The Science and Policy Advisory Council provides a disruptive force in our dynamic healthcare forum through expert observations and recommendations on DIA's content strategies, essential research questions, key opinion leaders, collaboration partners, and trends affecting the future life sciences landscape.
Michael Rosenblatt, MD, Chief Medical Officer of Flagship Pioneering, has advanced academic and biopharmaceutical research and development throughout his career. He was previously Chief Medical Officer for Merck, after serving as Dean of Tufts Medical School. Formerly, he was Ebert Professor of Molecular Medicine and Minot Professor at Harvard. He served as President of Beth Israel Deaconess Medical Center and as Director of the Harvard-MIT Division of Health Sciences & Technology. He is on the board of several biotech companies, and on the Harvard Medical School Board of Fellows and research advisory committees of the Massachusetts General, Brigham and Women’s, and Children’s Hospitals. He earned his MD from Harvard Medical School.
Fellow of DIA
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health, she also serves on the Clinical Trials Methods Advisory Panel for PCORI. She was named twice to PharmaVOICE’s list of 100 most influential and inspiring individuals in life sciences, and received DIA’s 2019 Global Inspire Award for Author of the Year for “Advancing a framework for regulatory use of real world evidence: When real is reliable.” Her work has been used by global regulators, with recent reference in the new RWE Chinese guidelines for using RWE.
C Sensei Group, LLC
Clark Golestani is an investor, advisor with a focus on the healthcare, life science and TMT sectors. Golestani currently serves as the Managing Director of C Sensei Group, LLC, as a senior advisor to New Mountain Capital, an investment advisor to The CXO Fund, and as a special advisor to the Dean at the University of Texas at Austin, Dell Medical School. He serves as chairman of the board for Sparta Systems, and as an independent director on the board for CIOX Health, eMids, TruU, Inc., UMUC/Ventures, and Zapata Computing. Golestani retired from Merck in 2018 as the President, Emerging Businesses and Global CIO. Prior to Merck, he was a principal with Oracle. He attended the Massachusetts Institute of Technology Sloan School of Management.
Astellas Pharma Inc.
Susanne Gronen leads the Data Science organization in Development for Astellas. Her responsibilities include Biostatistics, Statistical Programming, Data Management and Medical Writing for Clinical Development and Medical Affairs. Over the last few years, Susanne has fully globalized her organization. Under her leadership, the department has built a Central Monitoring & Data Surveillance team in support of the overall risk based monitoring effort. Susanne has spent most of her career in data science functions. Prior to joining Astellas, she worked at a global CRO as a statistician. Susanne holds an MSc in Statistics from the University of Dortmund, Germany.
Yeul Hong Kim
Yeul Hong Kim, MD, PhD, is a Professor in the Department of Internal Medicine at the Korea University College of Medicine in Seoul. He is actively involved in cancer genomic research, using circulating tumor DNA, for lung and gastrointestinal cancers. His primary area of interest is in the development of new therapies in gastric cancer, colon cancer, and other gastrointestinal cancers including pancreatic cancer and biliary cancer. Dr. Kim has also served as President of the Asian Clinical Oncology Society since 2016. He is also Director of the K-MASTER Cancer Precision Medicine Diagnosis and Treatment Enterprise, a cancer precision medicine project funded by the Korea Ministry of Health and Welfare.
Sandra A. Milligan
Fellow of DIA
Merck Research Laboratories
Sandra Milligan is head of Global Regulatory Affairs and Clinical Safety (GRACS) at Merck. GRACS optimizes regulatory plans to facilitate innovative product development, regulatory approval and commercialization around the world, assures the safe use of products worldwide, and maintains registrations for over 200 products across 183 international markets. She served as program chair on DIA’s Board of Directors from 2011 to 2017, and as President of DIA from 2015 to 2016. In 2017, Sandra was recognized as a DIA Fellow for her engagement and contributions to the mission of DIA and was appointed to DIA’s Science Advisory Council in 2018. She is a graduate of George Washington University School of Medicine and Georgetown University Law Center.
Samuel R. Nussbaum
EBG Advisors, Inc.
Samuel R. Nussbaum, MD, serves as an advisor to healthcare companies, healthcare systems, and healthcare provider organizations, as a Strategic Consultant with EBG Advisors, Inc. He is a Senior Fellow at the Schaeffer Center for Health Policy and Economics at the University of Southern California, and previously served as Executive Vice President, Clinical Health Policy, and Chief Medical Officer, for Anthem, and as Executive Vice President for BJC HealthCare. Dr. Nussbaum earned his Medical Degree from the Icahn School of Medicine at Mount Sinai.
Fellow of DIA
Shenyang Pharmaceutical University
Ling Su, PhD, is Professor in Shenyang Pharmaceutical University, and a Venture Partner with Lilly Asia Ventures. Dr. Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency and US FDA, as well as in various R&D management positions in the pharma industry, including VP for Clinical Research Asia Pacific at Wyeth, and SVP and Head of Pharma Development China at Novartis. In addition, he is a Research Fellow at the Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University and an inaugural member of the Biotech Expert Advisory Panel of Hong Kong Stock Exchange. He is the past president and a Fellow of DIA.
Robert M. Califf
Robert Califf, MD is the Donald F. Fortin, MD, Professor of Cardiology. He is also Professor of Medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the Commissioner of FDA in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.
Margaret A. Hamburg
The National Academies of Science, Engineering and Medicine
Dr. Hamburg is an internationally recognized leader in public health and medicine. She is the former Commissioner of the U.S. Food and Drug Administration (FDA), having stepped down from that role in April 2015 after almost six years of service. As FDA Commissioner she was known for advancing regulatory science, streamlining and modernizing FDA’s regulatory pathways, and globalization of the agency. Before joining FDA, Dr. Hamburg was founding vice president and senior scientist at the Nuclear Threat Initiative, a foundation dedicated to reducing nuclear, chemical and biological threats. Dr. Hamburg earned her B.A. from Harvard College, her M.D. from Harvard Medical School and completed her medical residency at Weill Cornell Medical Center.