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Bethesda North Marriott Hotel and Conference Center

Sep 20, 2018 7:00 AM - Sep 21, 2018 12:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advancing the Science of Study Endpoints


René  Allard, PhD

René Allard, PhD

Contractor, CTC, 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.

Emuella  Flood

Emuella Flood

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.

Michael  Lees, MA

Michael Lees, MA

Chief Operating Officer and Head of Market Access Strategy, PHMR Ltd, United Kingdom

Michael is the Chief Operating Officer and Head of Market Access Strategy at PHMR. In this role, he is responsible for ensuring that the research delivered matches the strategic needs of our clients. Michael has extensive experience in the development of health economic models and indirect treatment comparisons, utility measurement and health valuation, strategies for collection and use of real-world data, and the development of dossiers to support HTA submission. He also has substantial experience in working with different stakeholders, including through the use of early scientific advice through HTA agencies, to lead the development of integrated evidence plans and allow for access needs to be incorporated from early in development.

J. Jason  Lundy, PhD

J. Jason Lundy, PhD

Principal , 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, PhD, MSc

Matthew Reaney, PhD, MSc

Head of Science and Analytics, Patient Centered Solutions, IQVIA, United Kingdom

Matthew Reaney is Scientific Lead of Patient-Centered Endpoints at IQVIA, where he works to amplify the patient's story through science and technology to improve outcomes in clinical drug development and routine clinical practice. He is also the co-Chair of the DIA Study Endpoints Community, 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 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

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  Wenzel

Keith Wenzel

Volunteer, DIA Study Endpoints Community, United States

Mr. Wenzel worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working with and for contract research organizations, technology partners and clinical trial sponsors. His areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials. He has been on the program committee of several Drug Information Association meetings and is chairing a session at this year’s DIA Annual Meeting.

Theresa  Mullin, PhD

Theresa Mullin, PhD

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations for 2017 reauthorization of the Prescription Drug User Fee Act and also led the 2002, 2007 and 2012 PDUFA reauthorization cycles providing $1B in annual funding.  She received the 2019 Reagan-Udall Foundation Leadership Award for Innovations in Regulatory Science, US Food and Drug Law Institute 2017 Distinguished Service and Leadership Award, 2011 Presidential Rank Award for Distinguished Service, for Meritorious Service in 2006. 

Sudip  Parikh, PhD

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

Elise Berliner, PhD

Global Senior Principal for Real World Evidence Strategy, Oracle Life Sciences, United States

Robyn T. Carson, MPH

Robyn T. Carson, MPH

Vice President, Patient-Centered Outcomes Research, AbbVie, United States

Robyn T. Carson, MPH, is Vice President & Head, Patient-Centered Outcomes Research at AbbVie, where she leads a team focused on integrating the patient voice into medical product development and establishing best practices for clinical outcome assessment (COA) development, validation, and implementation across therapeutic areas. Robyn has driven patient-centered research in the pharmaceutical industry for 16 years where she has held roles of increasing responsibility at Pfizer, Forest Labs, Allergan and AbbVie. Prior to joining the pharmaceutical industry, Robyn conducted research at Columbia University, NYC Department of Health & Mental Hygiene, and served as a Research Fellow at NCI. Robyn earned her MPH at Columbia University.

Cheryl  Coon, PhD

Cheryl Coon, PhD

VP, Clinical Outcome Assessment Program, Critical Path Institute, 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

Stephen Joel Coons, PhD

Senior Advisor, 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 in 2009 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

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

Chad Gwaltney, PhD

President, 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

Laura Lee Johnson, PhD

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States

Laura Lee Johnson, Ph.D. is a division director in 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, and analysis of research from clinical outcome assessment (COA) qualification to trials of all sizes. Her division covers a wide variety of therapeutic areas. She works across FDA on patient focused drug development and rare disease initiatives, master protocols, and other programs. 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

Lisa Kammerman, PhD, MS

Regulatory Statistics and PRO Consultant, 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

Bellinda King-Kallimanis, PhD

Senior Director of Patient-Focused Research , LUNGevity, 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

Paul Kluetz, MD

Deputy Director, Oncology Center of Excellence, OC, 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

Donna Messner, PhD

President and CEO, Center for Medical Technology Policy (CMTP), United States

Donna Messner, PhD is President and CEO of the Center for Medical Technology Policy. She leads the Green Park Collaborative, a multi-stakeholder forum for clinical evidence that is patient-centered, stakeholder-informed, relevant to care and coverage decision-making, and regulator-aligned. She created and leads a GPC program to develop condition-specific core outcome sets with methods to prioritize patient-important outcomes. Current/recent projects include COS for hemophilia, non-alcoholic steatohepatitis, sickle cell disease, asthma, uterine fibroids, and others.

Linda  Nelsen, MHS

Linda Nelsen, MHS

Senior Director and Head, Oncology 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.

Jeffrey  Palmer

Jeffrey Palmer

Senior Director, Biostatistics, Pfizer Inc, United States

Elektra  Papadopoulos, MD, MPH

Elektra Papadopoulos, MD, MPH

Director, Patient Experience Data and Strategy, AbbVie, United States

Dr. Papadopoulos serves as the Deputy Director (acting) of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The Division 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

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

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

Philip Posner, PhD

Retired Academic, Patient Representative, 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-QIN-QIO-BFAC.

Jessica  Roydhouse, PhD

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

R.J. Wirth, PhD

CEO, Vector Psychometric Group, LLC, United States

R.J. Wirth is Chief Executive Officer, co-Founder, and a managing partner at VPG. Dr. Wirth received his PhD in quantitative psychology / psychometrics from the historic LL Thurstone Psychometric Laboratory at University of North Carolina – Chapel Hill. For nearly two decades, Dr. Wirth has collaborated widely within the pharmaceutical and medical device industries to develop/evaluate/implement clinical outcome assessments. Dr. Wirth has authored numerous peer-reviewed publications on such topics as item factor analysis, structural equation modeling, validity, as well as various aspects of scale development. He has participated as an invited expert on multiple regulatory panels and industry advisory boards focused on PRO/COA development.

Adam  Gater, MSc

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).

Michael  King

Michael King

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, PhD, MS

Martin Ho, PhD, MS

Head of Biostatistics, Google, United States

Mr. Martin Ho was the Associate Director of Quantitative Patient Inputs & Real-World Patient Evidence at Office of Biostatistics & Epidemiology, CBER, FDA. Prior, he was the Director of Quantitative Innovation at Center for Devices, turning new data sources into regulatory-grade evidence for decision making, e.g., developing good review practices and review capacity for patient preference information and clinical outcome assessments. He was building Real-World Performance component of Digital Health Program. Mr. Ho was President of FDA Statistical Association (2016). He was elected as Chair (2020) of American Statistical Association (ASA) Medical Device & Diagnostic Section and co-leads the ASA Real-World Evidence Scientific Working Group.

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