Agenda


All sessions are plenary

8:00am
Welcome
Introduction: 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
Douglas Yee, MD, John H. Kersey Chair in Cancer Research, Professor of Medicine & Pharmacology, Director, Masonic Cancer Center, University of Minnesota 

8:15am
Keynotes: Is Law Helping or Hurting Translation of Genomics into Clinical Practice? Two Views from the Trenches

Clinical Genomics: Legal Obstacles & Opportunities
• James P. Evans
, MD, PhD, Bryson Distinguished Professor of Genetics and Medicine and Director of Adult Genetic Services, School of Medicine University of North Carolina, Chapel Hill; Former Editor, Genetics in Medicine

The Past, Present and Future of Genomics Law
• Mark Barnes, JD, LLM, Partner, Ropes & Gray, LLP
Q/A

9:15am
Project Analyses, Recommendations, and Collaboration on Approaches to Underserved Populations 
• Susan M. Wolf, JD
• Ellen Wright Clayton, MD, JD, Co-PI, LawSeqSMCraig-Weaver Professor of Pediatrics, Professor of Law, Professor of Health Policy, and Co-founder of the Center for Biomedical Ethics and Society, Vanderbilt University School of Medicine
Q/A

10:00am
Project Empirical Research – What Problems and Solutions do Stakeholders Report?
• Frances Lawrenz, PhD, Co-PI, LawSeqSM; Associate Vice President for Research, Wallace Professor of Teaching and Learning, Department of Educational Psychology, College of Education and Human Development, University of Minnesota
Q/A

10:30am
Break

10:45am
Panel #1 – From Genetics to Genomics: Facing the Liability Implications in Clinical Care
• Gary Marchant, JD, PhD, MPP, Professor of Law, Regents' Professor, Lincoln Professor of Emerging Technologies, Law & Ethics, Arizona State University
(Panel moderator: Gary Marchant)

  • Bonnie LeRoy, MS, CGC, Professor and Director, Graduate Program of Study in Genetic Counseling, University of Minnesota; Editor, Journal of Genetic Counseling: Liability Exposure for Genetic Counselors in the Genomics Era: Problems & Solutions
  • Susan M. Wolf, JD: Establishing the Legal Standard of Care in Clinical Genomics
  • Discussant: James P. Evans, MD, PhD 
    Q/A

12:00pm
Networking Lunch – Humphrey Center Atrium

12:45pm
Panel #2 – Deconstructing Quality in the Age of Genomic Testing
• Ellen Wright Clayton, MD, JD 
(Panel moderators: Barbara J. Evans, JD, PhD, LLM, Mary Ann & Lawrence E. Faust Professor of Law, Professor, Electrical and Computer Engineering, Director, Center on Biotechnology & Law, University of Houston; Thomas Morgan, MD, FACMG, Associate Professor of Pediatrics, Vanderbilt University School of Medicine)

  • Kenneth Beckman, PhD, Director, University of Minnesota Genomics Center, Affiliate faculty, Institute for Health Informatics, University of Minnesota: Ensuring the Quality of Clinical Sequencing: Laboratory Perspectives on  Separating Sequencing from Interpretation 
  • Pilar Ossorio, PhD, JD, Professor of Law and Bioethics, Co-director of the Law and Neuroscience Program, University of Wisconsin, Madison; Bioethics Scholar in Residence, Morgridge Institute for Research: How Should Law Regulate the Quality of Black-Box Algorithms and Software for Genomic Variant Interpretation?
  • Ralph F. Hall, JD, Partner, Leavitt Partners; Professor of Practice, University of Minnesota Law School: How Should FDA Approach Laboratory-Developed Tests (LDTs) in Genomics?
  • Wylie Burke, MD, PhD, Professor and former Chair of the Department of Bioethics and Humanities, Adjunct Professor of Medicine (in the Division of Medical Genetics), and Member of the Fred Hutchinson Cancer Research Center, University of Washington: Improving Recommendations for Genomic Medicine: An Evolutionary Approach
    Q/A

2:00pm
Panel #3 – The Law of Genetic Privacy: Applications, Implications and Limitations
• 
Mark Rothstein, JD, Herbert F. Boehl Chair of Law and Medicine, Brandeis School of Law, Founding Director of the Institute for Bioethics, Health Policy and Law, School of Medicine, University of Louisville 
(Panel moderator: Ellen Wright Clayton, MD, JD) 

  • Kevin B. Johnson, MD, MS, Cornelius Vanderbilt Professor & Chair, Department of Biomedical Informatics, Professor, Department of Pediatrics, Senior Vice President of Health Information Technology, Vanderbilt University Medical Center: The Challenges of Incorporating Genomics into the Electronic Health Record (EHR) and Supporting Proper Use
  • Leslie E. Wolf, JD, MPH, Professor of Law, Distinguished University Professor, Center for Law Health and Society, Georgia State University: How Should Law Protect Genomic Research Data? From Certificates of Confidentiality to the Revised Common Rule
  • 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 Medical Center: How Effective Is De-identification in Securing Privacy? What Else Is Needed?
  • Barbara J. Evans, JD, PhD, LLM: The Law on Access to Genomic Data and Interpreted Results
  • William McGeveran, JD, Associate Dean for Academic Affairs, Professor of Law, Solly Robins Distinguished Research Fellow, University of Minnesota Law School: Incorporating Broader Trends of Privacy and Data Protection Law Into Regulation of Genomics

Q/A

3:15pm
Break

3:30pm
Panel #4 – Integrating Rules for Genomic Research, Clinical Care, Public Health Screening & DTC Testing: Creating Translational Law for Translational Genomics
• Susan M. Wolf, JD; Pilar Ossorio, JD, PhD
(Panel moderators: Susan M. Wolf, JD; Pilar Ossorio, JD, PhD)

  • Michelle Penny, PhD, Senior Director, Head of Translational Genomic Sciences, Biogen: Industry Perspectives on the Relationship Between Pharmaceutical Company Research and Clinical Genomics
  • Susan Berry, MD, Division Director for Genetics and Metabolism, Department of Pediatrics, University of Minnesota: The Interface Between Newborn Screening and Clinical Genomics
  • James W. Hazel, PhD, JD, Postdoctoral Fellow at the Center for Genetic Privacy and Identity in Community Settings (GetPreCiSe), Vanderbilt University Medical Center: Privacy Best Practices for Direct-to-Consumer Genetic Testing Services: Are Industry Efforts at Self-Regulation Sufficient?
  • Henry T. Greely, JD, Director, Center for Law and the Biosciences, Professor (by courtesy) of Genetics, Chair, Steering Committee of the Center for Biomedical Ethics, Director, Program in Neuroscience and Society, Stanford University: The Future of DTC Genomics: Facing the Legal Challenge
    Q/A

4:45pm
Wrap-up: The Future of the Law of Genomics
LawSeqSM PIs: Susan M. Wolf, JD; Ellen Wright Clayton, MD, JD; Frances Lawrenz, PhD

5:00pm
Adjourn