Dr. Barbara Bierer is the faculty co-chair of the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital (MRCT Center), a Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston and a hematologist/oncologist. She is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard clinical and translational sciences center. Previously she served as senior vice president, research at the Brigham and Women’s Hospital for 11 years, and was the institutional official for human subjects and animal research, for biosafety and for research integrity. She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation.
In addition, she was the Founding Director of the Center for Faculty Development and Diversity at the BWH. In addition to her academic responsibilities, she serves on the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R), dedicated to promoting the ethical conduct of biomedical and behavioral research; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P Evans Foundation, a foundation supporting biomedical research. Previously she has served as the chair of the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP) and as chair of the Secretary’s Advisory Committee on Human Research Protections, HHS. She has authored or co-authored over 180 publications and is on the editorial boards of a number of journals including Current Protocols of Immunology.
Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School.
Bill O’Neil is a Principal Software Engineer at Vivli.
Prior to joining Vivli, Bill worked at Parexel International where he led teams developing and implementing applications for supporting clinical trials, including the management of documents for same. Prior to Parexel Bill was with various commercial ERP software companies developing critical applications for business, including material management for manufacturers, order management, and SharePoint administration.
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.
Ida Sim, MD, PhD is Professor of Medicine at the University of California, San Francisco. She is UCSF’s inaugural Chief Research Informatics Officer and she co-directs the UCSF UC Berkeley Joint Program in Computational Precision Health. 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 the JupyterHealth project, an open software platform for secure personal health data ingestion and analytics. 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.
Before joining Vivli, Swapna was the Staff QA automation Engineer at Ripple Science, where she led the automation of Quality proofing the developed/enhanced code resulting in saving of hours of testing. Before Ripple science, Swapna was with NDS (now Cisco) and Tata Elxsi systems in the area of software development.
Swapna holds a Masters degree in computer science from Bellevue University Nebraska.
Alex joined the Vivli team in 2024 as an Executive Assistant where she provides support to our team.
Prior to joining Vivli, Alex worked with a boutique immigration law firm as a Law Clerk, supporting the partners and preparing substantive legal documents. Alex holds a Bachelor of Science degree in Legal Studies.
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.
Amanda Skarlupka is a Senior Program Manager for Vivli. She brings over 12 years of experience in pre-clinical and translational research, data management, and program management including providing strategic input and grants management for the National Institutes of Health. Amanda earned her Ph.D. in Infectious Diseases and her M.S. In Biostatistics and Epidemiology from the University of Georgia.
Prior to this role, Amanda was a Health Scientist Administrator and Presidential Management Fellow at the National Cancer Institute within the Division of Cancer Prevention. She oversaw the division’s initiation, development, and close-out of programs designed to build trans-disciplinary bridges between data scientists, oncologists, and federal agencies.
Sarah is a Senior Clinical Research Manager at Vivli. She received a Bachelor of Science in Biomedical Science (BS) from Salem State University in 2015 and a Master of Science in Biotechnology, Bioinformatics (MS) from University of Maryland in 2022.
Prior to this role, Sarah has worked in a Molecular Biology laboratory as an Associate Scientist at Azenta Life Sciences. Most recently, she worked at a precision oncology company, Guardant Health, which specializes in liquid biopsy. Here, she served as a supervisor where she led Biospecimen management operation teams in the San Diego and Redwood City laboratories and gained experience in clinical trial sample management and clinical trial project coordination.
Mark Barnes, J.D., law practice and his teaching at Yale focus on health care law and finance, human and animal research, stem cell and genetic research, research grants and contracts, research misconduct, and international research. Mr. Barnes formerly served at Harvard as the Senior Associate Provost and University Senior Research Officer and started and directed Harvard’s HIV/AIDS treatment programs in Nigeria, Tanzania and Botswana. He serves on the Ethics Working Group of the NIH’s HIV Prevention Trials Network (HPTN) and is the ethics advisor to HPTN Trial 071 in South Africa and Zambia. Mr. Barnes has held senior appointed positions in the New York City and State departments of health.
