May 5-6, 2016
Renaissance Downtown Hotel - 999 9th Street NW - Washington, DC 20001
*This Agenda is Subject to Change
Thursday May 5, 2016
7:30-8:30 AM | Registration and Continental Breakfast
8:30-8:45 AM | FDLI Welcome and Opening Remarks (Slides)
Amy Comstock Rick, JD, President and CEO, FDLI
8:45-10:30 AM | Keynote Address and Industry Reactor Panel (Slides)
Robert Califf, MD, Commissioner of Food and Drugs, Food and Drug Administration (FDA)
Elizabeth H. Dickinson, JD, Chief Counsel, FDA
Introduced by Allison M. Zieve, JD, Director, Public Citizen Litigation Group, and Chair, FDLI Board
Elizabeth H. Dickinson, JD, Chief Counsel, FDA
Introduced by Allison M. Zieve, JD, Director, Public Citizen Litigation Group, and Chair, FDLI Board
Reactor Panel:
Peter Pitts, President and Co-Founder, Center for Medicine in the Public Interest (CMPI)
Martin Hahn, Partner, Hogan Lovells LLP
Jim Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Corporate Legal Regulatory, Medtronic, Inc.
Moderated by Amy Comstock Rick, President and CEO, FDLI
Peter Pitts, President and Co-Founder, Center for Medicine in the Public Interest (CMPI)
Martin Hahn, Partner, Hogan Lovells LLP
Jim Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Corporate Legal Regulatory, Medtronic, Inc.
Moderated by Amy Comstock Rick, President and CEO, FDLI
10:30-10:45 AM | Networking Break
10:45-12:15 PM | Breakout Sessions: Hot Topics in Food and Drug Law
This session will be broken into two segments to allow for two sessions of concurrent rapid breakout panels. (2 Rounds – 40 minutes each)
10:45-11:25 AM Session 1:
I. GMO Labeling – Mandatory vs. Voluntary (Slides)
This session will focus on the debate on labeling genetically modified organisms within food products with specific reference to Vermont’s labeling requirements.
This session will focus on the debate on labeling genetically modified organisms within food products with specific reference to Vermont’s labeling requirements.
Steven H. Armstrong, Chief Food Law Counsel, Campbell Soup Company, and Member, FDLI Board of Directors
Greg Jaffe, Director of the Project on Biotechnology, Center for Science in the Public Interest
Karin Moore, Senior Vice President and General Counsel, Grocery Manufacturers Association (GMA)
Moderated by Stuart M. Pape, Shareholder, Polsinelli PC
Greg Jaffe, Director of the Project on Biotechnology, Center for Science in the Public Interest
Karin Moore, Senior Vice President and General Counsel, Grocery Manufacturers Association (GMA)
Moderated by Stuart M. Pape, Shareholder, Polsinelli PC
II. Current Issues Facing Compounding Pharmacies (Slides)
This session will dive into the ongoing implementation of the Compounding Quality Act, including discussion of final FDA guidance, preemption issues, and compounding pharmacy inspections.
This session will dive into the ongoing implementation of the Compounding Quality Act, including discussion of final FDA guidance, preemption issues, and compounding pharmacy inspections.
Rachael Pontikes, Partner, Duane Morris LLP
Elizabeth R. Jungman, Director, Public Health Programs, The Pew Charitable Trusts
Elizabeth R. Jungman, Director, Public Health Programs, The Pew Charitable Trusts
III. Integrating Patient Perspectives in Drug Development (Slides)
This session will explore patient engagement, particularly as it has evolved since the enactment of FDASIA and PDUFA-V. Speakers will discuss different approaches to effective engagement, strategies to obtain/provide meaningful patient input, and lessons learned from real world efforts to better integrate the patient voice into medical product development.
This session will explore patient engagement, particularly as it has evolved since the enactment of FDASIA and PDUFA-V. Speakers will discuss different approaches to effective engagement, strategies to obtain/provide meaningful patient input, and lessons learned from real world efforts to better integrate the patient voice into medical product development.
Leah McCormick Howard, JD, Vice President, Government Relations and Advocacy, National Psoriasis Foundation
Michele Oshman, Director, Global Advocacy & Professional Relations, Eli Lilly & Co.
Moderated by Maureen Japha, Director, Regulatory Policy, FasterCures and Legal Counsel, Milken Institute
Michele Oshman, Director, Global Advocacy & Professional Relations, Eli Lilly & Co.
Moderated by Maureen Japha, Director, Regulatory Policy, FasterCures and Legal Counsel, Milken Institute
IV. Current Trends in Medical Device Law: Wearables, MMAs, and Combo Products (Slides)
Speakers will address the legal and ethical concerns surrounding the development of wearables and mobile medical applications including issues surrounding interoperability, cybersecurity, data collection, usability studies, and home use labeling.
Speakers will address the legal and ethical concerns surrounding the development of wearables and mobile medical applications including issues surrounding interoperability, cybersecurity, data collection, usability studies, and home use labeling.
Bradley Merrill Thompson, JD, Member of the Firm, Epstein Becker & Green, PC
Linda Ricci, Acting Director, Digital Health Initiative, Office of Medical Products and Tobacco, FDA
Vernessa Pollard, JD, Partner, McDermott Will & Emery LLP
Linda Ricci, Acting Director, Digital Health Initiative, Office of Medical Products and Tobacco, FDA
Vernessa Pollard, JD, Partner, McDermott Will & Emery LLP
V. Enforcement and Compliance (Slides)
This session will address FDA’s enforcement goals and priorities, how industry should focus their compliance efforts, and what really happens when you don’t follow FDA regulations. Speakers will also analyze enforcement trends and implications of the Yates Memo.
This session will address FDA’s enforcement goals and priorities, how industry should focus their compliance efforts, and what really happens when you don’t follow FDA regulations. Speakers will also analyze enforcement trends and implications of the Yates Memo.
Andrea Chamblee, Acting Branch Chief DIPAP II, OPQ CDER, FDA
Tim Wells, CEO and Consulting Director, QualityHub. Inc
Mark Mansour, Partner, Mayer Brown LLP
Tim Wells, CEO and Consulting Director, QualityHub. Inc
Mark Mansour, Partner, Mayer Brown LLP
11:25-11:35 AM Transition Time
11:35-12:15 PM Session 2:
I. FDA Regulation of Dietary Supplements (Slides)
During this session, speakers will discuss the parameters for dietary supplement regulation, and advertising and promotion as well as the ongoing initiatives to improve quality in light of recent enforcement actions.
During this session, speakers will discuss the parameters for dietary supplement regulation, and advertising and promotion as well as the ongoing initiatives to improve quality in light of recent enforcement actions.
Robert Durkin, Deputy Director, Office of Dietary Supplement Programs, FDA
Jason Sapsin, Counsel, Faegre Baker Daniels LLP
Jill Furman, Deputy Director, Consumer Protection Branch, US Department of Justice
Moderated by Brooke Schumm III, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, PC
Jason Sapsin, Counsel, Faegre Baker Daniels LLP
Jill Furman, Deputy Director, Consumer Protection Branch, US Department of Justice
Moderated by Brooke Schumm III, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, PC
II. Expedited Review Pathways (Slides)
Speakers will discuss the regulatory and drug development benefits and other implications of using expedited pathways to FDA approval including but not limited to, Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review.
Speakers will discuss the regulatory and drug development benefits and other implications of using expedited pathways to FDA approval including but not limited to, Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review.
Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Pfizer, Inc.
Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization (BIO)
Jeff Allen, Executive Director, Friends of Cancer Research
Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization (BIO)
Jeff Allen, Executive Director, Friends of Cancer Research
III. FDA Regulation of Laboratory Developed Tests (Slides)
Final guidance from FDA on its regulation of LDTs is forthcoming, however, many stakeholders are uncertain of the legality of FDA’s regulation. Will Congress intervene with legislation? What is the viability of anticipated legal challenges? Join this breakout session to discuss these key concerns.
Final guidance from FDA on its regulation of LDTs is forthcoming, however, many stakeholders are uncertain of the legality of FDA’s regulation. Will Congress intervene with legislation? What is the viability of anticipated legal challenges? Join this breakout session to discuss these key concerns.
Katherine Serrano, Deputy Director, Division of Chemistry and Toxicology, Office of In Vitro Diagnostic Device Evaluation and Services, CDRH, FDA
Sheila D. Walcoff, JD, Founder & CEO, Goldbug Strategies LLC
Moderated by Jeffrey N. Gibbs, JD, Director, Hyman, Phelps & McNamara, PC, and Vice Chair, FDLI Board
Sheila D. Walcoff, JD, Founder & CEO, Goldbug Strategies LLC
Moderated by Jeffrey N. Gibbs, JD, Director, Hyman, Phelps & McNamara, PC, and Vice Chair, FDLI Board
IV. Tobacco Product Standards (Slides)
During this session, speakers will discuss the formation of specific product standards for tobacco and nicotine products including a potential ban on menthol and or flavorings.
During this session, speakers will discuss the formation of specific product standards for tobacco and nicotine products including a potential ban on menthol and or flavorings.
Stacy Ehrlich, JD, Partner, Kleinfeld, Kaplan & Becker LLP and Member, FDLI Board of Directors
Desmond Jenson, JD, Staff Attorney, Tobacco Control Legal Consortium at the Public Health Law Center
Bryan Haynes, JD, Partner, Troutman Sanders LLP
Desmond Jenson, JD, Staff Attorney, Tobacco Control Legal Consortium at the Public Health Law Center
Bryan Haynes, JD, Partner, Troutman Sanders LLP
12:30-2:00 PM | Networking Lunch with Substantive Table Discussions
Join the conversation. During lunch there will be over 30 different tables with hot topic discussions led by FDLI members. Please reference your program for a complete list of table topics.
1:30-2:00 PM | Distinguished Guest Speaker (Slides)
The Honorable Royce C. Lamberth, United States District Judge, District of Columbia
Introduced by Lewis A. Grossman, JD, PhD, Professor of Law, American University, Washington College of Law, and Member, FDLI Board of Directors
Introduced by Lewis A. Grossman, JD, PhD, Professor of Law, American University, Washington College of Law, and Member, FDLI Board of Directors
2:00-2:10 PM | Break
2:10-3:20 PM | Concurrent Breakout Sessions: FDA Center Directors
Center for Tobacco Products (CTP) (Slides)
Mitchell R. Zeller, JD, Director, Center for Tobacco Products (CTP), Office of Medical Products and Tobacco, FDA
Dennis Henigan, JD, Director, Legal and Policy Analysis, Campaign for Tobacco Free Kids
Joe Murillo, Vice President of Regulatory Affairs, Altria Client Services LLC
Cynthia Cabrera, Executive Director & President, Smoke-Free Alternatives Trade Association (SFATA)
Moderated by Kathleen Hoke, JD, Law School Professor and Director, Legal Resource Center for Public Health Policy, University of Maryland Francis King Carey School of Law
Dennis Henigan, JD, Director, Legal and Policy Analysis, Campaign for Tobacco Free Kids
Joe Murillo, Vice President of Regulatory Affairs, Altria Client Services LLC
Cynthia Cabrera, Executive Director & President, Smoke-Free Alternatives Trade Association (SFATA)
Moderated by Kathleen Hoke, JD, Law School Professor and Director, Legal Resource Center for Public Health Policy, University of Maryland Francis King Carey School of Law
Center for Drug Evaluation and Research (CDER) (Slides)
Richard A. Moscicki, MD, Deputy Center Director for Science Operations, Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco, FDA
Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP
Brian R. McCormick, General Counsel - Regulatory and Lifecycle, Teva Pharmaceutical Industries Ltd.
Lori Hirsch, Managing Counsel, Merck & Co., Inc.
Moderated by Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP
Brian R. McCormick, General Counsel - Regulatory and Lifecycle, Teva Pharmaceutical Industries Ltd.
Lori Hirsch, Managing Counsel, Merck & Co., Inc.
Moderated by Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Center for Food Safety and Applied Nutrition (CFSAN) (Slides)
Susan T. Mayne, PhD, Director, Center for Food Safety and Applied Nutrition (CFSAN), Office of Foods and Veterinary Medicine, FDA
Miriam J. Guggenheim, Partner, Covington & Burling LLP
Elizabeth Johnson, Principal & Founder, Food Directions, LLC
Moderated by Todd A. Harrison, Chair, FDA Group, Venable LLP
Miriam J. Guggenheim, Partner, Covington & Burling LLP
Elizabeth Johnson, Principal & Founder, Food Directions, LLC
Moderated by Todd A. Harrison, Chair, FDA Group, Venable LLP
Center for Biologics Evaluation and Research (CBER) (Slides)
Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), Office of Medical Products and Tobacco, FDA
Sheldon Bradshaw, Partner, King & Spalding LLP
Edward Li, Associate Professor, Pharmacy Practice, University of New England College of Pharmacy
Daniel A. Kracov, Partner, Arnold & Porter LLP
Sheldon Bradshaw, Partner, King & Spalding LLP
Edward Li, Associate Professor, Pharmacy Practice, University of New England College of Pharmacy
Daniel A. Kracov, Partner, Arnold & Porter LLP
Center for Devices and Radiological Health (CDRH) (Slides)
Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health (CDRH), Office of Medical Products and Tobacco, FDA
Janet Trunzo, Senior Executive Vice President, Technology & Regulatory Affairs, AdvaMed
Sonali P. Gunawardhana, Of Counsel, Wiley Rein LLP
Nadim Yared, CEO, CVRx, Inc.
Moderated by Jur Strobos, Partner, Olsson Frank Weeda Terman Matz PC
Janet Trunzo, Senior Executive Vice President, Technology & Regulatory Affairs, AdvaMed
Sonali P. Gunawardhana, Of Counsel, Wiley Rein LLP
Nadim Yared, CEO, CVRx, Inc.
Moderated by Jur Strobos, Partner, Olsson Frank Weeda Terman Matz PC
Center for Veterinary Medicine (CVM) (Slides)
Tracey Forfa, JD, Acting Director, Center for Veterinary Medicine (CVM), Office of Foods and Veterinary Medicine, FDA
Jennifer Spokes Johansson, JD, Senior Vice President, Regulatory Policy and Counsel, Putney, Inc. and Chair, Generic Animal Drug Alliance
Peter Tabor, Vice President for Regulatory and International Affairs, Pet Food Institute
Jennifer Spokes Johansson, JD, Senior Vice President, Regulatory Policy and Counsel, Putney, Inc. and Chair, Generic Animal Drug Alliance
Peter Tabor, Vice President for Regulatory and International Affairs, Pet Food Institute
3:20-3:30 PM | Breakout Transition Time
3:30-4:15 PM | Breakout Sessions: Hot Topics in Food and Drug Law
I. Research on Tobacco and Nicotine Products (Slides)
This session will focus on the scientific opportunities surrounding tobacco and nicotine regulation, and the ongoing work of scientists in the global community. Speakers will discuss recent studies, research institutions, outcomes, and the need for reliable data.
This session will focus on the scientific opportunities surrounding tobacco and nicotine regulation, and the ongoing work of scientists in the global community. Speakers will discuss recent studies, research institutions, outcomes, and the need for reliable data.
Aruni Bhatnagar, PhD, Professor of Medicine and Distinguished University Scholar, University of Louisville, and Volunteer, American Heart Association
Raymond S. Niaura, PhD, Director of Science and Training, Schroeder Institute for Tobacco Research and Policy Studies, Truth Initiative
Gal Cohen, PhD, Head of Scientific and Regulatory Affairs, PAX Labs, Inc.
Raymond S. Niaura, PhD, Director of Science and Training, Schroeder Institute for Tobacco Research and Policy Studies, Truth Initiative
Gal Cohen, PhD, Head of Scientific and Regulatory Affairs, PAX Labs, Inc.
II. Food Labeling and Content Claims (Slides)
This session will cover the broad area of food labeling in a discussion on the proposed nutrition label reforms, nutrient content claims, the definition of “healthy” when used on a food label, and various warning labels. The role of regulation as a tool to help consumers meet the goals of Dietary Guidelines will also be addressed.
This session will cover the broad area of food labeling in a discussion on the proposed nutrition label reforms, nutrient content claims, the definition of “healthy” when used on a food label, and various warning labels. The role of regulation as a tool to help consumers meet the goals of Dietary Guidelines will also be addressed.
Suzanne Trigg, Counsel, Haynes Boone LLP
Douglas Balentine, Director, Office of Nutrition and Food Labeling, FDA
Justin J. Prochnow, Shareholder, Greenberg Traurig LLP
Douglas Balentine, Director, Office of Nutrition and Food Labeling, FDA
Justin J. Prochnow, Shareholder, Greenberg Traurig LLP
III. Clinical Trials (Slides)
Clinical trials are regulated by a number of agencies and organizations around the world. This session will offer perspectives from regulators and industry on how to improve the quality and efficiency of clinical trials, while discussing the diversity in approach and execution.
Clinical trials are regulated by a number of agencies and organizations around the world. This session will offer perspectives from regulators and industry on how to improve the quality and efficiency of clinical trials, while discussing the diversity in approach and execution.
Jeffrey Francer, Vice President and Senior Counsel, PhRMA
J. Rick Turner, PhD, Senior Scientific Director, Clinical Communications and Chief Scientific Advisor, Cardiac Safety Services, Quintiles Inc.
Leanne Madre, Director of Strategy, Clinical Trials Transformation Initiative (CTTI)
Moderated by Lance L. Shea, MS, JD, Partner, Baker Hostetler LLP
J. Rick Turner, PhD, Senior Scientific Director, Clinical Communications and Chief Scientific Advisor, Cardiac Safety Services, Quintiles Inc.
Leanne Madre, Director of Strategy, Clinical Trials Transformation Initiative (CTTI)
Moderated by Lance L. Shea, MS, JD, Partner, Baker Hostetler LLP
IV. Update on CDRH Innovation Pathways (Slides)
This session will focus on the appropriate pathway to market for innovative devices and the tools CDRH uses to achieve appropriate risk-based regulation for novel technology. Speakers will discuss de novo classification, expedited access, breakthrough technology, and other regulatory tools that facilitate patient access to new devices, as well as legal and regulatory challenges that medical device innovators face.
This session will focus on the appropriate pathway to market for innovative devices and the tools CDRH uses to achieve appropriate risk-based regulation for novel technology. Speakers will discuss de novo classification, expedited access, breakthrough technology, and other regulatory tools that facilitate patient access to new devices, as well as legal and regulatory challenges that medical device innovators face.
Lauren Silvis, JD, Deputy Center Director for Policy, CDRH, Office of Medical Products and Tobacco, FDA
Marian J. Lee, JD, Partner, Gibson, Dunn & Crutcher LLP
Maura M. Norden, JD, Vice President, Medical Devices & Combination Products, Greenleaf Health LLC
Jonathan Sackner-Bernstein, MD, CEO, SRD Med, LLC
Marian J. Lee, JD, Partner, Gibson, Dunn & Crutcher LLP
Maura M. Norden, JD, Vice President, Medical Devices & Combination Products, Greenleaf Health LLC
Jonathan Sackner-Bernstein, MD, CEO, SRD Med, LLC
V. Drug Pricing (Slides)
How are drugs priced in the United States, and why are prices so high? Speakers will explore the process for determining price and discuss policy implications for future pricing structures.
How are drugs priced in the United States, and why are prices so high? Speakers will explore the process for determining price and discuss policy implications for future pricing structures.
Clay Alspach, Principal, Leavitt Partners
Marc M. Boutin, JD, Chief Executive Officer, National Health Council
Tim Gronniger, Deputy Chief of Staff, Centers for Medicare & Medicaid Services (CMS)
Marc M. Boutin, JD, Chief Executive Officer, National Health Council
Tim Gronniger, Deputy Chief of Staff, Centers for Medicare & Medicaid Services (CMS)
4:15-4:30 PM | Networking Break
4:30-5:30 PM | Current Trends in Individual and Corporate Enforcement (Slides)
What’s keeping you awake at night? In a heavily regulated area of law, one must be aware of recent trends in enforcement activity and recently released regulation and guidance. This session will offer tips and best practices for responding to an enforcement action, developing a Corporate Integrity Agreement, and understanding changes that have ensued following the Yates Memo.
Jeffrey Steger, Assistant Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice
Sarah Roller, Chair of Food and Drug Law Practice and Partner, Kelley Drye & Warren LLP
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Member, FDLI Board of Directors
Moderated by Steve Usdin, Senior Editor, Washington, BioCentury
Sarah Roller, Chair of Food and Drug Law Practice and Partner, Kelley Drye & Warren LLP
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Member, FDLI Board of Directors
Moderated by Steve Usdin, Senior Editor, Washington, BioCentury
5:30-7:00 PM | Networking Reception
Friday May 6, 2016
7:45-8:45 AM | Continental Breakfast
8:00-8:45 AM | Careers in Food and Drug Law Breakfast
Join us as experts in food and drug law discuss their career paths, skills that are imperative in this industry, and traits they look for when hiring. Bring your job and career questions to this interactive session, meant for those in all stages of their careers.
Scott M. Melville, President and CEO, Consumer Health Products Association (CPHA), and Member, FDLI Board of Directors
Leslie T. Krasny, Partner, Keller and Heckman LLP
Wade Ackerman, Senior FDA Counsel, U.S. Senate Committee on Health, Education, Labor and Pensions
Moderated by Nancy Singer, President, Compliance-Alliance, LLC
Leslie T. Krasny, Partner, Keller and Heckman LLP
Wade Ackerman, Senior FDA Counsel, U.S. Senate Committee on Health, Education, Labor and Pensions
Moderated by Nancy Singer, President, Compliance-Alliance, LLC
8:00-8:45 AM | Professors of Food and Drug Law Breakfast
Law faculty will engage in an informal discussion of food and drug law in academe. Topics will include community-building and networking, pedagogy, and scholarship.
Facilitated by Erika Lietzan, University of Missouri School of Law
8:45 AM | FDLI Welcome and Annoucements
8:45-10:00 AM | Ploy or Policy Tool - A Look at the Citizen Petition Process
How is the Citizen Petition process used within industry, and how has FDA responded to its use? Speakers will discuss the risks and rewards of using the petition process as a tool for market success, and potential changes to the process as a result of the recent draft FDA guidance. Attendees will learn about the multifaceted approach to deciding how and why to file a citizen petition and the pros and cons of doing so.
Marc J. Scheineson, Partner, Alston & Bird LLP
Mitchell Neuhauser, Vice President and Assistant General Counsel, RAI Services Company
Justin Mervis, Vice President & General Counsel, Kind LLC
Moderated by Chad Landmon, Axinn, Veltrop & Harkrider LLP
Mitchell Neuhauser, Vice President and Assistant General Counsel, RAI Services Company
Justin Mervis, Vice President & General Counsel, Kind LLC
Moderated by Chad Landmon, Axinn, Veltrop & Harkrider LLP
10:00-10:30 AM | Networking Break
10:30-11:15 AM | Recent Cases on Communicating Off-Label Information
Panelists will explore the significance of the three most recent cases implicating off-label communications and commercial speech: Amarin, Pacira, and Vascular Solutions.
Joy Liu, JD, Partner, Ropes & Gray LLP, and Secretary and General Counsel, FDLI Board of Directors
John Richter, JD, Partner, King & Spalding LLP
Joel Kurtzberg, JD, Partner, Cahill Gordon & Reindel LLP
John Richter, JD, Partner, King & Spalding LLP
Joel Kurtzberg, JD, Partner, Cahill Gordon & Reindel LLP
11:20-12:30 PM | Breakout Sessions: Hot Topics in Food and Drug Law
I. Developments in Data Integrity
Speakers will look at ways companies can detect, prevent, and correct data integrity issues. Speakers will also comment on notable enforcement actions surrounding data integrity breaches.
Speakers will look at ways companies can detect, prevent, and correct data integrity issues. Speakers will also comment on notable enforcement actions surrounding data integrity breaches.
Frances Zipp, President & CEO, Lachman Consultant Services Inc.
Richard M. Johnson, President & CEO, Parenteral Drug Association ® (PDA)
Bob Buhlmann, Director of Corporate Quality Assurance, Amgen, Inc.
Moderated by Neil DiSpirito, Of Counsel, Ballard Spahr LLP
Richard M. Johnson, President & CEO, Parenteral Drug Association ® (PDA)
Bob Buhlmann, Director of Corporate Quality Assurance, Amgen, Inc.
Moderated by Neil DiSpirito, Of Counsel, Ballard Spahr LLP
II. Key Issues Surrounding an Orphan Drug Designation
This session covers challenges with FDA designation of a product within the Orphan Drug pathway, with a focus on whether new versions of previously approved drugs and biologics submitted through the 505(b)(2) development pathway can be eligible for orphan status.
This session covers challenges with FDA designation of a product within the Orphan Drug pathway, with a focus on whether new versions of previously approved drugs and biologics submitted through the 505(b)(2) development pathway can be eligible for orphan status.
Gayatri R. Rao, MD, JD, Director, Office of Orphan Products Development (OOPD), FDA
George A. O'Brien, JD, Senior Associate, Hogan Lovells LLP
Martha Rinker, Vice President, Public Policy, National Organization for Rare Disorders
Moderated by Areta Kupchyk, JD, Partner, Foley Hoag LLP
George A. O'Brien, JD, Senior Associate, Hogan Lovells LLP
Martha Rinker, Vice President, Public Policy, National Organization for Rare Disorders
Moderated by Areta Kupchyk, JD, Partner, Foley Hoag LLP
III. FDA Regulation of Combination Products
How do different approval standards impact cross labeling of drug-device combination products? This session will approach the cross labeling challenges when drugs and devices are approved separately, and the process by which a combination product is reviewed and approved.
How do different approval standards impact cross labeling of drug-device combination products? This session will approach the cross labeling challenges when drugs and devices are approved separately, and the process by which a combination product is reviewed and approved.
Suzanne O’Shea, JD, Director, Navigant Consulting, Inc.
Philip Desjardins, JD, Vice President, Global Regulatory Affairs Policy & Intelligence, Medical Device, Johnson & Johnson
Rachel Turow, JD, Director, Regulatory Policy, Novo Nordisk Inc.
John (Barr) Weiner, JD, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
Moderated by Nancy K. Stade, JD, Partner, Sidley Austin LLP
Philip Desjardins, JD, Vice President, Global Regulatory Affairs Policy & Intelligence, Medical Device, Johnson & Johnson
Rachel Turow, JD, Director, Regulatory Policy, Novo Nordisk Inc.
John (Barr) Weiner, JD, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
Moderated by Nancy K. Stade, JD, Partner, Sidley Austin LLP
IV. FSMA Implementation
The Food Safety Modernization Act (FSMA) is the most sweeping reform of US food safety laws in over 70 years. This session will focus on how to meet the initial challenges of FSMA implementation, and tips for future compliance.
The Food Safety Modernization Act (FSMA) is the most sweeping reform of US food safety laws in over 70 years. This session will focus on how to meet the initial challenges of FSMA implementation, and tips for future compliance.
Esther Bleicher, Senior Policy Analyst, Office of Foods and Veterinary Medicine, FDA
Charles Breen, Senior Consultant, EAS Consulting Group LLC
Edward Savard, Vice President, Food Safety, Compliance and Engineering, Golden State Foods
Charles Breen, Senior Consultant, EAS Consulting Group LLC
Edward Savard, Vice President, Food Safety, Compliance and Engineering, Golden State Foods
V. FDA’s Work with Private & Public Payers
During the past year, FDA has increased its efforts to get payers involved early in the regulatory review cycle. Learn how FDA and CMS are collaborating on a Parallel Review Pilot Program and how FDA is promoting other avenues for public-private partnerships.
During the past year, FDA has increased its efforts to get payers involved early in the regulatory review cycle. Learn how FDA and CMS are collaborating on a Parallel Review Pilot Program and how FDA is promoting other avenues for public-private partnerships.
Murray Sheldon, Associate Director of Technology and Innovation, CDRH, Office of Medical Products and Tobacco, FDA
Tamara Syrek Jensen, Deputy Director, Coverage & Analysis Group, Centers for Medicare & Medicaid Services (CMS)
Louis Jacques, MD, SVP & Chief Clinical Officer, ADVI
Moderated by Rochelle Fink, Senior Health Science Project Specialist, Office of the Center Director, CDRH, Office of Medical Products and Tobacco, FDA
Tamara Syrek Jensen, Deputy Director, Coverage & Analysis Group, Centers for Medicare & Medicaid Services (CMS)
Louis Jacques, MD, SVP & Chief Clinical Officer, ADVI
Moderated by Rochelle Fink, Senior Health Science Project Specialist, Office of the Center Director, CDRH, Office of Medical Products and Tobacco, FDA
VI. Modified Risk Tobacco Products and Public Health
Speakers will cover the spectrum of modified risk products, the modified risk tobacco product application, the Swedish Match experience and its possible outcome. Speakers will also discuss the MRTP designation and its potential impact on public health.
Speakers will cover the spectrum of modified risk products, the modified risk tobacco product application, the Swedish Match experience and its possible outcome. Speakers will also discuss the MRTP designation and its potential impact on public health.
J. Benneville Haas, JD, Partner, Latham & Watkins LLP
Moira Gilchrist, PhD, Director Scientific Engagement, Philip Morris International
Eric N. Lindblom, JD, Senior Scholar, O'Neill Institute for National & Global Health Law, Georgetown University Law Center
Moderated by Stacey Gagosian, Director, Government Affairs, Truth Initiative
Moira Gilchrist, PhD, Director Scientific Engagement, Philip Morris International
Eric N. Lindblom, JD, Senior Scholar, O'Neill Institute for National & Global Health Law, Georgetown University Law Center
Moderated by Stacey Gagosian, Director, Government Affairs, Truth Initiative
12:30-1:40 PM | Luncheon Address and FDAAA Award Presentation
Mark B. McClellan, MD, PhD, Director, Duke-Robert J. Margolis, MD, Center for Health Policy, Duke University
Introduced by Amy Comstock Rick, JD, President & CEO, FDLI
Introduced by Amy Comstock Rick, JD, President & CEO, FDLI
Presentation of the Harvey W. Wiley Lecturer Award by Nancy Bradish Myers, JD, Board Chair, FDA Alumni Association
1:40-1:55 PM | Networking Break
1:55-3:10 PM | Global Regulatory Concerns - Keynote Address and Moderated Dialogue
Howard Sklamberg, JD, Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Reactor Panel:
Michael T. Roberts, Executive Director, Resnick Program for Food Law & Policy, UCLA
Sara Zborovski, Partner, DLA Piper (Canada) LLP
Christian B. Fulda, Partner, Jones Day
Kimberly A. Trautman, Executive Vice President, Medical Devices, NSF Health Sciences
Carla Cartwright, JD, Director, Global Regulatory Policy & Intelligence, Janssen R&D
Sara Zborovski, Partner, DLA Piper (Canada) LLP
Christian B. Fulda, Partner, Jones Day
Kimberly A. Trautman, Executive Vice President, Medical Devices, NSF Health Sciences
Carla Cartwright, JD, Director, Global Regulatory Policy & Intelligence, Janssen R&D
3:10-3:25 AM | Networking Break
3:25-4:30 PM | The Top 10 Cases in Food and Drug Law
This year, the food and drug law community saw several cases that heavily influenced the field and impacted business. During this session speakers will brief you on the top cases in food and drug law in 2015 and 2016, and point out cases to watch in the upcoming year.
William M. Janssen, Professor of Law, Charleston School of Law
Lewis A. Grossman, JD, PhD, Professor of Law, American University, Washington College of Law, and Member, FDLI Board of Directors
Marsha N. Cohen, Hon. Raymond L. Sullivan Professor of Law, Founding Executive Director, Lawyers for America, UC Hastings College of the Law
Moderated by Gregory J. Wartman, Partner, Saul Ewing LLP
Lewis A. Grossman, JD, PhD, Professor of Law, American University, Washington College of Law, and Member, FDLI Board of Directors
Marsha N. Cohen, Hon. Raymond L. Sullivan Professor of Law, Founding Executive Director, Lawyers for America, UC Hastings College of the Law
Moderated by Gregory J. Wartman, Partner, Saul Ewing LLP
4:30 PM | Closing Remarks
Amy Comstock Rick, JD, President & CEO, FDLI
No comments:
Post a Comment