2024 FDLI Annual Conference

May 15–16, 2024   Washington, DC   In-Person & Virtual Event

Preliminary Agenda

Agenda Subject to Change
All Times Listed in Eastern Time

Wednesday, May 15

Christine M. Simmon, President & CEO, FDLI
Winston S. Kirton, Partner, BakerHostetler and Co-Chair, 2024 FDLI Annual Conference
Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson & Co-Chair, 2024 FDLI Annual Conference

Robert Califf, Commissioner of Food and Drugs, FDA
Moderated by Vernessa T. Pollard, Partner, DLA Piper LLP and Vice-Chair, FDLI Board of Directors

Mark J. Raza, Chief Counsel, FDA

10:05–10:20 AM | Networking Break

A key component of FDA’s mission is “helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health,” including  via collaboration with stakeholders. This session will focus on the unique issues posed by health-related mis- and disinformation–including identification, prevalence, and legal and practical prevention challenges–and how government, industry, and public health groups can address this problem.

Julie Tierney, Deputy Director, CBER, FDA
Claire Wardle, Co-Director, Information Futures Lab and Professor of the Practice, Department of Health Services, Policy, and Practice, Brown University School of Public Health
Susan C. Winckler, CEO, Reagan-Udall Foundation
Moderated by Peter Pitts, President, Center for Medicine in the Public Interest

From drug and device development to foodborne illness outbreak tracking, AI has incredible potential to improve the manufacturing and oversight of FDA-regulated products and patient health. However, it also poses serious concerns over data security, biases, controllability, and more. Panelists will delve into industry efforts to utilize AI’s promise and how policymakers and regulatory agencies are grappling with its unique challenges.

Barrett Tenbarge, Senior Health Counsel, U.S. Senate Committee on Health, Education, Labor, & Pensions
Moderated by Lowell Zeta, Partner, Hogan Lovells

Additional Panelists to be Announced

2:00–3:00 PM | Concurrent Breakout Sessions 1

CDER leadership will discuss its current and future programmatic priorities and goals.

Patrizia Cavazzoni, Director, CDER
Moderated by John C. Garvey, Managing Partner, Compliance Architects LLC

Once the futuristic technologies of science fiction, AI and ML are now mainstream tools used to enhance medical device accuracy and precision. This session will provide clarity on the developing regulatory framework, guidance on leveraging these technologies effectively, and address issues such as algorithm bias, data threats, and global harmonization.

Eric Henry, Senior Quality Systems and Compliance Advisor, King & Spalding LLP
B.Y. MiRa Jacobs, Division Director, Division of Digital Health Policy, Digital Health Center of Excellence, FDA
Cassie Scherer, Senior Director, U.S. Regulatory and Global Digital Health Policy, Medtronic
Moderated by Tina Hu-Rodgers, Shareholder, Buchanan Ingersoll & Rooney PC

About half of all sterilized medical devices in the US are sterilized with ethylene oxide (EtO). This year, FDA and EPA made progress toward reducing reliance on EtO. EPA’s March rule seeks to mitigate cancer risks for residents near commercial sterilization facilities, while FDA’s virtual town hall meetings include wide-ranging concerns, including device supply chain integrity. Panelists will continue this discussion and address how best to engage with FDA and EPA amidst changes to the regulatory landscape.

Ryan Ortega, Regulatory Policy Advisor, Office of Product Evaluation and Quality, CDRH, FDA

Additional Panelists to be Announced

CVM leadership will discuss its current and future programmatic priorities and goals.

Tracey H. Forfa, Director, CVM
Moderated by Jeannie M. Perron, Partner, Covington & Burling LLP

Food and dietary supplement companies rely on online marketing and advertising strategies to connect with today’s consumers, and must navigate FDA, USDA and FTC requirements to do so legally.  In 2022, the FTC released the Health Products Compliance Guidance, adding another layer of standards in this arena for FDA-regulated companies. This panel will discuss what companies need to know when marketing food and dietary supplements on digital media platforms.

Katherine Armstrong, Deputy Director, National Advertising Division, Better Business Bureau
Jacqueline J. Chan, Assistant General Counsel, Regulatory & Marketing, Unilever
Michael Ostheimer, Senior Attorney, Division of Advertising Practices, Federal Trade Commission
Moderated by John P. Feldman, Partner, Reed Smith LLP

CTP leadership will discuss its current and future programmatic priorities and goals.

Brian A. King, Director, CTP, FDA
Moderated by J. Benneville “Ben” Haas, Partner, Latham & Watkins LLP

3:10–4:10 PM | Concurrent Breakout Sessions 2

CBER leadership will discuss its current and future programmatic priorities and goals.

Julie Tierney, Deputy Director, CBER, FDA
Moderated by Steven J. Lynn, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates Inc.

In October, FDA issued a proposed rule to explicitly classify in vitro diagnostic products as devices under the law. FDA and CMS then issued a joint statement on LDT oversight of individual laboratories based on historical concerns of patient safety, and more recent concerns over products intended to diagnosis Covid-19. Read together, these changes represent a shift in LDT oversight and enforcement discretion. This session will provide perspectives on implications for LDT stakeholders and patients, with specific focus on preparing for future pandemics, addressing rare disease patients’ needs, and untangling interstate commerce concerns.

Shelby Buettner, Assistant General Counsel, Regulatory Law and Compliance Counsel, Becton Dickinson (BD)
Moderated by Jeremiah J. Kelly, Partner, Venable LLP

Additional Panelists to be Announced

The transformational value of merging medical devices, drugs, and biologics is improved patient care. This session will explore ways manufacturers seek to address combination products’ unique developmental and quality challenges while meeting FDA expectations.

James Bertram, Office of Combination Products, Office of Clinical Policy and Programs, FDA
Eva Temkin, Partner, Paul Hastings LLP
Rumi Young, Director, Regulatory Policy, Becton Dickinson (BD)
Moderated by Philip R. Desjardins, Partner, Arnold & Porter

 

The Modernization of Cosmetics Regulation Act (MoCRA) significantly strengthened FDA’s jurisdiction over cosmetics and imposed new requirements on industry; meanwhile cosmetics-focused state regulation and private litigation has increased substantially in recent years. This session will explore MoCRA’s genesis and parameters, the emerging patchwork of state laws, safety substantiation considerations, and alleged contaminants and marketing claims at the center of consumer litigation.

Kelly Bonner, Associate, Duane Morris LLP
Paula Brock, Senior Regulatory and Scientific Consultant, EAS Consulting Group
Virginia Hill, Director, Product Safety & Regulatory Affairs, Wella Company
Moderated by Katlin McKelvie, Partner, Gibson, Dunn & Crutcher LLP

CFSAN leadership will discuss its current and future programmatic priorities and goals.

Donald A. Prater, Acting Director, CFSAN
Moderated by Keith A. Matthews, Of Counsel, Wiley Rein LLP

In December, CTP released its new five-year strategic plan, the first public announcement of its kind since 2017. Panelists will share their perspectives on the plan, including assessments of its goals, likely priorities, and potential unintended consequences.

John O’Brien, Vice President and Assistant General Counsel – Regulatory, RAI Services Company (Reynolds American, Inc.)
Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP

Additional Panelists to be Announced

4:20–5:20 PM | Concurrent Breakout Sessions 3

One of the IRA’s key objectives is reducing US drug prices, a goal which FDA seeks to further by allowing approved states to import certain drugs from Canada. This session will feature insights into the IRA’s impact on the pharmaceutical industry over its first two years, plus perspectives on potential future developments from Canadian drug importation.

Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates

Panelists to be Announced

CDRH leadership will discuss its current and future programmatic priorities and goals.

Jeffrey E. Shuren, Director, CDRH
Moderated by Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson and Co-Chair, 2024 Annual Conference Planning Committee

Clinical trial modernization and diversification are essential to a high standard of care for a broader patient demographic. Panelists will examine how industry can align with goals set by FDA in recent guidance, report to regulatory bodies, and manage requirements from global regulatory authorities when conducting clinical trials in other countries.

Jeffrey K. Francer, Vice President and Head of Global Regulatory Policy, Eli Lilly and Company
Peter V. Lindsay, Partner, Paul Hastings LLP
Moderated by Winston Kirton, Partner, BakerHostetler and Co-Chair, 2024 Annual Conference Planning Committee

FDA is prioritizing its nutrition initiatives, aiming to facilitate easier identification of, and enhance access to, healthier foods and nutrition information. Panelists will discuss the status of FDA’s front-of-labeling (FOP) nutrition labeling scheme and FDA’s proposed framework for the updated definition of “healthy.” This panel will also explore state activity on alternative protein labeling.

Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling, CFSAN, FDA
Sarah Sorscher, Director of Regulatory Affairs, Center for Science in the Public Interest (CSPI)
Moderated by Suzie Trigg, Partner, Haynes and Boone LLP

CTP has yet to issue a Marketing Granted Order (MGO) for a flavored e-cigarette and has not issued any MGOs in well over a year, leading to speculation about de facto flavor and new product bans. This session will review CTP’s recent PMTA decisions and litigation challenging its Marketing Denial Orders (MDOs), then address current and future implications for the alternative nicotine product marketplace.

Clive Bates, Director, Counterfactual Consulting Limited
Azim Chowdhury, Partner, Keller and Heckman LLP
Jessica Zdinak, Chief Research Officer, Applied Research and Analysis Company, LLC

Thursday, May 16

Steven Leslie, Director, Educational Programs, FDLI

Jim Jones, Deputy Commissioner for Human Foods, FDA
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara P.C. and Member, FDLI Board of Directors

The increasing globalization of supply chains means greater susceptibility to natural and man-made disruptions, such as adverse weather events, geopolitical conflicts, and accidental or intentional adulteration. This session will review recent supply chain upheavals impacting FDA regulated products, and discuss government and private stakeholder efforts to anticipate and mitigate these challenges.

Jacquelin Corrigan-Curay, Principal Deputy Center Director, CDER, FDA
Kimberlee Trzeciak, Deputy Commissioner for Policy, legislation, and International Affairs, FDA
Moderated by Laura Akowuah, Senior Advisor for Critical Foods Enforcement and Compliance, CFSAN, FDA

Additional Panelists to be Announced

10:40–11:00 AM | Networking Break

The U.S. Supreme Court will soon decide two cases centered on judicial deference to FDA on statutory interpretation and science-based decision making (Looper Bright Enterprises v. Raimondo and FDA v. Alliance for Hippocratic Medicine, respectively). Panelists will review the case history and arguments, then discuss potential ramifications for industry and the agency if judicial deference to FDA is limited or eliminated for either.

Kalah Auchincloss, Executive Vice President, Regulatory Compliance & Deputy General Counsel, ELIQUENT Life Sciences
Vanessa K. Burrows, Partner, Simpson Thacher & Bartlett LLP
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Moderated by Stacy Cline Amin, Partner, Morrison & Foerster LLP

Additional Panelists to be Announced

Scott Gottlieb, MD, Partner, New Enterprise Associates and Former Commissioner, FDA

1:10–2:10 PM | Concurrent Breakout Sessions 4

There are an estimated 6,000 diseases caused by single gene mutations affecting over 350 million people globally. In 2023 FDA approved the first cell-based gene therapy using CRISPR/Cas9. Cell and gene therapies are essential to targeting the underlying cause of genetic and acquired diseases, but regulatory framework and the global marketplace pose challenges. Panelists will address these challenges, including high costs and approval uncertainty.

Samantha Wilson Jones, Chief Legal Officer, Spark Therapeutics, Inc.
Collin Stabler, Senior Managing Engineer, Exponent
Nicole Verdun, Director, Office of Therapeutic Products, CBER, FDA

Additional Panelists to be Announced

This session will explore the impact of harmonization on GMPs. Panelists will consider the risk-based and quality-based approaches outlined in ISO 13485 to address compliance management, safety, and the role of individual processes within a company.

Arthur Kim, Legal Director for Quality, Clinical, and Regulatory Compliance, Medtronic
Janet L. Michener Whipple, Partner, ELIQUENT Life Sciences
Moderated by Benjamin K. Wolf, Senior Associate, Alston & Bird LLP

In October, FDA released draft guidance on scientific exchange between firms and health care providers on unapproved uses of approved or cleared medical products. However, compliance questions remain. In light of OPDP enforcement against entities communicating inconsistent or overstated product efficacy, panelists will provide clarifying insights, share practical guidance, address first amendment arguments, and opine on the future of communications, given the heightened importance of information sharing on digital platforms.

Panelists to be Announced

As Congress contemplates cannabis legislation and the Drug Enforcement Agency (DEA) assesses marijuana rescheduling, state authorities continue to act and respond to an evolving marketplace. Panelists will discuss recent developments and concerns for cannabis and cannabis-derived products, plus potential federal legislative and regulatory solutions to improve oversight.

Amy Cadwallader, Director, Regulatory and Public Policy Development, US Pharmacopeia
Andrew J. Kline, Senior Counsel, Perkins Coie LLP
Leah Sera, Associate Professor, University of Maryland School of Pharmacy
Moderated by Alva C. Mather, Partner, McDermott Will & Emery

Meredith Quinn Olearchik, Senior Vice President and Associate General Counsel – Intellectual Property, Marketing, Privacy and Food Law, Campbells Soup Company
Paul South, Director, Division of Plant Products and Beverages, Office of Food Safety, CFSAN, FDA
Moderated by Sharon Mayl, Partner, DLA Piper LLP

While CTP continues its high output of warning letters to manufacturers and retailers selling illegal e-cigarettes, many observers believe this is not sufficient to clean up the marketplace. This panel will feature perspectives on roles for both public and private stakeholders to improve and strengthen federal oversight and enforcement.

Moderated by Jarred L. Reiling, Of Counsel, DLA Piper LLP

Panelists to be Announced

2:20–3:20 PM | Concurrent Breakout Sessions 5

Teresa Buracchio, Acting Director, Office of Neuroscience, CDER, FDA
Darcy Frear, Associate Director, Regulatory Policy & Intel, BridgeBio Pharma
Kerry Jo Lee, Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
Moderated by Rachel Sher, Partner, Manatt, Phelps & Phillips LLP

Preemptive medicine presents a revolutionary approach to healthcare by enabling early intervention for patients in pre-disease states. However, obtaining approval for interventions poses challenges for industry. Panelists will share strategies for effective collaboration with FDA to facilitate healthcare entities’ access to next-generation diagnostics, novel biomarkers, and other tools to practice preemptive medicine.

Matthew Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA
David Fox, Partner, Hogan Lovells LLP
Moderated by M. Jason Brooke, Attorney & Managing Member, Brooke & Associates

This session will reflect on progress made at the federal and state level since the enactment of the Drug Quality Security Act (DQSA) of 2013. Panelists will draw upon FDA guidance and USP compounding chapters, as well as caselaw, recent enforcement activity, and concerns on the horizon to provide a comprehensive retrospective and prospective examination of DQSA.

Gail Bormel, Director, Office of Compounding Quality and Compliance, CDER, FDA
Scott Bruner, CEO, Alliance for Pharmacy Compounding
Lee H. Rosebush, Partner, BakerHostetler LLP
Moderated by Julie A. Dohm, Partner, Covington & Burling LLP

PDUFA VII articulates that modernizing and improving REMS assessments is an important FDA safety strategy goal. This session will analyze the practical challenges of running a REMS program and how to improve. Panelists will deliberate on mifepristone and opioid REMS programs in light of modifications over the past year.

Brian J. Malkin, Associate General Counsel – Regulatory Law, Teva Pharmaceuticals USA, Inc.

Additional Panelists to be Announced

Riette van Laack, Director, Hyman, Phelps & McNamara P.C.
Moderated by Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton

Additional Panelists to be Announced

States and localities continue to take their own approaches to combat youth vaping, including various flavor bans and nicotine product registration lists. Panelists will review these measures, including any evidence of their effectiveness, then discuss the role states can and should play in nicotine product regulation.

Agustin E. Rodriguez, Partner, Troutman Pepper Hamilton Sanders LLP
Moderated by Beth Oliva, Partner, Fox Rothschild LLP and Member, FDLI Board of Directors

Panelists to be Announced

Join legal experts from the FDLI community as they share overviews of and insights into the most significant current litigation plus the cases to watch in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2023, and Cases to Watch, 2024.

Anne Cai, Vice President, Analysis Group, Inc.
Gustav W. Eyler, Partner, Gibson, Dunn & Crutcher LLP
Erika F. Lietzan, William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law, University of Missouri School of Law
Moderated by August Horvath, Partner, Foley Hoag LLP

4:45 PM | Closing Remarks and Adjournment