Thursday, November 3
10:30–10:40 AM
Welcome and Announcements
Christine M. Simmon, President & CEO, FDLI
Paige Samson, Director, Innovative Programs and Publications, FDLI
10:40 AM–11:10 AM
Keynote Address
Erik P. Mettler, Assistant Commissioner for Partnerships and Policy, Office of Regulatory Affairs (ORA), FDA
Introduced by: Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors
11:20 AM–12:35 PM
Paper Presentation and Discussion
“FDA and the PTO: Is There a Role Beyond ‘Ministerial’ for FDA to Play in Administering Pharma and Biotech Patent Regimes?”
Author: George O’Brien, Partner, Mayer Brown LLP
Moderator: Sara W. Koblitz, Director, Hyman, Phelps & McNamara
Discussant: Brian J. Malkin, Partner, McDermott Will & Emery
12:50–2:05 PM
Paper Presentation and Discussion
“FDA and EPA Regulation of Antimicrobial Devices: Lessons Learned from New Use Patterns Considered During the COVID-19 Pandemic”
Authors: Nicholas Benetatos, Sr. Manager, Exponent, Inc. and Ian Van Trump, Principal Scientist, Exponent, Inc.
Moderator: John F. Johnson III, Senior Counsel, Shook, Hardy & Bacon LLP
Discussant: Keith A. Matthews, Of Counsel, Wiley Rein LLP
2:10–3:25 PM
Paper Presentation and Discussion
“Preparing for the Next Public Health Crisis: Implementing a Culture-Centered Approach to Collaborative Communication Efforts by the FDA and CDC”
Author: Sabrina Singh, Teaching Assistant, Rutgers University
Moderator: Christine P. Bump, Principal, Penn Avenue Law & Policy
Discussant: Jordan Paradise, Georgia Reithal Professor of Law and Co-Director, Beazley Institute for Health Law & Policy, Loyola University Chicago School of Law
3:30–4:45 PM
Paper Presentation and Discussion
“FDCA Preemption as a Means to Guarantee Access to FDA-Approved Abortion-Related Drugs”
Authors: James M. Beck, Senior Life Sciences Policy Analyst, Reed Smith LLP, Philip W. Danziger, Senior Associate, Reed Smith LLP, Sarah B. Johansen*, Associate, Reed Smith LLP and Andrew R. Hayes*, Associate, Reed Smith LLP
Moderator: James T. O’Reilly, Volunteer Professor, College of Medicine, University of Cincinnati
Discussant: Patricia J. Zettler, Associate Professor of Law, The Ohio State University Moritz College of Law, and Member, FDLI Board of Directors
Friday, November 4
10:00–10:10 AM
Welcome and Announcements
Erika Lietzan, William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law, University of Missouri-Columbia School of Law, and Chair, Food and Drug Law Journal Editorial Advisory Board
Paige Samson, Director, Innovative Programs and Publications, FDLI
10:10–11:25 AM
Paper Presentation and Discussion
“Parallel Enforcement: SEC Authorities and How they can Impact FDA’s Civil and Criminal Enforcement”
Authors: Luke Cadigan, Partner, Cooley LLP and Sonia W. Nath, Partner, Cooley LLP
Moderator: Kristin M. Kaplan, Of Counsel, Shook, Hardy & Bacon LLP
Discussant: Susan Lee, Partner, Goodwin Procter LLP
11:40 AM–12:55 PM
Paper Presentation and Discussion
“Enhanced Engagement: The Relationship Between FDA and DoD Regulatory Authorities”
Author: Jeremiah Kelly, Chief, FDA Regulatory Law Division, Office of the Staff Judge Advocate (JAG)
Moderator: Maxwell J. Mehlman, Distinguished University Professor, Case Western Reserve University School of Law
Discussant: Elizabeth Sadove, Director, Medical Countermeasure Regulatory Policy, Office of Counterterrorism and Emerging Threats, FDA
1:10–2:25 PM
Paper Presentation and Discussion
“Combination Products and Generic Substitution Laws”
Author: Amirala Pasha, Assistant Professor of Medicine, Mayo Clinic
Moderator: Erika Lietzan, William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law, University of Missouri-Columbia School of Law, and Chair, Food and Drug Law Journal Editorial Advisory Board
Discussant: Jonathan J. Darrow
2:25 PM
Symposium Adjournment
