Wednesday, May 17
Christine M. Simmon, President & CEO, FDLI
Mantej (Nimi) Chhina, Senior Director, Head of Global R&D and Regulatory Policy, Global Regulatory Affairs, BioMarin Pharmaceutical, Inc. and Co-Chair, 2023 FDLI Annual Conference
Jonathan Havens, Partner, Saul Ewing Arstein & Lehr LLP and Co-Chair, 2023 FDLI Annual Conference
Robert Califf, Commissioner of Food and Drugs, FDA (Invited)
Introduced by Freddy A. Jimenez, Senior Vice President and General Counsel, Celldex Therapeutics and Chair, FDLI Board of Directors
Mark J. Raza, Chief Counsel, FDA
10:00–10:30 AM | Break
Andi Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs, Office of the Commissioner, FDA
Barrett Tenbarge, Senior Health Counsel, Senate Committee on HELP
Moderated by Christine M. Simmon, President & CEO, FDLI
Brian Burgess, Partner, Goodwin Procter LLP
Moderated by Stacy Cline Amin, Partner, Morrison and Foerster, LLP
FDLI Distinguished Service and Leadership Award
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.
2:00–3:00 PM | Concurrent Breakout Sessions 1
During this session, FDA leadership will address the top issues CFSAN is facing as well as priorities and goals for the coming year.
Susan T. Mayne, Director, CFSAN, FDA
Douglas W. Stearn, Deputy Director, Regulatory Affairs, CFSAN, FDA
Jacqueline Corrigan-Curay, Principal Deputy Center Director, CDER, FDA
Michael K. Stern, Of Counsel, Covington & Burling LLP
Moderated by Annie Kennedy, Chief of Policy, Advocacy & Patient Engagement, EveryLife Foundation for Rare Diseases
Leah Christl, Executive Director, Head of Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy, Amgen, Inc.
Rachel Turow, Associate General Counsel, Regulatory Law & Policy, TEVA Pharmaceuticals USA, Inc. and Member, FDLI Board of Directors
Mustafa Unlu, Regulator Counsel, Office of Therapeutic Biologics and Biosimilars, CDER, FDA
Moderated by Michael Werner, Partner, Holland & Knight LLP
M. Jason Brooke, Attorney & Managing Member, Brooke & Associates
Cassie Scherer, Senior Director, U.S. Regulatory and Global Digital Health Policy, Medtronic
Blake E. Wilson, Partner, Hogan Lovells US LLP
Gustav W. Eyler, Partner, Gibson, Dunn & Crutcher LLP
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
3:15–4:15 PM | Concurrent Breakout Sessions 2
During this session, FDA leadership will address the top issues CDRH is facing as well as priorities and goals for the coming year.
Jeffrey Shuren, Director, Center for Devices and Radiological Health, FDA
Moderated by Vernessa Pollard, Partner, McDermott Will & Emery LLP and Member, FDLI Board of Directors
Lionel Phillips, President, Inside Edge Consulting Group
Shanta Whitaker, Senior Director, Policy, Government Affairs, and Advocacy, American Diabetes Association
Rachel Sher, Partner, Manatt, Phelps & Phillips, LLP
Pamela L. Simpkins, Senior Director, Child Health Innovation Leadership Department, Johnson & Johnson
Jeremiah J. Kelly, Partner, Venable LLP
Aaron Friedman, Associate Director for Policy, Office of Orphan Products Development, Office of the Commissioner, FDA
Michael Hidock, Principal Consultant, IQVIA
Bethany J. Hills, Partner, DLA Piper LLP (US)
Joshua M. Oyster, Partner, Ropes & Gray LLP
Moderated by Winston S. Kirton, Partner, BakerHostetler
Sharon Lindan Mayl, Partner, DLA Piper LLP (US)
Sarah Sorscher, Director of Regulatory Affairs, Center for Science in the Public Interest
4:30–5:30 PM | Concurrent Breakout Sessions 3
During this session, FDA leadership will address the top issues CBER is facing as well as priorities and goals for the coming year.
Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA
Jason Bunting, Science Policy Advisor, CDER, FDA
Cathy L. Burgess, Partner, Alston & Bird LLP
Julie Dohm, Of Counsel, Covington & Burling LLP
Bradley Merrill Thompson, Partner, Epstein Becker & Green, PC
Isabel Omer, Regulatory Policy Manager, Becton Dickinson (BD)
Madison Green, Director of Technical Operations, EMMA International
Xin Tao, Partner, Baker McKenzie
Jessica Tierney, Of Counsel, Jones Day
Patrick Cournoyer, Senior Science Advisor and Lead, Cannabis Products Committee, OC, FDA
Jonathan Havens, Partner, Saul Ewing Arstein & Lehr LLP and Co-Chair, 2023 FDLI Annual Conference
Andrew J. Kline, Senior Counsel, Perkins Coie LLP
5:30–7:00 PM | Networking Reception
Thursday, May 18
Laura Brown, Director, Educational Programs, FDLI
The Service to FDLI Award, established in 2017, honors FDLI members who have provided exceptional volunteer services to FDLI, in furtherance of our mission.
A lectureship in honor of Dr. Harvey W. Wiley, featuring the recipient of the namesake award bestowed by the FDA Alumni Association.
11:00 AM–12:00 PM | Concurrent Breakout Sessions 4
During this session, FDA leadership will address the top issues CDER is facing as well as priorities and goals for the coming year.
Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, FDA (Invited)
Moderated by Sonali P. Gunawardhana, Assistant General Counsel, Regulatory, Cardinal Health, Inc. and Member, FDLI Board of Directors
Mary Ann Chirba, Professor of the Practice, John C Ford, S.J., Distinguished Scholar, Boston College Law School
Collin Stabler, Managing Engineer, Exponent, Inc.
Eva Temkin, Partner, King & Spalding LLP
Celia M. Witten, Acting Super Office Director, Office of Therapeutic Products, CBER, FDA
Elizabeth J. Hillebrenner, Associate Director for Scientific and Regulatory Programs, CDRH, FDA
Elizabeth M. Richards, Partner, Latham & Watkins LLP
Rumi Young, Director, Regulatory Policy, Becton Dickinson (BD)
Dale Cooke, President, PhillyCooke Consulting
Meredith Quinn Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Smitha G. Stansbury, Partner, King & Spalding LLP
Bryan Haynes, Partner, Troutman Pepper Hamilton Sanders LLP
12:00–1:00 PM | Networking Lunch
1:00–2:00 PM | Concurrent Breakout Sessions 5
During this session, FDA leadership will address the top issues CVM is facing as well as priorities and goals for the coming year.
Tracey Forfa, Acting Director, Center for Veterinary Medicine, FDA (Invited)
Elizabeth Sadove, Director, MCM Regulatory Policy, Office of the Commissioner, FDA
Wade Ackerman, Partner, Covington & Burling LLP
Stephanie Kraus, Senior Regulator Counsel, CDER, FDA
David Spangler, Senior Vice President, Legal, Government Affairs & Policy, Consumer Healthcare Products Association (CHPA) and Member, FDLI Board of Directors
2:10–3:10 PM | Concurrent Breakout Sessions 6
During this session, FDA leadership will address the top issues CTP is facing as well as priorities and goals for the coming year.
Brian King, Director, Center for Tobacco Products, FDA
Joe Jimenez, Partner, Validant
Alan Minsk, Partner, Arnall Golden Gregory LLP
Howard Sklamberg, Partner, Arnold & Porter LLP
Jay Greissing, Senior Director, Government Affairs, BioMarin Pharmaceutical, Inc.
Brian Malkin, Partner, McDermott Will & Emery
Nisha Shah, Senior Regulatory Counsel, CDER, FDA
Moderated by Alexander Varond, Partner, Goodwin Procter LLP
Edison Alvarez, Senior Director, Strategic Planning for Cybersecurity, Becton Dickinson (BD)
Moderated by Zach Rothstein, Executive Director, AdvaMedDx and Member, FDLI Board of Directors
David Biderman, Partner, Perkins Coie LLP
Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton LLP
Moderated by Maia C. Kats, Managing Member/Founder, Just Food Law
Dean Bunce, EVP Global Regulatory Affairs, United Therapeutics Corporation
Moderated by Georgia C. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati
3:10–3:25 PM | Break
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 2022, and Cases to Watch, 2023.
4:45 PM | Closing Remarks and Adjournment