Emerging Issues and New Frontiers for FDA Regulation

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute were pleased to announce this collaborative academic symposium.
Agenda:
Note: All sessions included time for Q & A.
8:00 – 8:30 AM Registration and Continental Breakfast
8:30 – 8:40 AM FDLI, PFC Welcome Remarks
8:40 – 9:35 AM Food Regulation
“Untangling the Debate Over Genetically Modified Foods”
- Joanna K. Sax, Associate Dean for Research and Faculty Development; Associate Professor of Law; Co-Director, Institute of Health Law Studies – California Western School of Law
“Addressing Food Fraud Prevention in the Food Safety Modernization Act”
- John Spink, Director & Assistant Professor, Food Fraud Initiative – Michigan State University
- Moderator: Frederick H. Degnan, Partner – King & Spaulding
9:35 – 10:30 AM Drug Shortages
“‘Regulatory Flexibility’ after Cook v. FDA: How Flexible Is Flexible?”
- Kate Greenwood, Research Fellow & Lecturer in Law – Seton Hall University School of Law
“A Duty to Continue Selling Medicines”
- William M. Janssen, Professor of Law – Charleston School of Law
- Moderated by Philip R. Desjardins, JD, Counsel, Arnold & Porter LLP
10:30 – 10:45 AM Networking Break
10:45 – 11:40 AM Mobile Health
“Gatekeeping Regulation for mHealth”
- Nathan Cortez, Associate Professor; Associate Dean for Research – SMU Law School
“Big Data and Health Care”
- I. Glenn Cohen, Professor of Law; Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics – Harvard Law School
- Moderated by Lauren Silvis, Partner – Sidley Austin LLP
11:40 – 12:45 PM Luncheon Address
12:45 – 2:10 PM Personalized Medicine
“Regulation of Black-Box Personalized Medicine”
- W. Nicholson Price II, Assistant Professor of Law – University of New Hampshire School of Law
“Can FDA Serve As An Effective Gatekeeper For Personalized Medicine?”
- Margaret Foster Riley, Professor of Law; Professor of Public Health Sciences; Professor of Public Policy – University of Virginia
“The Limits of FDA’s Authority to Regulate Genomic Interpretation Services”
Barbara Evans, Professor of Law and George Butler Research Professor; Director, Center on Biotechnology & Law – University of Houston Law Center
Moderated by Courtenay Brinckerhoff, Partner – Foley & Lardner LLP
2:10 – 3:05 PM Stem Cells
“Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models”
- Barbara von Tigerstrom, Professor and Associate Dean, Research and Graduate Studies – University of Saskatchewan College of Law
“Access to (un) PROVEN Proven Cell Therapies: Do Legal and Regulatory Decisions Create an Unwanted Domino Effect?”
- Bianca Büchner, Affiliated Faculty Member, Indiana University Center for Bioethics; Associated Research Fellow, Center for Ethics and Law in the Life Sciences – CELLS, University of Hannover
- Moderated by Andrew Ittleman, Partner – Fuerst Ittleman David & Joseph, PL
3:05 – 3:20 PM Networking Break
3:20 – 5:10 PM New Paradigms
“Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment”
- Leili Fatehi, Director, Initiative on Governance of Emerging Technological Systems (IGETS); Research Fellow, Hubert H. Humphrey School of Public Affairs; Adjunct Professor of Law, University of Minnesota Law School; Affiliate Faculty, Center for Bioethics
- Ralph F. Hall, Professor of Practice – University of Minnesota Law School
“Envisioning FDA Evaluation and Approval of Pharmaceuticals for Non-Therapeutic Uses”
- Yaniv Heled, Assistant Professor of Law – Georgia State University College of Law
“How Should the FDA Regulate the Approval of Novel Vaccines for Non-Communicable Diseases?”
- Jonathan J. Darrow, Research Fellow, Harvard Medical School; Postdoctoral Research Fellow, Program On Regulation Therapeutics And Law (PORTAL), Brigham & Women’s Hosp.; Resident Tutor in Law and Business, Harvard University; Lecturer on Law, Bentley University
- Aaron S. Kesselheim, Assistant Professor of Medicine at Harvard Medical School; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital
“The Gen-Nano-Neuro Convergence: A New Biotechnology Paradigm for the FDA”
- Jordan K. Paradise, Professor of Law – Seton Hall University School of Law
- Moderated by Philip Katz, Partner – Hogan Lovells US LLP