Wednesday, May 17
Christine M. Simmon, President & CEO, FDLI
Mantej (Nimi) Chhina, Executive Director, Head of Global R&D and Regulatory Policy, Global Regulatory Affairs, BioMarin Pharmaceutical, Inc. and Co-Chair, 2023 FDLI Annual Conference
Jonathan A. Havens, Partner, Saul Ewing Arstein & Lehr LLP and Co-Chair, 2023 FDLI Annual Conference
Robert M. Califf, Commissioner of Food and Drugs, FDA
Introduced by Freddy A. Jimenez, Senior Vice President and General Counsel, Celldex Therapeutics and Chair, FDLI Board of Directors
Mark J. Raza, Chief Counsel, FDA
10:00–10:30 AM | Break
Congress continues to be active on issues affecting FDA and regulated industry. This panel will address the impacts of the Inflation Reduction Act of 2022, the 2022 Food and Drug Omnibus Reform Act including changes to cosmetics regulation, and effects of the Cancer Moonshot Program. Speakers will also discuss any gaps in legislation that could drive future developments.
Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs, Office of the Commissioner, FDA
Kelly F. Goldberg, Vice President, Law & Senior Counsel for Biopharmaceutical Regulation, PhRMA
Peter J. Pitts, President, Center for Medicine in the Public Interest
Barrett Tenbarge, Senior Health Counsel, U.S. Senate Committee on Health, Education, Labor, & Pensions
Moderated by Melanie Katrice Gross, Associate General Counsel & Practice Group Leader, Healthcare Law Group, Genentech, Inc. and Member, FDLI Board of Directors
Several important cases and decisions related to agency authority, deference, and reviewability of FDA actions have been published over the past year. In this session, speakers will discuss how these cases – including the recent rulings on mifepristone – could impact FDA product approval, agency statutory interpretation, established agency policy, and the availability of remedies under the Administrative Procedure Act. Speakers also will address how HHS’s Office of General Counsel and FDA’s Office of Chief Counsel may construe the scope of these cases, and what changes in FDA jurisprudence could mean for industry and FDA moving forward.
James C. Fraser, Senior Counsel, Thompson Hine LLP
Freddy A. Jimenez, Senior Vice President and General Counsel, Celldex Therapeutics and Chair, FDLI Board of Directors
William B. Schultz, Partner, Zuckerman Spaeder LLP
Patricia J. Zettler, Associate Professor, Moritz College of Law, The Ohio State University and Member, FDLI Board of Directors
Moderated by Stacy Cline Amin, Partner, Morrison and Foerster, LLP
FDLI CEO Address
Christine M. Simmon, President & CEO, FDLI
FDLI Distinguished Service and Leadership Award
The FDLI Distinguished Service and Leadership Award, established in 1993, recognizes individuals who have made notable contributions to the food and drug law community through their leadership.
Award Recipients:
Cathy L. Burgess, Partner, Alston & Bird LLP
Linda M. Katz, Director, Office of Cosmetics and Colors, CFSAN, FDA
Frank Palumbo, Of Counsel, BakerHostetler and Professor Emeritus, University of Maryland School of Pharmacy
Presented by Christine M. Simmon, President & CEO, FDLI and
Freddy A. Jimenez, Senior Vice President and General Counsel, Celldex Therapeutics and Chair, FDLI Board of Directors
2:00–3:00 PM | Concurrent Breakout Sessions 1
FDA leadership will address the top issues CFSAN is facing as well as priorities and goals for the coming year.
Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA
Douglas W. Stearn, Deputy Director, Regulatory Affairs, Center for Food Safety and Applied Nutrition, FDA
Moderated by Suzie Trigg, Partner, Haynes and Boone LLP
Over the past year, FDA’s Accelerated Approval program has continued to be a dominant issue for regulators and industry alike. In this session, speakers will discuss some of the challenges of FDA’s Accelerated Approval program and their impact on the Agency’s use of this pathway, including confirmatory trials and withdrawal of approval, and consider whether different methods for timely withdrawal of accelerated approval could increase use of this pathway. Legislative proposals to reform accelerated approval will also be addressed.
Jacqueline Corrigan-Curay, Principal Deputy Center Director, CDER, FDA
Maureen M. Japha, Director, Health Policy and Strategy, Eli Lilly and Company
John A. Murphy, Chief Policy Officer Deputy Counsel, Healthcare, Biotechnology Innovation Organization (BIO)
Michael K. Stern, Of Counsel, Covington & Burling LLP
Moderated by Annie Kennedy, Chief of Policy, Advocacy & Patient Engagement, EveryLife Foundation for Rare Diseases
The regulatory landscape for biosimilars is constantly shifting, but we are reaching an inflection point. The U.S. marketplace has not developed as expected, and global differences in clinical study requirements for biosimilarity and interchangeability, and certain provisions of the Inflation Reduction Act may affect the future of the industry. Speakers will address this future, including challenges moving forward and what regulatory enhancements could drive biosimilar advancement.
Leah A. Christl, Executive Director, Head of Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy, Amgen, Inc.
Aaron Josephson, Director, Regulatory Policy & Intelligence, TEVA Pharmaceuticals USA, Inc.
Mustafa Unlu, Policy Staff Director, Office of Therapeutic Biologics and Biosimilars, CDER, FDA
Moderated by Michael J. Werner, Partner, Holland & Knight LLP
This session will provide clarity on the developing regulatory framework for digital health technologies, including Clinical Decision Support Software, Virtual Reality, Augmented Reality, and other products incorporating Artificial Intelligence and predict how this framework will evolve based on recent FDA announcements and priorities. Panelists will also touch on efforts in global harmonization of regulatory approaches.
M. Jason Brooke, Attorney & Managing Member, Brooke & Associates
Sonja Fulmer, Acting Deputy Director, Digital Health Center of Excellence, CDRH, FDA
Cassie Scherer, Senior Director, U.S. Regulatory and Global Digital Health Policy, Medtronic
Blake E. Wilson, Partner, Hogan Lovells US LLP
In January 2023, DOJ announced updates to its voluntary disclosure policy related to potential criminal prosecution. Generally, these revisions provide incentives for corporations to self-disclose noncompliance, cooperate with DOJ, and remediate wrongdoing. Panelists will analyze these revisions, evaluate when voluntary disclosure is appropriate, discuss how and when to incorporate voluntary disclosure policies into business culture, and provide best practices while addressing DOJ enforcement to prevent escalation.
Gustav W. Eyler, Partner, Gibson, Dunn & Crutcher LLP
Perham Gorji, Deputy Chief Counsel, Office of the Chief Counsel, FDA
Amanda Liskamm, Director, Consumer Protection Branch, DOJ
Moderated by Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
In response to the Reagan-Udall Foundation’s operational evaluation of FDA’s tobacco program, CTP recently announced several new initiatives, including improving transparency, developing a comprehensive five-year strategic plan, creating a new policy unit to coordinate across CTP, increasing its Tobacco Products Scientific Advisory Committee (TPSAC) meetings, and holding an inter-agency enforcement summit. Panelists will discuss the outlook for and potential merits of these initiatives, while also considering current challenges in tobacco product regulation.
Dave Dobbins, Principal, Dobbins Consulting
Connor Fuchs, Senior Staff Attorney, Campaign for Tobacco-Free Kids
Matthew R. Holman, VP, US Scientific Engagement & Regulatory Strategy, Philip Morris International
Beth G. Oliva, Partner, Fox Rothschild LLP
Moderated by Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP
3:15–4:15 PM | Concurrent Breakout Sessions 2
FDA leadership will address the top issues CDRH is facing as well as priorities and goals for the coming year.
Jeffrey Shuren, Director, Center for Devices and Radiological Health, FDA
Moderated by Vernessa T. Pollard, Partner, McDermott Will & Emery LLP and Member, FDLI Board of Directors
FDA and the Federal Government have recently enacted a variety of initiatives, including draft guidance and legislation, to promote clinical trial diversity enrollment, encourage decentralized clinical trials, and streamline clinical trials. In this session, panelists will explore why clinical trial diversity matters and the barriers and opportunities to advancing it, including remote participation and using technology to recruit diverse populations. Panelists also will discuss the recent draft guidance, federal legislation, and complementary initiatives, such as increasing diversity among clinical trial administrators and healthcare providers.
RDML Richardae Araojo, Associate Commissioner for Minority Health and Director, Office of Minority Health and Health Equity, Office of the Commissioner, FDA
Jennifer De Camara, VP, Regulatory Law, Research & Development and Quality, Johnson & Johnson
Lionel Phillips, President, Inside Edge Consulting Group
Shanta Whitaker, Senior Director, Policy, Government Affairs, and Advocacy, American Diabetes Association
Moderated by Sarah Thompson Schick, Counsel, Reed Smith LLP
Clinical issues associated with rare diseases, including small heterogenous patient population and slow disease progression, are just some of the challenges in this important field. Regulatory flexibility built into the existing framework has allowed industry to overcome some of these difficulties, but not without controversy. Panelists will analyze the current state of rare disease drug development, recent decisions and initiatives in PDUFA VII, and suggest solutions to some of the complexities faced in this important field.
Aaron Friedman, Associate Director for Policy, Office of Orphan Products Development, Office of the Commissioner, FDA
Rachel Sher, Partner, Manatt, Phelps & Phillips, LLP
Pamela L. Simpkins, Senior Director, Child Health Innovation Leadership Department, Johnson & Johnson
Moderated by Jeremiah J. Kelly, Partner, Venable LLP
Due diligence can uncover regulatory and compliance concerns, and it is important to know how to mitigate your risk. How is your company tracking and remediating issues that have come to light during the due diligence process? How do you ensure that your company won’t be held legally liable for regulatory issues inherited during acquisition? Speakers will address these issues and discuss techniques to determine whether due diligence concerns exist from the start.
Michael Hidock, Principal Consultant, IQVIA
Bethany J. Hills, Partner, DLA Piper LLP (US)
Joshua M. Oyster, Partner, Ropes & Gray LLP
Moderated by Winston S. Kirton, Partner, BakerHostetler
In January, Commissioner Califf announced a proposed redesign of FDA’s food programs to enhance coordination, prevention, and response activities following the report from the Regan-Udall Foundation. This followed a slate of issues with food safety regulation, including funding, adequate oversight authority, and infant formula safety outbreaks. Are these reforms transformative, or do they not go far enough? What are the potential outcomes for improving food safety, and what are the prospects for industry and public health?
Amy Norris, Former General Counsel, Clif Bar & Company
Sarah Sorscher, Director of Regulatory Affairs, Center for Science in the Public Interest
Matthew Thomas, Health Policy Advisor, U.S. Senate Committee on Health, Education, Labor, & Pensions
Moderated by Sharon Lindan Mayl, Partner, DLA Piper LLP (US)
Premarket Tobacco Applications (PMTAs) covering some of the most popular products remain under review, and dozens of its marketing denials have been stayed or reversed and remanded by the courts. Panelists will review recently granted orders in response to both PMTAs and Modified Risk Tobacco Product applications, recent litigation developments in response to marketing denials, and how CTP can improve the transparency and consistency of its application review process going forward.
Jasjit S. Ahluwalia, Professor, Behavioral and Social Sciences and Professor, Medicine, Brown University School of Public Health and Alpert Medical School
Brittani Cushman, SVP, General Counsel, and Secretary, Turning Point Brands, Inc.
Eric Heyer, Partner, Thompson Hine LLP
Mark J. Vaders, Associate, Womble Bond Dickinson (US) LLP
4:30–5:30 PM | Concurrent Breakout Sessions 3
FDA leadership will address the top issues CBER is facing as well as priorities and goals for the coming year.
Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA
Moderated by Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Since 2018, the presence of previously undetected carcinogenic nitrosamine impurities in a range of drug products has triggered industry-wide recalls, drug shortages, and class action lawsuits. The FDA, European Medicines Agency, and Health Canada are conducting a 3-step call for review to assess risk, conduct confirmatory testing, and implement control and mitigation strategies to prevent or reduce nitrosamine impurities. This session will discuss the status of that process, how companies should prepare for increased scrutiny surrounding the prevention and detection of nitrosamines and other impurities, and address questions on the scientific, legal, and regulatory front.
Jason Bunting, Science Policy Advisor, CDER, FDA
Cathy L. Burgess, Partner, Alston & Bird LLP
Sarah Topy, Assistant General Counsel, The Procter & Gamble Company
Moderated by Julie Dohm, Of Counsel, Covington & Burling LLP
HHS and FDA require that digital devices and therapeutics, including sensors and wearables, and the algorithms that drive them, do not discriminate in practice and are safe and effective for all who use them. Panelists will discuss how and when to test an algorithm for potential discrimination, address the importance of human factors and useability engineering to increase the likelihood that products are safe and effective, and consider a framework to increase equitable access.
Madison Green, Director of Technical Operations, EMMA International
Isabel Omer, Regulatory Policy Manager, Becton Dickinson (BD)
Anindita (Annie) Saha, Assistant Director, Digital Health Center of Excellence, CDRH, FDA
Moderated by Bradley Merrill Thompson, Member of the Firm, Epstein Becker & Green, PC
As the demand for cultivated meat products and alternative meat products created utilizing plant biotechnology grows stronger, hurdles remain regarding ensuring product safety, frameworks for FDA review, consumer acceptance, and product production. Panelists will address these issues and others concerning labeling, manufacturing, and transparency, as well as FDA and USDA efforts to foster innovation.
William Griffin, Alameda District Manager, Office of Field Operations, FSIS, USDA
Brian Ronholm, Director, Food Policy, Consumer Reports
Xin Tao, Partner, Baker McKenzie
Moderated by Jessica Tierney, Of Counsel, Jones Day
Panelists will opine on a structure for the federal regulation of cannabis in light of FDA’s recent statement on the need to work with Congress to determine a new regulatory pathway to balance public access to these products and oversight to manage risks. Panelists will consider product safety, labeling, marketing, and cannabis scheduling concerns. Speakers will also discuss how regulatory change may affect state laws governing cannabis and how to transition from primarily state regulation to a federal/state regulatory model.
Patrick Cournoyer, Senior Science Advisor and Lead, Cannabis Products Committee, Office of the Commissioner, FDA
Jensen N. Jose, Regulatory Counsel, Center for Science in the Public Interest
Andrew J. Kline, Senior Counsel, Perkins Coie LLP
Moderated by Jonathan A. Havens, Partner, Saul Ewing Arstein & Lehr LLP and Co-Chair, 2023 FDLI Annual Conference
CTP has announced plans for product standards that would eliminate menthol in cigarettes, eliminate characterizing flavors in cigars, and cap nicotine levels in combustible tobacco products. Panelists will discuss the reasoning behind and potential benefits of these standards, likely obstacles in their creation and implementation, and potential standards for non-combustible products that could further advance CTP’s public health goals.
Tara Lin Couch, Owner, TLC Regulatory and Laboratory Consulting
Stacey Gagosian, Vice President, Public Policy, Truth Initiative
Carol McGruder, Founding Member and Co-Chair, African American Tobacco Control Leadership Counsel
Brian Yagi, Assistant Professor, Johns Hopkins University School of Medicine
Moderated by Bryan M. Haynes, Partner, Troutman Pepper Hamilton Sanders LLP
5:30–7:00 PM | FDLI Rising Star Reception
Award Recipients:
Abraham Gitterman, Senior Associate, Arnold & Porter LLP
Schevon Salmon, Director, Corporate Counsel, Otsuka America Pharmaceutical, Inc.
Sarah Thompson Schick, Counsel, Reed Smith LLP
Presented by Christine M. Simmon, President & CEO, FDLI
Thursday, May 18
Laura Brown, Director, Educational Programs, FDLI
Richard Burr, Principal Policy Advisor and Chair, Health Policy Strategic Consulting Practice, DLA Piper LLP (US) and Former U. S. Senator, North Carolina
David A. Kessler, Former Commissioner, FDA
Moderated by Christine M. Simmon, President & CEO, FDLI
This session will address supply chain resilience for the food and medical product supply chains in light of COVID-19 and other local and global crises. Speakers will discuss how industry can combat shortages, the roles of FDA, the Administration, and Congress in ensuring a secure supply chain for all products, and reflect on successes and areas for improvement drawn from COVID-19. Panelists will discuss executive orders, legislation, FDA guidance, and other recent actions taken to improve the supply chain, as well as suggest future actions to ensure resilience.
Mark Abdoo, Associate Commissioner for Global Policy and Strategy, Office of the Commissioner, FDA
Tammy Beckham, Associate Director, Resilient Supply Chain Program, CDRH, FDA
Brian McCormick, VP & Chief Regulatory Counsel and Head, Global Regulatory Policy, TEVA Pharmaceuticals USA, Inc.
Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization, Medtronic
Moderated by Lowell M. Zeta, Partner, Hogan Lovells US LLP
10:45–11:00 AM | Break
11:00 AM–12:00 PM | Concurrent Breakout Sessions 4
FDA leadership will address the top issues CDER is facing as well as priorities and goals for the coming year.
Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, FDA
Moderated by Sonali P. Gunawardhana, Assistant General Counsel, Regulatory, Cardinal Health, Inc. and Member, FDLI Board of Directors
Cell and gene therapy research and development continues to grow at a fast rate. FDA has issued recent guidance documents and undertaken an initiative to better enable informal meetings with industry, signaling interest in providing greater regulatory support and guidance to industry. Speakers will address these topics and delve further into how both FDA and industry can work to facilitate communication – and subsequent product development – in this ever-evolving area.
Mantej (Nimi) Chhina, Executive Director, Head of Global R&D and Regulatory Policy, Global Regulatory Affairs, BioMarin Pharmaceutical, Inc. and Co-Chair, 2023 FDLI Annual Conference
Collin Stabler, Senior Managing Engineer, Exponent, Inc.
Celia M. Witten, Acting Super Office Director, Office of Therapeutic Products, CBER, FDA
Moderated by Eva Temkin, Partner, King & Spalding LLP
Proposed legislation could modernize and change the existing regulatory framework for diagnostics, compelling companies to prepare for these changes and learn new frameworks. This session will consider the impacts of the enactment of the VALID Act and opine on next steps if the Act is not passed as well as other opportunities for regulatory reform in this field. Speakers will also address how progress compares globally to the new EU In Vitro Diagnostic Medical Device Regulation.
Mark Hendrickson, Senior Director, Leavitt Partners, LLC
Elizabeth J. Hillebrenner, Associate Director for Scientific and Regulatory Programs, CDRH, FDA
Ryan M. Hohman, Vice President – Public Affairs, Friends of Cancer Research
Rumi Young, Director, Regulatory Policy, Becton Dickinson (BD)
Moderated by Elizabeth M. Richards, Partner, Latham & Watkins LLP
Social media advertising has enabled a network of campaigns and influencers to promote FDA-regulated products. This panel will delve into the evolving regulatory requirements for marketing in the ever-changing landscape of social media, including FTC’s guidance around influencers and endorsements, as well as recent enforcement actions. Speakers will also address how to prevent false claims and deceptive advertising, including misinformation, which has been noted as a priority area for FDA and FTC.
Dale Cooke, President, PhillyCooke Consulting
John P. Feldman, Partner, Reed Smith LLP
Michael Ostheimer, Attorney, Federal Trade Commission
Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson
On September 29, 2022, FDA issued a proposed rule to update the definition of “healthy” claims to align with current nutrition science and federal dietary guidance. Panelists will discuss the impact of the new definition, as well as other label claims and potential front-of-package label changes, on industry and public health. Panelists will also comment on what may be missing in light of burgeoning food innovations.
Eva Greenthal, Senior Policy Scientist, Center for Science in the Public Interest
Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling, CFSAN, FDA
Meredith Quinn Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Smitha G. Stansbury, Partner, King & Spalding LLP
The U.S. legal system poses unique legal challenges to comprehensive national tobacco product regulation, including First Amendment protections for corporate commercial speech, limits on federal authority over state and local jurisdictions, and potential district and circuit court splits on questions of federal law. This panel will feature a discussion on a reasoned and consistent federal approach to public health policy goals, including both adult harm reduction and youth use prevention, within the U.S. legal framework.
Tony Abboud, Executive Director, Vapor Technology Association
Clive Bates, Director, Counterfactual Consulting Limited
Kevin R.J. Schroth, Associate Professor, Rutgers School of Public Health
Moderated by Scott Ballin, Tobacco and Health Policy Consultant
Service to FDLI Award
The Service to FDLI Award, established in 2017, honors FDLI members who have provided exceptional volunteer services to FDLI, in furtherance of our mission.
Award Recipient: Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic
Presented by: Laura Brown, Director, Educational Programs, FDLI and Benjamin Butz, Director, Membership and Stakeholder Engagement, FDLI
Dr. Harvey Wiley Lecture and FDAAA Award
A lectureship in honor of Dr. Harvey W. Wiley, featuring the recipient of the namesake award bestowed by the FDA Alumni Association.
Steven M. Solomon, Former Director, Center for Veterinary Medicine, FDA
Introduced by Deborah M. Autor, CEO, Autor Strategies; Non-Executive Director, Pardes Biosciences; and Chair, Board of Directors, FDA Alumni Association
1:15–2:15 PM | Concurrent Breakout Sessions 5
FDA leadership will address the top issues CVM is facing as well as priorities and goals for the coming year.
Tracey H. Forfa, Director, Center for Veterinary Medicine, FDA
Moderated by Laura R. Epstein, Senior Policy Advisor, CVM, FDA
After more than three years, the public health emergency (PHE) for COVID-19 ended last week. Panelists will discuss how this does – and doesn’t – impact the hundreds of EUAs and 72 guidance documents FDA has issued and what this transition to a post-PHE world looks like. Speakers will also address the importance of the regulatory flexibility permitted by the PHE and what can be best utilized long-term from the lessons learned by FDA, industry, and other stakeholders during COVID-19.
Jeffrey K. Francer, Vice President, Head of Global Regulatory Policy & Strategy, Eli Lilly and Company
Jean McCue, Senior Policy Advisor, Office of the Commissioner, FDA
Carly McWilliams, Head of Regulatory Policy, North America, Roche, Inc.
Elizabeth J. Sadove, Director, MCM Regulatory Policy, Office of the Commissioner, FDA
Moderated by Marian J. Lee, Partner, Gibson, Dunn, & Crutcher LLP
In December 2021 FDA released a draft guidance for industry concerning use of RWD and RWE to support regulatory decision-making for drug and biologics. This panel will explore the current state of FDA’s RWE efforts, examine the key legal and regulatory considerations for harnessing RWE, provide insights on how these legal and regulatory considerations are likely to evolve, and consider other critical factors when utilizing real-world data.
Felipe Aguel, Deputy Director, Office of Clinical Evidence and Analysis, CDRH, FDA
John Concato, Associate Director for Real-World Evidence Analytics, CDER, FDA
Stefanie Kraus, Senior Regulatory Counsel, CDER, FDA
Nicole Mahoney, Executive Director, Regulatory Policy and Intelligence, Novartis Pharmaceuticals Corporation
Kendal K. Whitlock, Head of Digital Optimization, Real World Evidence Clinical Trials, Walgreens Boots Alliance
Moderated by Wade Ackerman, Partner, Covington & Burling LLP
This session will discuss the international programs and procedures that impact the domestic medical device industry. Topics of discussion will include how global authorities are managing inspections post-pandemic and working with FDA, updates on the Medical Device Single Audit Program, the impending transition deadline for the EU Medical Device Regulation, and the EU In Vitro Diagnostics Directive. Panelists will provide suggestions for global-selling manufacturers on managing the requirements for each.
Sarah Moore, Director, Global Medical Device and IVD Consulting, NSF International
Yarmela Pavlovic, VP of Regulatory Strategy, Medtronic
Moderated by Suzan Onel, Partner, Kleinfeld, Kaplan & Becker, LLP
This session will opine on the future of dietary supplement regulation since the inception of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Panelists will discuss this in view of FDA statements on reforms, recent trends relating to inspections, FDA’s use of DSHEA’s drug preclusion provision, and what potential legislative changes may benefit stakeholders.
Raqiyyah Pippins, Partner, Arnold & Porter LLP
David Spangler, Senior Vice President, Legal, Government Affairs & Policy, Consumer Healthcare Products Association (CHPA) and Member, FDLI Board of Directors
Cara Welch, Director, Office of Dietary Supplement Programs, CFSAN, FDA
Moderated by Claudia A. Lewis, Partner, Venable LLP
Among non-combustible nicotine products, e-cigarettes and vaping devices receive the most attention from politicians, regulators, and the media. However, oral-only nicotine products have also increased in popularity in recent years, and many stakeholders anticipate heated tobacco products will become a significant category in the U.S. nicotine market as well. Panelists will discuss these products and their risks relative to combustible tobacco, evidence of effectiveness in smoking cessation, and potential for youth nicotine addiction.
Azim Chowdhury, Partner, Keller and Heckman LLP
Mohamadi Sarkar, Fellow, Regulatory Strategy and Engagement, Altria Client Services LLC and Affiliate Professor of Clinical Pharmacology, VCU School of Pharmacy
Tracy Smith, Assistant Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Moderated by Elizabeth A. Oestreich, Senior Vice President, Regulatory Compliance, Greenleaf Health, Inc.
2:25–3:25 PM | Concurrent Breakout Sessions 6
FDA leadership will discuss CTP’s current and future programmatic priorities and goals.
Brian King, Director, Center for Tobacco Products, FDA
Moderated by Raymond S. Niaura, Professor of Social and Behavioral Science, New York University
COVID-19 provided a challenge for conducting routine and pre-approval inspections which lead to greater use of Remote Regulatory Assessments, utilizing record reviews and remote interactive evaluations. Post-pandemic, FDA has increased its enforcement vigilance and taken action against egregious violations. What is FDA’s current perspective on the oversight tools used during COVID-19 and what are the agency’s priorities and direction moving forward? This session will address these questions and what it means for companies inevitably facing domestic and international inspections.
Joseph Jimenez, Senior Principal Consultant, Validant
Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco Operations, ORA, FDA
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP
Rising competition in the drug and biologics industries has led to recent litigation and brought into focus new and important patent and exclusivity questions. Outcomes in Catalyst, Jazz v. Avadel, and GSK v. TEVA mean companies may need to rethink their strategies with respect to both innovator and follow-on competition. Panelists will discuss the lingering implications of these cases, statutory changes and potential legislative fixes, and how the FDA and USPTO are working together to balance meaningful innovation incentives and drug affordability.
Jay Greissing, Senior Director, Government Affairs, BioMarin Pharmaceutical, Inc.
Brian J. Malkin, Partner, McDermott Will & Emery
Nisha Shah, Senior Regulatory Counsel, CDER, FDA
Moderated by Alexander J. Varond, Partner, Goodwin Procter LLP
Cybersecurity continues to be a hot topic with multiple agencies implementing new requirements for critical infrastructure entities, including the healthcare sector. This session will discuss best practices in navigating the current and future state of cybersecurity and address requirements put forth in recent FDA draft guidance, FDA’s discussion paper on strengthening cybersecurity practices, and requirements implemented by other agencies. Panelists will also address issues surrounding legacy devices and IoT interoperability security challenges.
Edison Alvarez, Senior Director, Strategic Planning for Cybersecurity, Becton Dickinson (BD)
Nidhi Gani, Archimedes Medical Device Security Fellow, Archimedes Center for Medical Device Security, Northeastern University
Matthew Hazelett, Cybersecurity Policy Analyst, CDRH, FDA
Moderated by Zach Rothstein, Executive Director, AdvaMedDx and Member, FDLI Board of Directors
Class actions are supposed to be exceptional, but the exception seems to have swallowed the rule for food and dietary supplement companies. This panel will take a critical look at how and why these class actions are likely to develop, ways to avoid litigation, and what companies can do to mitigate litigation risk exposure. Panelists will also take a look at recent trends in litigation procedure, the types of claims pursued, and areas of focus such as PFAS and heavy metals.
David T. Biderman, Partner, Perkins Coie LLP
Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton LLP
Nury Helena Yoo, Partner, Faegre Drinker Biddle & Reath LLP
Moderated by Maia C. Kats, Managing Member/Founder, Just Food Law
In 2022, a historic surgery implanted a genetically modified pig heart into a patient with terminal heart disease. The success of this surgery is predicted to result in a global increase in the xenotransplantation market to remedy the insufficient supply of transplantable human organs. This session will explore this breakthrough technology, opine on future FDA regulation of this field, and consider the opportunities for FDA-regulated industry.
Judith Arcidiacono, Biologist, CBER, FDA
Dean Bunce, EVP Global Regulatory Affairs, United Therapeutics Corporation
Adam Moyer, Leader, Animal Biotechnology Team, CVM, FDA
Moderated by Georgia C. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati
3:25–3:40 PM | Break
Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2022, and Cases to Watch, 2023.
Anand Agneshwar, Partner, Arnold & Porter LLP
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
William M. Janssen, Professor of Law, Charleston School of Law
Moderated by August T. Horvath, Partner, Foley Hoag LLP
4:45 PM | Closing Remarks and Adjournment