Planning Committee

Mark Barnes

Mark Barnes, JD, LLM, is a Partner at Ropes & Gray, LLP. He has extensive experience in legal issues related to research with humans and animals, stem cell and genetic research, research grants and contracts, research misconduct, international research, and data privacy. In 2012 with Dr. Barbara Bierer, Mark started, and continues to serve as faculty co-chair of, the Multi-Regional Clinical Trials Center of Harvard University and Brigham and Women’s Hospital, a project designed to improve the planning, conduct, and regulation of multi-national clinical trials, with a special emphasis on trials in the emerging economies. He is currently a Working Group member on a project funded by the National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) of the National Institutes of Health, LawSeqSM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605). 

Ellen Wright Clayton

Ellen Wright Clayton, MD, JD, is Craig-Weaver Professor of Pediatrics, Professor of Law, and Co-founder of the Center for Biomedical Ethics and Society, Vanderbilt University. She is the 2010 recipient of the William G. Bartholome Award for Ethical Excellence from the American Academy of Pediatrics’ Section on Bioethics. Prof. Clayton is an elected member of the National Academy of Medicine (NAM), where she serves on the National Advisory Council, and a Fellow of the American Association for the Advancement of Science (AAAS). She has advised the National Institutes of Health and other federal and international bodies on topics ranging from children's and women's health to the ethical conduct of human subjects research. She is currently a Principal Investigator on a project funded by the National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) of the National Institutes of Health, LawSeqSM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605). 

Gail Javitt

Gail Javitt, JD, MPH, is a member of the Firm of Hyman, Phelps & McNamara, PC. Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, human cellular, and tissue-based products (HCT/Ps), and dietary supplement companies through the product life cycle and has successfully resolved disputes at both the pre-and post-market stage. She has significant experience advising clinical laboratories on FDA and CLIA requirements for laboratory developed tests. She is currently a Working Group member on a project funded by the National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) of the National Institutes of Health, LawSeqSM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605). 

Frances Lawrenz

Frances LawrenzPhD, is Associate Vice President for Research and Wallace Professor of Teaching and Learning at the University of Minnesota. Her research focuses on science and mathematics program evaluation, utilizing a variety of techniques and usually involving mixed methodologies. She has been recognized by the American Educational Research Association, having been awarded the 2016 Research on Evaluation SIG Distinguished Scholar Award for outstanding contributions to advance research in the field of evaluation, and by the National Association for Research in Science Teaching, with the Distinguished Contributions to Science Education through Research Award for outstanding contributions to science education. She is currently a Principal Investigator on a project funded by the National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) of the National Institutes of Health, LawSeqSM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605).

David Peloquin

David Peloquin, JD, is an Associate at Ropes & Gray, LLP. He focuses his practice on advising academic medical centers, life sciences companies, and information technology companies on issues related to human subjects and animal research, data privacy, and Medicare/Medicaid and other third-party payor reimbursement issues. He frequently writes and speaks on topics related to each of these areas. In addition to his advisory practice, David regularly works with members of the firm’s private equity group in conducting regulatory diligence of private equity investments in the clinical research space. He also collaborates with members of the firm’s litigation practice on government investigations involving the clinical research enterprise.

Susan Wolf

Susan M. Wolf, JD, is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine at the University of Minnesota. Prof. Wolf is Chair of the University’s Consortium on Law and Values in Health, Environment & the Life Sciences. She is an elected member of the National Academy of Medicine (NAM), a Fellow of the American Association for the Advancement of Science (AAAS), a Fellow of The Hastings Center, and a member of the American Law Institute (ALI). Prof. Wolf's research has been supported by the National Institutes of Health (NIH) and National Science Foundation (NSF) as well as private foundations including the Robert Wood Johnson Foundation and The Greenwall Foundation. She is currently a Principal Investigator on a project funded by the National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) of the National Institutes of Health, LawSeqSM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605).