Why Attend?

Preliminary Agenda

Location & CLE

Agenda Subject to Change

The change of date means that the Annual Conference will now be held two weeks prior to the Tobacco and Nicotine Products Regulation and Policy Conference, scheduled for October 22-23. For this year only, we have made the decision to move tobacco-specific sessions from the Annual Conference to the Tobacco Conference. In addition, Center updates from Mitchell Zeller, Director of FDA’s Center for Tobacco Products, will also be provided at the Tobacco Conference. If you are interested in tobacco-related programming, we hope you will join us at that conference: Learn more here.

Wednesday, May 6

Location: Penn Avenue Terrace, JW Marriott Hotel
1331 Pennsylvania Ave NW, Washington, DC 20004


Thursday, May 7

8:15 – 9:00 AM | Registration and Continental Breakfast

Amy Comstock Rick, President & CEO, FDLI


Dr. Stephen M. Hahn, Commissioner of Food and Drugs, FDA
Introduced by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Chair, FDLI Board of Directors

10:15 – 10:45 AM | Coffee and Networking Break

10:45 – 11:45 PM | Breakout Sessions

Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
Moderated by Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors and Monaya Krause, Senior Legal Director, Enterprise Legal Regulatory – FDA/Life Sciences, Medtronic

Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Brian McCormick, VP & Chief Regulatory Counsel, Teva Pharmaceuticals USA, Inc.
Eva Temkin, Associate Director for Policy (Acting), Office of Therapeutic Biologics and Biosimilars, CDER, FDA
Moderated by John R. Manthei, Partner, Latham & Watkins LLP

Sandra B. Eskin, Project Director, Safe Food, The Pew Charitable Trusts
Bryan Hitchcock, Senior Director, Food Chain and Executive Director, Global Food Traceability Center, Institute of Food Technologists (IFT)
Sharon L. Mayl, Senior Advisor for Policy, OC, FDA
Moderated by Martin J. Hahn, Partner, Hogan Lovells US LLP

Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
Stacey Younger Gagosian, Managing Director, Public Policy, Truth Initiative
Matthew R. Holman, Director, Office of Science, CTP, FDA

Laura Epstein, Sr. Policy Advisor, CVM, FDA
Clint Nesbitt, Senior Director, Science and Regulatory Affairs, Food & Agriculture, Biotechnology Innovation Organization (BIO)
Moderated by Karen Ellis Carr, Partner, Arent Fox LLP

11:45 AM – 12:00 PM | Transition

1:25 – 1:30 PM | Transition

1:30 – 2:30 PM | Breakout Sessions

Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
Moderated by Margaret (Mimi) Foster Riley, Professor, University of Virginia, Schools of Law and Medicine and Member, FDLI Board of Directors

Jeffrey K. Francer, Interim CEO & General Counsel, Association for Accessible Medicines (AAM) and Member, FDLI Board of Directors
Gregory H. Levine, Partner, Ropes & Gray LLP

Megan Coder, Executive Director, Digital Therapeutics Alliance
Kyle Y. Faget, Of Counsel, Foley & Lardner LLP
Moderated by Suzan Onel, Partner, Kleinfeld, Kaplan, & Becker, LLP

Christopher M. Mikson, Partner, DLA Piper LLP (US)
Joshua Whitehill, Counsel, Goodwin Procter LLP

Andrea G. Ferrenz, Food Law Counsel, Campbell Soup Company
Moderated by Stuart M. Pape, Shareholder, Polsinelli PC

Clive Bates, Director, Counterfactual Consulting Limited
Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Moderated by Barry Schaevitz, Partner, Fox Rothschild LLP

2:30 – 2:40 PM | Transition

2:40 – 3:40 PM | Breakout Sessions

Mitchell R. Zeller, Director, Center for Tobacco Products, FDA
Moderated by Dean R. Cirotta, President, EAS Consulting Group and Member, FDLI Board of Directors

Wade Ackerman, Partner, Covington & Burling LLP
Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP
Elizabeth Richardson, Director, Health Care Products Project, The Pew Charitable Trusts

Robert C. Fish, Senior Advisor for Quality and Compliance, EAS Consulting Group, LLC
Anita R. Michael, Principal Consultant, Parexel International
Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors

Megan Olsen, Vice President & Associate General Counsel, Council for Responsible Nutrition
Sarah T. Roller, Partner, Kelley Drye & Warren LLP
Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton LLP

Nancy E. Halpern, Partner, Fox Rothschild LLP

3:40 – 4:00 PM | Coffee and Networking Break

Benjamin L. England, Founder and CEO, Benjamin L. England & Associates LLC / FDAImports.com, LLC
John A. Murphy, Deputy General Counsel, Biotechnology Innovation Organization (BIO)

5:30 – 7:00 PM | Networking Reception

Friday, May 8

Led by a FDLI-member expert, these informal facilitated discussions provide an ideal way to engage with colleagues, gain new information, and share best practices on a hot topic in food and drug law. Attendees have the option to choose from one of the 20+ topics or enjoy open seating during breakfast.

Laura Brown, Director, Educational Programs, FDLI

Sheldon Bradshaw, Partner, King & Spalding LLP
Elizabeth Dickinson, Senior Deputy Chief Counsel, FDA Office of the Commissioner
Peter Barton Hutt, Senior Counsel, Covington & Burling LLP
Rebecca Wood, Partner, Sidley Austin LLP
Interviewed by Amy Comstock Rick, President & CEO, FDLI

10:00 – 10:20 AM | Coffee and Networking Break

10:20 – 11:20 AM | Breakout Sessions

Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA  
Moderated by Freddy A. Jimenez, Vice-President, Law and Compliance, Celldex Therapeutics, Inc. and Secretary and General Counsel, FDLI Board of Directors

Julie A. Dohm, Of Counsel, Covington & Burling LLP
Eileen McMahon, Partner, Torys LLP
Moderated by Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP

Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health, Inc. and Member, FDLI Board of Directors
Kimberly J. Gold, Partner, Reed Smith LLP

Dale J. Giali, Partner, Mayer Brown LLP
Maia C. Kats, Of Counsel, Kaplan Fox & Kilsheimer, LLP
Nury H. Yoo, Counsel, Keller and Heckman LLP

11:20 – 11:30 AM | Transition

11:30 – 12:30 PM | Breakout Sessions

Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
Moderated by Miriam Guggenheim, Partner, Covington & Burling and Member, FDLI Board of Directors

Alexis Miller, Senior Director, Global Regulatory Science & Policy, Sanofi
Moderated by Deborah M. Shelton, Partner, Arent Fox LLP

John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, Office of the Commissioner, FDA

Sara Tucker, Partner, Womble Bond Dickinson (US) LLP
Zach Rothstein, VP, Technology & Regulatory Affairs, AdvaMed
Moderated by David J. Bloch, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic

Paul Joseph, Of Counsel, Foley & Lardner LLP
David C. Spangler, Sr. Vice President, Policy, and General Counsel, Consumer Healthcare Products Association (CHPA)
Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP

Kathleen Hoke, Professor & Director, Network for Public Health Policy and Center for Tobacco Regulation, University of Maryland Carey School of Law
Desmond Jenson, Lead Senior Staff Attorney for Federal Regulation, Commercial Tobacco Control Program, Public Health Law Center, Mitchell Hamline School of Law

Service to FDLI Award

Presented by Amy Comstock Rick, President & CEO, FDLI and Laura Brown, Director, Educational Programs, FDLI


Dr. Harvey Wiley Lecture and FDAAA Award

A lectureship named in honor of Dr. Harvey W. Wiley, the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of “Father of the Pure Food and Drugs Act” when it was enacted into law in 1906.

1:40 –1:45 PM | Transition

1:45-2:45 PM | Breakout Sessions

Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA
Moderated by Daniel A. Kracov, Partner, Arnold & Porter LLP and Vice Chair, FDLI Board of Directors

Kalah Auchincloss, SVP, Regulatory Compliance & Deputy General Counsel, Greenleaf Health, Inc.
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP
Adora Ndu, Vice President, Regulatory Affairs, Policy, Research, Engagement (PRE) & Reg International, BioMarin Pharmaceutical Inc. and Co-Chair, 2020 FDLI Annual Conference

Jonathan M. Cohen, Partner, K&L Gates LLP
Robert Durkin, Of Counsel, Arnall Golden Gregory LLP
Meredith Q. Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company

2:45 – 3:00 PM | Coffee and Networking Break

Always informative and entertaining, this perennially popular session promises insight into the most significant litigation from 2019 and a look at cases to keep an eye on in 2020. Annual Conference attendees receive the companion publication, Top Food and Drug Law Cases 2019, and Cases to Watch, 2020

4:15 PM | Conference Adjournment