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Advancing the Science of Study Endpoints

Examine global strategies for selecting study endpoints and the impact of endpoints during the analysis of clinical evidence for various types of drug approval processes.


Speakers

  • René  Allard, PhD

    René Allard, PhD

    • Contractor
    • Self Employed, 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.

  • 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.

  • Michael  Lees

    Michael Lees

    • 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

    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.

  • 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

  • David H. Schubert

    David H. Schubert

    • Vice President of Regulatory and Quality
    • Stealth BioTherapeutics, United States

    David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc. Previously, Mr. Schubert held positions at MediVector Inc., Logical Therapeutics Inc., Coley Pharmaceutical Group, Genzyme and Cubist Pharmaceuticals. Mr. Schubert has over 30 years of experience in biotechnology regulatory, rare disease drug development, quality, process development, and research and development and has chaired several Oligo-based Therapeutics Conferences co-sponsored by DIA and FDA.

  • 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

    • Senior Director, Scientific Data Organization
    • Parexel, United States

    Mr. Wenzel holds the position of Senior Director within Parexel's Scientific Data Organization, a team that brings innovation to clinical trials by applying RWD. He is responsible for advising clinical trial sponsors and consults with regulatory authorities and industry organizations to advance the knowledge of RWD, eClinical, 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.

  • Bill  Byrom, PhD

    Bill Byrom, PhD

    • Vice President, Product Strategy and Innovation
    • Signant Health , United Kingdom

    Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable technology and BYOD eCOA in clinical trials. Bill is an active member of the C-PATH ePRO Consortium, is a member of the scientific leadership board of the Digital Medicine Society, and leads a group on wearable technology within DIA's Study Endpoints Community. Bill provides eClinical commentary on LinkedIn and Twitter (@billbyrom).

  • Stephen Joel  Coons, PhD

    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 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.

  • Jean  Paty, PhD

    Jean Paty, PhD

    • Vice President, Patient-Centered Endpoints
    • IQVIA, United States

    Dr. Paty is an acknowledged leader in the effective strategies and practices of capturing patient perspective data for use in the clinical development of new medical products. He has published extensively in the areas of Patient Reported Outcomes (PRO) and electronic PRO (ePRO), as well as the regulations guiding development and implementation of ePRO. He has worked closely with international industry and regulatory agencies on ePRO best practices. His years of work developing solutions to study patient perspective is well-referenced in a wide variety of peer reviewed journals and in numerous conferences and events.

  • Dragos  Roman, MD

    Dragos Roman, MD

    • Associate Dir., Division of Gastroenterology & Inborn Errors Products, OND, CDER
    • FDA, United States

    Dr. Dragos Roman is Associate Director in the Division of Gastroenterology and Inborn Errors Products (DGIEP) in the Center for Drug Evaluation and Research (CDER) within the Office of New Drugs at FDA. A pediatric geneticist by training, he began his FDA career 16 years go in the Division of Metabolism and Endocrinology in CDER as a medical officer and subsequently as a team leader. He joined DGEIP 2 years ago and is involved primarily in inborn errors of metabolism and other rare/orphan diseases.

  • Richard J. Willke, PhD

    Richard J. Willke, PhD

    • Chief Science Officer
    • International Society for Pharmacoeconomics and Outcomes Research (ISPOR), United States

    Dick became ISPOR’s first Chief Science Officer in 2016, where he develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. Prior to ISPOR he worked for 25 years at Pfizer and its legacy companies, where he retired as a vice president in the HEOR group. He received a PhD in economics from Johns Hopkins, taught economics at Ohio State, and was senior economist at the American Medical Association. He has been a co-editor for Value in Health, on AHRQ, NIH, and PCORI study sections, and chaired the PhRMA Health Outcomes Committee.

  • Janet  Woodcock, MD

    Janet Woodcock, MD

    • Director, Center for Drug Evaluation and Research (CDER)
    • FDA, United States

    Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). In 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served FDA’s Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations.

  • Norbert  Benda, PhD

    Norbert Benda, PhD

    • Head of Biostatistics and Special Pharmacokinetics
    • Federal Institute For Drugs and Medical Devices (BfArM), Germany

  • Carolina  Beraldo Meloto, DDS, PhD

    Carolina Beraldo Meloto, DDS, PhD

    • Human Pain Genetics Lab, Faulty of Dentistry
    • McGill University, Canada

    Graduated in Dentistry, Dr. Meloto has dedicated her post-graduate studies to better understand the genetic and molecular pathophysiological mechanisms involved in temporomandibular disorders. After obtaining her PhD from the University of North Carolina at Chapel Hill under the supervision of Dr. Luda Diatchenko, one of the world’s top researchers in the basic molecular and genetic mechanisms of pain, Dr. Meloto is dedicating her career to translating basic science findings into the clinic with the ultimate goal of providing more effective treatment options for chronic pain patients.

  • Pall  Jonsson, PhD, MS

    Pall Jonsson, PhD, MS

    • Associate Director Research and Development
    • National Institute for Health and Care Excellence (NICE), United Kingdom

    Dr Jonsson heads Research and Development UK's National Institute for Health and Care Excellence (NICE). He leads NICE's contribution to a portfolio of international research projects, in areas including big data and real-world evidence. Dr Jonsson has a PhD in biochemistry from University College London and worked in academia and the pharmaceutical industry before joining NICE. He sits on advisory boards of several international projects in the area of health technology assessment.

  • Paul  Kluetz, MD

    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.

  • Mark B. McClellan, MD, PhD

    Mark B. McClellan, MD, PhD

    • Director and Robert J. Margolis M.D. Professor of Business, Medicine and Policy
    • Duke-Margolis Center For Health Policy, United States

    Mark McClellan, MD, PhD, is the Robert J. Margolis Professor of Business, Medicine, and Policy, and Director of the Margolis Center for Health Policy at Duke University. He is a physician-economist who focuses on quality and value in health care including payment reform, real-world evidence and more effective drug and device innovation. He is former administrator of the Centers for Medicare & Medicaid Services and former commissioner of the U.S. Food and Drug Administration, where he developed and implemented major reforms in health policy. He was previously Senior Fellow at the Brookings Institution and a faculty member at Stanford University.

  • Alan  Shields, PhD

    Alan Shields, PhD

    • Vice President Patient Centered Outcomes
    • Adelphi Values, United States

    Alan is Vice-president at Adelphi Values, a global health outcomes consultancy, and is trained as a clinical psychologist with emphasis in research methods, instrument development, and psychometrics. He has 20 years of experience in clinical research focusing on PRO questionnaire development, implementation, and evaluation. As an industry consultant, Alan works cross-functionally with sponsors to implement PRO and other COA instruments for use in regulated trials to support labeling, achieve product differentiation, and inform patient, physician, and payer decisions. Alan received his PhD from the University of Montana and completed his clinical training at McLean Hospital in the Harvard Medical School.

  • Karon  Cook, PhD

    Karon Cook, PhD

    • Research Professor
    • Northwestern University, United States

    Dr. Karon Cook is Research Professor at the Feinberg School of Medicine, Northwestern University, Chicago. Her work has focused both on applications of modern psychometric approaches and on advancing methodological science. Dr. Cook has been an investigator on NIH PROMIS-funded projects for the last 11 years and has served as principle investigator on multiple grants and contracts funded by National Institutes of Health, Agency for Healthcare Research and Quality, the Department of Defense, and VA Health Services and Rehabilitation Research. In addition, she commits substantial effort in communicating the science of PROs.

  • Lynn D. Disney, JD, PhD, MPH

    Lynn D. Disney, JD, PhD, MPH

    • Dir of Research, PATIENTS Program Pharmaceutical Health Services Research Depart
    • University of Maryland, United States

    Lynn D. Disney, Ph.D., J.D., M.P.H., is the Director of Research for the PATIENTS Program at the University of Maryland. PATIENTS is supported, in part by an infrastructure grant from the Agency for Health Research and Quality (AHRQ) and serves to integrate the patient voice into research. Dr. Disney is actively engaged in designing and conducting health services research, as well as overseeing engagement efforts. Prior to her joining the University of Maryland, she worked as a Senior Program Officer in the Improving Healthcare Systems Program at the Patient Centered Outcomes Research Institute.

  • 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 including numerous rare diseases. 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.

  • François  Meyer, MD

    François Meyer, MD

    • Advisor to the President, International Affairs
    • French National Authority for Health (HAS), France

    François Meyer joined the HAS in 2005 as Director of the Health Technology Assessment (HTA) Division. He took his current position of Advisor to the President, in charge of International affairs in 2011. Dr Meyer has been involved in the European cooperation on HTA (EUnetHTA) since its launch and has been a member of the Board of Directors of HTAi, the international society for HTA from 2011 till 2017. He earned his MD from the University of Montpellier and served the teaching hospitals of Montpellier as a practicing physician qualified in Endocrinology and Internal Medicine. He worked then 5 years in the R&D department of an international pharmaceutical company. From 1997 to 2005 he held various positions at the French Medicines Agency.

  • Elektra Johanna Papadopoulos, MD, MPH

    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.

  • Katherine  Zarzar

    Katherine Zarzar

    • Manager, Outcomes Measurement, Patient-Centered Outcomes Research
    • Genentech, A Member of the Roche Group, United States

    Ms Zarzar focuses on improving the execution of COA strategies to generate patient-relevant evidence. Her past experience includes 3 years supporting the development and delivery of PCOR strategies at Roche, and six years at TransPerfect leading the design and oversight of linguistic validation programs for a variety of sponsors. Past publication topics include linguistic validation methodology, development of measures in a global context, and improving translation and eCOA delivery in global trials. Katie is passionate about designing systems that enable development and implementation of robust patient-centered outcomes strategies, as well as exploring new technologies and methods for capturing the patient experience.

  • Edmund Joseph Pezalla, MD, MPH

    Edmund Joseph Pezalla, MD, MPH

    • Chief Executive Officer
    • Enlightment Bioconsult, LLC, United States

  • Robert Alan Vigersky, MD, FACP

    Robert Alan Vigersky, MD, FACP

    • Medical Director
    • Medtronic, United States

    Robert Vigersky, M.D. is the Medical Director of Medtronic Diabetes. He graduated Boston University, did his house staff training at The Johns Hopkins Hospital and Fellowship in Endocrinology at the NIH. His career has spanned Academia, Private Practice, and Industry. He is a retired Army Colonel and a Professor of Medicine at the Uniformed Services University of the Health Sciences. He established the Endocrine Society’s Clinical Practice Guideline program and served as the Endocrine Society’s President 2009-2010. Dr. Vigersky has published 143 scholarly papers and 115 abstracts concentrating on the use of technology to improve outcomes of patients with diabetes.

  • Robert  DiCicco, PharmD

    Robert DiCicco, PharmD

    • Deputy Chief Health Officer
    • IBM Watson Health, United States

    Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical trial design and project management. During his career he has successfully led the development a number of late phase oncology projects leading to product approvals. Rob also has extensive experience in leading transformational projects with TransCelerate (Common Protocol Template) and CTTI (Mobile Devices in Clinical Trials Novel Endpoints). Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia.

  • Marta  Segerdahl, MD, PhD

    Marta Segerdahl, MD, PhD

    • Chief Medical Specialist, CRD Neurology
    • H. Lundbeck A/S, Belgium

    She is MD, Dr Med and Assoc Professor at Karolinska Institute. She is board certified in Anesthesiology and in Pain Medicine. Her research includes all aspects of clinical pain. She joined AstraZeneca in 2006 hods a position as Medical Science Director. Coordinator of IMI EUROPAIN.

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