Why Attend?

Agenda

CLE

Agenda Subject to Change.
All Times are Eastern Time.

The change of date means that the Annual Conference will now be held two weeks prior to the Tobacco and Nicotine Products Regulation and Policy Conference, scheduled for October 21-23. For this year only, we have made the decision to move tobacco-specific sessions from the Annual Conference to the Tobacco Conference. In addition, Center updates from Mitchell Zeller, Director of FDA’s Center for Tobacco Products, will also be provided at the Tobacco Conference. If you are interested in tobacco-related programming, we hope you will join us at that conference: Learn more here.

Tuesday, October 6

First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.

Amy Comstock Rick, President & CEO, FDLI
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Chair, FDLI Board of Directors
Adora Ndu, Vice President, Regulatory Affairs, Policy, Research, Engagement (PRE) & Reg International, BioMarin Pharmaceutical Inc. and Co-Chair, 2020 FDLI Annual Conference

 

Stephen M. Hahn, Commissioner of Food and Drugs, FDA

Stacy Cline Amin, 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: Andrew E. Clark, Former Assistant Director, Consumer Protection Branch, Civil Division, DOJ
Presented by: Amy Comstock Rick, President & CEO, FDLI; Stacy Cline Amin, Chief Counsel, FDA; Elizabeth Dickinson, Senior Deputy Chief Counsel, FDA; Perham Gorji, Deputy Chief Counsel for Litigation, FDA; Annamarie Kempic, Deputy Chief Counsel for Litigation, FDA; and Janet Woodcock, Senior Advisor on Therapeutics, Operation Warp Speed (on detail)

Amy P. Abernethy, Principal Deputy Commissioner, Office of the Commissioner, FDA
Interviewed by Wade Ackerman, Partner, Covington & Burling LLP

2:00 – 3:00 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
Moderated by Miriam Guggenheim, Partner, Covington & Burling and Member, FDLI Board of Directors

Acting on authority granted by the 21st Century Cures Act, the FDA CDER embarked on an initiative to modernize its New Drugs Regulatory Program. A critical component of this initiative is reorganizing the program, including expanding the number of drug review divisions, allowing for greater specialization and improved effectiveness and efficiency in new drug reviews. Panelists will discuss whether these changes are having the desired effect, including during FDA’s response to COVID-19, while also considering other objectives of the overall initiative, such as boosting CDER scientific leadership and talent. Panelists will also review some of the changes to processes and policies made during the COVID-19 pandemic which further accelerate FDA action, responsiveness, and effectiveness in establishing and implementing modern regulatory science within the agency.

 

Jeffrey B. Chasnow, Senior Vice President and Associate General Counsel, Pfizer, Inc 
Pat Furlong, Founding President & CEO, Parent Project Muscular Dystrophy
Maarika Kimbrell, Deputy Director, Office of New Drug Policy, CDER, FDA
Moderated by Peter Pitts, President, Center for Medicine in the Public Interest

New and novel medical devices that provide for more effective treatment or diagnosis of life-threatening or debilitating conditions often utilize new technologies that do not fit squarely into the traditional regulatory pathways that exist for medical devices. In this session, panelists will discuss the successes of the de novo submission program and how the breakthrough devices program differs and improves upon the previous expedited access program for medical devices and device-led combination products.  Because many novel devices and diagnostics use innovative approaches to disease prevention and treatment to take into account differences in genetics, environments, and lifestyles, panelists will also discuss how developments in precision medicine, 3D-printing, and real-world evidence impacts the regulatory pathway to market.

 

Megan Coder, Executive Director, Digital Therapeutics Alliance
Matthew Diamond, Chief Medical Officer for Digital Health, CDRH, FDA
Elizabeth Richardson, Director, Health Care Products Project, The Pew Charitable Trusts
Moderated by Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP

There is no shortage of challenges to FDA rulemaking and other actions claiming a violation of its authority under the APA. In this session, panelists will discuss recent and pending challenges against or relating to FDA regulation and the issues and topics these challenges raise, including: standing to sue; the types of actions that can be challenged; the role of Citizen Petitions in advance of litigation; the “final agency action” requirement; evidence admissibility; rights and roles of intervenors; “plain language” arguments and strategies; challenges to the deference standard; demonstrating “arbitrary and capricious” agency action; APA procedural requirements; and remedies.

 

Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Scott M. Lassman, Principal, Lassman Law + Policy
Hilary Perkins, Assistant Director, Consumer Protection Branch, US Department of Justice
Moderated by John R. Manthei, Partner, Latham & Watkins LLP

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

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

 

Moderated by Miriam Guggenheim, Partner, Covington & Burling and Member, FDLI Board of Directors

Visit the virtual sponsor booths and meet live with company representatives.

It’s not too late to apply for 2021 FDLI Committee service! Learn about the application process, the different types of committees, and what is expected for FDLI committee service.

Amy Comstock Rick, President & CEO, FDLI
Benjamin Butz, Director, Membership and Stakeholder Engagement, FDLI

Join your fellow colleagues in one of the following informal networking sessions to catch up and connect!

  • Government Employees, including FDA
  • Company In-House, Legal and Regulatory
  • Non-profit Organizations
  • Academics and students
  • Law Firm Attorneys
  • New to Food and Drug Law, including younger associates
  • California Food & Drug Community

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: Jonathan S. Kahan, Partner, Hogan Lovells US LLP
Presented by: Amy Comstock Rick, President & CEO, FDLI; Frank Bonadio, CEO, Advanced Surgical Concepts; Thomas Burke, Chief, Division of Global Health Innovation, Massachusetts General Hospital, and Associate Professor, Harvard Medical School and Harvard T.H. Chan School of Public Health; Richard M. Cooper, Senior Counsel, Williams & Connolly LLP; Randy J. Prebula, Partner, Hogan Lovells US LLP; Jodi K. Scott, Partner, Hogan Lovells US LLP; and Marlene Tandy, Assistant General Counsel (Retired), Johnson & Johnson

FDA-regulated companies have increasingly operated in a global environment, and the stresses and strains of this have come into increased focus in light of the COVID-19 pandemic. During this session, speakers will discuss recent challenges regarding supply chain demands related to imports and exports. Panelists will also explore the status of FDA’s mutual recognition program, how FDA works with sister agencies in other countries, and the state of FDA inspections outside the US.

 

Mark Abdoo, Associate Commissioner for Global Policy and Strategy, Office of the Commissioner, FDA
Benjamin L. England, Founder and CEO, Benjamin L. England & Associates LLC / FDAImports.com, LLC
John A. Murphy, Deputy General Counsel, Biotechnology Innovation Organization
Kimberly A. Trautman, Executive Vice President, Medical Device International Services, NSF International
Moderated by Carla Cartwright, Senior Director, Global Digital and Regulatory Policy, Johnson & Johnson and Member, FDLI Board of Directors

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

Join a Zoom group of your choice to network and discuss hot-button issues that were brought up during the day. Coffee or cocktail optional!

  • Drugs
    • Led by Bob Rhoades, Managing Partner, Validant
  • Medical Devices
    • Led by Kimberly A. Trautman, Executive Vice President, Medical Device International Services, NSF International
  • Focus on Litigation
    • Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
  • Food and Dietary Supplements
    • Led by Nury H. Yoo, Counsel, Keller and Heckman LLP
  • Cannabis
    • Led by Paul Joseph, Of Counsel, Foley & Lardner LLP
  • Wine, Beer, and “Spirited” Discussion
    • Led by Carla Cartwright, Senior Director, Global Digital and Regulatory Policy, Johnson & Johnson and Member, FDLI Board of Directors
  •  

Wednesday, October 7

First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.

Laura Brown, Director, Educational Programs, FDLI
James N. Czaban, Partner, Loeb & Loeb LLP and Co-Chair, FDLI 2020 Annual Conference

Michelle McMurry-Heath, President & CEO, Biotechnology Innovation Organization (BIO)
Interviewed by Amy Comstock Rick, President & CEO, FDLI

Sheldon Bradshaw, Partner, King & Spalding LLP
Elizabeth Dickinson, Senior Deputy Chief Counsel, FDA
Peter Barton Hutt, Senior Counsel, Covington & Burling LLP
Gerald Masoudi, Partner, Covington & Burling LLP
Rebecca K. Wood, Partner, Sidley Austin LLP
Interviewed 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: Beverly I. Chernaik, Office Director, Office of Regulations, CTP, FDA
Presented by: Amy Comstock Rick, President & CEO, FDLI; Katherine Collins, Regulatory Counsel, CVM, FDA; Laura R. Epstein, Senior Policy Advisor, CVM, FDA; Daniel Gittleson, Senior Policy Analyst, CTP,  FDA;  May D. Nelson, Deputy Director, Office of Regulations, CTP, FDA; Zachary Rothstein, VP, Technology & Regulatory Affairs, Advamed; and Sarah E. Walinsky, Policy Advisor, CDER, FDA

Visit the virtual sponsor booths and meet live with company representatives.

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 Margaret (Mimi) Foster Riley, Professor, University of Virginia, Schools of Law and Medicine and Member, FDLI Board of Directors

Over the past months, FDA has issued countless EUAs to allow the use of unapproved products to address the COVID-19 pandemic and facilitate the availability of important medical products. EUAs have been issued in the areas of medical devices, personal protective equipment, in vitro diagnostics, and therapeutic products. This session will consider FDA’s use of EUAs during the COVID-19 pandemic, limitations on FDA authority, and what happens to products that received EUAs after the emergency designations are lifted.

 

Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
Ryan Murray, Assistant General Counsel, Regulatory Legal, Eli Lilly and Company
Michael W. Ryan, Partner, McDermott Will & Emery LLP
Timothy Stenzel, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA
Moderated by Suzan Onel, Partner, Kleinfeld, Kaplan & Becker, LLP

Recently, FDA released its New Era of Smarter Food Safety Blueprint, which seeks to build on its efforts to implement the Food Safety Modernization Act and further increase the safety of the American food supply. The blueprint focuses on leveraging cutting-edge technologies and using new approaches to solve some of today’s biggest food safety challenges. In this session, panelists will discuss potential technologies and approaches to be utilized, including tech-enabled traceability and outbreak response that utilizes artificial intelligence, improved equipment for preventing contamination, business model modernization, and an overall improved food safety culture. Panelists will also cover the concerns, challenges, and potential consequences of implementing these changes, including the financial and practical feasibility.

 

Sandra B. Eskin, Project Director, Safe Food, The Pew Charitable Trusts
Bryan Hitchcock, Senior Director, Food Chain and Executive Director, Global Food Traceability Center, Institute of Food Technologists
Sharon L. Mayl, Senior Advisor for Policy, OC, FDA
Moderated by Martin J. Hahn, Partner, Hogan Lovells US LLP

Cell and gene therapy development is on the rise. CBER has approved a handful of cell and gene therapy Investigational New Drug Applications, with several hundred currently pending. In this session, panelists will discuss FDA efforts to regulate while also spurring innovation, including the scope and availability of orphan drug exclusivity and the regenerative medicine advanced therapy designation. Panelists will also explore the unique development, manufacturing, and post-market monitoring challenges for these complex new technologies.

 

Kalah Auchincloss, SVP, Regulatory Compliance & Deputy General Counsel, Greenleaf Health, Inc.
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP
Julia C. Tierney, Chief of Staff, CBER, FDA
Moderated by Adora Ndu, Vice President, Regulatory Affairs, Policy, Research, Engagement (PRE) & Reg International, BioMarin Pharmaceutical Inc. and Co-Chair, 2020 FDLI Annual Conference

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

Gather with fellow colleagues for a 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 Margaret (Mimi) Foster Riley, Professor, University of Virginia, Schools of Law and Medicine and Member, FDLI Board of Directors

Visit the virtual sponsor booths and meet live with company representatives.

Learn about the FDLI Board of Directors, their oversight role in the organization, and their current priorities. Come with your questions about how the Board functions and how to get more involved in FDLI.

 

Amy Comstock Rick, President & CEO, FDLI
Daniel A. Kracov, Partner, Arnold & Porter LLP and Vice Chair, FDLI Board of Directors
Benjamin Butz, Director, Membership and Stakeholder Engagement, FDLI

Join your fellow colleagues in one of the following informal networking sessions to catch up and connect!

  • Government Employees, including FDA
  • Company In-House, Legal and Regulatory
  • Non-profit Organizations
  • Academics and students
  • Law Firm Attorneys
  • New to Food and Drug Law, including younger associates
  • California Food & Drug Community

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 Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors
and Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic and Member, FDLI Board of Directors

 

Recalls and other potentially adverse publicity can be expensive problems that impact all FDA regulated industries, often resulting in significant immediate costs and lingering damage to brand reputation. This makes recall and PR crisis preparedness vital for manufacturers. In this session, panelists will review recent recall trends, FDA’s new recall guidance, and discuss best practices in preparing for, managing, and handling fallout from recalls or other investigations. Topics will include internal processes and procedures for handling a crisis, insurance coverage, and the importance of positive PR for brand rehabilitation and as a trial strategy.

 

Jonathan M. Cohen, Partner, K&L Gates LLP
Robert Durkin, Of Counsel, Arnall Golden Gregory LLP
Lillian S. Hardy, Partner, Hogan Lovells LLP
Meredith Q. Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company

 

FDA has undertaken several initiatives to bolster Patient-Focused Drug Development (PFDD) and the use of PED in drug development and review. However, there is confusion over how PED informs FDA review and decision making, and there is no FDA-accepted criteria for developing a patient-focused risk-benefit tool. In this session, panelists will survey how FDA has used real-world evidence and PED, then discuss how this information should be used going forward. Panelists will also address use of real-world evidence and PED in the 505(b)(2) pathway, along with steps all stakeholders can take to ensure the patient’s voice is properly accounted for before, during, and after the drug approval process.

 

Ebony Dashiell-Aje, Director, Patient Engagement and Outcomes Research, BioMarin Pharmaceutical, Inc.
Andrea C. Furia-Helms, Director, Patient Affairs Staff, Office of the Commissioner, FDA
Annie Kennedy, Chief of Policy & Advocacy, Everylife Foundation for Rare Diseases
Moderated by Karen C. Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP

In February, FDA issued a press release entitled “FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals,” noting the technology “has the potential to improve human and animal health, animal well-being and to enhance food production and quality” while also stressing the importance of safety and effectiveness standards. In this session, panelists will discuss the current and potential future regulatory scheme, including FDA’s draft revised industry guidance on the topic, the Veterinary Innovation Program, monitoring of unintended consequences of genome alteration, and the public education campaign. 

 

Clint Nesbitt, Senior Director, Science and Regulatory Affairs, Food & Agriculture, Biotechnology Innovation Association
Angela M. Olsen, General Counsel & Corporate Secretary, AquaBounty Technologies, Inc.
Alison Van Eenennaam, Cooperative Extension Specialist, Animal Genomics and Biotechnology, Department of Animal Science, University of California, Davis
Moderated by Karen Ellis Carr, Partner, Arent Fox LLP

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

Gather with fellow colleagues for a 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 Frederick R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors and Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic and Member, FDLI Board of Directors

Visit the virtual sponsor booths and meet live with company representatives.

Have you attended an FDLI event or read one of our publications and wondered how you can contribute? Learn how you can share your expertise through FDLI from the directors of the Educational Programs and Publications teams.

 

Laura Brown, Director, Educational Programs, FDLI
Paige Samson, Director, Innovative Programs and Publications, FDLI
Benjamin Butz, Director, Membership and Stakeholder Engagement, FDLI

Join your fellow colleagues in one of the following informal networking sessions to catch up and connect!

  • Government Employees, including FDA
  • Company In-House, Legal and Regulatory
  • Non-profit Organizations
  • Academics and students
  • Law Firm Attorneys
  • New to Food and Drug Law, including younger associates
  • California Food & Drug Community

This session will discuss FDA’s response to the COVID-19 pandemic, across all product areas. What changes have been implemented, whether and how has FDA changed permanently, and how changes have impacted business practices.

 

David V. Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
Amy Norris, Executive Counsel, Clif Bar & Company and Member, FDLI Board of Directors
John M. Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health, Inc.
Moderated by Howard R. Sklamberg, Partner, Arnold & Porter LLP 

Join a Zoom group of your choice to network and discuss hot-button issues that were brought up during the day. Coffee or cocktail optional!

  • Drugs
    • Led by David C. Spangler, Senior Vice President, Legal, Government Affairs, and Policy, Consumer Healthcare Products Association (CHPA)
  • Medical Devices
    • Led by Marta L. Villarraga, Principal, Exponent, Inc.
  • Biologics and Biosimilars
    • Led by Michael Werner, Partner, Holland & Knight LLP
  • Food and Dietary Supplements
    • Led by Susan M. Bond, Vice President, Regulatory & Scientific Affairs, Kerry, Inc.
  • Veterinary Products
  • Vacations and Trips: Where I Didn’t Get to Go, and Where I’m Going Next
    • Led by Atiq Chowdhury, Associate, Sidley Austin LLP

Thursday, October 8

First virtual conference? Unsure about technology? Join FDLI staff and a Pathable Platform expert for this informal, open session to make sure your audio and technology are prepared for the day’s sessions and to answer your questions about the virtual platform.

Led by FDLI-member experts, these informal facilitated discussions provide an ideal way to engage with colleagues, gain new information, and share best practices on a hot topic in food and drug law. Attendees have the option to choose from one of the 20+ topics. The list of topics are available in the conference platform.

Laura Brown, Director, Educational Programs, 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.

 

Michael M. Landa, Former Acting Chief Counsel and Deputy Chief Counsel, Office of the Chief Counsel, FDA and Director, CFSAN (Retired), FDA
Introduced by Deborah M. Autor, Vice President, Global Regulatory Excellence, AstraZeneca Pharmaceuticals and Chair, Board of Directors, FDA Alumni Association 

1:00 – 2:00 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 Freddy A. Jimenez, Vice-President, Law and Compliance, Celldex Therapeutics, Inc. and Secretary and General Counsel, FDLI Board of Directors

The CBD product market has exploded since the passage of the 2018 Farm Bill, however it remains an impermissible ingredient in many FDA-regulated products. Meanwhile, states continue to pass their own laws regarding cannabis and cannabis-derived products, creating a patchwork network of rules and regulations. In this session, panelists will outline the current federal and state regulations, as well as statements and other indicators from key regulatory bodies, including FDA, USDA, FTC, DEA, and state health departments. Panelists will also discuss what developments they would like to see in the near future to create more certainty in the market.

 

Jonathan A. Havens, Partner, Saul Ewing Arnstein & Lehr LLP
Paul Joseph, Of Counsel, Foley & Lardner LLP
Suzie Loonam Trigg, Partner, Haynes and Boone LLP

On March 27, Congress passed Over-the-Counter (OTC) monograph reform as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. These provisions represent a sea-change in FDA’s regulation of OTC drug products, including moving to an administrative order process rather than the longstanding monograph rulemaking process, opening a pathway for migration of certain products to OTC monographs, offering a way out of the New Drug Application requirements for some OTC products, and allowing for the assessment of user fees. During this panel, speakers will address these provisions as well as other aspects of the reform, including whether the lingering sunscreen review problems have been fixed, potential changes to FDA’s OTC enforcement authority and procedures, and the new 18-month exclusivity period for certain OTC drugs, which will lead to new competitive opportunities, risks, and litigation in this space.

 

James N. Czaban, Partner, Loeb & Loeb LLP and Co-Chair, FDLI 2020 Annual Conference
Deborah L. Livornese, Director, Hyman, Phelps & McNamara, PC
Theresa Michele, Director, Office of Nonprescription Drugs, CDER, FDA
David C. Spangler, Senior Vice President, Legal, Government Affairs, and Policy, Consumer Healthcare Products Association (CHPA)

All companies are dealing with increasing concerns over data privacy and cybersecurity in the healthcare field and complying with various privacy laws around the globe. In this session, panelists will discuss general and FDA-regulated company-specific data privacy and cybersecurity issues. Topics will include data privacy laws such as the EU’s General Data Privacy Regulation  and California Consumer Privacy Act, data privacy and integrity for research data, protecting against and navigating data breaches (including those of suppliers, distributors, and retailers), and new secure data technologies.

 

Kimberly J. Gold, Chief Privacy Officer, Head of Privacy Law Group and Associate General Counsel, Genentech, Inc.
Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
Brenda R. Sharton, Global Chair of Privacy + Cybersecurity, Goodwin Procter LLP
Sara Tucker, Partner, Womble Bond Dickinson (US) LLP
Moderated by David J. Bloch, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic

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

Gather with fellow colleagues for a 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 Freddy A. Jimenez, Vice-President, Law and Compliance, Celldex Therapeutics, Inc. and Secretary and General Counsel, FDLI Board of Directors

Visit the virtual sponsor booths and meet live with company representatives.

Make sure your organization is fully utilizing your FDLI membership benefits. Our membership and marketing teams will share tips and tricks to ensure your team is engaged with FDLI.

Benjamin Butz, Director, Membership and Stakeholder Engagement, FDLI
Zersha Munir, Director, Marketing, FDLI

Join your fellow colleagues in one of the following informal networking sessions to catch up and connect!

  • Government Employees, including FDA
  • Company In-House, Legal and Regulatory
  • Non-profit Organizations
  • Academics and students
  • Law Firm Attorneys
  • New to Food and Drug Law, including younger associates
  • California Food & Drug Community

2:30 – 3:30 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, Acting Director, Center for Drug Evaluation and Research, FDA
Moderated by Daniel A. Kracov, Partner, Arnold & Porter LLP and Vice Chair, FDLI Board of Directors

In recent years, there has been a rapid increase in new and innovative food products entering the market. However, this innovation can create conflicts with existing regulatory definitions, as well as with traditional consumer understanding of common product names like “meat” and “milk.”  This session will feature an in-depth discussion on labeling and marketing for a wide variety of innovative products, including plant-based, flora-based, and cell-cultured foods, in light of FDA’s Standards of Identity, USDA definitions for meat and dairy, and existing consumer perceptions.

 

Andrea G. Ferrenz, Food Law Counsel, Campbell Soup Company
Jason W. Gordon, Partner, Reed Smith LLP
Gregory Jaffe, Biotechnology Project Director, Center for Science in the Public Interest 
Moderated by Stuart M. Pape, Shareholder, Polsinelli PC

Launched in 2011, FDA’s Case for Quality seeks to improve medical device manufacturing by recognizing companies and identifying practices that consistently create high quality products, emphasizing quality system regulation as a tool for improving product quality. In this session, stakeholders will discuss the current state of FDA’s Case for Quality programs, including the Case for Quality pilot program and Corrective and Preventive Action Plan process improvement pilot study. Speakers will also discuss FDA’s harmonization of Quality System Regulation with the international quality systems standard ISO 13485 and the draft rule expected out this fall, including what manufacturers need to do to prepare.

 

John C. (Jack) Garvey, Principal / Chief Executive Officer, Compliance Architects LLC
Marian J. Lee, Partner, Gibson, Dunn & Crutcher LLP
Francisco Vicenty, Case for Quality Program Manager, Office of Compliance, CDRH, FDA
Moderated by Neil P. Di Spirito, Member of the Firm, Epstein Becker & Green, P.C.

3:30 – 4:00 PM | Concurrent Activities:

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

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

Visit the virtual sponsor booths and meet live with company representatives.

Engagement with FDLI can help build your network and establish your expertise. Learn what opportunities are available to you early in your career and how others have successfully leveraged their FDLI membership to progress in their career.

Amy Comstock Rick, President & CEO, FDLI
Benjamin Butz, Director, Membership and Stakeholder Engagement, FDLI

Join your fellow colleagues in one of the following informal networking sessions to catch up and connect!

  • Government Employees, including FDA
  • Company In-House, Legal and Regulatory
  • Non-profit Organizations
  • Academics and students
  • Law Firm Attorneys
  • New to Food and Drug Law, including younger associates
  • California Food & Drug Community

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: Ralph F. Hall, Principal, Leavitt Partners LLC, and Professor of Practice, University of Minnesota
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 2019, and Cases to Watch, 2020. 

 

Ralph F. Hall, Professor of Practice, University of Minnesota Law School
William M. Janssen, Professor of Law, Charleston School of Law
Anne K. Walsh, Director, Hyman, Phelps & McNamara, PC
Moderated by August T. Horvath, Partner, Foley Hoag LLP

5:20 PM | Conference Adjournment