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
Laboratory Developed Tests: What Now? Helena Duncan, Assistant Director of Economic and Regulatory Affairs, College of American PathologistsJeanne Ireland, Principal, Ireland Strategies LLCSheila Walcoff, CEO & Founder, Goldbug Strategies LLCModerated by Nancy Stade, Partner, Sidley Austin LLP
Key Regulatory Issues in BiosimilarsJoe Franklin, Associate Director for Policy, Therapeutic Biologics & Biosimilars Staff, Office of New Drugs, CDER, FDAChad Landmon, Partner, Axinn, Veltrop & Harkrider LLPChristine Simmon, Senior Vice President of Policy and Strategic Alliances, Association of Accessible Medicines and Executive Director, Biosimilars CouncilModerated by John R. Manthei, Partner, Latham & Watkins LLP
New Food Ingredients: US and EU Requirements and Strategic ConsiderationsNicole Coutrelis, Partner, Coutrelis & AssociesDennis M. Keefe, Director, Office of Food Additive Safety, CFSAN, FDACathy Weir, Adjunct Faculty Member, Institute for Food Laws and Regulations, Michigan State UniversityModerated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC
The Animal Drug Compounding DebateRachael G. Pontikes, Partner, Duane Morris LLPTed Sullivan, Partner, Quarles & Brady LLPModerated by Brian J. Malkin, Counsel, Arent Fox LLP
Tobacco Product Standards for Combustible Products: Nicotine and BeyondMichael Cummings, Professor, Psychiatry & Behavioral Sciences, Co-lead Tobacco Research, Hollings Cancer Center, Medical University of South CarolinaRaymond Niaura, Director of Science and Training, Schroeder Institute for Tobacco Research and Policy StudiesSudhanshu Patwardhan, Senior International Engagement Manager, Nicoventures Ltd., British American TobaccoIrina Stepanov, Associate Professor, Division of Environmental Health Science, Masonic Cancer Center, University of MinnesotaModerated 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 ApprovalMichelle Drodz, Deputy Vice President, Policy and Research, Pharmaceutical Research Manufacturers Association (PhRMA)Michael Labson, Partner, Covington & Burling LLPModerated by Soumi Saha, Assistant Director of Pharmacy & Regulatory Affairs, Academy of Managed Care Pharmacy (AMCP)
Biologics Across the Globe: New Regulatory Challenges and OpportunitiesFreddy 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
Patient-Centric Perspectives: Models for Patient EngagementMarc Boutin, Chief Executive Officer, National Health CouncilKathryn O’Callaghan, Assistant Director for Strategic Programs, CDRH, FDAModerated by Jeffrey N. Gibbs, Director, Hyman Phelps & McNamara, PC and Chair, FDLI Board of Directors
Criminal Prosecutions Under the Food, Drug & Cosmetic ActPerham Gorji, Deputy Chief Counsel for Litigation, Office of Chief Counsel, FDAGeorge M. Karavetsos, Partner, DLA Piper LLPModerated by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Member, FDLI Board of Directors
12:30–2:00 PM: Luncheon
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
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
What’s the Score with SCORE? FDA’s Guidelines for Food Safety and EnforcementGlenn Bass, Director, Office of Food and Feed Operations, ORA, FDA,William Correll, Director, Office of Compliance, CFSAN, FDADon L. Zink, President – Division of Foods & Regulatory Compliance, IEH Laboratories and Consulting GroupModerated by Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, 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.
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
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 RegulationJames A. Boiani, Member of the Firm, Epstein, Becker & Green PCJohn (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDAModerated by Kirsten Paulson, Senior Director, Global CMC – Medical Devices, Pfizer, Inc.
FDA’s Implementation of the 21st Century Cures ActWade Ackerman, Partner, Covington & Burling LLPJonette Foy, Acting Associate Director for Policy, CDRH, FDAJulia Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDAModerated by Carla Cartwright, Director, Federal Affairs, Johnson & Johnson
Regulation of Cannabis in FDA-Regulated ProductsJonathan A. Havens, Associate, Saul Ewing LLPColin Mudd, National Compliance Director, MC Management LLCDouglas Throckmorton, Deputy Center Director for Regulatory Programs, CDER, FDAEmily Leongini, Associate, Arent Fox LLP
Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug IndustryRichard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTCJason W. Gordon, Counsel, Reed Smith LLPKristi L. Wolff, Partner, Kelley Drye & Warren LLPModerated by Linda Goldstein, Partner, Baker & Hostetler LLP
FDA’s User Fee Program Reauthorization UpdateRemy Brim, Minority Health Policy Office, U.S. Senate HELP CommitteeMargaret Coulter, Majority Health Policy Office, U.S. Senate HELP CommitteeTiffany Guarascio, Deputy Chief of Staff and Chief Health Advisor, Committee on Energy and Commerce, U.S. House of RepresentativesJohn Stone, Senior Counsel, Committee on Energy and Commerce, U.S. House of RepresentativesModerated by Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts
Changing Landscape of IoT: Medical Device Privacy and CybersecurityMatthew Barrett, Program Manager of Cybersecurity Framework, National Institute of Standards and Technology (NIST)Zachary Rothstein, Associate Vice President, Technology & Regulatory Affairs, AdvaMedSuzanne Schwartz, Associate Director for Science, CDRH, FDAModerated by Sonali Gunawardhana, Of Counsel, Wiley Rein LLP
Defending Your Product: Crisis Management, Recalls, and StrategyJames Ladner, Deputy General Counsel – Litigation & Investigations, Abbott Meredith Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup CompanyModerated by Mark Mansour, Partner, Mayer Brown LLP
Tobacco Harm Reduction: Opportunities and Regulatory Pathways to Achieve Marc S. Firestone, Senior Vice President & General Counsel, Philip Morris InternationalJoe Murillo, Vice President Regulatory Affairs, Altria Client ServicesJames M. Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North AmericaModerated by Dean R. Cirotta, President & COO, EAS Consulting Group
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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