Why Attend

Agenda

Agenda Subject to Change.
All Times are Eastern Time.

CLE

Tuesday, May 18

Amy Comstock Rick, President & CEO, FDLI
Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference

 

Janet Woodcock, Acting Commissioner of Food and Drugs, FDA
Introduced by Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

 

Mark J. Raza, Acting Chief Counsel, FDA
Introduced by Amy Comstock Rick, President & CEO, FDLI

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 Recipient: Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA

Presented by: Amy Comstock Rick, President & CEO, FDLI; Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors; Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Immediate Past Chair, FDLI Board of Directors; Freddy A. Jimenez, Vice-President, Law and Compliance, Celldex Therapeutics, Inc. and Secretary and General Counsel, FDLI Board of Directors; and Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

 

Thank You to FDA

FDA has been a leader for the US and the world in helping combat COVID-19. Please join us as we present the virtual thank you card to FDA in recognition of their efforts. Attendees are encouraged to add words of thanks, inspiration, or reflection to FDA colleagues throughout the conference.

Robert M. Califf, Head of Clinical Policy and Strategy for Verily Life Sciences LLC and Google Health and Adjunct Professor of Medicine, Duke University School of Medicine and Stanford University School of Medicine (FDA Commissioner, 2016-2017)
Mark B. McClellan, Robert J. Margolis Professor of Business, Medicine, and Policy and Director, Duke-Robert J. Margolis Center for Health Policy, Duke University (FDA Commissioner, 2002-2004)
Andrew C. von Eschenbach, President, Samaritan Health Initiatives (FDA Comissioner, 2006-2009)
Moderated by Amy Comstock Rick, President & CEO, FDLI

2:45 – 3:45 PM | Concurrent Breakout Sessions

During this session, 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 for Regulatory Affairs, CFSAN, FDA
Moderated by Amy Norris, Executive Counsel, Clif Bar & Company and Member, FDLI Board of Directors

During this session, FDA leadership will address the top issues CTP is facing as well as priorities and goals for the coming year.

 

Mitchell R. Zeller, Director, Center for Tobacco Products, FDA
Moderated by Dean R. Cirotta, President, EAS Consulting Group and Member, FDLI Board of Directors

FDA and industry have made numerous short-term policy decisions and actions in response to COVID-19. As the distribution of vaccines raises hope for an end to the crisis, what will happen to these temporary measures? How will FDA convert or “unwind” the many EUAs it has issued? Will sales of those products be halted? Will product in the field need to be recalled? How should other products get back on track for approvals and clinical trials be restarted?

 

Angela C. Krueger, Deputy Director for Regulatory Policy, Office of Product Evaluation and Quality, CDRH, FDA
Rita Livadas, Director of Public Affairs, Government Affairs, Becton, Dickinson and Company (BD)
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Moderated by Neil P. Di Spirito, Member of the Firm, Epstein Becker & Green, PC

This panel will explore the innovative modifications and approaches manufacturers have adopted while the pandemic has limited opportunities to interact in-person with customers and in light of restricted access to clinics and hospitals. Speakers will explore what manufacturers have learned about how to effectively reach and educate doctors and patients in virtual environments, acknowledge the inherent limitations of virtual marketing, and discuss how to prepare for virtual congresses. Speakers will also discuss what aspects of virtual marketing may be here to stay, and what aspects are likely to be quickly and happily tossed aside once in-person interactions can safely resume.

 

Kenita Barrow, Deputy General Counsel, Legal Affairs, Otsuka America Pharmaceutical, Inc.
Mark Gaydos, Vice President, US Advertising & Promotion, Global Regulatory Affairs, Sanofi
Susan S. Lee, Partner, Hogan Lovells US LLP
Moderated by Matthew Keenan, Partner, Shook, Hardy & Bacon LLP

The field of regenerative medicine continues to grow, and these promising therapies continue to present challenges throughout the product approval process. This session will discuss: key issues in product applications; managing issues under expedited review timelines; lessons learned related to manufacturing struggles; current expectations for PDUFA discussions related to cell and gene therapy; and how to apply the lessons of COVID-19 to cell and gene therapies. In addition, speakers will address whether FDA achieved its goal of increasing HCT/P regulatory compliance as we near the end of the enforcement discretion period in May, and what happens beginning June 1.

 

Edward Berg, Vice President, Deputy General Counsel, BioMarin Pharmaceutical Inc.
Michael Frohbergh, Managing Scientist, Exponent, Inc.
Nathan C. Sheers, Partner, Paul Hastings
Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, CBER, FDA
Moderated by Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC

Recent reports have suggested that certain medical device products –artificial intelligence (AI)-powered medical technologies in particular – can replicate racial bias and exacerbate historical healthcare inequities for Black Americans. A recent study found that even common pulse oximetry devices can discriminate, with Black patients having nearly three times the instance of non-detection of hypoxemia as white patients. What are the existing FDA regulatory authorities and requirements to address such issues? How can we address the impact of existing medical devices that present racial impact concerns and ensure mechanisms to prevent exacerbation of racial bias in future products?

 

Ravyn R. Miller, Senior Director, Global Growth Strategy, Defibrillation Solutions (ICD and CRT-D Therapies), Medtronic
Jonelle Saunders
, Associate Product Counsel, Google Health
Michelle Tarver, Deputy Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
Moderated by Kristin R. Davenport, Of Counsel, Covington & Burling LLP

3:45 – 4:15 PM | Concurrent Activities:

Gather with fellow colleagues for a Q&A and facilitated discussion on issues and topics that were addressed during the Center Director presentation.

 

Joined by Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition, FDA and Douglas W. Stearn, Deputy Director for Regulatory Affairs, CFSAN, FDA
Moderated by Amy Norris, Executive Counsel, Clif Bar & Company and Member, FDLI Board of Directors

Gather with fellow colleagues for a Q&A on issues and topics that were addressed during the Center Director presentation.

 

Mitchell R. Zeller, Director, Center for Tobacco Products, FDA
Moderated by Dean R. Cirotta, President, EAS Consulting Group and Member, FDLI Board of Directors

  • Machine Learning for Regulatory Attorneys and English Majors

Led by Bradley Merrill Thompson, Partner, Epstein Becker& Green, PC

 

  • Communicating Science

Led by Jennifer Luray, Vice President, Strategy and Communications, Research!America

 

  • The Impact of the Purple Book Continuity Act on Strategies for Biosimilar Development

Led by Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP

Visit the virtual sponsor booths and chat now with company representatives.

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 Recipient: Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP

Presented by: Amy Comstock Rick, President & CEO, FDLI; Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors; Jonathan S. Kahan, Partner, Hogan Lovells US LLP; Stephen Paul Mahinka, Partner, Morgan, Lewis & Bockious LLP; and Alexis Reisin Miller, Executive Director, Global Regulatory Policy (US Lead), Merck & Co., Inc.

Erica M. Katherine, Ombudsman, Office of Regulatory Affairs, FDA
Introduced by Amy Comstock Rick, President & CEO, FDLI

A lectureship named in honor of Dr. Harvey W. Wiley, the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of “Father of the Pure Food and Drugs Act” when it was enacted into law in 1906.

 

Luciana Borio, Senior Vice President, In-Q-Tel, Former Director for Medical and Biodefense Preparedness Policy, National Security Council, The White House; Acting Chief Scientist, FDA; and Assistant Commissioner for Counterterrorism and Emerging Threats, FDA
Introduced by Deborah M. Autor, Vice President, Global Regulatory Excellence, AstraZeneca Pharmaceuticals and Chair, Board of Directors, FDA Alumni Association

Join the FDLI Annual Conference Co-Chairs, Erika F. Lietzan, Professor of Law, University of Missouri – Columbia School of Law and Stuart M. Pape, Senior Partner, Polsinelli PC, and the Annual Conference Planning Committee to catch up with colleagues and discuss outcomes from the first day of the conference.

 

 

Wednesday, May 19

Laura Brown, Director, Educational Programs, FDLI
Erika F. Lietzan, Associate Professor, University of Missouri – Columbia School of Law and Co-Chair, 2021 FDLI Annual Conference

Judy A. McMeekin, Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, FDA
Introduced by Laura Brown, Director, Educational Programs, FDLI

The COVID-19 pandemic has brought unprecedented attention to, and reinforced pre-existing concerns about, vulnerabilities in the nation’s supply chain and the significant reliance on foreign manufacturers. This panel will address lessons learned from the impact of the pandemic on supply chains across all FDA-regulated product areas, initiatives to incentivize reshoring and boost domestic manufacturing, and the potential outcomes of the Biden Administration’s 100-day review of vulnerabilities in supply chains for products from pharmaceuticals to food.

 

Mark Abdoo, Associate Commissioner for Global Policy and Strategy, OC, FDA
Sally R. K. Fisk, Vice President & Assistant General Counsel, Environmental & Sustainability Law, Pfizer Inc.
Winston S. Kirton, Partner, Winston & Strawn LLP
Peter V. Lindsay, Partner, Paul Hastings
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP

1:30 – 2:30 PM | Concurrent Breakout Sessions

During this session, FDA leadership will address the top issues CVM is facing as well as priorities and goals for the coming year.

Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
Moderated by Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health, Inc. and Member, FDLI Board of Directors

  • Center Director Post-Session Q&A and Discussion: CVM (2:10–2:30 PM)

Gather with fellow colleagues for a Q&A and facilitated discussion on issues and topics that were addressed during the Center Director presentation.

 Joined by Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
Moderated by Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health, Inc. and Member, FDLI Board of Directors

In March 2020, FDA temporarily postponed all domestic and foreign routine surveillance facility inspections (excepting mission-critical inspections) because of the COVID-19 outbreak. Since, FDA has been utilizing its authority under 704(a)(4) to request and review records and resume prioritized domestic inspections. In April 2021, FDA released guidance on remote interactive evaluations (REIs). This session will delve into how and when REI’s will be used, what it means for companies, and areas of risk. Speakers will also address what new COVID-driven inspection practices may continue post-pandemic.

 

Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health, Inc.
Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco, ORA, FDA
Vipul Sheth, Vice President, Quality and Regulatory Compliance, Becton, Dickinson and Company (BD)
Moderated by John (Jack) C. Garvey, Managing Partner, Compliance Architects LLC

Patents and product exclusivity are at the heart of companies’ business models and consumer pricing. With recent high-profile cases on exclusivity for drug and biological products, there is great interest in the future of patent exclusivity and the impact on regulatory frameworks and product approvals. In this session, panelists will cover the impact of cases such as GSK v. Teva, In re: Lantus Direct Purchaser Antitrust Litigation, and Genus Lifesciences, Inc. v. Azar. They will also discuss Purple book reform, proposed exclusivity reform efforts in Congress, and developments for biological products that lack guidance, such as umbrella exclusivity and first interchangeable exclusivity.

 

Brian R. McCormick, Vice President & Chief Regulatory Counsel, Head, Global Regulatory Policy, TEVA Pharmaceuticals USA, Inc.
George O’Brien, Partner, Hogan Lovells US LLP
Michael K. Stern, Of Counsel, Covington & Burling LLP
Eva Temkin, Partner, King & Spalding LLP
Moderated by Andrew Wasson, Partner, Haug Partners LLP

This session will discuss the Breakthrough Devices program and the recently established STeP program.  Speakers will describe both programs, why they were established, and how the two programs differ from each other.  The panel will also address the benefits and requirements of the two programs, the challenges and advantages of utilizing one program versus the other, what makes for a successful Breakthrough Device submission, practical advice on common pitfalls, and potential challenges with how the programs are, or will be, implemented.

 

Maureen Dreher, Assistant Director, Policy & Operations Team, Division of Clinical Science & Quality, Office of Product Evaluation and Quality, CDRH, FDA
Janice M. Hogan, Partner, Hogan Lovells US LLP
Janet L. Michener Whipple, Partner, Validant
Moderated by Suzan Onel, Partner, Kleinfeld, Kaplan & Becker LLP

Signed into law in January of 2011, most provisions of FSMA have now been implemented, and FDA recently announced the next steps in food safety goals via its New Era of Smarter Food Safety Blueprint. This panel will discuss lessons learned from FSMA implementation, remaining challenges such as compliance with and enforcement of the Agricultural Water Rule, and we can expect food safety to evolve through use of technology and the other core elements of FDA’s Blueprint.

 

Laurie J. Beyranevand, Professor of Law, Director, Center for Agriculture and Food Systems, Vermont Law School
Meredith Q. Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Douglas W. Stearn, Deputy Director for Regulatory Affairs, CFSAN, FDA
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC

Premarket Tobacco Product Applications (PMTAs) for millions of tobacco and nicotine products were submitted prior to last September’s deadline for non-grandfathered products marketed before August 8, 2016. With the first wave of new PMTA decisions expected soon, panelists will review these approvals and discuss both what companies can expect and what they would like to see from CTP for pending applications. The discussion will also cover the landscape for approved products, including marketing and reporting requirements, and whether an approved PMTA makes it easier for similar products to find pathways to market.

 

Tara Lin Couch, Senior Director, Dietary Supplements and Tobacco Services, EAS Consulting Group
Eric N. Lindblom, Independent Consultant and Senior Scholar, O’Neill Institute for National and Global Health Law, Georgetown Law
Patricia M. Miller, Managing Director, Regulatory Affairs, Altria Client Services LLC
Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP

2:30 – 3:00 PM | Concurrent Activities:

  • Diagnostics Reform

Led by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs, CDRH, FDA

 

  • How can lessons learned in the pandemic be applied towards advancing 21st century regulatory science?

Led by Peter Pitts, President, Center for Medicine in the Public Interest

Visit the virtual sponsor booths and chat now with company representatives.

3:00 – 4:00 PM | Concurrent Breakout Sessions

During this session, FDA leadership will address the top issues CDRH is facing as well as priorities and goals for the coming year.

 

Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Immediate Past Chair, FDLI Board of Directors

Over the course of the pandemic, there has been an increase in reliance on real-world evidence (RWE) and data by FDA as well as industry. The innovative approaches, flexibility, and collaborations are likely to accelerate the uptake of real-world evidence approaches post-pandemic. This session will address the current and future direction of FDA’s RWE Program at CDER and CBER and explore the challenges and opportunities associated with the use of RWE.

 

Kellie B. Combs, Partner, Ropes & Gray LLP
John Concato, Associate Director, Real-World Evidence Analytics, Office of Medical Policy, CDER
Stefanie Kraus, Senior Regulatory Counsel, Office of Regulatory Policy, CDER, FDA
Alexis Reisin Miller, Executive Director, Global Regulatory Policy (US Lead), Merck & Co., Inc.
Moderated by William B. Schultz, Partner, Zuckerman Spaeder LLP

Gene therapy is now one of the fastest growing therapeutic categories, with 20 approved cell and gene therapy products and at least 80 products in various stages of development. Despite the progress that has been made, technical, regulatory, and business risks remain and must be overcome by companies wanting to bring their gene therapy solutions to patients. This panel will address these risks and how they can be mitigated. Speakers will discuss issues from overcoming barriers to entry, post-approval compliance, to enforcement risks. Key topics will include uncertainty in expectations from regulators, product safety, maintaining data integrity, and how to prevent the need for remediation or enforcement.

 

Andreas Hartmann, Executive Director Preclinical Safety, Therapeutic Area Head, Novartis Pharmaceuticals Corporation
Katie Laney, Principal Consultant, Validant
Collin Stabler, Senior Associate, Exponent, Inc.
Moderated by James N. Czaban, Partner, Loeb & Loeb LLP

In the 25-plus years since the Dietary Supplement Health and Education Act (DSEHA) was signed into law, the dietary supplement industry has grown from 4,000 products to 50,000-plus products, with approximately three quarters of Americans regularly take dietary supplements. This growth has led to calls to revisit, if not outright replace, DSHEA and strengthen FDA’s ability to regulate these products. This session will feature a comprehensive discussion of dietary supplement regulation, including provisions and limitations of DSHEA, and potential legislative and regulatory options to improve both oversight and enforcement.

 

Scott Bass, Partner, Sidley Austin LLP
Carrie Harney, Senior Director, US Government & Regulatory Affairs, US Pharmacopeia
Steven M. Mister, President & CEO, Council for Responsible Nutrition
Cara Welch, Acting Director, Office of Dietary Supplement Programs, CFSAN, FDA
Moderated by Miriam J. Guggenheim, Partner, Covington & Burling LLP

Heath disparities exist in all FDA-regulated fields, and tobacco and nicotine products are no exception as differences in marketing, and use patterns among, population groups create different health outcomes. This session will feature a review of the disparities among different groups, such as the impact of mentholated product availability and use on Black Americans, before turning to how FDA can work to improve health outcomes, including through public education and increased regulation for products that pose a greater risk to racial and ethnic minority groups.

 

Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville
Darlene Huang, Legislative and Policy Counsel, Campaign for Tobacco-Free Kids
John Prichard, Vice President of Regulatory Science, 22nd Century Group, Inc.
Moderated by Jasjit S. Ahluwalia, Professor, Behavioral and Social Sciences, Brown University School of Public Health; Professor of Medicine, Alpert School of Medicine; and Associate Director (Populations Sciences), Brown Cancer Center

The One Health Initiative is an interdisciplinary approach that recognizes that the health of people, animals, and the environment are intrinsically interconnected and must be treated as such to provide for optimal, global health. By using one health approaches and collaborating across disciplines, we can expand our knowledge and can accelerate advancements, resulting in an enhanced approach to challenging public health issues. In this session, speakers will address how FDA, and specifically CVM, are implementing the One Health Initiative, including as it relates to COVID. Speakers will also discuss pending legislation to encourage collaborative agency efforts to prevent, prepare for, and respond to zoonotic disease outbreaks, and what actions are currently be undertaken in other agencies.

 

Kelly Nickel, Legislative Director, Office of Congressman Kurt Schrader (OR-05), US House of Representatives
Steven M. Solomon, Director, Center for Veterinary Medicine, FDA
Moderated by Margaret (Mimi) Foster Riley, Professor, University of Virginia, Schools of Law and Medicine and Member, FDLI Board of Directors

4:00 – 4:30 PM | Concurrent Activities:

Gather with fellow colleagues for a Q&A and facilitated discussion on issues and topics that were addressed during the Center Director presentation.

 

 Joined by Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, FDA
Moderated by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Immediate Past Chair, FDLI Board of Directors

  • Regulatory Implications of Innovative Clinical Trial Designs

Led by Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP

 

  • Healthcare Innovation During the Pandemic

Led by Rachael G. Pontikes, Partner, Reed Smith LLP

Visit the virtual sponsor booths and chat now with company representatives.

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 Recipient: Mark J. Raza, Acting Chief Counsel, FDA

Presented by: Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Immediate Past Chair, FDLI Board of Directors; Lisa Barclay, Deputy General Counsel, Office of the General Counsel, HHS; Daniel J. Barry, Acting General Counsel, Office of the General Counsel, HHS; Elizabeth Dickinson, Senior Deputy Chief Counsel, FDA; Amanda Edmonds, Deputy Associate General Counsel for Drugs and Biologics, Office of Chief Counsel, FDA; Dinesh Kumar, Associate Chief Counsel for Drugs, Office of Chief Counsel, FDA; Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA; and Stuart TenHoor, President, Stuart Tenhoor Legal Search

While FDA-regulated companies remain a favorite enforcement target for regulators and prosecutors, enforcement of core FDCA prohibited acts appears to be on a downward trajectory. This panel will explore trends in “other” legal theories currently being utilized by DOJ, FTC, and SEC, including the increasing use of the False Claims Act and other civil and criminal fraud theories to pursue conduct historically regulated and enforced by FDA. Speakers will discuss potential reasons for the shift toward enforcement outside of the FDCA, what trends are likely to be for the coming year, and the implications for industry.

 

Christine Lee DeLorme, Division of Advertising Practices, Federal Trade Commission
Gustav W. Eyler, Director, Consumer Protection Branch, US Department of Justice
Moderated by Beth P. Weinman, Counsel, Ropes & Gray LLP

Thursday, May 20

Amy Comstock Rick, President & CEO, FDLI

RADM Richardae Araojo, Associate Commissioner for Minority Health, Office of the Commissioner, FDA
Introduced by Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

Daniel A. Kracov, Partner, Arnold & Porter LLP and Chair, FDLI Board of Directors

12:45 – 1:45 PM | Concurrent Breakout Sessions

During this session, 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 Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors

The CARES Act introduced the administrative order system, retiring FDA’s nearly 40-year-old OTC monograph regime, which had been critiqued as unduly burdensome and hampered product innovation. In this session, panelists will discuss how administrative orders differ from monographs, the resulting benefits and hurdles, FDA initiatives to advance this new approach, and perspectives on whether the administrative order system can be used to institute a risk-based approach for regulating OTC products.

 

Ann M. Begley, Partner, Wiley LLP
Theresa Michele, Director, Division of Nonprescription Drug Products, CDER, FDA
David C. Spangler, Senior Vice President, Legal Government Affairs & Policy, Consumer Healthcare Products Association
Moderated by John F. Johnson, Of Counsel, Shook, Hardy & Bacon LLP

This session will discuss the evolution of rare disease drug development and regulation of orphan drugs. Panelists will address the sameness and clinical superiority determinations for orphan drugs and the reauthorization of the rare pediatric disease priority review voucher program. The discussion will also cover the various existing or soon-to-be implemented FDA leadership councils involved in developing rare drug policies and granting Orphan Drug Designations (ODD) and Orphan Drug Exclusivity (ODE), and how applications are considered across the relevant FDA Centers, with particular focus on CDER and CBER.

 

Aaron Friedman, Senior Regulatory Counsel, Office of Orphan Products Development, OC, FDA 
Brian J. Malkin, Partner, McDermott Will & Emery
Amy Waterhouse, Advisor, Regulatory Affairs, BioMarin Pharmaceutical, Inc.
Moderated by Erika F. Lietzan, William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law, University of Missouri – Columbia School of Law and Co-Chair, 2021 FDLI Annual Conference

Medical devices are continuously evolving, including the increased ability to connect to the internet, hospital networks, and other devices. While such features offer clear benefits for patients, they also inherently create cybersecurity risks. This panel will feature perspectives on the key current and future device security concerns, and how manufacturers, health care facilities, and FDA can work together to minimize these risks.

 

Kevin Fu, Acting Director, Medical Device Cybersecurity, Program Director for Cybersecurity, Digital Health Center of Excellence, CDRH, FDA
Vernessa T. Pollard, Partner, McDermott Will & Emery LLP
Zachary Rothstein, Vice President, Technology & Regulatory Affairs, AdvaMed
Moderated by David J. Bloch, Senior Principal Legal Counsel, Medtronic

Health and dietary science are critical to FDA’s mission of ensuring the safety of our nation’s food supply. But, what can and should FDA’s role be in influencing diet and health through regulation and policy? Panelists will discuss the interplay between dietary and nutrition science and regulation with a focus on current initiatives and pressing issues, such as FDA’s Nutrition and Innovation Strategy, potential rulemaking on “healthy” claims, and claim substantiation standards. The goals of reducing added sugar and sodium intake will specifically be addressed.

 

Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling, CFSAN, FDA
Sarah Sorscher, Deputy Director of Regulatory Affairs, CSPI
John Troup, Vice President, Scientific Affairs and Dietary Supplements, Consumer Healthcare Products Association
Christopher Van Gundy, Partner, Sheppard Mullin Richter & Hampton LLP
Moderated by Suzie L. Trigg, Partner, Haynes and Boone LLP

All tobacco and nicotine products carry some degree of risk to users. However, these risks vary in nature and severity across product type, and public confusion abounds. Successfully moving users down the continuum of risk, or convincing them to quit using tobacco and nicotine product altogether, requires better education on relative risks for all product types. This discussion will cover comparative risks associated with various product types – including traditional tobacco products, tobaccoless nicotine products, and very low nicotine (VLN) products – how these risks should be communicated, and the roles and responsibilities different stakeholders should bear in this endeavor.

 

Micah Berman, Associate Professor of Public Health and Law, Ohio State University
Clifford E. Douglas, Director, Tobacco Research Network and Adjunct Professor, University of Michigan
Paige Magness, Senior Vice President, Regulatory Affairs, Altria Client Services
Moderated by Elizabeth Oestreich, Vice President, Regulatory Compliance, Greenleaf Health, Inc.

1:45 – 2:15 PM | Concurrent Activities:

Gather with fellow colleagues for a Q&A and facilitated discussion on issues and topics that were addressed during the Center Director presentation.

 

Joined by Peter W. Marks, Director, Center for Biologics Evaluation and Research, FDA
Moderated by Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors

  • Moving from Unapproved to Approved Drug Products – How Can Companies Utilize Compounded and DESI Product Markets?

Led by Lee Rosebush, Partner, BakerHostetler

 

  • Remote Regulatory Assessments: To Be Avoided or Embraced?

Led by Andrea Chamblee, Associate Adjunct Professor, George Washington University School of Medicine and Public Health

 

 

  • EU MDR: How Are These Regulations Impacting the Medical Device Industry?

Marta L. Villarraga, Principal, Exponent, Inc.

Visit the virtual sponsor booths and chat now with company representatives.

2:15 – 3:15 PM | Concurrent Breakout Sessions

During this session, 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 Carla Cartwright, Senior Director, Global Digital and Regulatory Policy, Johnson & Johnson and Member, FDLI Board of Directors

The COVID-19 pandemic has accelerated the use and development of digital health technologies, including increased use of telemedicine and remote patient monitoring, as well as the development of software for health-related communications and contact tracing and tracking. In this session, panelists will discuss the future of digital health regulation and innovation, including FDA updates on its Digital Health Center of Excellence, new initiatives, and how digital therapeutics fits into the current regulatory structure. Increased use of digital apps and artificial intelligence will also be discussed.

 

Thomas (Tommy) Miller, Senior Counsel, Nixon Gwilt Law
Imein Bousnina, Program Director, US Regulatory Policy, Product Development Regulatory, Genentech, Inc.
Bakul Patel, Director, Digital Health Center of Excellence, CDRH, FDA
Moderated by Lisa M. Dwyer, Partner, King & Spalding, LLP

As biotechnology continues to evolve rapidly in the food sector, regulatory and enforcement agencies must coordinate and cooperate to keep pace. This discussion will cover pressing regulatory considerations on topics such as bioengineered livestock, new gene-editing technologies, and cell-cultured meat and seafood. Speakers will consider questions such as: What should regulation look like and who should lead it? Is the current regulatory structure nimble enough to address new technologies? How much oversight is needed? How heavily is consumer confidence based on oversight?

 

Jason Dietz, Senior Policy Advisor, CFSAN, FDA
Laura R. Epstein, Senior Policy Advisor, CVM, FDA
Robert (Bob) Hibbert, Senior Counsel, Wiley LLP
Gregory Jaffe, Biotechnology Project Director, CSPI
Moderated by Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference

As CTP works to issue decisions on thousands of products with pending PMTAs, many stakeholders anticipate a subsequent increase in SE Reports being filed. Panelists will discuss this “next generation” of SE Reports, including whether a product approved under a PMTA can be used as a predicate for an SE Report, other potential pathways for companies seeking to bring new products to market, and factors CTP should prioritize in making these decisions.

 

Stacey Younger Gagosian, Managing Director, Public Policy, Truth Initiative
Beth G. Oliva, Partner, Fox Rothschild LLP
Moderated by J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP

As FDA and the states grapple with the overall regulation of cannabis, cannabis-derived products have proliferated in the market. This session will begin with an over of the current types of products available and their intended use. Panelists will then share their perspectives on ideal regulatory approaches for different types of THC, CBD, and other hemp-derived ingredient products, including possible federal frameworks modeled after food safety, tobacco control, or others, whether an FDA Center for Cannabis Products should be established, lessons learned from current state regulation, and thoughts on where federal oversight should end and state discretion should begin.

 

Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Michael McGuffin, President, American Herbal Products Association (AHPA)
Deborah Miran, Consultant, DMiran Consulting
David M. Woods, Partner, Hughes Hubbard & Reed LLP
Moderated by Katherine Ciambrone, Executive Vice President, Compliance, Cresco Labs

3:15 – 3:45 PM | Concurrent Activities:

Gather with fellow colleagues for a Q&A and facilitated discussion on issues and topics that were addressed during the Center Director presentation.

 

Joined by Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, FDA
Moderated by Carla Cartwright, Senior Director, Global Digital and Regulatory Policy, Johnson & Johnson and Member, FDLI Board of Directors

Visit the virtual sponsor booths and chat now with company representatives.

The Service to FDLI Award, established in 2017, honors FDLI members who have provided exceptional volunteer services to FDLI, furthering FDLI’s mission as a neutral convener to educate and spark innovative change.

 

Award Recipient: August T. Horvath, Partner, Foley Hoag LLP
Presented by: Laura Brown, Director, Educational Programs, FDLI and Paige Samson, Director, Innovative Programs and Publications, FDLI

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 2020, and Cases to Watch, 2021.

 

Sonali P. Gunawardhana, Chief Counsel FDA & Regulatory, McKesson Corporation; Adjunct Associate Professor, American University Washington College of Law; and Member, FDLI Board of Directors
Ralph F. Hall, Professor of Practice, University of Minnesota Law School
William M. Janssen, Professor of Law, Charleston School of Law
Moderated by August T. Horvath, Partner, Foley Hoag LLP

5:15 PM | Conference Adjournment