FDLI Annual Conference to Discuss the Animal Drug Compounding Debate and other important issues

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast8:30–8:45 AM: Welcome

Amy Comstock Rick, President & CEO, FDLI
David V. Ceryak, Senior Director – Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, Acting Commissioner of Food and Drugs, Food and Drug Administration (FDA)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Chair, FDLI Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization
Eric Lindblom, Director, Tobacco Control and Food & Drug Law, O’Neill Institute for National and Global Health Law, Georgetown Law
Nancy Myers, President, Catalyst Healthcare Consulting
William Schultz, Partner, Zuckerman Spaeder LLP
Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break10:45–11:30 AM: Breakout Sessions

Drug Development: Legal Considerations, Challenges, and Solutions for Data Collaboration in the Pre-Competitive Setting
Behnam Dayanim, Partner, Paul Hastings LLP
Richard Liwski, Chief Technology Officer and Director of Data Collaboration Center, Critical Path Institute
Moderated by Klaus Romero, Director, Clinical Pharmacology, Critical Path Institute

Laboratory Developed Tests: What Now? 
Helena Duncan, Assistant Director of Economic and Regulatory Affairs, College of American Pathologists
Jeanne Ireland, Principal, Ireland Strategies LLC
Sheila Walcoff, CEO & Founder, Goldbug Strategies LLC
Moderated by Nancy Stade, Partner, Sidley Austin LLP

Key Regulatory Issues in Biosimilars
Joe Franklin, Associate Director for Policy, Therapeutic Biologics & Biosimilars Staff, Office of New Drugs, CDER, FDA
Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Christine Simmon, Senior Vice President of Policy and Strategic Alliances, Association of Accessible Medicines and Executive Director, Biosimilars Council
Moderated by John R. Manthei, Partner, Latham & Watkins LLP

New Food Ingredients: US and EU Requirements and Strategic Considerations
Nicole Coutrelis, Partner, Coutrelis & Associes
Dennis M. Keefe, Director, Office of Food Additive Safety, CFSAN, FDA
Cathy Weir, Adjunct Faculty Member, Institute for Food Laws and Regulations, Michigan State University
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC

The Animal Drug Compounding Debate
Rachael G. Pontikes, Partner, Duane Morris LLP
Ted Sullivan, Partner, Quarles & Brady LLP
Moderated by Brian J. Malkin, Counsel, Arent Fox LLP

Tobacco Product Standards for Combustible Products: Nicotine and Beyond
Michael Cummings, Professor, Psychiatry & Behavioral Sciences, Co-lead Tobacco Research, Hollings Cancer Center, Medical University of South Carolina
Raymond Niaura, Director of Science and Training, Schroeder Institute for Tobacco Research and Policy Studies
Sudhanshu Patwardhan, Senior International Engagement Manager, Nicoventures Ltd., British American Tobacco
Irina Stepanov, Associate Professor, Division of Environmental Health Science, Masonic Cancer Center, University of Minnesota
Moderated by Jack Henningfield, Vice President, Research & Health Policy, Pinney Associates, Inc.

11:30–11:45 AM: Transition11:45 AM–12:30 PM: Breakout Sessions

Communicating Emerging Drug Therapies Prior to FDA Approval
Michelle Drodz, Deputy Vice President, Policy and Research, Pharmaceutical Research Manufacturers Association (PhRMA)
Michael Labson, Partner, Covington & Burling LLP
Moderated by Soumi Saha, Assistant Director of Pharmacy & Regulatory Affairs, Academy of Managed Care Pharmacy (AMCP)

Digital Health Technologies: A New FDA Regulatory Paradigm
Moderated by Kim Tyrrell-Knott, Member of the Firm, Epstein, Becker & Green, PC

Biologics Across the Globe: New Regulatory Challenges and Opportunities
Freddy A. Jimenez, Vice-President, Law and Compliance, Celldex Therapeutics, Inc. and Member, FDLI Board of Directors
Adora Ndu, Senior Director of Regulatory Policy, BioMarin Pharmaceutical, Inc.
Moderated by Lance Shea, Partner, Baker & Hostetler LLP

Food and Dietary Supplement Class Action Litigation in a World of Less Regulation
Jonathan Berman, Partner, Jones Day
Maia Kats, Director of Litigation, Center for Science in the Public Interest
Moderated by Anthony Anscombe, Partner, Sedgwick LLP

Patient-Centric Perspectives: Models for Patient Engagement
Marc Boutin, Chief Executive Officer, National Health Council
Kathryn O’Callaghan, Assistant Director for Strategic Programs, CDRH, FDA
Moderated by Jeffrey N. Gibbs, Director, Hyman Phelps & McNamara, PC and Chair, FDLI Board of Directors

Criminal Prosecutions Under the Food, Drug & Cosmetic Act
Perham Gorji, Deputy Chief Counsel for Litigation, Office of Chief Counsel, FDA
George M. Karavetsos, Partner, DLA Piper LLP
Moderated by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Member, FDLI Board of Directors

12:30–2:00 PM: Luncheon

FDLI Distinguished Service and Leadership AwardsPresented by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Chair, FDLI Board of Directors and Amy Comstock Rick, President & CEO, FDLI

Award Recipients:
Edward Basile, Senior Partner (retired), King & Spalding LLP
Theresa Mullin, Director, Office of Strategic Programs, CDER, FDA
Anthony Young, Partner, Kleinfeld, Kaplan & Becker, LLP

Keynote Speaker

2:00–2:15 PM: Transition2:15–3:30 PM: Breakout Sessions: FDA Center Directors

Center for Drug Evaluation and Research (CDER)
Richard A. Moscicki, Deputy Director for Science Operations, CDER, Office of Medical Products and Tobacco, FDA
Cathy Burgess, Partner, Alston & Bird LLP
Peter Pitts, President, Center for Medicine in the Public Interest
Rachel Turow, Executive Counsel – Regulatory Law, TEVA Pharmaceuticals
Moderated by Sheldon Bradshaw, Partner, King & Spalding LLP

Center for Devices and Radiological Health (CDRH)
Jeffrey Shuren, Director, CDRH, Office of Medical Products and Tobacco, FDA
Mark Brown, Partner, King & Spalding LLP
David K. Elder, Executive Vice President, Regulatory Compliance, Greenleaf Health LLC
Janet E. Trunzo, Senior Executive Vice President, Technology & Regulatory Affairs, AdvaMed
Moderated by Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic and Member, FDLI Board of Directors

Center for Biologics Evaluation and Research (CBER)
Peter W. Marks, Director, CBER, Office of Medical Products and Tobacco, FDA
Lori Hirsch, Managing Counsel, Merck & Co., Inc.
Daniel Kracov, Partner, Arnold & Porter Kaye Scholer LLP, and Member, FDLI Board of Directors
Michael Werner, Partner, Holland & Knight LLP and Executive Director, Alliance for Regenerative Medicine
Moderated by Neil DiSpirito, Of Counsel, Ballard Spahr LLP

Center for Food Safety and Applied Nutrition (CFSAN)
Susan T. Mayne, Director, CFSAN, Office of Foods and Veterinary Medicine, FDA
Rend Al-Mondhiry, Associate General Counsel, Council for Responsible Nutrition
John H. Fuson, Partner, Crowell & Moring LLP
Amy Norris, Chief Counsel, Clif Bar & Company
Moderated by Melvin S. Drozen, Partner, Keller and Heckman LLP

Center for Veterinary Medicine (CVM)
Steven M. Solomon, Director, CVM, Office of Foods and Veterinary Medicine, FDA
Adam Ekonomon, Vice President and Deputy General Counsel, The J.M. Smucker Company
David P. Jones, Legal Director, Merck Animal Health
Moderated by Jeannie M. Perron, Partner, Covington & Burling LLP

Center for Tobacco Products (CTP)
Mitchell R. Zeller, Director, CTP, Office of Medical Products and Tobacco, FDA
Scott Ballin, Health Policy Analyst
Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville and a Fellow of the American Heart Association
David Sweanor, Adjunct Professor, Faculty of Law, University of Ottowa
Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP and Member, FDLI Board of Directors

3:30–4:00 PM: Coffee and Networking Break4:00–4:45 PM: Breakout Sessions

Legal Limits on Pharmacy Adherence and Discount Programs
Don L. Bell, II, SVP & General Counsel, National Association of Chain Drug Stores (NACDS)
Moderated by J. Mason Weeda, Attorney, Olsson Frank Weeda Terman Matz PC

The New EU Medical Device Regulations
Sarah H. Stec, Associate, Squire Patton Boggs
Moderated by Phil Johnson, Senior Director, Quality & Compliance Services, QuintilesIMS

Emerging Issues and Trends in Biologics Compliance and Enforcement
John McShane, Managing Partner, Validant
Mark Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
Moderated by Michael Druckman, Partner, Hogan Lovells LLP

What’s the Score with SCORE? FDA’s Guidelines for Food Safety and Enforcement
Glenn Bass, Director, Office of Food and Feed Operations, ORA, FDA,
William Correll, Director, Office of Compliance, CFSAN, FDA
Don L. Zink, President – Division of Foods & Regulatory Compliance, IEH Laboratories and Consulting Group
Moderated by Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP

Veterinary Products and FTC Enforcement
Jesse J. Sevcik, Sr. Director, Global Government Affairs, Elanco Animal Health
Moderated by Gary L. Yingling, Senior Counsel, Morgan, Lewis & Bockius LLP

CTP’s Evaluation of Premarket and Modified Risk Tobacco Product Applications
Benjamin J. Apelberg, Supervisory Health Scientist, Office of Science, CTP, FDA
Moderated by Bryan M. Haynes, Partner, Troutman Sanders LLP

4:45–5:00 PM: Transition

5:00–5:30 PM: Address

Elizabeth H. Dickinson, Chief Counsel, FDA
Introduced by Scott M. Melville, President & CEO, Consumer Healthcare Products Association (CHPA) and Member, FDLI Board of Directors

5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged   RSVP Required
8:45–9:30 AM: Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Service to FDLI Award
Presented by Bob Rhoades, Managing Partner, Validant and Member, FDLI Board of Directors and Amy Comstock Rick, President & CEO, FDLI
Award Recipient: Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Pfizer, Inc.

Dr. Harvey W. Wiley Lecture and FDAAA Award Presentation 
Margaret Hamburg, Foreign Secretary, National Academy of Medicine – National Academy of Science, Engineering and Medicine and former FDA Commissioner
Presented by Nancy Myers, President, Catalyst Healthcare Consulting

9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization Update

Dara Corrigan, Acting Deputy Commissioner for Global Regulatory Operations and Policy, FDAIntroduced by Frederick R. Ball, Partner, Duane Morris LLP and Member, FDLI Board of Directors

10:00–10:30 AM: Coffee and Networking Break10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks

Thomas J. Cosgrove, Director, Office of Manufacturing Quality, CDER, FDA
Retsef Levi, J. Spencer Standish Professor of Operations Management, MIT Sloan School of Management
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health LLC
Moderated by Brooke Schumm III, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, PC

11:15–11:30 AM: Transition11:30 AM–12:15 PM: Breakout Sessions

Challenges and Opportunities in Combination Medical Product Regulation
James A. Boiani, Member of the Firm, Epstein, Becker & Green PCJohn (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
Moderated by Kirsten Paulson, Senior Director, Global CMC – Medical Devices, Pfizer, Inc.

FDA’s Implementation of the 21st Century Cures Act
Wade Ackerman, Partner, Covington & Burling LLP
Jonette Foy, Acting Associate Director for Policy, CDRH, FDA
Julia Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDA
Moderated by Carla Cartwright, Director, Federal Affairs, Johnson & Johnson

Regulation of Cannabis in FDA-Regulated Products
Jonathan A. Havens, Associate, Saul Ewing LLP
Colin Mudd, National Compliance Director, MC Management LLC
Douglas Throckmorton, Deputy Center Director for Regulatory Programs, CDER, FDA
Emily Leongini, Associate, Arent Fox LLP

Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTC
Jason W. Gordon, Counsel, Reed Smith LLP
Kristi L. Wolff, Partner, Kelley Drye & Warren LLP
Moderated by Linda Goldstein, Partner, Baker & Hostetler LLP

CTP’s Compliance and Enforcement Initiatives Post-Deeming
Ann Simoneau, Director, Office of Compliance and Enforcement, CTP, FDA
Moderated by Stacey Gagosian, Managing Director of Public Policy, Truth Initiative

12:15–12:30 PM: Transition 
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition 
1:45–2:30 PM: Breakout Sessions

FDA’s User Fee Program Reauthorization Update
Remy Brim, Minority Health Policy Office, U.S. Senate HELP Committee
Margaret Coulter, Majority Health Policy Office, U.S. Senate HELP Committee
Tiffany Guarascio, Deputy Chief of Staff and Chief Health Advisor, Committee on Energy and Commerce, U.S. House of Representatives
John Stone, Senior Counsel, Committee on Energy and Commerce, U.S. House of Representatives
Moderated by Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts

Changing Landscape of IoT: Medical Device Privacy and Cybersecurity
Matthew Barrett, Program Manager of Cybersecurity Framework, National Institute of Standards and Technology (NIST)
Zachary Rothstein, Associate Vice President, Technology & Regulatory Affairs, AdvaMed
Suzanne Schwartz, Associate Director for Science, CDRH, FDA
Moderated by Sonali Gunawardhana, Of Counsel, Wiley Rein LLP

Defending Your Product: Crisis Management, Recalls, and Strategy
James Ladner, Deputy General Counsel – Litigation & Investigations, Abbott 
Meredith Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Mark Mansour, Partner, Mayer Brown LLP

Economic Considerations for Biosimilar Litigation 
Richard Mortimer, Managing Principal, Analysis Group, Inc.
Anne Marie Polak, Senior Director, Leavitt Partners, LLCModerated by Lynn Rzonca, Partner, Ballard Spahr LLP

Tobacco Harm Reduction: Opportunities and Regulatory Pathways to Achieve 
Marc S. Firestone, Senior Vice President & General Counsel, Philip Morris International
Joe Murillo, Vice President Regulatory Affairs, Altria Client Services
James M. Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Moderated by Dean R. Cirotta, President & COO, EAS Consulting Group

2:30–2:45 PM: Coffee and Networking Break2:45–3:30 PM: Keynote Address3:30–4:30 PM: Top 10 Cases in Food and Drug Law

Laurie Beyranevand, Senior Faculty Fellow of Food Law and Policy, Center for Agriculture and Food Systems, and Professor of Law, Vermont Law School
William M. Janssen, Professor of Law, Charleston School of Law
Francis B. Palumbo, Professor and Executive Director, University of Maryland School of Pharmacy and Member, FDLI Board of Directors
Moderated by Lynn Tyler, Partner, Barnes & Thornburg LLP

4:30 PM: Conference Adjournment

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