Barbara Bierer, MD
Barbara Bierer is the program director of the Regulatory Foundations, Law and Ethics Program of the Harvard Catalyst, the Harvard Clinical and Translational Science Award. Dr. Bierer co-founded and now leads – as faculty director – the Multi-Regional Clinical Trials (MRCT) Center at Brigham and Women’s Hospital and Harvard, a University-wide and collaborative effort to improve standards for the ethics, conduct, and regulatory environment of international clinical trials. From 2003 to 2014, she served as Senior Vice President, Research, at Brigham and Women’s Hospital (BWH) and was the institutional official for human subjects and animal research, for biosafety, and for research integrity at BWH. She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the Co-Chair of the Partners HealthCare Committee on Conflict of Interest. Dr. Bierer established and directed the Center for Faculty Development and Diversity at the BWH; for these efforts, she was the first recipient of the HMS Harold Amos Faculty Diversity Award in 2008.
Barbara’s affiliation with Tullis began when she served with Jim Tullis on the board of directors of ViaCell, a former Tullis portfolio company. Barbara joined the Tullis advisory board in 2004 and later became a venture partner. With her wealth of clinical, research, and scientific knowledge, Barbara participates in deal sourcing, deal review, due diligence, and investment management.
A hematologist-oncologist, Barbara is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). She co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center), a collaborative effort to improve standards for the ethics, conduct, and regulatory environment of international clinical trials. In this capacity, she works with regulators around the world, major pharmaceutical companies, biotech, clinical research organizations, academia and patients/patient advocates to harmonize policies for and approaches to clinical trial regulation and conduct. In 2017, the MRCT Center launched the non-profit organization Vivli, a global clinical research data sharing platform. In addition, she is the Director of the Regulatory Foundations, Ethics, and the Law program at the Harvard Catalyst, the Harvard Clinical and Translational Science Award, working across the academic spectrum to enable the clinical trial enterprise from study planning through recruitment to data acquisition and dissemination. Barbara is the Director of Regulatory Policy for SMART IRB, a national effort to align single-site IRB review of multi-site trials. From 2003 – 2014, she served as Senior Vice President, Research at the Brigham and Women’s Hospital, during which time she founded and served as Executive Sponsor of the Brigham Research Institute and the Brigham Innovation Hub (iHub), a focus for entrepreneurship and innovation in healthcare. She has authored over 240 publications.
In addition to her academic responsibilities, Barbara served as Chair of the Secretary’s Advisory Committee for Human Research Protections, HHS and as a member of the National Academies of Sciences Committee on Science, Technology and the Law. She currently serves on the Board of Directors of Management Sciences for Health (MSH), Clinithink, North Star Review Board, and Vivli; and chairs the Board of Trustees of the Edward P. Evans Foundation.
Barbara received a BS from Yale University and an MD from Harvard Medical School.
Where It Counts
Speaking Engagements Over 25 Years
Countries Visited in a Professional Capacity
Original Articles Authored