Agenda Subject to Change
All Times Listed in Eastern Time

Wednesday, December 6

FDLI Welcome, Opening Remarks, and Keynote Address
Christine M. Simmon, President & CEO, Food and Drug Law Institute
Beth P. Weinman, Counsel, Ropes & Gray LLP and Chair, FDLI Enforcement, Litigation, and Compliance Conference Planning Committee


Keynote Address
Arun G. Rao, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, U.S. Department of Justice

Jill Atencio, Deputy Director, Office of Compliance and Enforcement, Center for Tobacco Products, FDA
Jill Furman, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
Maria Knirk, Acting Director, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA
Melissa Mendoza, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, FDA
Timothy C. Schell, Director, Office of Surveillance and Compliance, Center for Veterinary Medicine, FDA
Keisha Thomas, Associate Director for Compliance and Quality, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, FDA
Moderated by John C. Garvey, Managing Partner, Compliance Architects LLC

11:10–11:30 AM | Networking and Refreshment Break

Donald D. Ashley, Executive Vice President, Regulatory Compliance, Greenleaf Health
Elizabeth B. Fawell, Partner, Hogan Lovells LLP
Douglas Stearn, Acting Deputy Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, FDA
Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP

12:30–1:30 PM  | Luncheon

1:30–2:30 PM | Concurrent Breakout Sessions 1

Nate Krevor, Managing Associate, Sidley Austin LLP
Peter V. Lindsay, Partner, Paul Hastings, LLP
Chris Middendorf, Vice President, Technical, Parexel
Moderated by Steven J. Lynn, Executive Principal Consultant, Pharma and Biologics, Regulatory Compliance Associates

M. Jason Brooke, Managing Member and Attorney, Brooke & Associates
Sonia Nath, Partner, Cooley LLP
Dharmesh Patel, Associate Director, Regulatory Policy Public Affairs, Beckton Dickinson (BD)

William M. Droze, Partner, Troutman Pepper Hamilton Sanders LLP
Evangelia C. Pelonis, Partner, Keller and Heckman LLP
Xin Tao, Partner, Baker & McKenzie LLP (rec by Maria McMahon
Moderated by Andrea G. Ferrenz, Food Law Counsel, Campbell Soup Company

Brittani Cushman, Senior Vice President, General Counsel, and Secretary, Turning Point Brands, Inc.
Barry Schaevitz, Partner, Fox Rothschild LLP
Moderated by J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP

2:45–3:45 PM | Concurrent Breakout Sessions 2

Shelby Buettner, Assistant General Counsel, Regulatory Law and Compliance Counsel, Becton Dickinson (BD)
Minal M. Caron, Counsel, Ropes & Gray LLP
Eric S. Pittman, Program Division Director, Bioresearch Monitoring West, Office of Bioresearch Monitoring Operations, ORA, FDA
Moderated by Blake E. Wilson, Partner, Hogan Lovells LLP

Shannon Bennett, Quality Manager, Mayo Clinic
Mahnu V. Davar, Partner, Arnold & Porter
Carly McWilliams, Head of Regulatory Policy, North America, Roche, Inc.
Moderated by Stacy Cline Amin, Partner, Morrison and Foerster, LLP

John Bailey, Consultant for Cosmetics and Colors, EAS Consulting Group
Jacqueline J. Chan, Assistant General Counsel, Regulatory & Marketing, Unilever
Linda M. Katz, Director, Office of Cosmetics & Colors, CFSAN, FDA
Moderated by Kalah Auchincloss, Executive Vice President, Regulatory Compliance & Deputy General Counsel, Greenleaf Health, Inc.

John O’Brien, Vice President and Assistant General Counsel – Regulatory, RAI Services Company (Reynolds American Inc.)
Captain Sonia Pruitt (Retired), Past President, National Black Police Association and Founder, Black Police Experience
Lindsey Stroud, Director, Consumer Center, Taxpayers Protection Alliance
Moderated by Bryan M. Haynes, Partner, Troutman Pepper Hamilton Sanders LLP

Alan Phelps, Deputy Director, Consumer Protection Branch, U.S. DOJ
Shannon M. Singleton, Assistant Deputy Chief Counsel for Litigation, Office of the Chief Counsel (OCC), FDA
Serena Viswanathan, Associate Director, Division of Advertising Practices, Bureau of Consumer Protection, FTC
Moderated by Gustav W. Eyler, Partner, Gibson, Dunn & Crutcher LLP

5:15–7:30 PM | FDLI 2023 Annual Holiday Reception

Thursday, December 7

Steven Leslie, Director, Educational Programs, Food and Drug Law Institute

John W.M. Claud, Counsel, Hyman Phelps & McNamara P.C.
Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Beth P. Weinman, Counsel, Ropes & Gray LLP and Chair, FDLI Enforcement, Litigation, and Compliance Conference Planning Committee
Moderated by John D.W. Partridge, Partner, Gibson Dunn LLP

10:30–11:30 AM | Concurrent Breakout Sessions 3

Kelly A. Bonner, Associate, Duane Morris LLP
Andrew Kim, Partner, Goodwin Procter LLP

Perham Gorji, Partner, DLA Piper LLP
Anne K. Miller, Legal Counsel, Medtronic
Marc N. Wagner, Associate, Baker & Hostetler LLP
Moderated by Mark C. Levy, Member, Eckert Seamans Cherin & Mellott, LLC

11:45–12:45 PM | Concurrent Breakout Sessions 4

Ethan P. Davis, Partner, King & Spalding LLP
Hamsa Mahendranathan, Partner, Constantine Cannon LLP
Jamie Yavelberg, Director, Commercial Litigation Branch, Civil Division – Fraud Section, U.S. DOJ
Moderated by Ilene Albala, Partner, Goodwin Procter LLP

Taryn Horr, Managing Scientist, Exponent, Inc.
Edward A. Imperatore, Partner, Morrison & Foerster LLP
Fred Medick, Assistant General Counsel, Genentech, Inc.
Moderated by Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC

Neil P. Di Spirito, Principal Partner, Di Spirito Law PLLC
Kim Gold, Chief Privacy Officer, Genentech, Inc.
Nancy L. Perkins, Counsel, Arnold & Porter

12:45–2:00 PM  | Luncheon Address: Tenth Annual Eric M. Blumberg Memorial Lecture
Peter Barton Hutt, Senior Counsel, Covington & Burling LLP

2:00 PM  | Conference Adjournment