her PhD degree in Quantitative Psychology at the University of North Carolina at Chapel Hill, focusing on item response theory and the early work on PROMIS.
Stephen Joel Coons, PhD
- Executive Director, PRO Consortium
- Critical Path Institute, United States
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). C-Path, an independent nonprofit organization, established the PRO Consortium in cooperation with the U.S. Food and Drug Administration and the pharmaceutical industry to advance the assessment of patient-focused clinical trial endpoints. Stephen earned BS (University of Connecticut), MS, MEd, and PhD (University of Arizona) degrees and completed post-doctoral training at the University of California, San Diego. He joined C-Path after a 23-year academic career. Stephen is a fellow in the American Association of Pharmaceutical Scientists and Professor Emeritus at the University of Arizona.
Cynthia Grossman, PhD
- Director, Science of Patient Input
- FasterCures, a center of the Milken Institute, United States
Dr. Cynthia (Cyndi) Grossman is director, Science of Patient Input at FasterCures, a center of the Milken Institute, leading efforts to improve health by expanding opportunities for patients’ perspectives to shape the processes by which new therapies are discovered, developed and delivered. Dr. Grossman earned her PhD in clinical psychology from the University of Vermont, completed a Postdoctoral Fellowship at Brown University, and has been the recipient of awards from NSF and NIH.
Chad Gwaltney, PhD
- Gwaltney Consulting, United States
Chad Gwaltney, Ph.D. is President and Principal Consultant at Gwaltney Consulting. Dr. Gwaltney develops innovative methods to measure patient-centered outcomes in clinical trials. His academic and industry research include the design of electronic platforms for the collection of information in real-time in the patient’s natural environment. He has published numerous articles and book chapters addressing how the patient’s perspective can be examined to better understand medical product efficacy and safety. He has served on US NIH review committees and has co-authored ISPOR best practice guidelines on the development and use of patient-reported outcomes.
Laura Lee Johnson, PhD
- Director (Acting), Division III, Office of Biostatistics, OTS, CDER
- FDA, United States
Laura Lee Johnson, Ph.D. is the patient focused drug development liaison and an acting division director for the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, implementation, and analysis of research studies ranging from clinical outcome assessment (COA) qualification to trials of all sizes. She works across FDA on patient focused drug development initiatives. Prior to working at the FDA she spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs.
Lisa Kammerman, PhD, MS
- Kammerman Consulting, LLC, United States
Lisa Kammerman, PhD, owner of Kammerman Consulting, draws upon her industry and FDA experience, and provides statistical regulatory expertise and endpoint development guidance to pharmaceutical projects advancing to regulatory interactions and submissions. At AstraZeneca, as a Senior Statistical Science Director and Regulatory Specialist, she advised teams and wrote a guidance document on the analysis and interpretation of studies that use PROs. In her 24-year career as a biostatistical Master Reviewer and Team Leader in the Office of Biostatistics, CDER, FDA, she oversaw the Office’s Clinical Outcome Assessments program, and facilitated policy for the study design/analysis/interpretation of studies that use COAs.
Bellinda King-Kallimanis, PhD
- Senior Staff Fellow, CDER, OHOP
- FDA, United States
Bellinda King-Kallimanis is a psychometrician working at the US FDA in the Office of Oncology and Hematology Products in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). Her work focuses on the use of clinical outcome assessments (COAs) to support patient focused drug development. She has 14 years experience working on the analysis of COA data. She received her PhD in psychometrics from the University of Amsterdam, the Netherlands. Prior to joining the FDA she was Associate Director of COAs at Pharmerit International.
Paul Kluetz, MD
- Associate Director for Patient Outcomes (Acting), OCE
- FDA, United States
Paul Kluetz is a medical oncologist and the Associate Director of Patient Outcomes in the Oncology Center of Excellence at the U.S. FDA. His interests include defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval, and opportunities and challenges associated with patient reported outcomes (PRO) data, wearable technologies, and other methods to obtain data on the patient experience both in the clinical trial and “real-world” settings. He is currently leading a team to develop regulatory science and policy initiatives to advance patient-focused drug development in cancer trials.
Donna Messner, PhD
- Center for Medical Technology Policy (CMTP), United States
Donna A. Messner, PhD is President of the Center for Medical Technology Policy (CMTP) where she oversees programs for research and stakeholder engagement to promote clinical evidence development that is patient-centered, stakeholder-informed, and relevant to real-world decision-making. She directs the Green Park Collaborative (GPC), a multi-stakeholder forum to develop condition- and technology-specific recommendations for research studies and policies to inform clinical and payment decisions. Under her leadership, GPC has grown into a multifaceted program spanning a range of conditions, including neurologic, metabolic, hematologic, oncologic, and rare genetic disorders.
Linda Nelsen, MHS, MS
- Senior Director and Head, Value Evidence and Outcomes-Patient Centered Outcomes
- GlaxoSmithKline, United States
Linda Nelsen is Senior Director and Head, Patient Centered Outcomes at GlaxoSmithKline, leading a team with responsibility to develop and implement PRO measures, and define and support COA endpoint asset strategies. Prior to GSK, Linda was Director of Epidemiology at Merck, Sharp & Dohme. She has extensive experience in the development and implementation of PROs for use in clinical research, and has developed measures across a range of therapeutic areas. Linda is active in industry-wide initiatives in PRO Development, including the Critical Path Institute PRO Consortium and ISOQOL. Linda received a master's degree in Epidemiology from the Johns Hopkins Bloomberg School of Public Health.
- Group Head, Rare Disease Statistics
- Pfizer, Inc., United States
Elektra Johanna Papadopoulos, MD, MPH
- Associate Director, Clinical Outcome Assessments Staff, OND, CDER
- FDA, United States
Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome assessments (COAs) regarding their development, validation, interpretation and overall suitability to support labeling claims and also manages the COA drug development qualification program.
Acacia Parks, PhD
- Chief Scientist
- Happify Health, United States
Dr. Parks’ research focuses on self-help methods for increasing well-being via books and digital technology. She is Chief Scientist for tech startup Happily, which brings the cutting edge in research-based well-being interventions to large businesses and consumers. Her work has been published in peer-reviewed journals, and in addition to editing three books, she is also an Associate Editor at the Journal of Positive Psychology.
Joseph V. Pergolizzi, MD
- Co-Founder and Chief Operating Officer
- NEMA Research, Inc., United States
Dr. Pergolizzi is the co-founder and Chief Operating Officer of NEMA Research since 1997. He was previously the Director of Business Development and Financial Affairs for The Johns Hopkins University School of Medicine's Clinical Trials Unit. Dr. Pergolizzi holds an M.D. with highest honors from Ross University School of Medicine. He completed his residency in Anesthesia at Georgetown University School of Medicine and a Clinical Research Fellowship in the Department of Medicine at Johns Hopkins University School of Medicine.
Philip Posner, PhD
- Patient Reviewer/ PEAP
- Patient-Centered Outcomes Research Institute (PCORI), United States
Dr. Posner is a patient with MS and Atrial Fibrillation He has been involved in research and teaching at several major institutions. He has served as a patient representative for the FDA and P.C.O.R.I. He also volunteers with the National Capitol MS Society through various programs. He is currently a PCORI Ambassador and served on the Patient Engagement Advisory Panel. He has also served as Chair and Vice Chair of WMATA’s Accessibility Advisory Committee. He has been active with the Capitol MS Society. He is a patient representative on several Patient Centered research projects and co-chair of the NCC-QIO-BFAC.
Jessica Roydhouse, PhD
- ORISE Fellow
- FDA, United States
Jessica is an ORISE Fellow in the Office of Hematology and Oncology Products at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She received her MPH (Hons) from the University of Sydney and a PhD in Health Services Research from the Brown University School of Public Health. Her research interests include patient- and caregiver-reported outcomes and experience of care, missing data, and causal inference methods.
R.J. Wirth, PhD
- Vector Psychometric Group, LLC, United States
Dr. R.J. Wirth is President and a managing partner at Vector Psychometric Group, LLC (VPG). He trained in the L. L. Thurstone Psychometric Lab at the University of North Carolina. Prior to taking over the daily operations of VPG, Dr. Wirth held research positions at the University of North Carolina and the University of Washington. Dr. Wirth’s research focuses on modern psychometrics with an emphasis on longitudinal models. He has published numerous book chapters and journal articles focused on the development and application of psychometrics. He currently serves as the Biostatistics Editor for Cephalalgia: An international journal of headache.
Adam Gater, MSc
- Director, Patient-Centered Outcomes
- Adelphi Values, United Kingdom
Adam provides senior strategic input and leads designated research teams in the delivery of projects within the Patient-Centered Outcomes team at Adelphi Values. Adam has over 10 years’ experience of assisting clients in the selection, modification, development and validation of a range of Clinical Outcomes Assessments (COAs) for both regulatory and market access purposes. Adam has experience of conducting and publishing qualitative and quantitative research in a variety of therapeutic areas. He has also published research concerning treatment tolerability, satisfaction and adherence. Adam holds an MSc in Health Psychology and a BSc (Hons) degree in Psychology from the University of Leeds (UK).
- Senior Director, Diabetes Project Leader
- Sanofi, United States
Michael King is a Senior Director, Diabetes Project Leader at Sanofi. He has over 23 years of clinical research experience, with over 18 years within the pharmaceutical industry, in the areas of diabetes, analgesia, neurological/psychological disorders. In his current role, he is responsible for the overall compound operational strategy, adapting operational plans to produce the optimal clinical operations solutions. He is leading multiple projects incorporating, remote/digital clinical solutions in clinical trials for the patient’s benefit. Michael received his Doctorate in Pharmacology from Kent State University, his Masters in Clinical Research from Duke University and his Bachelors from Ohio Wesleyan University.
Martin Ho, MS
- Associate Director of Quantitative Innovation, CDRH
- FDA, United States
Mr. Martin Ho is the finding Director of Quantitative Innovation Program (QuIP) at FDA Center for Devices and Radiological Health. QuIP turns novel types of data into regulatory-grade evidence for CDRH's decision-making, e.g., developing good review practices, review capacity, and research agendas for patient preference information and clinical outcome assessments. He is building Real-World Performance component of Digital Health Program. Mr. Ho was President of FDA Statistical Association (2016). He is also elected as Program-Chair (2018) and Chair (2019) of American Statistical Association (ASA) Medical Device & Diagnostic Section. He co-leads the ASA Real-World Evidence Scientific Working Group.