Webinar

Barbara E. Bierer, MD

Barbara Bierer, a hematologist-oncologist, is professor of Medicine at Harvard Medical School (HMS) and the Brigham and Women’s Hospital (BWH). Dr. Bierer 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 planning and conduct of international clinical trials. In this capacity, she works with regulators around the world, pharmaceutical companies, CROs, academia and patients/patient advocates to harmonize policies for and approaches to clinical trial regulation. In 2017, the MRCT Center launched the non-profit Vivli, a global clinical research data sharing platform. She is also the director of the Regulatory Foundations, Ethics, and Law program at the Harvard Catalyst, and director of Regulatory Policy for SMART IRB. She serves as faculty in the Center for Bioethics, HMS, and Affiliate Faculty in the Petrie-Flom Center for Health Law at Harvard Law School. From 2003 – 2014, Dr. Bierer served as senior Vice-President, Research, BWH. During her tenure, Dr. Bierer 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 is a past chair of SACHRP and has served or serves on the Board of Directors of AAHRPP, PRIMR, MSH, Vivli, and the Edward P. Evans Foundation. She has authored over 220 publications.

David H. Strauss, MD

David Strauss’ primary area of expertise has been the ethics and regulation of research involving vulnerable populations. During his tenure at the NYS Psychiatric Institute (NYSPI) and Columbia Department of Psychiatry (CU Psychiatry), as director of the Schizophrenia Research Unit, clinical director, director of the Office of Human Research Protections, chair of the IRB, and vice-chair for Research, his prime interest was in translating regulatory standards into practical applications to promote the interests of both science and research subjects. As a member of the HHS Secretary’s Advisory Committee on Human Research Protections or its subcommittees, and as chair of its subcommittee on the Inclusion of Individuals with impaired decision-making, he led the development of a series recommendations guiding regarding research with such populations which is often sited and applied at institutions across the U.S. As an active member of Public Responsibility in Medicine and Research (PRIM&R), former officer of its Board of Directors, and chair of its Public Policy Committee, he was routinely called upon to address contemporary matters in research ethics and research protections. He has served an ethics advisory function on a number of NIH funded awards, co-directed the Ethics Core of the HIV Center for Clinical and Behavioral Studies at NYSPI for which he also taught an ethics seminar for the T32 HIV Research Fellows. As senior advisor to the Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard, and Co-Chair of its diversity in clinical trials initiative, he is working on methodological and analytic solutions to effectively promote diversity and inclusion in clinical research. He lectures widely on research with psychiatric and substance using populations.

Sarah White, MPH

Sarah White joined the MRCT Center as the executive director in January of 2018 and is responsible for developing, defining, and implementing the overall strategy and vision for the Center as well as oversee all management aspects of the MRCT Center functions. Sarah has almost 20 years of experience in human subjects’ research including experience at both academic medical centers and industry.

Prior to joining the MRCT Center, Sarah was the director of the Human Research Quality Improvement Program (QI Program) at Partners’ Healthcare in Boston, Massachusetts. In this capacity, she was responsible for strategic planning and oversight of the QI Program activities across the human research communities at Partners Healthcare, including Massachusetts General Hospital and Brigham and Women’s Hospital. In addition, Sarah oversaw FDA Sponsor-Investigator support and the centralized support of clinical trials registration and disclosure. Sarah is the co-chair of the national Clinical Trials Registration Taskforce, a large consortium of academic medical centers, hospitals and universities that identify best practices, develop tools, and serve as a communication forum associated with the requirements for clinical trials registration and results reporting that affect US academic health centers. Sarah also co-chaired of the Harvard Catalyst Quality Assurance/Quality Improvement Subcommittee from 2010 to 2018.  Sarah received her undergraduate degree from Dartmouth College and her MPH from Boston University School of Public Health.