LawSeq℠ : Facing the Legal Barriers to Genomic Research & Precision Medicine

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 a member of the LawSeq^SM Working Group. 

 

Barbara E. Bierer, MD, is the faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital (BWH) and Harvard (MRCT Center), a Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and a hematologist/oncologist. She is the Director of the Regulatory Foundations, Law and Ethics Program of the Harvard Clinical and Translational Science Center. From 2003-2014, she served as Senior Vice President of Research at the BWH and was the institutional official for human subjects and animal research, for biosafety, and for research integrity. 

 

 

Wendy K. Chung, MD, PhD is an ABMG board-certified clinical and molecular geneticist at Columbia University with 20 years of experience in human genetic research of monogenic and complex traits. She has extensive experience in mapping and cloning genes in humans, describing the clinical characteristics and natural history of novel genetic conditions and characterizing the spectrum of disease, and developing tailored care and treatments for rare genetic diseases. Dr. Chung directs NIH-funded research programs in the human genetics of birth defects including congenital diaphragmatic hernia, congenital heart disease, and esophageal atresia, autism, neurodevelopmental disorders, pulmonary hypertension, cardiomyopathy, obesity, diabetes, and breast cancer. She leads the Precision Medicine Resource in the Irving Institute at Columbia University.

 

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 at Vanderbilt University. She is the 2010 recipient of the Williams 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 a Principal Investigator on the LawSeq^SM grant project.

 

Barbara Evans, JD, PhD, LLM, is Professor of Law and Stephen C. O’Connell Chair at the University of Florida Levin College of Law and Professor of Engineering at the University of Florida Wertheim College of Engineering. Her current research interests include FDA regulation of machine-learning clinical and patient decision support software and gene sequencing and editing technologies, health data privacy and access, genomic civil rights, and citizen science and citizen-led bioethics standard-setting. She is a member of the LawSeq^SM Working Group. 

 

 

Alberto Gutierrez, PhD, is Partner & Expert Consultant at NDA Partners LLC dealing with preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices, premarket notifications of devices, applications for approval, and post-marketing surveillance and compliance. Dr. Gutierrez oversaw the Personalized Medicine Staff at the Food and Drug Administration and developed and managed the policies surrounding companion diagnostic devices. Dr. Gutierrez was also a member of the Center for Devices and Radiological Health committee that oversaw policies on Digital Health.

 

 

Michael Hamilton, JD, has worked on healthcare privacy matters for more than 8 years. At Invitae, a genetic testing company, Michael works on a range of privacy and regulatory issues related to the use of genetic and health data. Prior to Invitae, Michael held senior healthcare privacy roles at McKesson Corporation and Salesforce. Michael has extensive experience working with business to identify ways that healthcare and genetic data can be used in compliance with privacy laws to further scientific understanding and advancement. 

 

 

Gail P. Jarvik, MD, PhD, is the Arno G. Motulsky Chair of Medical Genetics, Professor of Medicine and Genome Sciences, and Head, Division of Medical Genetics, University of Washington Medical Center. She is also an Adjunct Professor of Epidemiology at the UW Medical Center (UWMC) and an Affiliate Member of the Fred Hutchinson Cancer Research Center. She is a Pew Scholar in the Biomedical Sciences, and has been made a Lifetime National Associate of the National Academies. Her abilities as a scholar and a leader have been recognized by the National Institutes of Health, for which she chaired the Genomics, Computational Biology and Technology Study Section. In addition to that service, leading the Division of Medical Genetics and actively pursuing her own research, she continues to be a practicing clinician in Internal Medicine and Medical Genetics.

 

Gail H. Javitt, JD, MPH, is a Director of the Firm of Hyman, Phelps & McNamara, PC. She provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage. She also has significant experience advising clinical laboratories on FDA and CLIA requirements for laboratory developed tests. She is a member of the LawSeq^SM Working Group.

 

 

Frances Lawrenz, PhD 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 and the National Association for Research in Science Teaching. She is a Principal Investigator on the LawSeq^SMproject.

 

 

 

Bradley Malin, PhD, is Professor of Biomedical Informatics & Vice Chair for Research, Professor of Biostatistics, Professor of Computer Science, and Affiliated Faculty of the Center for Biomedical Ethics & Society at Vanderbilt University Medical Center. He co-directs the Health Data Science Center and the Center for Genetic Privacy and Identity in Community Settings (GetPreCiSe). He chairs the Committee on Access, Privacy, and Security for the of the All of Us Research Program of the U.S. Precision Medicine Initiative and is an appointed member of the Technical Anonymisation Group of the European Medicines Agency. He is an elected member of the National Academy of Medicine and the American College of Medical Informatics. He is member of the LawSeq^SM Working Group.

 

Priya M. Mannan, JD, LLM, is Associate General Counsel at Novartis Institutes of BioMedical Research where her work focuses on corporate governance; clinical, research and licensing contracts; and compliance and regulatory matters. She was a biochemist before becoming a lawyer with experience in heathcare and intellectual property law. She previously worked at Pfizer and Baxter’s.

 

 

 

Elizabeth Mansfield, PhD, is Vice President, Regulatory at Foundation Medicine, Inc. She was the Director of the Personalized Medicine Staff in the Office of In Vitro Diagnostic Devices in the Center for Devices, Federal Drug Administration, from 2006-2017, where she developed a program to address companion and novel diagnostic devices. She was previously a Senior Policy Analyst in the Office of In Vitro Diagnostic Devices (OIVD), managing policy and scientific issues. Dr. Mansfield formerly served as the Director of Regulatory Affairs at Affymetrix, Inc. from 2004-2006. She previously served in other positions, including Scientific Reviewer and Genetics Expert, while at the FDA. Dr. Mansfield received her PhD from Johns Hopkins University, and completed further postdoctoral training at the National Cancer Institute (NCI) and the National Institute for Arthritis, Musculoskeletal, and Skin Diseases (NIAMS).

 

Michelle Penny, PhD is a geneticist with 18 years’ experience developing and implementing integrated genetic and genomic biomarker strategies to advance programs in pharmaceutical research and development. Prior to joining Goldfinch Bio to lead their genomics efforts in January of 2020, she held roles at Biogen, Eli Lilly, and Pfizer, where she has worked on drug development teams across multiple disease areas across all phases of clinical development. She has built and led cross-functional teams with a track record in delivering genomic data to test specific hypotheses to support drug registration as well as exploratory data for hypothesis generation. A passionate advocate for patient-focused and genetically guided drug development, she is co-chair of the National Academy of Sciences Roundtable on Genomics and Precision Health and a past co-chair of the Industry Pharmacogenomics Working Group. Michelle received her PhD from the University of Birmingham (UK).

Erik Phelps, JD, is Executive Vice President and General Counsel at Tempus. He is responsible for a broad range of legal areas including general corporate matters and strategy. He previously served as General Counsel at Epic, a software company that provides electronic health records for medical groups, hospitals, and healthcare organizations. He has also served as a partner at Michael Best & Friedrich LLP in Madison, WI, where he focused on software licensing and technology-related work, including work with early-stage companies.

 

 

Rachel Rice Ackman, JD, is Director of Research Integrity and Compliance at NYU Langone Health. She was formerly Research Compliance Officer in the Office of General Counsel at Dana-Farber Cancer Institute (DFCI), where she was responsible for creating and implementing DFCI’s first formal Research Compliance program, including oversight of animal and human subjects research, research administration and finance, contract negotiation, conflicts of interest, interactions with industry, lab safety, export controls, data use and security, controlled substances, and federally-funded invention reporting. Additionally, she previously worked at Massachusetts General Hospital and Partners Healthcare (MGH) in research compliance.  

 

Alexandra E. Shields, PhD, is Associate Professor of Medicine at Harvard Medical School (HMS) and Senior Scientist at Massachusetts General Hospital (MGH); Director of the Harvard/MGH Center on Genomics, Vulnerable Populations, and Health Disparities; Associate Member of the Broad Institute of MIT and Harvard; and Director of the Consortium on Psychosocial Stress, Spirituality, and Health. She is also a Presidential Scholar at the Dana Farber Cancer Institute. Her work focuses on the intersection of genomics research and genomic medicine with the interests of minority and low-income communities. Dr. Shields has expertise in qualitative research (interviews, case studies), survey research, health services research, and policy development and dissemination.

 

Jason L. Vassy, MD, MPH, SM, is an Assistant Professor of Medicine at Harvard Medical School, a practicing primary care physician at the VA Boston Healthcare System, and Director of the Genomes2Veterans research program. His research examines the clinical integration of genomics into routine medicine. Current project include a randomized trial of polygenic risk scoring for common diseases in primary care, two clinical trials of pharmacogenetic testing, and a pilot project returning unanticipated genetic results to participants in the Million Veteran Program.

 

 

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) and a Fellow of the American Association for the Advancement of Science (AAAS). 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 on "LawSeq^SM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application" (R01HG008605).

Carrie Blout Zawatsky, MS, CGC, is Senior Genetic Counselor and Project Manager at Brigham and Women’s Hospital (BWH) and is the Director of Research Development for the Genomes2People translational research group. She is Adjunct Assistant Professor in the School of Health and Rehabilitation Sciences in the Master of Science in Genetic Counseling program at Massachusetts General Hospital (MGH) Institute of Health Professions.

 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, LawSeq^SM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605). 

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, LawSeq^SM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605). 

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, LawSeq^SM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605). 

 

Frances Lawrenz, PhD, 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, LawSeq^SM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605).

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 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, LawSeq^SM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application (R01HG008605). 

Background articles that may be useful for this conference include:

• Amendola, L.M., Robinson, J.O., Hart, R., Biswas, S., Lee, K., Bernhardt, B.A., East, K., Gilmore, M.J., Kauffman, T.L., Lewis, K.L., Roche, M., Scollon, S., Wynn, J. and Blout, C. Why Patients Decline Genomic Sequencing Studies: Experiences from the CSER Consortium. J Genet Counsel 2018;27: 1220-1227. 

• Bélisle-Pipon, J., Vayena, E., Green, R.C. et al. Genetic testing, insurance discrimination and medical research: what the United States can learn from peer countries. Nature Medicine 2019;25:1198–1204. 

• Bombard Y, Brothers KB, Fitzgerald-Butt S, et al. The Responsibility to Recontact Research Participants after Reinterpretation of Genetic and Genomic Research Results. American Journal of Human Genetics 2019;104(4)578-595.

• Bruce MA, Bonham VL, Wolf SM, eds., Law, Genomic Medicine & Health Equity: How Can Law Support Genomics and Precision Medicine to Advance the Health of Underserved Populations? Ethnicity & Disease 2019;29 Suppl 3:623-674.

• Burke W, Clayton EW, Wolf SM, Berry SA, Evans BJ, Evans JP, Hall R, Korngiebel D, Laberge AM, LeRoy BS, McGuire AL. Improving Recommendations for Genomic Medicine: Building an Evolutionary Process from Clinical Practice Advisory Documents to Guidelines. Genetics in Medicine 2019;21(7):1-8.

• Clayton EW, Evans BJ, Hazel JW, Rothstein MA. The Law of Genetic Privacy: Applications, Implications, and Limitations. Journal of Law and the Biosciences 2019;6(1)1–36.

• Couzin-Frankel J. Genomics Breeds New Legal Questions. Science 2019;364(6440)521.

• David KL, Best RG, Brenman LM, et al. Patient Re-contact After Revision of Genomic Test Results: Points to Consider — A Statement of the American College of Medical Genetics and Genomics (ACMG). Genetics in Medicine 2019;21(4)768-771.

• Evans BJ. Commentary: HIPAA’s Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights. American Journal of Human Genetics 2018;102:05-10.

• Evans BJ, Clayton EW. Deadly Delay: The FDA’s Role in America’s COVID Testing Debacle. The Yale Law Journal Forum 2020;130:78-100.

• Evans BJ, Javitt GH, Hall R, Robertson M, Ossorio PN, Wolf SM, Morgan TM, Clayton EW. How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care? Journal of Law, Medicine & Ethics Spring 2020; 48-1 in press.

• Evans BJ, Ossorio P. The Challenge of Regulating Clinical Decision Support Software after 21st Century Cures. American Journal of Law and Medicine 2018;44:237-251.

• Evans BJ, Wolf SM. A Faustian Bargain That Imperils People’s Rights to See Their Own Personal Information. Florida Law Review 2019;71(5). Note: online version forthcoming

• Guerrini CJ, Wagner JK, Nelson SC, Javitt GH, McGuire AL. Who’s on Third? Regulation of Third-Party Genetic Interpretation Services. Genetics in Medicine 2019;22:4-11.

• Klonoff DC, Gutierrez A, Fleming A. Real-World Evidence Should be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes. Journal of Diabetes Science and Technology 2019;13(6)995-1000.

• Lynch HF, Wolf LE, Barnes M. Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence. Journal of Law, Medicine & Ethics 2019;47(2):213-231.

• Hazel JW, Slobogin C. Who Knows What, and When?: A Survey of the Privacy Policies Proffered by US Direct-to-Consumer Genetic Testing Companies. Cornell Journal of Law and Public Policy 2018;28(35):35-66.

• Majumder MA, Guerrini CJ, Bollinger JM, Cook-Deegan R, McGuire AL. Sharing Data Under the 21st Century Cures Act. Genetics in Medicine 2017;19:1289-1294.

• Mansfield E, Donigan K, Tjoe S, Berger AC. Chapter 21-Regulation of Genomic Technologies. Genomic and Precision Medicine (Third Edition) 2017;313-326.

• Marchant GW, Barnes M, Clayton EW, Evans JP, LeRoy BS, Wolf SM. From Genetics to Genomics: Facing the Liability Implications in Clinical Care. Journal of Law, Medicine & Ethics Spring 2020;48-1 in press.

• Marchant GW, Lindor RA. Genomic Malpractice: An Emerging Tide or Gentle Ripple? Food and Drug Law Journal 2018;73:1-37.

• Milko, L.V., Chen, F., Chan, K. et al. FDA oversight of NSIGHT genomic research: the need for an integrated systems approach to regulation. npj Genomic Medicine 2019;4(32).

• Rothstein MA. GINA at Ten and the Future of Nondiscrimination Law. Hastings Center Report 2018;48(3):5-7.

• Rothstein MA. Reconsidering the Duty to Warn Genetically At-Risk Relatives. Genetics in Medicine 2018;20:285-290.

• Stevens YA, Senner GD, Marchant GE. Physicians’ Duty to Recontact and Update Genetic Advice. Personalized Medicine 2017;14(4):367-374.

• Wolf LE, Brown EF, Kerr R, Razick G, Tanner G, Duvall B, Jones S, Brackney J, Posada T. The Web of Legal Protections for Participants in Genomic Research. Health Matrix Cleveland 2019;29(1):3.

• Wolf SM, Evans BJ. Defending the Return of Results and Data. Science 2018;362(6 420):1255-1256.

• Wolf SM, Evans BJ. Return of Results and Data to Study Participants. Science 2018;362(6 411):159-160.

• Wolf SM, Ossorio PN, Berry SA, Greely HT, McGuire AL, Penny MA, Terry SF. Integrating Rules for Genomic Research, Clinical Care, Public Health Screening & DTC Testing: Creating Translational Law for Translational Genomics. Journal of Law, Medicine & Ethics Spring 2020;48-1 in press.