Why Attend

Preliminary Agenda

 

CLE

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.

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

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