Ida Sim, MD, PhD is a primary care physician, informatics researcher, and entrepreneur. She is a Professor of Medicine at the University of California, San Francisco, and Co-director of Informatics and Research Innovation at UCSF's Clinical and Translational Sciences Institute. Her research focuses on computational methods for data sharing and decision making to advance clinical care and research. Dr. Sim is co-founder of Open mHealth, a non-profit organization that is building open standards and open source tools for integrating mobile health data, and co-founder of Vivli, a global data sharing platform for participant-level clinical trials data. Dr. Sim is a recipient of the United States Presidential Early Career Award for Scientists and Engineers (PECASE), a Fellow of the American College of Medical Informatics, and a member of the American Society for Clinical Investigation.

Andreas Kogelnik, MD, PhD is Director of the Open Medicine Institute – a community-centered, precision medicine organization. He received his MD from Emory University School of Medicine and his PhD in bioengineering/computer science from the Georgia Institute of Technology. He completed a residency in Internal Medicine and a Fellowship in Infectious Diseases at Stanford University. After 8 years at Stanford as an NIH and HP funded physician-scientist working at the intersection of genomics, microbiology/immunology, and bioinformatics with Dr. Ellen Jo Baron, Dr. Stanley Falkow, and Dr. Atul Butte, he left Stanford to found the Open Medicine Institute (OMI) in 2011. At OMI, he has successfully driven forward a new collaborative model for precision medicine and patient-centric clinical research networks by harnessing information and biotechnology in a clinical multi-omics approach. At OMI –omic technologies and IT tools such as OpenMedNet intersect to bring together physicians and patients, pharma, diagnostic companies, government, and foundations. OMI is at the forefront of applying microbiome, metabolome and other – omic measurements to clinical outcomes.

Henry Kautz is a professor in the Department of Computer Science at the University of Rochester, and is current serving as Division Director for Information & Intelligent Systems (IIS) at the National Science Foundation. He was the founding director of the Goergen Institute for Data Science, has served as President of the Association for Advancement of Artificial Intelligence. In 2019 he received the Allen Newell Award from the Association for Computing Machinery (ACM) for “contributions to artificial intelligence and computational social science, including fundamental results on the complexity of inference, planning and media analytics for public health.”

As the Principal Deputy Commissioner of Food and Drugs, Dr. Amy P. Abernethy, M.D., Ph.D., helps oversee the agency’s day-to-day functioning and directs special and high-priority initiatives that cut across offices overseeing FDA’s regulation of drugs, medical devices, tobacco and food. Dr. Abernethy, a hematologist/oncologist and palliative medicine physician, is an internationally recognized clinical data expert and clinical researcher. Her areas of expertise include cancer data, real world evidence, clinical trials, health services research, patient reported outcomes (PROs), clinical informatics, and patient-centered care. Before coming to FDA, Dr. Abernethy served as chief medical officer, chief scientific officer, and senior vice president for oncology at Flatiron Health (a member of the Roche Group), where she led the research oncology, clinical operations and data science teams, and contributed to the overall strategic vision of the company, including directing their research vision on real world evidence. Dr. Abernethy received her M.D. at Duke University, where she also did her internal medicine residency, served as chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University in Australia, with a focus on evidence-based medicine and clinical informatics, and her bachelor’s degree from the University of Pennsylvania.

Norman E. “Ned” Sharpless, M.D., became Acting Commissioner of Food and Drugs on the afternoon of April 5, 2019. He previously served as the 15th director of the National Cancer Institute (NCI). Prior to his NCI appointment, Dr. Sharpless served as the director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center, a position he held since January 2014. Dr. Sharpless was a Morehead Scholar at UNC–Chapel Hill and received his undergraduate degree in mathematics. He went on to pursue his medical degree from the UNC School of Medicine, graduating with honors and distinction in 1993. He then completed his internal medicine residency at the Massachusetts General Hospital and a hematology/oncology fellowship at Dana-Farber/Partners Cancer Care, both of Harvard Medical School in Boston.After 2 years on the faculty at Harvard Medical School, he joined the faculty of the UNC School of Medicine in the Departments of Medicine and Genetics in 2002. He became the Wellcome Professor of Cancer Research at UNC in 2012

RADM Denise Hinton is FDA’s Chief Scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives, including the Advancing Regulatory Science Initiative, the Critical Path Initiative, health informatics, scientific professional development, scientific integrity, and the Medical Countermeasures Initiative (MCMi). RADM Hinton previously served as Deputy Director of the Office of Medical Policy (OMP) in FDA’s Center for Drug Evaluation and Research (CDER), where she concurrently served as Acting OMP Director from 2014 to 2016. There, she led the development, coordination, and implementation of medical policy programs and strategic initiatives, including the efficient integration of rapidly evolving science and new technologies into the drug development and regulatory review processes. RADM Hinton’s work involved close collaboration with other CDER program areas, FDA product centers, and a broad variety of stakeholders. RADM Hinton joined FDA in 2002 in CDER’s Division of Cardiovascular and Renal Products and, later, served in the center’s former Division of Training and Development. Before coming to FDA, she was an officer in the U.S. Air Force. RADM Hinton earned her Bachelor of Science in Nursing from Florida State University and her Master of Science degree from Boston University.

Dr. Weichold is the director for Critical Path and Regulatory Science Initiatives in the office of the Chief Scientist and the Office of the Commissioner for the US-Food and Drug Administration. The expertise he brings to the regulatory agency builds on his ability to advance, coordinate, and integrate scientific resources for FDA by addressing mission critical scientific regulatory challenges in a global environment. The FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) network has been built under Dr. Weichold’s leadership in collaboration with academic institutions to leverage scientific expertise, resources and capacity toward FDA’s mission. He represents FDA at the Maryland Life Science Advisory Board and at the NIH National Center for Advancing Translational Sciences. He also chaired the FDA Senior Science Council and he was leading strategic partnership development and technology transfer. Health data liberation, value generation and knowledge management in the public health sector are the focus of his current work.

Dr. Weichold’s experience includes execution of strategic and operational initiatives across the sciences’ value chain. Dr. Weichold has led the development of international collaborations and public private partnerships for discovery and early medical product development, implemented global operating and development models, and executed large-scale business model transformations. He has accumulated more than a decade of industrial research and medical product development experience while leading teams in Clinical Pharmacology, DMPK, as a Director at MedImmune LLC, and AstraZeneca. Prior, he directed research and clinical development of vaccines at the Aeras Foundation (founded by The Bill and Melinda Gates Foundation).