Agenda & Speakers Slides
Day 1

Agenda & Speakers Slides | Day 2
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Thursday, May 2

8:00 – 9:00 AM 

Registration and Continental Breakfast | ATRIUM

9:15 – 9:30 AM 

Welcome | ATRIUM HALL
Amy Comstock Rick, President & CEO, FDLI
Amy Norris, Chief Counsel, Clif Bar & Company and Co-Chair, FDLI Annual Conference Planning Committee

9:15 – 9:45 AM 

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.

Norman E. Sharpless, Acting Commissioner of Food and Drugs, FDA
Introduced by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Chair, FDLI Board of Directors

9:45 – 10:45 AM

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
Jesse J. Sevcik, Sr. Director, Global Government Affairs, Elanco Animal Health
Moderated by Rebecca K. Wood, Partner, Sidley Austin LLP

10:45 – 11:15 AM

Coffee and Networking Break

11:15 – 12:15 AM

Breakout Sessions

Recently, FDA has taken policy steps toward facilitating more efficient generic drug development by reducing barriers with the intent to incentivize competition and affect drug pricing. Actions include: application of FDARA’s Competitive Generic Therapy designation; GDUFA II pathways for priority and expedited reviews; revised FDA guidance documents related to ANDAs; and revised thinking regarding 180-day exclusivity. This panel will address how these actions practically impact generic drug development and work to meet FDA goals with regard to drug price competition and drug accessibility, as well as discuss potential new and innovative ways FDA might spur 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.
Martha C. Nguyen, Director, Division of Policy Development, Office of Generic Drugs, CDER, FDA
Maryll Toufanian, Director, Office of Generic Drug Policy, CDER, FDA 
Moderated by Markham Luke, Director, Division of Therapeutic Performance, Office of Generic Drugs, CDER

CDRH has exponentially increased the number of de novo classification orders in the past 18 months. Should this be a pathway used for a truly novel product? This influx of new regulatory classifications creates a “blank” page for 510(k) submissions claiming substantial equivalence. FDA inherently must take a modified approach to reviewing those early submissions in new regulatory categories, and companies must understand the review risks when using either approval pathway. As FDA continues to deregulate or exempt more device categories from the requirement for a premarket notification, or 510(k), and to down-classify high-risk devices into moderate risk classes, how might this affect other aspects of medical device manufacturers’ legal and regulatory risks?

Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
Bethany Hills
, Member, Mintz, Levin, Cohen, Ferris, Glovsky and Popeo, PC
Marjorie Shulman, Director, Premarket Notification (510(k)) Program, Office of Device Evaluation, CDRH, FDA
Nicole Taylor Smith, Vice President, Global Regulatory Policy, Medtronic
Peter Yang, De Novo Policy Analyst, CDRH, FDA

Medical technology innovation is exploding and disrupting longstanding patterns of innovation, research, development, regulation, and marketing in the life sciences industry. Big data, the Internet of Things, neurotechnology, AI, and cloud computing are just a few recent innovative tools. The pace of change is unrelenting, but is FDA able to regulate these emerging technologies without compromising innovation or delaying the next generation of technology to patients in need? What programs and policies have FDA considered, and must Congress provide new authorities to FDA to address the challenges in line with FDA’s core public health mission?

Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP
Ellen Flannery, Deputy Center Director for Policy, CDRH, FDA 
Grail Sipes, Deputy Center Director, Regulatory Policy, CDER, FDA
Andrew Wasson, Partner, Haug Partners LLP
Moderated by Elizabeth R. Jungman, Director, Public Health Programs, The Pew Charitable Trusts and Member, FDLI Board of Directors

Late last year, FDA released a five-year plan to further address the use of medically important microbials and antimicrobial stewardship in veterinary settings. The detailed strategy includes 32 points of action toward the goals of appropriate antimicrobial use, fostering appropriate use in veterinary settings, and enhanced monitoring of resistance and antimicrobial drug use in animals. What are the potential impacts and implications of this strategy? Is progress being made toward public health goals? Are we having fewer resistant outbreaks in humans? Panelists will discuss these issues and where roadblocks and legal actions are most likely to occur throughout implementation of this voluntary strategy.

William Flynn, Deputy Director for Science Policy, CVM, FDA
John Hallberg, Director of Regulatory Affairs, Zoetis
Karin Hoelzer, Senior Officer, Health Programs, The Pew Charitable Trusts
Moderated by Ron Phillips, Vice President, Legislative and Public Affairs, Animal Health Institute

Recently, there has been an escalation in federal activity regarding the regulation of biotechnology as it relates to food. USDA recently released its final rule for the disclosure and labeling of bioengineered foods. FDA and USDA also announced they will jointly regulate cell-based meat products. USDA is also in the process of finalized a proposed rule on gene-edited plants. This panel will discuss actions in these areas, including how the agencies may move forward in developing a regulatory pathway for novel products and priorities outlined in FDA’s Plant and Animal Biotechnology Innovation Action Plan.

Trevor Findley, Deputy Director, Food Disclosure and Labeling, Agriculture Marketing Service, USDA 
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
Nicole Negowetti
, Lecturer on Law & Clinical Instructor, Harvard Law School
Moderated by Smitha G. Stansbury, Partner, King & Spalding LLP

The Tobacco Control Act requires manufacturers of modified risk tobacco products (MRTP) to submit a premarket application and obtain market authorization before marketing the product. The application must provide information on the product sufficient to allow the agency to determine that the product will or is expected to reduce harm and the risk of tobacco-related disease as compared to commercially marketed tobacco products. In this panel, speakers will delve into the latest developments on the status of MRTP applications, including a discussion of the most recent Tobacco Products Scientific Advisory Committee (TPSAC) hearings and FDA decisions on pending MRTP applications.

Michael Fisher, Senior Research Scientist, Altria Client Services LLC
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

12:15  – 1:25 PM 

FDLI Annual Remarks
Amy Comstock Rick, President & CEO, FDLI

 

FDLI Distinguished Service and Leadership Awards
Presented by Amy Comstock Rick, President & CEO, FDLI and Laura Brown, Director, Educational Programs, FDLI

 

Award Recipients:
Jeremiah J. Kelly, Chief of FDA Regulatory Law, Office of the Staff Judge Advocate (JAG), US Army Medical Research and Materiel Command (USAMRMC)
Leslie Krasny, Senior Counsel, Keller and Heckman LLP
Captain Martin Shimer, Deputy Director, Division of Legal and Regulatory Support, CDER, FDA

1:25 – 1:30 PM

Transition

1:30– 2:00 PM 

Stacy Cline Amin, Chief Counsel, FDA
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Immediate Past Chair, FDLI Board of Directors

2:00 – 2:10 PM 

Transition

2:10 – 3:25 PM 

Breakout Sessions: FDA Center Directors

Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA 
Jeff Allen, President & CEO, Friends of Cancer Research
Dave Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company 
Philip Katz, Partner, Hogan Lovells US LLP
Christine Simmon, Senior Vice President, Policy & Strategic Alliances, Association for Accessible Medicines
Moderated by Deborah M. Shelton, Partner, McCarter & English LLP

Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA 
Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC
Richard A. Moscicki, Chief Medical Officer and Executive Vice President, Science and Regulatory Advocacy, PhRMA
Rachel Sher, Vice President, Policy and Regulatory Affairs, National Organization for Rare Disorders
Moderated by Neil Di Spirito, Member of the Firm, Epstein Becker & Green, PC

Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
Mahnu Davar, Partner, Arnold & Porter LLP
Heather S. Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Inc.
Kristi Schrode Travers, Assistant General Counsel and Group Leader, Medical Device Regulatory Law, Johnson & Johnson 
Moderated by Vernessa Pollard, Partner, McDermott Will & Emery LLP

Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
Jessica Almy, Director of Policy, The Good Food Institute
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
Megan Olsen, Assistant General Counsel, Council for Responsible Nutrition
Moderated by Stuart M. Pape, Shareholder, Polsinelli PC

Mitchell R. Zeller, Director, Center for Tobacco Products, FDA 
Tony Abboud, Executive Director, Vapor Technology Association
Moira Gilchrist, Vice President, Scientific and Public Communications, Philip Morris International
Seth A. Mailhot, Partner, Husch Blackwell LLP
Moderated by Kathleen Hoke, Professor & Director, Network for Public Health Policy and Center for Tobacco Regulation, University of Maryland Carey School of Law

Steven M. Solomon, Director, Center for Veterinary Medicine, FDA 
Rachel Cumberbach, Director, International and Regulatory Affairs, Animal Health Institute
Brian D. Eyink, Counsel, Hogan Lovells US LLP
Kristin Landis, Deputy General Counsel, Biotechnology Innovation Organization
Moderated by Sean Lee, Of Counsel, Shook, Hardy & Bacon LLP

3:25 – 3:50 PM

Coffee and Networking Break 

3:50 – 4:50 PM

Breakout Sessions

FDA, companies, and clinical researchers are increasingly making use of real-world data. Expanded use of real-world evidence (RWE) and data registries could reduce the time and cost of new product approvals, while providing greater understanding of how products perform under “real life” conditions. Given this increased focus on real-world data in clinical research, FDA has recently published multiple guidance and draft guidance documents aimed at encouraging greater use of RWE and product and patient registries in new product approvals. This panel will explore the circumstances under which FDA will accept real-world evidence, different possible uses of RWE and Data Registries for regulatory purposes, potential challenges associated with their use, and how to work collaboratively with the agency to take advantage of these new approaches.

Kara Kilpatrick, Senior Manager, Center for Observational Research, Amgen Inc.
David B. Martin, Associate Director for Real World Evidence Analytics, CDER, FDA
Eric Solowey, Vice President and Assistant General Counsel, Parexel International
Moderated by John R. Manthei, Partner, Latham & Watkins LLP

FDA has recently unveiled its Software Precertification Pilot Program version 1.0. This new regulatory paradigm will fundamentally shift FDA’s oversight of software, with the goal of speeding up premarket access for new software-based technologies, and at the same time giving FDA greater control over the total product lifecycle of the software. Panelists will discuss the strengths and weaknesses of the program and how it might be adopted for technologies beyond standalone software in the future.

Lesley Maloney, Head, US Regulatory Policy, Roche Diagnostics
Bakul Patel, Associate Director of Digital Health, CDRH, FDA
Ian Pearson, Senior Associate, Jones Day
Moderated by Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors

This panel will address new developments and updates in the biosimilar landscape, including regulatory, legal, and state updates. Speakers will address: takeaways from FDA’s September 2018 hearing on enhancing competition and innovation in the marketplace by facilitating availability of biosimilar and interchangeable products and current barriers; insight from both innovator and biosimilar perspectives on how FDA’s final naming guidance has impacted their own business and practices; an update on patent dance cases and interpretations of BPCIA provisions by patent courts; biosimilar reimbursement; and how international agencies, including FDA, approach biosimilar extrapolation of indications and how outcomes can vary across agencies.

Daniel A. Kracov, Partner, Arnold & Porter LLP and Secretary and General Counsel, FDLI Board of Directors
Teresa Stanek Rea, Partner, Crowell & Moring LLP
Sarah Yim, Acting Director, Therapeutic Biologics and Biosimilars Staff, CDER, FDA
Moderated by Freddy A. Jimenez, Vice-President, Law and Compliance, Celldex Therapeutics, Inc. and Member, FDLI Board of Directors

There is quite a lot happening in the animal food and feed space from both manufacturer and consumer perspectives, particularly surrounding concerns about what is in the food being consumed by pets, as well as livestock that will become food production animals. Speakers will delve into the issues surrounding pet food and heart disease, how pet food regulation differs in the US and EU, updates on state actions, and how the treatment of food and feed additives is evolving for both pets and to improve livestock health and performance. The implementation of the FSMA rule on Preventive Controls for Animal Food, updates on third-party certification bodies for animal food safety audits, and current enforcement actions and policy initiatives with respect to animal food and feed will also be discussed.

John Dillard, Principal Attorney, Olsson Frank Weeda Terman Matz PC
Jeanette Murphy, Consumer Safety Officer, Office of Surveillance and Compliance, CVM, FDA
Peter Tabor, Vice President, Regulatory & International Affairs, Pet Food Institute
Moderated by Jason W. Sapsin, Counsel, Faegre Baker Daniels LLP

Recently, more courts are holding that class action plaintiffs lack standing to seek injunctive relief where they now understand that the food labels or advertisements over which they are suing are deceptive, and thus are in no danger of being misled in the future. There are also advancements in personal jurisdiction, failure to state a claim under the “reasonable consumer” standard, and settlements. This panel will consider litigation developments and procedural strategies to protect your client in class action suits.

Marisol C. Mork, Partner, Squire Patton Boggs (US) LLP
Ronald Y. Rothstein
, Partner, Winston & Strawn LLP
Nury H. Yoo
, Counsel, Keller and Heckman LLP

Since the announcement of the Comprehensive Plan for Tobacco and Nicotine Regulation in 2017, FDA has recently issued policy statements and taken actions regarding combustible tobacco products. FDA seeks to regulate nicotine levels in combustible products so that they are minimally or non-addictive by promulgating a nicotine product standard. In addition, it is moving forward with a proposed rule to ban flavored cigars, as well as considering proposals to prohibit menthol in cigarettes. This panel will contemplate the legal considerations of these actions, public health implications, and potential impacts on the marketplace and illicit trade.

Carole Folmar, Director, Regulatory and Scientific Affairs and Associate General Counsel, ITG Brands, LLC
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: Randall J. Ortman, Product Counsel, Verily Life Sciences LLC
Interviewed by
Margaret (Peggy) Dotzel, Partner, Zuckerman Spaeder LLP

5:30 – 7:00 PM

Networking Reception | ATRIUM