Dr. Hardison is the current Chair of the CDISC Board of Directors and Vice President of Health Sciences for ConvergeHEALTH by Deloitte. He 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. Dr. Hardison 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. Dr. Hardison has served in several industry leadership roles and previously served as Chair of the CDISC Board from 2005-2007.
CDISC Board of Directors
David Hardison, Ph.D.
Mr. Pyke is Chair-Elect of the CDISC Board of Directors and Senior Vice President, Clinical Projects & Quantitative Sciences at GlaxoSmithKline (GSK). He 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.
Charles Cooper, M.D.
Dr. Cooper is Vice President of Medical Affairs at Becton Dickinson Diagnostic Systems. Prior to this role, he 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.
David Evans, MS
David Evans is Principal Director, Global Head of Quality Governance and Regulatory Compliance for Accenture Research and Development Services. With over 35 years’ experience in the clinical research, regulatory and healthcare industries, he is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions. Mr. Evans was the architect and developer of the first electronic drug submission to the FDA in 1985, and has been responsible for more than 100 electronic regulatory submission and complex clinical data warehouse systems. He holds a master’s degree in Biomedical Engineering and has previously held executive-level positions (CIO, CTO, COO, CQO) at software development, clinical research, regulatory and industry consulting companies.
Masanori Fukushima, M.D., Ph.D.
Dr. Fukushima is a Professor Emeritus at Kyoto University and Director and Chairman of Translational Research Informatics Center (TRI), Japan. An oncologist, he has over 25 years’ experience engaging in the practice and dissemination of standard cancer treatment and reforming Japan’s medical care system. Dr. Fukushima actively contributes to building the clinical trial infrastructure, with a focus on translational research. He promotes using CDISC Standards in academic research toward the goal of complete, harmonized data standardization. Dr. Fukushima also supervises the national translational research promotion programs conducted by the government of Japan, which led to the formation of the Academic Research Organization (ARO) Council.
Ms. 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, Ph.D.
Rebecca Kush is a Founder and the current President and CEO of CDISC. Dr. Kush has over 25 years of experience in the area of clinical research. She has worked for the U.S. National Institutes of Health, academia, a global contract research organization and pharmaceutical companies in the U.S. and Japan. Among numerous publications, Dr. Kush is lead author of the book, eClinical Trials: Planning and Implementation. She has given invited presentations (including keynotes) and tutorials at industry conferences, FDA and other venues in the U.S., Europe, and Japan for over 20 years. Dr. Kush earned a Ph.D. in Physiology and Pharmacology from the University of California (UCSD) School of Medicine in La Jolla, CA and has a B.S. in Chemistry and Biology from the University of New Mexico.
Douglas Peddicord, Ph.D.
Dr. Peddicord 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. He 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.
Steve Rosenberg is Senior Vice President and General Manager of Oracle Health Sciences. He has over 30 years’ experience in the life sciences and healthcare arenas, leading development, services, support, and consulting. Mr. Rosenberg possesses a unique ability to address and influence the changing life sciences landscape, using his deep domain understanding, customer relationships, and technology vision. He served as the visionary and lead evangelist for the integrated clinical technology suite introduced by Phase Forward. As senior vice president of Software and Services at Phase Forward, Mr. Rosenberg was an integral member of the senior management team and championed the integrated technology approach.
Joyce Sensmeier, MS, RN
Ms. Sensemeier 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, 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. She 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.
Mr. 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.
Hiro Shirasawa, M.D.
Dr. Shirasawa is VP of Japan Development at Merck/MSD. He 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. Dr. Shirasawa previously worked at Pfizer. Prior to joining the industry, he was trained as a physician in internal medicine and respiratory.
Névine Zariffa, M. Math
Ms. Zariffa 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.
Dr. Zung is Group President of Clinical Development & Commercialization Services for Covance Drug Development. A member of the Covance Global Operating Committee, he is responsible for overseeing Early Clinical Services, Phase II-IV Clinical Development and Market Access Services. Dr. Zung 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.