Celebrating 125 Years

Lectures & Events

Legal Challenges in Precision Medicine

Friday, April 7, 2017
8:00 AM - 5:00 PM
6 hours of in-person CLE credit, pending approval

Many diseases do not have a proven means of prevention or effective treatments. President Obama’s Precision Medicine Initiative® (PMI) announced in January 2015 hopes to remedy that by finding new treatments using the PMI medical model that proposes a customization of healthcare, with medical decisions, practices, and/or products being tailored to the individual patient’s genetic makeup and other patient-specific factors. This conference discusses the emerging legal challenges of transitioning the practice of health care to the PMI model.

Continuing Legal Education Readings & Additional Materials
Speaker Information
Maxwell J. Mehlman
Maxwell J. Mehlman
Maxwell J. Mehlman is Distinguished University Professor, Arthur E. Petersilge Professor of Law and Director of the Law-Medicine Center, Case Western Reserve University School of Law, and Professor of Biomedical Ethics, Case Western Reserve University School of Medicine. He received his JD from Yale Law School in 1975, and holds two bachelors degrees, one from Reed College and one from Oxford University, which he attended as a Rhodes Scholar. Prior to joining the Case Western Reserve faculty in 1984, Mehlman practiced law with Arnold & Porter in Washington, D.C., where he specialized in federal regulation of health care and medical technology. He is the co-author of Access to the Genome: The Challenge to Equality co-editor, with Tom Murray, of the Encyclopedia of Ethical, Legal and Policy Issues in Biotechnology co-author of Genetics: Ethics, Law and Policy, the first casebook on genetics and law, now in its fourth edition and author of Wondergenes: Genetic Enhancement and the Future of Society, published in 2003 by the Indiana University Press The Price of Perfection: Individualism and Society in the Era of Biomedical Enhancement, published in 2009 by the Johns Hopkins University Press and Transhumanist Dreams and Dystopian Nightmares: The Promise and Peril of genetic Engineering, published in 2012 by the Johns Hopkins University Press.

Peter Pavarini
Peter Pavarini
Peter Pavarini co-chairs the health law practice of the global law firm Squire Patton Boggs (US) LLP and is a partner resident in the firm’s Columbus, Ohio office. He focuses his practice on the representation of hospitals and a variety of other health care providers in a wide range of strategic, regulatory and transactional matters, particularly physician alignment models and the development of clinically integrated networks and accountable care organizations. Mr. Pavarini has devoted his entire legal career to addressing the challenges and opportunities presented by regulatory reforms and marketplace trends. He has been listed in Woodward/White’s Best Lawyers in America for health care since 1991, has been recognized by his peers in numerous other surveys and directories, and is frequently quoted in national trade, legal and business publications. From 2014 to 2015, Mr. Pavarini was president of the American Health Lawyers Association, the Nation’s largest educational organization devoted to health law issues, and has served on the AHLA’s Executive, Nominating, Public Interest, Membership and Programs Committees. Mr. Pavarini has also been a member of the faculty of the American College of Healthcare Executives and is a frequent speaker/author on the transformation of the U.S. health care system.

Carolyn Mary Hutter, Ph.D.
Carolyn Mary Hutter, Ph.D.
Carolyn Hutter is the Acting Division Director for the Division of Genome Sciences at the National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH). The Division of Genome Sciences plans, directs and facilitates multi-disciplinary research to understand the structure and function of genomes in health and disease. Dr. Hutter has participated as a member of the leadership team for several NIH projects, including: The Cancer Genome Atlas (TCGA), the Clinical Sequencing Exploratory Research (CSER) program, the NIH Centers for Common Disease Genomics (CCDG) and the Precision Medicine Initiative All of US Research Program.

Prior to NIH, Dr. Hutter was a Senior Staff scientist at the Fred Hutchinson Cancer Research Center and a Lecturer (Part-Time) in the Epidemiology Department at the University of Washington School of Public Health. Her research focused on large-scale consortia studies of genome-wide association studies and gene-environment interactions in colorectal cancer and other complex diseases.

Dr. Hutter received her Sc.B. in Applied Mathematics-Biology with Honors from Brown University (1994), her M.S. in Genetics from Cornell University (1998), her M.S. in Biostatistics and her Ph.D. in Epidemiology from the University of Washington (2009 2008).

Mark A. Rothstein
Mark A. Rothstein
Mark A. Rothstein is the Herbert F. Boehl Chair of Law and Medicine and Director of the Institute for Bioethics, Health Policy, and Law at the University of Louisville School of Medicine.

He received a B.A. from the University of Pittsburgh and a J.D. from Georgetown University.

Professor Rothstein has concentrated his research on health privacy, bioethics, genetics, and public health. From 1999-2008, he was a member of the National Committee on Vital and Health Statistics (NCVHS), where he chaired the Subcommittee on Privacy and Confidentiality. NCVHS is the statutory federal advisory committee to the Secretary of HHS on health information policy. He is a past president of the American Society of Law, Medicine and Ethics, an elected member of the American Law Institute, and an elected fellow of the Hastings Center.

He currently serves as Department Editor for Public Health Ethics of the American Journal of Public Health. Since 2000, he has written a regular column on bioethics for the Journal of Law, Medicine and Ethics.

Ellen Wright Clayton
Ellen Wright Clayton
Ellen Wright Clayton is an internationally respected leader in the field of law and genetics who holds appointments in both the law and medical schools at Vanderbilt, where she also co-founded and directed the Center for Biomedical Ethics and Society. She has published two books and more than 150 scholarly articles and chapters in medical journals, interdisciplinary journals and law journals on the intersection of law, medicine and public health. In addition, she has collaborated with faculty and students throughout Vanderbilt and in many institutions around the country and the world on interdisciplinary research projects, and helped to develop policy statements for numerous national and international organizations. She currently chairs the Paediatric Platform of the international Public Population Program in Genomics. An active participant in policy debates, she has advised the National Institutes of Health as well as other federal and international bodies on an array of topics ranging from children's health to the ethical conduct of research involving human subjects. Professor Clayton has worked on a number of projects for the National Academy of Medicine, of which she is a member of the executive committee of its National Advisory Council, chair of the Board on Population Health and Public Health Practice, and was chair of its committee to define myalgic encephalomyelitis/chronic fatigue syndrome. She is also a member of the National Academies’ Report Review Committee. She is an elected Fellow of the American Academy for the Advancement of Science.

Vence L. Bonham J.D.
Vence L. Bonham J.D.
Vence Bonham received his bachelor of arts from James Madison College at Michigan State University and his juris doctor degree from the Moritz College of Law at the Ohio State University. Mr. Bonham was a tenured faculty member at Michigan State University in the College of Human Medicine and adjunct professor in the Michigan State University College of Law. Since 2003, Mr. Bonham has served as an investigator in the National Human Genome Research Institute (NHGRI) within the Division of Intramural Research’s Social and Behavioral Research Branch. He leads the Health Disparities Genomics Unit, which conducts research that evaluates approaches to integrating new genomic knowledge and precision medicine into clinical settings without exacerbating inequities in healthcare delivery. Mr. Bonham also serves as the senior advisor to the director of the National Human Genome Research Institute on genomics and health disparities.

Shawneequa Callier
Shawneequa Callier
Ms. Callier is an Assistant Professor of Bioethics and Health Care Law and Regulation in the George Washington University School of Medicine and Health Sciences. In addition, she teaches Genetics and the Law as a Professorial Lecturer in Law at the George Washington University School of Law. Outside of her work at GW, Ms. Callier serves as a Special Volunteer at the National Human Genome Research Institute’s Center for Research on Genomics and Global Health. Her scholarship focuses on topics related to precision medicine and health disparities, genomic incidental findings, race and genetics, and pharmacogenomics. Prior to joining the GW faculty, Ms. Callier completed a post-doctoral fellowship at the Center for Genetic Research Ethics and Law in the Bioethics Department of Case Western Reserve University’s School of Medicine. For three years, Ms. Callier practiced health care law in Washington, D.C.

Ruqaiijah Yearby
Ruqaiijah Yearby
Ruqaiijah A. Yearby is the Oliver C. Schroeder Jr. Distinguished Research Scholar, Professor of Law, and Associate Director of the Law-Medicine Center at Case Western Reserve University School of Law. A nationally and internationally recognized scholar and presenter, Yearby's scholarship focuses on two emerging fields of health law: 1) racial disparities in health care and 2) law, justice and medical research. She recently presented her work on law, justice and medical research at the Oxford Global Health and Bioethics International Conference in Oxford, England.

Kristen Rosati
Kristen Rosati
Kristen is considered one of the nation’s leading HIPAA compliance attorneys. She also has deep expertise with large data breaches, health information exchange, data sharing, clinical research, biobanking, and all things “Big Data.” Kristen is a sought-after national speaker on these issues and has been active in national healthcare policy. She is Past President (2013-2014) of the American Health Lawyers Association, the nation’s largest health care legal organization.


Event Location
CWRU Law School
11075 East Blvd.
Cleveland, Ohio 44106

8:00 - 8:30 am
Registration and continental breakfast
8:30 - 8:45 am
Welcome & Introduction
Maxwell J. Mehlman, Professor of Law, Director, The Law-Medicine Center, Case Western Reserve University School of Law
Peter Pavarini, J.D., Co-Leader, Healthcare Practice Group, Squire Patton Boggs, Past President, AHLA
8:45 - 9:45 am
Scientific and Clinical Overview
Carolyn Hutter, Ph.D., Program Director at the Division of Genomic Medicine, NHGRI
9:45 - 10:00 am
Break
10:00 - 11:00 am
Policy Overview
Mark Rothstein, J.D., Herbert F. Boehl Chair of Law and Medicine and Director of the Institute for Bioethics, Health Policy and Law, University of Louisville School of Medicine
11:00 am - 12:00 pm
Liability Issues in Clinical Translation
Ellen Wright Clayton, M.D., J.D., Craig-Weaver Professor of Pediatrics and Professor of Law, Vanderbilt University
Maxwell Mehlman, J.D., Professor of Law and Bioethics, Director, The Law-Medicine Center, Case Western Reserve University
12:00 - 1:15 pm
Networking lunch
1:15 - 2:15 pm
Legal Issues Relating to Health Disparities and Discrimination
Vence Bonham, Jr., J.D., Senior Advisor to NHGRI on Genomics and Health Disparities
Shawneequa Callier, J.D., Professorial Lecturer in Law, George Washington University
Ruqaiijah Yearby, J.D., Associate Dean of Institutional Diversity and Inclusiveness, Professor of Law, Oliver C. Schroeder Jr. Distinguished Research Scholar, Case Western Reserve University School of Law
2:15 - 2:30 pm
Break
2:30 - 3:30 pm
Insurance and Payment Issues
Peter Pavarini, J.D., Co-Leader, Healthcare Practice Group, Squire Patton Boggs, Past President, AHLA
3:30 - 4:30 pm
Control and Protection of Biospecimens and Genomic Data
Kristen Rosati, J.D., Coppersmith Brockelman PLC, Past President, AHLA
4:30 - 5:00 pm
Closing remarks and final Q&A
5:00 - 6:00 pm
Networking reception
  
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