Tuesday, May 18
Amy Comstock Rick, President & CEO, FDLI
Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference
Janet Woodcock, Acting Commissioner of Food and Drugs, FDA
Introduced by Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors
Mark J. Raza, Acting Chief Counsel, FDA
The FDLI Distinguished Service and Leadership Award, established in 1993, recognizes individuals who have made notable contributions to the food and drug law community through their leadership.
Robert M. Califf, Donald F. Fortin, M.D. Distinguished Professor of Cardiology, Duke University School of Medicine
Andrew C. von Eschenbach, President, Samaritan Health Initiatives
Moderated by Amy Comstock Rick, President & CEO, FDLI
2:45 – 3:45 PM | Concurrent Breakout Sessions
Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
Moderated by Amy Norris, Executive Counsel, Clif Bar & Company and Member, FDLI Board of Directors
Mitchell R. Zeller, Director, Center for Tobacco Products, FDA
Moderated by Dean R. Cirotta, President, EAS Consulting Group and Member, FDLI Board of Directors
Angela Krueger, Deputy Director for Regulatory Policy, Office of Product Evaluation and Quality, CDRH, FDA
Rita Livadas, Director, Government Affairs, Becton, Dickinson and Company (BD)
Ryan Murray, Assistant General Counsel, Eli Lilly and Company
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Moderated by Neil P. Di Spirito, Member of the Firm, Epstein Becker & Green, PC
Susan S. Lee, Partner, Hogan Lovells US LLP
Moderated by Matthew Keenan, Partner, Shook, Hardy & Bacon LLP
Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC
Michael Frohbergh, Managing Scientist, Exponent, Inc.
Nathan Sheers, Partner, Paul Hastings
3:45 – 4:15 PM | Concurrent Activities:
Joined by Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
Joined by Mitchell R. Zeller, Director, Center for Tobacco Products, FDA
- Machine Learning for Regulatory Attorneys and English Majors
Led by Bradley Merrill Thompson, Partner, Epstein Becker& Green, PC
- User Fee Reauthorization: What Can We Expect from Future Programs?
- Communicating Science
Jennifer Luray, Vice President, Strategy and Communications, Research!America
Erica M. Katherine, Ombudsman, Office of Regulatory Affairs, FDA
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.
Luciana Borio, Vice President, In-Q-Tel, Former Director for Medical and Biodefense Preparedness Policy, National Security Council, The White House; Acting Chief Scientist, FDA; and Assistant Commissioner for Counterterrorism and Emerging Threats, FDA
Wednesday, May 19
Laura Brown, Director, Educational Programs, FDLI
Erika F. Lietzan, Associate Professor, University of Missouri – Columbia School of Law and Co-Chair, 2021 FDLI Annual Conference
Judy A. McMeekin, Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, FDA
Mark Abdoo, Associate Commissioner for Global Policy and Strategy, OC, FDA
Winston S. Kirton, Partner, Winston & Strawn LLP
Peter V. Lindsay, Partner, Paul Hastings
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP
1:30 – 2:30 PM | Concurrent Breakout Sessions
Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
Moderated by Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health, Inc. and Member, FDLI Board of Directors
Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health, Inc.
John (Jack) C. Garvey, Managing Partner, Compliance Architects LLC
Brian R. McCormick, Vice President & Chief Regulatory Counsel, Head, Global Regulatory Policy, TEVA Pharmaceuticals USA, Inc.
George O’Brien, Partner, Hogan Lovells US LLP
Michael K. Stern, Of Counsel, Covington & Burling LLP
Eva Temkin, Partner, King & Spalding LLP
Moderated by Andrew Wasson, Partner, Haug Partners LLP
Janice M. Hogan, Partner, Hogan Lovells US LLP
Bakul Patel, Director, Digital Health Center of Excellence, CDRH, FDA
Janet L. Michener Whipple, Partner, Validant
Moderated by Suzan Onel, Partner, Kleinfeld, Kaplan & Becker LLP
Meredith Q. Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Tara Lin Couch, Senior Director, Dietary Supplements and Tobacco Services, EAS Consulting Group
Patricia M. Miller, Managing Director, Regulatory Affairs, Altria Client Services LLC
Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
2:30 – 3:00 PM | Concurrent Activities:
Joined by Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
- Diagnostics Reform
Led by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs, CDRH, FDA
- How can lessons learned in the pandemic be applied towards advancing 21st century regulatory science?
Led by Peter Pitts, President, Center for Medicine in the Public Interest
3:00 – 4:00 PM | Concurrent Breakout Sessions
Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Immediate Past Chair, FDLI Board of Directors
Kellie B. Combs, Partner, Ropes & Gray LLP
John Concato, Associate Director, Real-World Evidence Analytics, Office of Medical Policy, CDER
Moderated by William B. Schultz, Partner, Zuckerman Spaeder LLP
Katie Laney, Principal Consultant, Validant
Collin Stabler, Senior Associate, Exponent, Inc.
Moderated by James N. Czaban, Partner, Loeb & Loeb LLP
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
Scott Bass, Partner, Sidley Austin LLP
Steven M. Mister, President & CEO, Council for Responsible Nutrition
4:00 – 4:30 PM | Concurrent Activities:
Joined by Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
- Regulatory Implications of Innovative Clinical Trial Designs
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP
The FDLI Distinguished Service and Leadership Award, established in 1993, recognizes individuals who have made notable contributions to the food and drug law community through their leadership.
Beth P. Weinman, Counsel, Ropes & Gray LLP
Thursday, May 20
Amy Comstock Rick, President & CEO, FDLI
RADM Richardae Araojo, Associate Commissioner for Minority Health, Office of the Commissioner, FDA
Introduced by Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors
Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors
12:45 – 1:45 PM | Concurrent Breakout Sessions
Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA
Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
Ann M. Begley, Partner, Wiley LLP
John F. Johnson, Of Counsel, Shook, Hardy & Bacon LLP
David C. Spangler, Senior Vice President, Legal Government Affairs & Policy, Consumer Healthcare Products Association
Aaron Friedman, Senior Regulatory Counsel, Office of Orphan Products Development, OC, FDA
Brian J. Malkin, Partner, McDermott Will & Emery
Jewell Martin, Associate Director for US Regulatory Policy, BioMarin Pharmaceutical, Inc.
Moderated by Erika F. Lietzan, Associate Professor, University of Missouri – Columbia School of Law and
Kevin Fu, Acting Director, Medical Device Cybersecurity, Program Director for Cybersecurity, Digital Health Center of Excellence, CDRH, FDA
Vernessa T. Pollard, Partner, McDermott Will & Emery LLP
Moderated by David J. Bloch, Senior Principal Legal Counsel, Medtronic
Sarah Sorscher, Deputy Director of Regulatory Affairs, CSPI
John Troup, Vice President, Scientific Affairs and Dietary Supplements, Consumer Healthcare Products Association
Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton LLP
Paige Magness, Senior Vice President, Regulatory Affairs, Altria Client Services
Moderated by Elizabeth Oestreich, Vice President, Regulatory Compliance, Greenleaf Health, Inc.
1:45 – 2:15 PM | Concurrent Activities:
Joined by Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA
- Moving from Unapproved to Approved Drug Products – How Can Companies Utilize Compounded and DESI Product Markets?
Led by Lee Rosebush, Partner, BakerHostetler
- Remote Regulatory Assessments: To Be Avoided or Embraced?
Led by Andrea Chamblee, Associate Adjunct Professor, George Washington University School of Medicine and Public Health
2:15 – 3:15 PM | Concurrent Breakout Sessions
Patrizia Cavazzoni, Acting Director, Center for Drug Evaluation and Research, FDA
Moderated by Carla Cartwright, Senior Director, Global Digital and Regulatory Policy, Johnson & Johnson and Member, FDLI Board of Directors
Thomas (Tommy) Miller, Senior Counsel, Nixon Gwilt Law
Imein Bousnina, Associate Program Director, US Regulatory Policy, Genentech, Inc.
Bakul Patel, Director, Digital Health Center of Excellence, CDRH, FDA
Moderated by Lisa M. Dwyer, Partner, King & Spalding, LLP
Jason Dietz, Senior Policy Advisor, CFSAN, FDA
Laura R. Epstein, Senior Policy Advisor, CVM, FDA
Robert (Bob) Hibbert, Senior Counsel, Wiley LLP
Gregory Jaffe, Biotechnology Project Director, CSPI
Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference
Beth G. Oliva, Partner, Fox Rothschild LLP
Katherine Ciambrone, Executive Vice President, Compliance, Cresco Labs
Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Deborah Miran, Consultant, DMiran Consulting
David M. Woods, Partner, Hughes Hubbard & Reed LLP
3:15 – 3:45 PM | Concurrent Activities:
Joined by Patrizia Cavazzoni, Acting Director, Center for Drug Evaluation and Research, FDA
The Service to FDLI Award, established in 2017, honors FDLI members who have provided exceptional volunteer services to FDLI, furthering FDLI’s mission as a neutral convener to educate and spark innovative change.
Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2020, and Cases to Watch, 2021.
William M. Janssen, Professor of Law, Charleston School of Law
Moderated by August T. Horvath, Partner, Foley Hoag LLP
5:15 PM | Conference Adjournment