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 are pleased to announce this collaborative academic symposium.
Registration for this event is now open online.
A limited number of free seats are available to Harvard affiliates. For more information or to request a seat, please email us at firstname.lastname@example.org.
Note: All sessions will include 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
Register online now.
bioethics biotechnology fda genetics gmos health information technology health law policy health technologies international market medical safety pharmaceuticals public health regulation stem cells tobacco