Robert M. Califf, MD, MACC, is vice chancellor for health data science and director of Duke Forge, the Center for Actionable Health Data Science at Duke Health, Donald F. Fortin, MD Professor of Cardiology in the Duke University School of Medicine, Chair of the Board of the People Centered Research Foundation, and an advisor for Verily Life Sciences, a member of the Alphabet family of companies formed by Google. He served in the administration of President Barack Obama as Deputy Commissioner for Medical Products and Tobacco in the U.S. Food and Drug Administration (FDA) from 2015-2016, and as Commissioner of Food and Drugs from 2016-2017. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He was founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with 1,250 publications in the peer-reviewed literature. Dr. Califf is a member of the National Academy of Medicine (formerly the Institute of Medicine [IOM]). Dr. Califf has served on numerous IOM committees, and was a member of the FDA Cardiorenal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences, and the Council of the National Institute on Aging. Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.

Jane Liang White is currently a senior director at Pfizer managing a group of statisticians in Oncology Hematology Franchise. Jane joined Pfizer Oncology in 2004 and has worked on numerous projects across Phase 1-4 with extensive submission experience in both solid tumors and hematology. Prior to Pfizer, Jane worked at Bristol-Myers Squibb Oncology and Fidelity Investments. Jane received her B.S. in Applied Mathematics from Beijing Institute of Technology in 1990 and Doctor of Science (ScD) in Biostatistics from Harvard University in 1996.

Rebecca Miksad is a medical oncologist and health outcomes researcher who serves as senior medical director at Flatiron Health. In this role, Rebecca focuses on generating real-world evidence, establishing regulatory-grade quality standards and contributing to the development of clinically-relevant methods to real-world data evaluation and analyses. Rebecca maintains a clinical practice at Boston Medical Center. A nationally recognized clinician and researcher, Rebecca regularly publishes in leading medical journals, serves on national committees and lectures internationally. Prior to joining Flatiron Health, Rebecca was an assistant professor at Harvard Medical School, senior scientist at the Institute for Technology Assessment at Massachusetts General Hospital, and director of gastrointestinal oncology and gastrointestinal oncology clinical trials at Beth Israel Deaconess Medical Center (BIDMC). Rebecca’s academic research focused on improving cancer treatment decision-making through better characterization of patient outcomes and increasing relevance of clinical trial endpoints. Rebecca earned a BA cum laude in economics from Harvard University and an MD with honors in research from Cornell University. She was a resident in internal medicine at Cornell University/New York-Presbyterian Hospital, and completed hematology and medical oncology fellowships at Harvard Medical School/BIDMC. Rebecca earned a MMS from Harvard Medical School and an MPH in Clinical Effectiveness from the Harvard School of Public Health in clinical effectiveness (with an emphasis on decision science). She also completed a post-doctoral fellowship in the Dana-Farber/Harvard Cancer Center Program in Cancer Outcomes Research Training (PCORT).

Dr. Miganush Stepanians is the President and CEO of PROMETRIKA, which she founded in 2003. Dr. Stepanians has more than 30 years of experience in drug development, with a specific focus on biostatistics and data management. In addition to overall responsibility for the company’s scientific and operational activities, Dr. Stepanians is a practicing biostatistician, directly involved in study design and analysis, strategic product development planning, and commercialization support. Dr. Stepanians has designed the analyses for the Integrated Summaries of Efficacy and Safety for more than 15 successful marketing applications (NDAs; MAAs) and has presented on behalf of sponsors in meetings with FDA. She has particular expertise in challenging study design and analysis problems, including adaptive design trials, and has participated as a voting or non-voting member of a number of Independent Data Monitoring Committees. Prior to founding PROMETRIKA, Dr. Stepanians served as Director of Biostatistics and Data Management at Muro Pharmaceutical/Viatris, Inc., which she joined in 1993. In this capacity, Dr. Stepanians headed a department of 20 biostatisticians, programmers and data managers. As a member of several global project teams at Muro, Dr. Stepanians was a key contributor to the design of drug development programs and had primary oversight of statistical and data management activities. She had statistical oversight for the development and submission of three successful NDAs and interacted extensively with the FDA. Prior to joining Muro, Dr. Stepanians worked in the biostatistical arena for seven years, first at the New England Medical Center and then at Boston University’s Statistics and Consulting Unit, providing statistical services for a number of pharmaceutical companies in a wide range of indications. She has authored a number of journal articles.