Subha is a dynamic and results-driven leader with a strong track record of excellence in organizations that operate at the nexus of science, technology and business. She has initiated and successfully directed several productive clinical research and development programs at the Georgetown Lombardi Comprehensive Cancer Center, MedStar hospital network, FDA, NIH and BioPharma industry. She was co-leader of the FDA’s Center for Excellence in Regulatory Science and worked with the Oncology and Vaccine teams. She was an advisory member to the Biden Foundation’s Cancer Moonshot Program and advised on pre-competitive data sharing initiatives across Pharma, Health Tech companies and research organizations to drive innovation. She has been recognized for her work through several awards including the Service to America award in the Science and Environment category (2005), Research Acceleration Award by AACR and Pancreatic Cancer Action Network (2015), and Women in Tech Global award (2021). She is currently the Head of Clinical AI/ML & Digital Sciences at Pfizer worldwide R&D where she leads a team focused on advancing precision therapies across multiple treatment areas including Anti-Infectives, Oncology, Immunology & Inflammation among others.
Steven E. Kern, PhD, is Executive Director of Global Health Labs (www.ghlabs.org) whose mission is to develop innovative technologies to address unmet healthcare needs, especially in low and middle income countries. Global Health Labs helps to advance the strategic priorities of the Bill & Melinda Gates Foundation with technology innovations focused on diagnostics, reproductive, maternal and child health, and tools and equipment for primary care. It is created and funded by Gates Ventures, the private office of Bill Gates.
Previously he served as for nearly 10 years as Deputy Director of Quantitative Sciences at the Bill and Melinda Gates Foundation. The Quantitative Sciences group is focused on data analysis to support program strategies for therapeutic projects that the foundation funds. This effort extends across all therapeutic areas in which the foundation is involved including maternal & child health, family planning, malaria, tuberculosis, neglected tropical diseases, HIV, and pandemic preparedness. He and his team are strong advocates of making research data “always FAIR and sometimes OPEN” to improve the impact data can have towards the problem it was collected to address, and beyond.
Prior to this, he was Global Head of Pharmacology Modeling at Novartis Pharma AG based in Basel Switzerland where he led a team focused on providing model-based drug development support to therapeutics across all stages of drug development. He joined Novartis in 2010 from the University of Utah in Salt Lake City, Utah where he was Associate Professor of Pharmaceutics, Anesthesiology, and Bioengineering, and served as co-investigator for their NIH funded Pediatric Pharmacology Research Unit. He has designed, conducted, and served as a principal investigator for clinical pharmacology studies that spanned the population from preterm infants to elderly adults.
Brian McCourt currently serves as Senior Director, Data and Knowledge Management at Duke Clinical Research Institute. He began his career as a study coordinator at Massachusetts General Hospital and has since held a variety of senior leadership roles spanning Clinical Data Management, Research Informatics and Technology areas at DCRI. His personal interests include the informatics methods and tools needed to operationalize complex industry and government research programs.
With over 25 years at Duke, he has been at the forefront of many strategic efforts to develop the infrastructure and capabilities needed to run demonstration projects and then scale-up capabilities for broader adoption of new best practices. Brian was central to launching DCRI’s Supporting Open Access for Researchers (SOAR) initiative – the set of data preparation, hosting, approval and provisioning practices for sharing of research datasets. Today, in addition to overseeing data operations for many research programs, he is helping drive the development and transition to a new cloud platform for research tools that includes data integration, hosting and visualization services.
Vivli announced that its Board of Directors has promoted Rebecca Li to the position of CEO. Li previously held the position of Executive Director and has been with the Vivli since its founding when it launched as a project from the MRCT Center of the Brigham and Women’s Hospital and Harvard.
“Rebecca has overseen the extraordinary growth of Vivli from the start and we are excited that she will continue to lead Vivli through the next phase of growth as we aim to go even further in our mission to make clinical trial available for research. She has demonstrated herself to be an exceptional team leader and strategic thinker with a clear vision for how we will develop globally in the coming years,” said Dr. Michael Stebbins, Vivli’s Board Chair.
“I am privileged to lead Vivli and envision further expanding our successful platform technology into Europe and Asia as we enter our next phase of innovation and growth” said Dr. Rebecca Li.
Vivli was founded in 2018 as a non-profit organization that is currently the largest individual participant-level (IPD) data sharing platform focused on sharing clinical trial data serving the international research community.
Rebecca Li will be speaking at the NIA-DUKE-Alzheimer’s Association Workshop held on March 15-16th sponsored by the National Institute on Aging.
The focus of the talk by Rebecca Li and Katherine Welsh-Bohmer (Duke University School of Medicine) is on how the Vivli platform can be used to access trials in Alzheimer’s Disease. Dr. Welsh-Bohmer will discuss the TOMMORROW trial – a large prevention study in Alzheimer’s Disease – as a specific use case.
Ida Sim, MD, PhD is Professor of Medicine at the University of California, San Francisco and co-directs Biomedical Informatics at UCSF’s Clinical and Translational Sciences Institute. Dr. Sim earned her MD and her PhD in Medical Informatics from Stanford University, where her dissertation was on computational methods for data sharing of clinical trial results. She was trained in Primary Care Internal Medicine at the Massachusetts General Hospital, and completed fellowships in General Medicine and Medical Informatics at Stanford.
In 2005-6, Dr. Sim led the World Health Organization’s International Clinical Trials Registry Platform which established the first global policy on clinical trial registration and defined the common 20-item Trial Registration Data Set. She has led multiple NIH and other grants on “trial bank publishing,” ontology-based data sharing of human studies, and clinical trial visualization. Dr. Sim was a member of the 2015 Institute of Medicine committee on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.” She joined the MRCT Clinical Trials Data Sharing project in 2015 and is a co-founder of Vivli.
In other work, Dr. Sim is a national leader in mobile health and co-founder of Open mHealth, a non-profit organization building open APIs and tools for integrating mobile health data. She has served on multiple national advisory committees on health information infrastructure for clinical care and research. She 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. She is a practicing clinician.
Rebecca Li, PhD, is the CEO of Vivli and on faculty at the Center for Bioethics at the Harvard Medical School. Previous to her current role she was the Executive Director of the MRCT Center of Brigham and Women’s Hospital and Harvard for over 5 years and remains a Senior Advisor at the Center. She has over 25 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. She completed a Fellowship in 2013 in the Division of Medical Ethics at Harvard Medical School. She earned her PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.
Michael Stebbins is the President of Science Advisors, a science and health consulting firm he founded in 2018 to provide science, technology, and public policy guidance to private companies, philanthropies, and non-profit organizations. He previously served as the Vice President of Science and Technology for the Laura and John Arnold Foundation where he was responsible for identifying and pursuing opportunities for philanthropic investment in Science and Technology. While at the Arnold Foundation he led initiatives that opened public access to data and publications created in the course of federally funded scientific research, and championed efforts in scientific reproducibility. His work at the Foundation addressed a broad set of critical issues including FDA policy on transparency, improving organ donation rates, leveraging the intellectual property sitting on shelves of universities and Federal agencies as well as opening access to scientific research publications and data.
Dr. Stebbins served as the Assistant Director for Biotechnology in the Obama White House Office of Science and Technology Policy. At the White House, he developed eight Executive Orders and other directives addressing issues ranging from the antibiotic resistance crisis to restoring pollinator health. His work led to broad changes in practice across the Federal government regarding the purchasing of bio-based products, improving veterans’ mental health, increasing access to federally funded scientific research publications and data, improving scientific reproducibility, evaluating and addressing the preferential purchasing of antibiotic free meats, reforming the regulatory system for biotechnology products, and improving the management of scientific collections.
Dr. Stebbins previously served as a science advisor to the Obama Presidential Campaign and on the Obama White House Transition Team. He is the former director of biology policy for the Federation of American Scientists (FAS) where he led their biosecurity project. His work at FAS led to changes in how agents are trained to interact with scientists at the FBI Training Academy at Quantico. His team developed the first tools to train scientists on dual-use research of concern. He co-founded, and served on the board of directors for, Scientists and Engineers for America, and served as President of Scientists and Engineers for America Action Fund. In addition, Dr. Stebbins worked as a legislative fellow for U.S. Senator Harry Reid and a public policy fellow for the National Human Genome Research Institute. He is a former adjunct professor of bioethics at the University of Pennsylvania. Before coming to Washington, he was a senior editor at Nature Genetics.
Dr. Stebbins serves on the National Academies of Science Board of Research Data and Infrastructure. He received his B.S. in biology at SUNY Stony Brook and his Ph.D. in genetics while working at Cold Spring Harbor Laboratory.
Murray Stewart, M.D., is Chief Medical Officer at Rhythm Pharmaceuticals, Inc. Previously, he was Executive Vice President, Head of R&D, at Novelion Therapeutics Inc. From April 2014-September 2017, he was the Chief Medical Officer at GlaxoSmithKline. Dr. Stewart joined GSK in 2000 as Associate Director for Clinical Research & Development in the UK and since then has held a variety of positions in GSK he worked in Biopharm, was Therapy Area Head for the Cardiovascular and Metabolic therapy area. He has had extensive clinical development experience and worldwide regulatory interactions. Before joining the pharmaceutical industry, Dr. Stewart worked as a diabetes consultant and senior lecturer and was Consultant Physician/Honorary Senior Lecturer and Head of Clinical Services at the Diabetes Centre, Newcastle upon Tyne in the UK. His research was in lipid metabolism in type-2 diabetes, and he completed his medical training at Southampton Medical School in the UK and is a Fellow of the Royal College of Physicians.
Justin McCarthy has over 27 years of experience in the pharmaceutical industry, with expertise in pricing, market access, global health policy, legal and compliance. In his most recent role, he led the Patient & Health Impact (PHI) team at Pfizer, one of the world’s premier innovative biopharmaceutical companies whose global portfolio includes medicines and vaccines. He led a team of experts in health economics and outcomes research, real-world data and analytics, patient-centered outcomes assessment, market access, pricing, strategy and contracting, to generate evidence of the value of Pfizer medicines and vaccines and negotiate with governments and payers around the world to ensure access for patients. He also formed a team to explore novel approaches to bring medicines to the market through innovative partnerships and payment models.
Previously, Justin led Pfizer’s Global Policy & International Public Affairs efforts, responsible for defining Pfizer’s public policy positions and advancing government and public affairs strategies internationally. Additionally, Justin was Chief Counsel for Pfizer’s Worldwide Research and Development division, advising on regulatory, licensing and clinical trial issues, and overseeing global intellectual property activities.
Justin serves as a health policy and market access advisor, and has previously served on the Secretary’s Advisory Committee for Human Subject Protection, Subcommittee on Harmonization