Emerging Issues and New Frontiers for FDA Regulation image

October 20, 2014 8:00 AM - 5:00 PM
Washington, DC

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.


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”

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”

“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”


bioethics   biotechnology   fda   food   genetics   health information technology   health law policy   international   market   medical safety   pharmaceuticals   public health   regulation   stem cells   tobacco