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The premier conference for the food and drug law community, the FDLI Annual Conference addresses complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. The two-day event provides in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, the private bar, non-profits, patient and consumer advocates, consulting organizations, and academia.

Conference Highlights:

  • Hear FDA’s 2019 strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency
  • Join more than 900 high-level colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding
  • Select from nearly 30 breakout sessions covering the latest in legal, regulatory, compliance, policy, marketing, and related issues
  • Learn from more than 100 well-known officials and experts
  • Hear about the Top Cases in Food and Drug Law
  • Network and build relationships with seasoned law, regulatory, compliance, marketing/advertising, and management professionals

Call For Proposals

FDLI and the 2019 Annual Conference Planning Committee thank those who participated in the Call for Proposals this past fall. The input received from industry stakeholders helps us plan a timely program. If you submitted a proposal, you will be notified of the status of your proposal in February.

Register by March 21 and SAVE

Industry & Firms

$1,499
  • +$500 for nonmembers
  • +$100 after 03/21/19

Non-Profit

$1,099
  • +$200 for nonmembers
  • +$100 after 03/21/19

Government

$1,099
  • +$200 for nonmembers
  • +$100 after 03/21/19

Academic

$1,099
  • +$200 for nonmembers
  • +$100 after 03/21/19

Student

$299
  • student registration
  • transcripts required
Register Now

  
Does Your FDLI Membership Qualify You for a Complimentary or Discounted Registration?
Member manufacturers, suppliers and distributors with more than $1 billion in sales as well as member law firms get one complimentary registration as part of their annual membership dues. Member manufacturers, suppliers and distributors with less than $1 billion in sales get one registration at 50% off as part of their annual membership dues. To take advantage of these opportunities, please contact us.

 

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

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Agenda

subject to change

Thursday, May 2

8:00–9:15 AM
Registration and Continental Breakfast

9:15–9:30 AM  
Welcome
Amy Comstock Rick, President & CEO, FDLI

9:30–10:00 AM    
FDA Keynote Address
Scott Gottlieb, Commissioner of Food and Drugs, FDA or Acting Commissioner
Introduced by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Chair, FDLI Board of Directors

10:00–11:00 AM
Policies and Politics – Opportunities and Challenges Facing the FDA
This panel features an interactive, forward-looking discussion on the bigger picture direction and anticipated short- and long-term issues facing FDA and the food and drug communities.

Jeffrey B. Chasnow, Senior Vice President and Associate General Counsel, Pfizer, Inc.
Monaya M. Krause, Senior Legal Director, Medtronic
Joe Murillo, Senior Vice President, Regulatory Affairs, Altria Client Services LLC
Amy Norris, Chief Counsel, Clif Bar & Company
Paul J. Savidge, US General Counsel, Spark Therapeutics
Moderated by
Rebecca K. Wood, Sidley Austin LLP

11:00–11:30 AM
Coffee and Networking Break

11:30—12:30 PM  
Breakout Sessions

  • Incentivizing Generic Drug Competition
    Jeffrey K. Francer, Senior Vice President & General Counsel, Association for Accessible Medicines (AAM) and Member, FDLI Board of Directors
    Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
    Brian McCormick, Vice President & Chief Regulatory Counsel, Teva Pharmaceuticals USA, Inc.
    Maryll Toufanian, Director, Office of Generic Drug Policy, CDER, FDA (Invited)
    Moderated by Markham Luke, Director, Division of Therapeutic Performance, Office of Generic Drugs, CDER
  • Evolving 510(k) Program and De Novo Process
    Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
    Bethany Hills
    , Member, Mintz, Levin, Cohen, Ferris, Glovsky and Popeo, PC
  • Innovative Medical Product Technologies, Novel Products, and FDA Regulation
    Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP
    Ellen Flannery, Deputy Director for Policy, CDRH, FDA (Invited)
    Grail Sipes, Deputy Center Director, Regulatory Policy, CDER, FDA (Invited)
    Andrew Wasson, Partner, Haug Partners LLP
  • Animal Drugs and Antimicrobial Resistance
    William Flynn, Deputy Director for Science Policy, CVM, FDA
    Jesse J. Sevcik
    , Sr. Director, Global Government Affairs, Elanco Animal Health
  • Federal Oversight of Food Biotechnology
    Trevor Findley, Deputy Director, Food Disclosure and Labeling, Agriculture and Marketing Service, USDA (Invited)
    Gregory Jaffe
    , Biotechnology Project Director, Center for Science in the Public Interest (CSPI)
    Matthew Michael, Director, Issuances Staff, Office of Policy and Program Development, Food Safety and Inspection Service, USDA (Invited)
    Nicole Negowetti
    , Lecturer on Law & Clinical Instructor, Harvard Law School
  • Modified Risk Tobacco Product Applications: Status Update
    Dennis Henigan, Vice President, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
    Matthew R. Holman
    , Director, Office of Science, CTP, FDA
    James M. Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
    Moderated by J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP

12:30–1:30 PM   
Networking Luncheon and FDLI Awards Presentation

1:30–2:00 PM 
Luncheon Speaker
Randall J. Ortman
, Product Counsel, Verily Life Sciences LLC (Invited)

2:00–2:10 PM 
Transition

2:10–3:25 PM      
Breakout Sessions: FDA Center Directors

  • Center for Drug Evaluation and Research (CDER)
    Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA
    Dave Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
    Philip Katz, Partner, Hogan Lovells US LLP
    Moderated by Deborah M. Shelton, Partner, McCarter & English LLP
  • Center for Biologics Evaluation and Research (CBER)
    Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA 
    Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC
    Moderated by
    Neil Di Spirito, Member of the Firm, Epstein Becker & Green, PC
  • Center for Devices and Radiological Health (CDRH)
    Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
    Heather S. Rosencrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Inc.
    Moderated by Vernessa Pollard, Partner, McDermott Will & Emery LLP
  • Center for Food Safety and Applied Nutrition (CFSAN)
    Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
    Amy E. Hancock, Executive Vice President | General Counsel, American Beverage Association
    Meredith Quinn Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
    Moderated by Stuart M. Pape, Shareholder, Polsinelli PC
  • Center for Tobacco Products (CTP)          
    Mitchell R. Zeller, Director, Center for Tobacco Products, FDA
    Tony Abboud, Executive Director, Vapor Technology Association
    Moderated by
    Kathleen Hoke, Professor & Director, Network for Public Health Policy and Center for Tobacco Regulation, University of Maryland Carey School of Law
  • Center for Veterinary Medicine (CVM)
    Steven M. Solomon, Director, Center for Veterinary Medicine, FDA 

3:25–3:50 PM  
Coffee and Networking Break

3:50–4:50 PM     
Breakout Sessions

  • Clinical Trials and the Use of Real-World Data in Medical Product Development
    David B. Martin, Associate Director for Real World Evidence Analytics, CDER, FDA
    Eric Solowey
    , Assistant General Counsel, Parexel International
    Moderated by John R. Manthei, Partner, Latham & Watkins LLP
  • FDA’s Software Precertification Program
    Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors
    Lesley Maloney, Head, US Regulatory Policy, Roche Diagnostics
    Ian Pearson, Associate, Jones Day
  • New Advances and Updates in the Biologics and Biosimilars Landscape
    Daniel A. Kracov, Partner, Arnold & Porter LLP
    Teresa Stanek Ray, Partner, Crowell & Moring LLP
    Sarah Yim, Acting Director, Therapeutic Biologics and Biosimilars Staff, CDER, FDA (Invited)
  • Updates in Animal Food and Feed: State Changes, GRAS, and FSMA
    John Dillard, Principal Attorney, Olsson Frank Weeda Terman Matz PC
    Peter Tabor, Vice President, Regulatory & International Affairs, Pet Food Institute
    Moderated by Sarah L. Brew, Partner, Faegre Baker Daniels LLP
  • Food and Dietary Supplement Class Action Litigation: Developments and Strategies
    Nury H. Yoo, Counsel, Keller and Heckman LLP
  • What’s New in the World of Combustible Tobacco Products
    Stacey Younger Gagosian, Managing Director, Public Policy, Truth Initiative
    Eric N. Lindblom
    , Director, Tobacco Control and Food & Drug Law, O’Neill Institute for National and Global Health Law, Georgetown University Law Center
    Barry Schaevitz
    , Partner, Fox Rothschild LLP

4:50–5:00 PM      
Transition

5:00–5:30 PM                   
Speaker:
Stacy Cline Amin, Chief Counsel, FDA (Invited)

5:30–7:00 PM
Networking Reception

Friday, May 3

8:00—8:45 AM      
Breakfast

8:45—9:00 AM 
FDLI Welcome and Service to FDLI Award

9:00—9:20 AM   
Dr. Harvey Wiley Lecture and FDAAA Award
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.

Richard Pazdur, Director, Oncology Center of Excellence, FDA
Presented by Nancy Myers, President, Catalyst Healthcare Consulting

9:20–10:20 AM   
Globalization, Emerging Markets, and International Trends

Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, Office of the Commissioner, FDA (Invited)
Howard R. Sklamberg
, Partner, Akin Gump Strauss Hauer & Feld LLP
Moderated by
James N. Czaban, Partner, DLA Piper LLP

10:20–10:40 AM         
Coffee and Networking Break

10:40–11:30 AM             
Breakout Sessions

  • Understanding DEA Regulations and FDA Interactions: A Case Study on Opioids
    Larry K. Houck, Director, Hyman, Phelps & McNamara, PC
  • Machine Learning, AI, and Digital Health
    Wade Ackerman, Partner, Covington & Burling LLP
    Mark C. Levy
    , Partner, Eckert Seamans Cherin & Mellott, LLC
  • Precision Medicine, Next-Generation Sequencing, and Diagnostics
    Aaron L. Josephson, Senior Director, ML Strategies LLC
    Eric M. Marshall
    , Senior Director, Leavitt Partners LLC
    Elizabeth Richardson, Director, Health Care Products Project, The Pew Charitable Trusts
  • Updates in International Food Regulation and Trade: Foreign Supplier Verification Program, Efforts in Harmonization, EU Regulations, and the United States-Mexico-Canada Agreement
    Jose Alberto Campos Vargas, Partner, Sanchez Devanny
  • Electronic Nicotine Delivery Systems Part I: Regulation to Prevent Youth Initiation and Use
    Clive Bates,Director, Counterfactual Consulting Limited
    Stacy L. Ehrlich
    , Partner, Kleinfeld, Kaplan & Becker, LLP and Member, FDLI Board of Directors
  • Focus on Investigations: Government Trends and Best Practices for Internal Investigations
    John Bentivoglio, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
    John Claud, Assistant Director, Consumer Protection Branch, US Department of Justice
    William F. Gould
    , Partner, Holland & Knight LLP
    Beth P. Weinman, Counsel, Ropes & Gray LLP

11:30–11:40 AM      
Transition

11:40 AM–12:30 PM     
Breakout Sessions

  • Orphan Drug and Rare Disease Developments
    Brian J. Malkin, Counsel, Arent Fox LLP
    Kendra Martello, Senior Director, Public Policy, Mallinckrodt Pharmaceuticals
    Adora Ndu, Executive Director, Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical Inc.
    Julia Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDA
  • Issues in Drug Quality and Manufacturing: ConOps, Quality Metrics, and Outsourcing
    Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
    Lori F. Hirsch, VP of Regulatory Compliance and External Engagement, Bristol-Myers Squibb Company
    Janet L. Michener Whipple
    , Partner, Medical Devices and Invitro-Diagnostics, Validant
  • Drug and Device Privacy and Cybersecurity Considerations
    Kimberly J. Gold, Partner, Reed Smith LLP
    Zach Rothstein, VP, Technology & Regulatory Affairs, AdvaMed
    Suzanne Schwartz, Associate Director for Science and Strategic Partnerships, CDRH, FDA (Invited)
    Tara Sklar
    , Professor of Health Law, University of Arizona
  • “Sugar” and “Natural” Food Label Claims and Litigation – What’s Next?
    Susan M. Bond, VP, Regulatory and Scientific Affairs, Kerry, Inc.
    Maia C. Kats, Of Counsel, Kaplan Fox & Kilsheimer, LLP
    Suzie L. Trigg, Partner, Haynes and Boone LLP
  • Electronic Nicotine Delivery Systems Part II: Adult Smoker Cessation and Harm Reduction
    Aruni Bhatangar, Professor of Medicine and Distinguished University Scholar, University of Louisville and Fellow, American Heart Association
    Gregory Conley
    , President, American Vaping Association
    Moderated by Robyn Gougelet, Senior Associate, Pinney Associates, Inc.
  • Marijuana, CBD, and Hemp: Understanding the Current Regulatory Landscape and How it Might Change
    Dominic Chiapperino, Director, Controlled Substance Staff, CDER, FDA (Invited)
    Miriam Guggenheim, Partner, Covington & Burling LLP and Member, FDLI Board of Directors
    Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
    Sarah Sorscher, Deputy Director of Regulatory Affairs, Center for Science in the Public Interest (CSPI)

12:30–1:40 PM         
Luncheon

  • Facilitated Table Topic Discussions
    Led by FDLI-member experts, these informal facilitated discussions provide an ideal way to engage with colleagues, gain new information, and share best practices on a hot topic in food and drug law. Attendees have the option to choose from one of the 30+ topics or enjoy open-seating during lunch.

1:40–1:45 PM      
Transition

1:45–2:30 PM  
Breakout Sessions

  • Regenerative Medicine, Gene Therapies, and FDA Regulation
    Joanne Hawana, Of Counsel, Mintz, Levin, Cohen, Ferris, Glovsky and Popeo, PC
    Marc J. Scheineson, Partner, Alston & Bird LLP
    Michael Werner
    , Partner, Holland & Knight LLP
  • Patient Input in Medical Product Development
    Andrea Furia-Helms, Director of Patient Affairs Staff, FDA (Invited)
    David R. Zook
    , Partner, Faegre Baker Daniels LLP
  • Issues and Updates in Combination Products Regulation
    Steven Silverman, VP, Technology and Regulatory Affairs, AdvaMEd
    Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals USA, Inc.
    John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office Combination Products, FDA (Invited)
  • International Medical Device Regulation and Harmonization
    Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP
    Kimberly Snyder, Senior Partner, Validant
    Jur Strobos, Partner, Baker & McKenzie LLP
  • An In-Depth Look at GRAS and Food Ingredient Regulation
    Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC
    Mark Mansour, Partner, Locke Lord LLP
  • Tobacco Litigation Update
    Eric Gotting, Partner, Keller and Heckman, LLP
    Moderated by Tara Lin Couch, Senior Director of Dietary Supplement and Tobacco Services, EAS Consulting Group, LLC

2:30–2:45 PM        
Coffee and Networking Break

2:45–4:00 PM     
Top Cases in Food and Drug Law
Always informative and entertaining, this perennially popular session promises insight into the most significant litigation from 2018, and a look at cases to keep an eye on in 2019. Annual Conference attendees receive the companion publication, Top Food and Drug Law Cases 2018, and Cases to Watch, 2019

Ralph F. Hall, Professor of Practice, University of Minnesota Law School
William M, Janssen, Professor of Law, Charleston School of Law
Erika Lietzan, Associate Professor, University of Missouri-Columbia School of Law
Moderated by
August T. Horvath, Partner, Foley Hoag LLP

4:00 PM    
Conference Adjournment

Planning Committee

Co-Chairs

Amy Norris
Chief Counsel, Clif Bar & Company

William Schultz
Partner, Zuckerman Spaeder LLP

Committee Members

Azim Chowdhury, Partner, Keller and Heckman LLP
Dean R. Cirotta, President & COO, EAS Consulting Group, LLC
James N. Czaban, Partner, DLA Piper LLP
Kathleen Hoke, Professor & Director, Network for Public Health Policy and Center for Tobacco Regulation,
University of Maryland Carey School of Law
Brenda Huneycutt, Director, Regulatory Innovation, FasterCures
Madeleine M. McDonough, Partner and Chair, Shook, Hardy & Bacon LLP
John A. Murphy, Deputy General Counsel, Biotechnology Innovation Organization
Adora Ndu, Executive Director, Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical Inc.
Vernessa Pollard, Partner, McDermott Will & Emery
Stuart Pape, Shareholder, Polsinelli PC
Cassie Scherer, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic
Jesse J. Sevcik, Sr. Director, Global Government Affairs, Elanco Animal Health
Julia (Julie) Tierney, Senior Policy Advisor for Strategic Planning and Legislation, CBER, FDA
Michael Werner, Partner, Holland & Knight LLP
José Alberto Campos Vargas, Partner, Sánchez Devanny

 

Continuing Legal Education (CLE)

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

 

Location and Overnight Accommodations

Conference Location

Ronald Reagan Building and International Trade Center 
1300 Pennsylvania Avenue NW
Washington, DC 20004

Business attire is suggested and some meeting rooms may have cooler temperatures.

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.

Overnight Accommodations

JW Marriott
1331 Pennsylvania Avenue NW
Washington, DC 20004

A discounted block of rooms has been reserved at the JW Marriott for conference attendees.  The JW Marriott is a short walk from the Ronald Reagan Building.  Reservations can be made online and must be completed by Tuesday, April 9 to receive the $329.00 rate.  After this date, rooms are subject to prevailing rates and availability.  If you need further assistance contact us at [email protected].

2019-03-25T12:59:53-04:00