David Hardison, PhD, is the current Chair of the CDISC Board of Directors and Vice President of Health Sciences for ConvergeHEALTH by Deloitte. David focuses on helping clients integrate evidence planning and generation throughout the product life cycle and value dossier development process. This includes strategies and tactics for gaining optimal insights from both proprietary data and Real World Data to help clients improve the benefit-risk profiles of their products. David also has extensive experience aligning R&D IT strategy with R&D business strategy for biopharmaceutical companies, government health and research organizations, and healthcare providers in the areas of Global R&D Operations, Data Transparency and Standards, Submission Management, Pharmacovigilance, and Translational Research. Additionally, he has been both a member of, and a strategic advisor to healthcare executive teams, physician organizations and boards of trustees on continuous quality improvement. David has served in several industry leadership roles and previously served as Chair of the CDISC Board from 2005-2007.
Stephen Pyke is Chair-Elect of the CDISC Board of Directors and Senior Vice President, Clinical Projects & Quantitative Sciences at GlaxoSmithKline (GSK). Mr. Pyke leads a multi-disciplinary group providing end-to-end support for the planning, conduct and delivery of clinical trials and observational studies across Pharmaceutical R&D. He trained as a statistician, and began his career in academia before moving to join the pharmaceutical industry in 1996, since when he held various clinical and non-clinical roles, both at GSK and at Pfizer. Mr. Pyke has held a number of honorary professional positions including: Chair, PSI (2009-11); Vice President, RSS (2013-2016); CDISC Board Member (2013-15). He studied Mathematics and Statistics at, respectively, University of York and Imperial College, London. He is a Chartered Statistician.
Pierre-Yves Lastic, PhD, is the past Chair of the CDISC Board of Directors and Associate Vice-President and Chief Privacy Officer at Sanofi, with over 20 years of experience in diverse management positions in the field of clinical research and information management. He is an expert in the development and implementation of standards for the exchange of information in healthcare and medical research, as well as in the field of privacy and data protection. Dr. Lastic is a member of the BoD of the International Pharmaceutical Privacy Consortium, the Advisory Council Europe of the Drug Information Association, the Knowledge Management Group of the European Innovative Medicines Initiative, and is one of the experts on the European Medicine Agency’s EudraVigilance Expert Working Group and EudraCT Joint Operations Group.
Charles Cooper, MD, is Vice President of Medical Affairs at Becton Dickinson Diagnostic Systems. Prior to this role, Dr. Cooper served as Deputy Director of the Office of Computational Science at the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). In addition to his experience as a practicing infectious disease physician, Dr. Cooper has a broad range of FDA regulatory expertise, including master level clinical reviewer, co-creator of the Quantitative Safety Division, member of the FDA Genomics Work Group and leader of efforts to create the Computational Science Center. Dr. Cooper received his B.A. from the University of Virginia in 1989, and his M.D. in 1995 from Georgetown University School of Medicine.
Margaret Keegan is President of Data Sciences, Safety, and Regulatory for Quintiles. She leads the divisions of Central Monitoring, Data Management, Biostatistics, Medical Writing, Safety and Regulatory. Ms. Keegan is also a member of the Quintiles Executive Committee. Prior to this, she held senior leadership positions as Global Head of Data Management, Head of North America Clinical Operations, Global Head of Integrated Processes and Technologies and Global Head of Enterprise Solutions Development. Ms. Keegan has over 25 years’ biopharmaceutical industry experience, holding leadership roles at large pharmaceutical and CRO companies. She has led statistics, programming, data management, late phase and clinical functions, and has worked in Europe and the United States. Ms. Keegan holds a Bachelor of Science degree in Pure and Applied Mathematics and is a Chartered Statistician.
Rebecca Kush, PhD, is a Founder and the current President and CEO of CDISC. Dr. Kush has over 30 years of experience in the area of clinical research. She has worked for the U.S. National Institutes of Health, has held positions in academia, a global contract research organization and global pharmaceutical companies based both in the U.S. and Japan. Dr. Kush has published numerous articles in key journals, including the New England Journal of Medicine and Science Translational Research and has been cited in a number of publications of the National Academy of Sciences Institute of Medicine. She was appointed by the head of HHS/ONC to represent Research on the Health Information Technology (HIT) Standards Committee; she has served on the boards of DIA, HL7 and ACRES; and she currently serves on the National Cancer Advisory Board Informatics Work Group. Dr. Kush holds a BS in Chemistry and Biology from the University of New Mexico and a PhD in Physiology and Pharmacology from the University of California San Diego (UCSD) School of Medicine.
Douglas Peddicord, PhD, serves as Executive Director of the Association of Clinical Research Organizations (ACRO), which has been a major supporter of CDISC and the move toward clinical data standards to improve the quality and efficiency of clinical trials. Dr. Peddicord is also President of Washington Health Strategies Group, LLC, which provides a full range of strategic consulting, government affairs and association management services to healthcare organizations. His particular areas of expertise include health information technology and medical privacy, clinical trials, medical informatics, and Medicare coverage and payment policy.
Joyce Sensmeier, MS, RN, is the Vice President of Informatics at the Healthcare Information and Management Systems Society (HIMSS). She has made contributions to enabling health information exchange through standards profiling, testing and harmonization initiatives. Ms. Sensmeier led the advancement of and currently serves as President of Integrating the Healthcare Enterprise (IHE) USA. IHE USA is a regional deployment committee of IHE International, a standards profiling organization, which over the past decade has achieved both national and international adoption of its public domain technical framework. Ms. Sensmeier is a fellow in the American Academy of Nursing, and has led consortia that include industry, government and clinical leaders in efforts to advance widespread adoption of interoperable electronic health records.
Hiro Shirasawa, MD, is VP of Japan Development at Merck/MSD. Dr. Shirasawa has broad experience in the pharmaceutical industry, including such areas of expertise as clinical research, clinical operations, regulatory affairs and medical affairs in Japan, the US, and the Asia-Pacific region. He previously worked at Pfizer. Prior to joining the industry, Dr. Shirasawa was trained as a physician in internal medicine and respiratory.
John Speakman serves as Senior Director of Research Information Technology for the New York University Langone Medical Center. He collaborates with the research community at NYU and beyond to connect people and technology, furthering the research mission of the Center in basic science, clinical trials, investigator-initiated and sponsored projects. Before July 2012, Mr. Speakman served at the National Cancer Institute (NCI) as Chief Program Officer for the Center for Biomedical Informatics and Information Technology, where he led NCI’s informatics programs, many of which involved partnering with CDISC in clinical research data standards.
Kiyoteru Takenouchi, PhD, is the CDISC Program Coordinator of Translational Research Informatics Center (TRI), Japan. In this role he promotes CDISC Standards-compliant, investigator-initiated clinical researches in Japan, as well as fostering alliances with EHR vendors in Japan to promote RFD and the Regional Health Information Organization. Prior to his current role with TRI, Dr. Takenouchi was the VP of eClinical and eHealth Business at Medical Front Co. Ltd and Corporate Officer of eClinical Business at CMIC Co. Ltd., Japan. He was one of the founding members of the Japan CDISC Coordinating Committee (J3C), and continues to promote CDISC’s mission in Japan and throughout the Asia Pacific.
Névine Zariffa, M. Math, is Vice President of Biometrics and Information Sciences at AstraZeneca Pharmaceuticals. Prior to this role, she held a number of positions at GlaxoSmithKline Pharmaceuticals across all phases of drug development. Ms. Zariffa is a pharmaceutical executive with 20 years experience across all phases of drug development. She is an expert in statistics, drug development, portfolio-level decisions, regulatory interactions, strategy, innovation, bridging the discovery/development interface, and business development. Ms. Zariffa received her B.S. in Mathematics from McGill University in 1987, and her M. Math from the University of Waterloo in 1988.
Jonathan Zung, Ph.D. is Group President of Clinical Development & Commercialization Services for Covance Drug Development. A member of the Covance Global Operating Committee, Dr. Zung is responsible for overseeing Early Clinical Services, Phase II-IV Clinical Development and Market Access Services. He is a proven R&D leader with more than two decades of biopharmaceutical experience in all phases of drug development. He has led major development projects in oncology, immunology, cardiovascular diseases, central nervous system diseases and virology. Prior to joining Covance, Dr. Zung was Vice President and Head of Global Clinical Sciences and Operations at UCB. Prior to UCB, he was Vice President and Head of Global Development Operations at Bristol-Myers Squibb. Dr. Zung also held several positions of increasing responsibility at Pfizer Global Research and Development. He served as chair of the TransCelerate BioPharma operations committee from 2013-2015.