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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
    • 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.

  • 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, 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.

  • 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

    • DH Schubert Regulatory Solutions LLC, 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 International, United States

    Mr. Wenzel has 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 and speaking at this year’s DIA Annual Meeting.

  • Bill  Byrom, PhD

    Bill Byrom, PhD

    • Principal, eCOA Science
    • Signant Health , United Kingdom

    Bill is an eCOA scientist and VP of product intelligence and positioning 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, MS

    Jean Paty, PhD, MS

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

    Jean Paty is a leader in effective strategies and practices of capturing patient experience data for use in clinical development and commercial success of new and existing medical products. Jean has been published extensively in the areas of Clinical Outcome Assessments (COA) and electronic COA (eCOA). He has deep expertise regarding regulatory guidance for development and implementation of eCOA, in addition to scientific, clinical, regulatory implications of COA data collection in clinical trials. Jean joined IQVIA in 2014 and has held a variety of leadership positions within the company.

  • 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

    • Acting Commissioner
    • FDA, United States

    Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER, overseeing the center’s work that is the world’s gold standard for drug approval and safety. In that position, she has led many of the FDA’s groundbreaking drug initiatives. She has also served in other leadership roles at the FDA, including as Deputy Commissioner and Chief Medical Officer.With the onset of the COVID-19 public health emergency last year, Dr. Woodcock was asked to lend her expertise to “Operation Warp Speed” the initiative to develop therapeutics in response to the pandemic. Dr. Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021.

  • 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

    • Programme Director - Data
    • National Institute for Health and Care Excellence (NICE), United Kingdom

    Dr Jonsson is Programme Director at the National Institute for Health and Care Excellence (NICE) where he heads up Data and Analytics. His team has a strategic role in ensuring NICE is at the forefront of harnessing new and emerging opportunities for using real world data to inform NICE’s guidance to the health and care sectors. Before joining the Data and Analytics team, he was Associate Director for Science Policy and Research, responsible for NICE’s portfolio of international research projects in areas such as big data and real-world evidence. Dr Jonsson has a PhD in bioinformatics from the University College London. Before joining NICE, he worked in academia, biotech and the pharmaceutical industry.

  • 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.

  • 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. 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  Papadopoulos, MD, MPH

    Elektra Papadopoulos, MD, MPH

    • Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER
    • FDA, 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.

  • Katherine  Zarzar

    Katherine Zarzar

    • Head of Agile Execution, Patient-Centered Outcomes Research
    • Genentech, A Member of the Roche Group, United States

    Kate Zarzar is a Principal PCOR Scientist and Head of Agile Execution focused on designing and delivering COA strategies at Roche. As head of Agile Execution, she focuses on leveraging agile methodology to improve how the business executes paper COA and eCOA strategies to generate patient-relevant evidence. Prior to joining Roche eight years ago, Kate spent six years at TransPerfect leading the design and oversight of linguistic validation programs for a variety of sponsors. Kate specializes in global cross-functional and cross-industry partnerships to drive improvement in the development and implementation of COA strategies. Kate is passionate about enabling further understanding and insight into the patient experience.

  • Edmund Joseph Pezalla, MD, MPH

    Edmund Joseph Pezalla, MD, MPH

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

    Dr. Pezalla is Founder and CEO of Enlightenment Bioconsult, LLC, a strategic payer consultancy advising biopharmaceutical firms on access, technology assessment, and drug evaluation in the US market. His clients include established pharmaceutical firms and emerging companies with innovative therapies. Dr. Pezalla served for nine years as VP for Pharmaceutical Policy and Strategy for Aetna, and four years as VP of Clinical Services for RxSolutions. In these roles he developed programs for drug and device evaluation, creation of clinical policy and formulary inclusion. Dr. Pezalla also served as the leading executive for Aetna on public policy issues related to drug approval, drug pricing and regulation. He is a member of the MIT Center fo

  • 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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