Conference Agenda

10:00 a.m. Central                      

Welcome and Introductions 

                                                        

Susan M. Wolf, JD, Co-PI, LawSeqSM; McKnight Presidential Professor of Law, Medicine & Public Policy; Chair, Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota

Mark Barnes, JD, LLM, Partner, Ropes & Gray LLP

Gail H. Javitt, JD, MPH, Director, Hyman, Phelps & McNamara, PC

10:15 a.m. Central

Keynote: Legal & Policy Problems in Genomic Research & Clinical Care

Moderator: Susan M. Wolf, JD

Gail P. Jarvik, MD, PhD, Arno G. Motulsky Chair of Medical Genetics; Professor of Medicine and Genome Sciences; Head, Division of Medical Genetics, University of Washington Medical Center

Q/A

10:50 a.m. Central

Keynote: Overcoming Legal Obstacles and Improving the Law of Genomics

Moderator: Ellen Wright Clayton, MD, JD, Co-PI, LawSeqSM; Craig-Weaver Professor of Pediatrics, Professor of Law, Professor of Health Policy, and Co-founder of the Center for Biomedical Ethics and Society, Vanderbilt University

Mark Barnes, JD, LLM 

Q/A

11:25 a.m. Central

Break

11:30 a.m. Central

Panel #1 – What are the pressing legal and policy issues confronting genomic research and clinical care?

Moderator: Frances Lawrenz, PhD, Co-PI, LawSeqSM; Associate Vice President for Research, Wallace Professor of Teaching and Learning, Department of Educational Psychology, University of Minnesota

Jason L. Vassy, MD, MPH, SM, Assistant Professor of Medicine, Brigham and Women’s Hospital; Director, Genomes2Veterans

Ellen Wright Clayton, MD, JD

Alexandra E. Shields, PhD, Harvard Medical School; Massachusetts General Hospital; Director, Harvard/MGH Center on Genomics, Vulnerable Populations, and Health Disparities; Associate Member, Broad Institute

Rachel Rice Ackman, JD, Director of Research Integrity and Compliance, NYU Langone Health

Michael Hamilton, JD, Chief Privacy Officer, Invitae

Q/A

12:30 p.m. Central

Panel #2 – Issues in FDA regulation of genomic analysis and reporting in research and clinical care

Moderator: Gail H. Javitt, JD, MPH 

Elizabeth Mansfield, PhD, Vice President, Regulatory, Foundation Medicine, Inc.; formerly Director of the Personalized Medicine Staff, Center for Devices, FDA

Barbara Evans, JD, PhD, LLM, Professor of Law and Stephen C. O’Connell Chair, Law School; Professor of Engineering, Herbert Wertheim School of Engineering, University of Florida Levin College of Law; Director, Biotechnology & Law Program

Michelle Penny, PhD, Vice President, Head of Genomics, Goldfinch Bio

Priya M. Mannan, JD, LLM, Global Compliance Officer, Executive Director and Associate General Counsel, Novartis Institutes of BioMedical Research, Inc.

Alberto Gutierrez, PhD, Partner & Expert Consultant, NDA Partners LLC; formerly Director, Office of In Vitro Diagnostics and Radiological Health, FDA

Q/A

1:30 p.m. Central

Break

1:35 p.m. Central

Panel #3 – Genomic data governance: Legal and policy issues in data access and use, including by research participants, patients, and families

Moderator: Susan M. Wolf, JD

Erik Phelps, JD, Executive Vice President and General Counsel, Tempus; formerly General Counsel at Epic

Bradley Malin, PhD, Professor of Biomedical Informatics; Vice Chair for Research; Professor of Biostatistics, Professor of Computer Science; Affiliated Faculty of the Center for Biomedical Ethics & Society, Vanderbilt University

Barbara E. Bierer, MD, Professor of Medicine; Faculty Co-director, Multi-Regional Clinical Trials (MRCT) Center of Brigham & Women’s Hospital, Harvard Medical School

Wendy K. Chung, MD, PhD, Chief, Division of Clinical Genetics, Department of Pediatrics, Columbia University; Precision Medicine Resource Leader, Irving Institute

Carrie Blout Zawatsky, MS, CGC, Senior Genetic Counselor & Project Manager, Brigham and Women’s Hospital; Director of Research Development, Genomes2People translational research group

Q/A

2:35 p.m. Central

Wrap-up

Susan M. Wolf, JD

Ellen Wright Clayton, MD, JD

Gail Javitt, JD, MPH

Mark Barnes, JD, LLM

2:45 p.m. Central

Adjourn