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CDISC Adds Four New Members and Re-appoints Two to 2020 Board of Directors

AUSTIN, TX – 15 January 2020 – CDISC today announced four new members have joined its Board of Directors: Dr. Wenjun Bao, Dr. Mihoko Okada, Dr. Erik Pulkstenis, and Dr. Christina Reith. Each began serving a three-year term at the beginning of the year. These members join current, sitting members, including David Evans and Steve Rosenberg, who will each be serving a second three-year term.

Dr. Wenjun Bao is a Chief Scientist and Sr. R&D Manager for JMP Life Sciences of SAS Institute Inc. She has rich experiences in clinical, biochemistry, molecular biology and bioinformatics research. She has been a research grant review committee member for the NIH since 2005 and research advisor for scientists in universities and government agencies. Dr. Bao is an adjunct professor at Fudan University in Shanghai and a Chinese CDISC Coordinating Committee Member.

Dr. Mihoko Okada became President of the Institute of Health Data Infrastructure for All in May 2018. Prior to this role, she was a Professor of Health Informatics at Kawasaki University of Medical Welfare for 20 years, after serving as an Associate Professor of Statistics at Niigata University. Dr. Okada was the President of the Japan Association for Medical Informatics from 2013 to 2016 and has been with the ICH M2 EWG (Electronic Transfer of Regulatory Information) since 1998 and is currently an M2 Co-Rapporteur.

Dr. Erik Pulkstenis is Vice President and Global Head of Data and Statistical Sciences in support of clinical development strategy, data science, statistical analysis and reporting/analytics at AbbVie. Previously, Dr. Pulkstenis headed Clinical Biostatistics & Data Management at MedImmune, led the Biostatistics Department at Human Genome Sciences, and served at C.L. McIntosh & Associates, consulting with medical device manufacturers with respect to study design, regulatory strategy, and FDA Advisory Committee preparation. From 2013 to 2019 he served on the American Statistical Association Biopharmaceutical Section Executive Committee and currently serves on the ICH E20 Adaptive Design Expert Working Group.

Dr. Christina Reith is a Senior Clinical Research Fellow at the University of Oxford’s Nuffield Department of Population Health (NDPH), where she primarily works on large-scale clinical trials and meta-analyses in relation to cardiovascular disease. She is also involved in teaching on the NDPH Global Health Sciences MSc, is a UK General Medical Council Educational Supervisor for Pharmaceutical Medicine specialty training, and acts as a College Advisor for students at the University of Oxford's Green Templeton College.

"CDISC continues to draw talented leaders from across this global community to serve as members of our Board of Directors. I am humbled by the breadth and depth of experience brought by Dr. Bao, Dr. Okada, Dr. Pulkstenis, and Dr. Reith.” said President and CEO David R. Bobbitt. “As CDISC continues to evolve into the standards organization of the future, our members and stakeholders can feel confident we are governed by a highly talented, engaged Board that represents the diversity of both the industries and geographies we serve. CDISC is united in our vision of clear data which supports better treatments, sooner."

“Our newest Board members bring unique insights and perspectives that are aligned with CDISC’s mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare,” said Jonathan Zung, CDISC Board Chair.

Continuing CDISC Board Members include Board Chair Dr. Jonathan Zung, WCG ; Chair-Elect Margaret Keegan, PRA Health Sciences; Chris Decker, d-Wise; David Evans, Accenture Research and Development Services; Dr. David Hardison, ConvergeHEALTH by Deloitte; Pam Howard, ICON; Dr. Pandu Kulkarni, Eli Lilly; Dr. Zhengqing Li, MSD China, Merck; Dr. Hiroshi Masumoto, Daiichi Sankyo; Dr. Douglas Peddicord, Association of Clinical Research Organizations; Steve Rosenberg, Oracle Health Sciences; non-voting CDISC Advisory Council Chair Jonathan Chainey, Roche; and ex-officio, David R. Bobbitt, CDISC.

For more information on the CDISC Board of Directors and the strategic plan, please visit www.cdisc.org/about.

ABOUT CDISC

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.