Pierre-Yves Lastic, PhD, is the current 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.
Paula Brown Stafford, MPH, is Past-Chair of the CDISC Board of Directors, and is President of Clinical Development at Quintiles. Ms. Stafford has received a number of prestigious accolades and awards, including being named one of the Top 10 Women in Biotech in 2012 by fiercebiotech.com, and a 2011 Women in Business Award Winner by Triangle Business Journal. Prior to her current role, she has held numerous positions within Quintiles over the past 28 years, including the position of Executive Vice President of Global Data Management, where she was essential in the integration of practices across nine regional offices, developing one set of global practices for Quintiles. She also founded and was Chair of Quintiles Data Council for five years, establishing policies and standards for multi-source clinical trial data.
C. David Hardison, PhD, is Chair-Elect of the CDISC Board of Directors and Managing Director of Health Sciences for ConvergeHEALTH by Deloitte, which is now Recombinant by Deloitte. Dr. Hardison is a seasoned executive with over 30 years of experience working as a team builder and change agent at the intersection of biopharmaceuticals, health care delivery, performance improvement and information technology in both executive and board-level roles. Dr. Hardison has a long history with such organizations as SAIC where he was Chief Health Scientist and an SAIC Fellow, First Consulting Group, Inc. serving as Vice President of Global Life Sciences Consulting, Wheaton Franciscan Services, Carolina Medicorp, Inc. (now Novant Health), Quorum Health Group, Hospital Corporation of America, and Eli Lilly. Previously, he served as Chair of the CDISC Board from 2005-2007.
Charles Cooper, MD, is the Medical Director of Becton Dickinson Diagnostics. 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.
Michael Glickman, MSE, is the founder and President of Computer Network Architects, Inc., through which he has worked with hundreds of healthcare organizations and has experience with every popular EHR system currently available. Mr. Glickman has over 45 years of experience in the computer industry, specializing the last 35 years in the unique problems of systems integration in healthcare. Mr. Glickman was a founding member of the HL7 Working Group and currently serves as Chair of the U.S. Technical Advisory Group to ISO TC215 Health Informatics, in addition to many further prestigious activities.
Dipak Kalra, PhD, is Professor of Health Informatics and Director of the Centre for Health Informatics and Multi-professional Education (CHIME) at University College London. In addition to this role, Dr. Kalra also holds the positions of Honorary Senior Academic General Practitioner at the Whittington Hospital NHS Trust in London, the President of the European Institute for Health Records (EuroRec) Institute, Director of the openEHR Foundation, Editor-in-Chief of the AMIA Standards Standard, and Consultant and Advisor on semantic interoperability to the European Commission, English National Health Service, Ministry of Health in Singapore and Ministry of Health in the Kingdom of Saudi Arabia.
Wayne Kubick, MBA,* is the Chief Technical Officer at CDISC. Mr. Kubick has over 25 years of experience in clinical research and drug safety, including executive management and strategy development. Prior to his CDISC role, Mr. Kubick worked for Oracle Health Sciences as Senior Director of Product Strategy. Preceding this, he was Senior Vice President and Chief Quality Officer of Lincoln Technologies, Inc. where he served as the Principal Investigator for its Cooperative Agreement with the FDA to develop tools for receiving, assessing and reviewing eSubmissions data in CDISC standard format. Mr. Kubick has served as Chief Information Officer and Vice President for IT at PAREXEL International, and as Manager of Information Systems at BBN Software Products. He is a frequent speaker at industry conferences, and holds a BA degree from the University of Illinois and an MBA in MIS and Public Management from Boston University.
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.
Stephen Pyke is Vice President of Quantitative Sciences at GlaxoSmithKline (GSK), with 17 years experience in the pharmaceutical industry. Mr. Pyke leads a multidisciplinary group of 600 quantitative scientists spanning statistics and programming, clinical pharmacology modeling and simulation, epidemiology, genetics and computational biology. Mr. Pyke has been active in statistical societies over many years holding a number of honorary positions, including Past-Chair and Board Member of Statisticians in the Pharmaceutical Industry, and is currently Vice President and Council member of the Royal Statistical Society.
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
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 a Corporate Officer of eClinical Business at CMIC Co. Ltd., Japan. In this role he promotes eClinical trial and eHealth business through developing alliances with EDC, ePRO and IVRS/IWRS vendors in the U.S., 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 CMIC, Dr. Takenouchi was the VP of eClinical and eHealth Business at Medical Front Co. Ltd. He was one of the founding members of the Japan CDISC Coordinating Committee, 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, PhD, is the VP of Global Clinical Sciences & Operations at UCB, Chair of the TransCelerate BioPharma, Inc. Operations Committee, and an ex-officio member of the TransCelerate Board of Directors. In his TransCelerate role, Dr. Zung is responsible for providing leadership oversight of the on-going work streams and in engaging with key internal and external stakeholders around TransCelerate deliverables and focus areas. Prior to this experience, Dr. Zung held numerous roles at Bristol-Myers Squibb and Pfizer; he has extensive experience as a change agent for enhancing performance and streamlining processes, particularly in the biopharmaceutical industry.
*Ex-Officio members of the Board of Directors