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, Genetic Medicine Clinic and Center on Human Development & Disability, University of Washington

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

Douglas F. Flood, JD, Strategic Adviser, former Chief Commercial Officer and General Counsel, Veritas Genetics

Q/A

12:30 p.m. Central

Panel #2 – Issues in FDA regulation of genomic devices, software, and algorithms: Issues in research and clinical care

Moderator: Gail H. Javitt, JD, MPH 

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

Elizabeth Mansfield, PhD, Consultant; formerly at FDA

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

Alberto Gutierrez, PhD, Partner & Expert Consultant, NDA Partners LLC; formerly at FDA

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

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 and families

Moderator: Susan M. Wolf, JD

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

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

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

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

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

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