2024 FDLI Annual Conference

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


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, Assistant General Counsel, Regulatory Law, MedTech, 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 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 for the FDA
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.

Brian Anderson, Chief Executive Officer, Coalition for Health AI (CHAI)
Joe Franklin, Head of Strategic Affairs, Verily Life Sciences
Coleen Glessner, Executive Vice President Quality and Ethics and Compliance, Emergent BioSolutions
Barrett Tenbarge, General Counsel, U.S. Senate Committee on Health, Education, Labor, & Pensions
Moderated by Lowell Zeta, Partner, Hogan Lovells

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.

Kaitlin Alexander, Senior Scientist, Exponent
Ryan Ortega, Regulatory Policy Advisor, Office of Product Evaluation and Quality, CDRH, FDA
Moderated by Lewis A. Grossman, Ann Loeb Bronfman Professor of Law and Affiliate Professor of History, American University Washington College of Law

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
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.

FDA has released its final rule establishing LDTs as medical devices under the law, and also announced it will phase out its enforcement discretion policy over the next few years. Panelists will dissect the new rule and enforcement policy, then discuss implications for stakeholders and likely basis for legal challenges.

Shelby Buettner, Assistant General Counsel, Regulatory Law and Compliance Counsel, Becton Dickinson (BD)
Ralph Hall, Principal, Leavitt Partners
Cara Tenenbaum, Principal, Strathmore Health Strategy
Moderated by Jeremiah J. Kelly, Partner, Venable LLP

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, Novo Nordisk
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
Jessica Madrigal, Vice President, Associate General Counsel, Rodan + Fields
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.

Clifford E. Douglas, President and CEO, Global Action to End Smoking
Stacey Younger Gagosian, Senior Vice President of Public Policy, Truth Initiative
John O’Brien, Vice President and Assistant General Counsel – Regulatory, RAI Services Company (Reynolds American, Inc.)
Barry S. Schaevitz, Partner, Fox Rothschild LLP
Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP

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. Panelists will discuss IRA’s impact on the pharmaceutical industry over its first two years, IRA-focused litigation, and potential future developments for Canadian drug importation.

Brian Burgess, Partner, Goodwin Procter LLP
Stephen L. Forster, Partner, Morgan, Lewis & Bockius LLP
Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates

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

Jeffrey Shuren, Director, CDRH
Moderated by Sarah H. Stec, Assistant General Counsel, Regulatory Law, MedTech, 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
Christine S. Lee, Acting Associate Commissioner for Minority Health, Office of Minority Health and Health Equity (OMHHE), FDA
Peter V. Lindsay, Partner, Paul Hastings LLP
Moderated by Winston Kirton, Partner, BakerHostetler and Co-Chair, 2024 Annual Conference Planning Committee

The potential for antimicrobial drug use in veterinary medicine to contribute to antimicrobial resistance in humans has been a focus of federal agencies for decades, and in recent years FDA and USDA have launched sweeping new initiatives to address this concern. This session will explore FDA and USDA’s efforts to combat antimicrobial resistance and towards judicious antimicrobial use through industry guidance, initiatives, and communication with global partners.

Patrick C. Gallagher, Principal, PC Gallagher Law, P.A.
Karl M. Nobert, Senior Counsel, Michael Best & Friedrich LLP
Moderated by Elizabeth Butterworth Stutts, Principal, Elizabeth Butterworth Stutts, Esq, PLLC

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.

Susan M. Bond, VP, Regulatory and Scientific Affairs, Kerry, Inc.
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

Shelby Buettner, Assistant General Counsel, Regulatory Law and Compliance Counsel, Becton Dickinson (BD)
Philip R. Desjardins, Partner, Arnold & Porter
Elizabeth Jungman, Chief of Staff, Office of the Commissioner, FDA
Moderated by Stuart TenHoor, President, Stuart TenHoor Legal Search

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 FDA’s recent and ongoing efforts to anticipate and mitigate these challenges.

Jacqueline Corrigan-Curay, Principal Deputy Center Director, CDER, FDA
Suzanne Roosen, Acting Director, Office of Food Policy and Response, FDA
Douglas Stearn, Deputy Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, 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

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

A lectureship in honor of Dr. Harvey W. Wiley, featuring the recipient of the namesake aware bestowed by the FDA Alumni Association.

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

Introduced by Deborah M. Autor, CEO, ; and Chair, Board of Directors, FDA Alumni Association

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.

Collin Stabler, Senior Managing Engineer, Exponent
Deborah Tolomeo, Associate General Counsel, Spark Therapeutics, Inc.
Nicole Verdun, Director, Office of Therapeutic Products, CBER, FDA
Moderated by Michael J. Werner, Partner, Holland & Knight LLP

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.

Kellie B. Combs, Partner, Ropes & Gray LLP
Torrey Cope, Partner, Sidley Austin LLP
Karen Day, Senior Counsel, Pfizer

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
Patrick Cournoyer, Senior Science Advisor and Lead, Cannabis Product Committee, OC, FDA
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

Increased concerns over the presence of heavy metals and PFAS in the food supply has driven federal regulatory interest, state legislation efforts, and private litigation. This session will cover recent activity in this space, including FDA’s Closer to Zero program, state efforts to limit the discharge or use of PFAS, and contaminant-driven consumer litigation. Panelists will also discuss issues in testing for and the risk evaluation of these contaminants.

Tom Neltner, National Director, Unleaded Kids
Greg Sperla, Partner, DLA Piper LLP
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.

Tony Abboud, Executive Director, Vapor Technology Association
David Fernandez, Vice President, Altria Client Services
Moderated by Jarred L. Reiling, Of Counsel, DLA Piper LLP

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

Historically, emerging therapies for heterogenous diseases with low patient populations have presented practical development difficulties for drug manufacturers, including limited clinical data, lack of established clinical trial endpoints, and quality inconsistency. This session will explore FDA’s approach to reviewing these novel drug development tools to better serve rare and neurodegenerative disease patients, and best practices to proactively engage with regulators to identify expectations and potential hurdles.

Teresa Buracchio, 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
James Myers, Associate Director for Policy, CBER, 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
Nicole Taylor Smith, Vice President, Global Head of Regulatory Science and Policy, Philips
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. 

Gerald Dal Pan, Director, Office of Surveillance and Epidemiology (OSE), CDER, FDA
Jamie Wilkins, Senior Director- Head-Risk Management Center of Excellence and Secretariat- Pharmacovigilance Policy Committee, Worldwide Safety, Pfizer
Moderated by Brian J. Malkin, Associate General Counsel – Regulatory Law, Teva Pharmaceuticals USA, Inc.

There is growing tension between FDA and state authorities on food ingredient and additive safety. States are becoming increasingly active in this space, including California’s recent ban on four food ingredients and Illinois’s proposed bill that would ban five food additives, all of which FDA has deemed permissible. Panelists will review this increasing divergence between FDA and state regulation, plus related legal issues and potential practical challenges.

Laura A. Rich, Counsel, Venable LLP
Riette van Laack, Director, Hyman, Phelps & McNamara P.C.
Moderated by Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton

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.

Abigail S. Friedman, Associate Professor, Department of Health Policy and Management, Yale School of Public Health
Kathleen Hoke, Professor, Director, Legal Resource Center for Public Health Policy, and Director, Network for Public Health Law–Eastern Region, University of Maryland School of Law
Agustin E. Rodriguez, Partner, Troutman Pepper Hamilton Sanders LLP
Moderated by Beth Oliva, Partner, Fox Rothschild LLP and Member, FDLI Board of Directors

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