Why Attend?

Preliminary Agenda

CLE

Agenda Subject to Change.
All Times are Eastern Standard Daylight 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 22-23. 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

Amy Comstock Rick, President & CEO, FDLI

 

Dr. Stephen M. Hahn, Commissioner of Food and Drugs, FDA
Introduced by Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Chair, FDLI Board of Directors

1:15 – 1:30 PM | FDLI Distinguished Service and Leadership Awards – Award #1

Visit the lobby, sponsor booths, and sign up to meet and network with fellow attendees during the conference.

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

Acting on authority granted by the 21st Century Cures Act, the FDA Center for Drug Evaluation and Research (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.

 

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 people’s genes, environments, and lifestyles, panelists will also discuss how developments in precision medicine, 3D-printing, and real-world evidence impacts the regulatory pathway to market.

 

Wade Ackerman, Partner, Covington & Burling LLP
Megan Coder, Executive Director, Digital Therapeutics Alliance
Allison Fulton
, Partner, Sheppard Mullin Richter & Hampton LLP
Elizabeth Richardson, Director, Health Care Products Project, The Pew Charitable Trusts

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.

 

Scott M. Lassman, Principal, Lassman Law + Policy

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

3:00 – 3:45 PM | Networking
 

3:45 – 4:00 PM | FDLI Distinguished Service and Leadership Awards – Award #2

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 and political considerations related to imports and exports. Panelists will also explore the current 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.

 

Benjamin L. England, Founder and CEO, Benjamin L. England & Associates LLC / FDAImports.com, LLC
John A. Murphy, Deputy General Counsel, Biotechnology Innovation Organization (BIO)

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!

Wednesday, October 7

Sheldon Bradshaw, Partner, King & Spalding LLP
Elizabeth Dickinson, Senior Deputy Chief Counsel, FDA Office of the Commissioner
Peter Barton Hutt, Senior Counsel, Covington & Burling LLP
Rebecca Wood, Partner, Sidley Austin LLP
Interviewed by Amy Comstock Rick, President & CEO, FDLI

1:00 – 1:10 PM | FDLI Distinguished Service and Leadership Awards – Award #3

1:10 – 1:30 PM | “Small Bites” Sessions 

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

Over the past months, FDA has issued countless EUAs to allow the use of unapproved products in order 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

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 (FSMA) 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.

 

Bryan Hitchcock, Senior Director, Food Chain and Executive Director, Global Food Traceability Center, Institute of Food Technologists (IFT)
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 (INDs), 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 (RMAT) 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

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

2:30 – 3:00 PM | Networking
 

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

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
Meredith Q. O’Learchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law

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.

 

Moderated by Deborah M. Shelton, Partner, Arent Fox LLP

In February, Commissioner Hahn 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 (BIO)
Moderated by Karen Ellis Carr, Partner, Arent Fox LLP

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

4:00 – 4:30 PM | Networking

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 will be focuses of the discussion.

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!

Thursday, October 8

12:00 – 1:00 PM | Virtual Luncheon with Table Topic Discussions

12:30–12:55 PM  | Dr. Harvey Wiley Lecture and FDAAA Award
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.

 

 

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  

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 adjudication process rather than the longstanding monograph rulemaking process, opening a pathway for potential new OTC switches, 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.

 

David C. Spangler, Sr. Vice President, Policy, and General Counsel, 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 (GDPR) and California Consumer Privacy Act (CCPA), 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.

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

2:00 – 2:30 PM | Networking

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

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.

 

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 (CAPA) 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.

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

3:30 – 4:00 PM | Networking

4:00 – 4:10 PM | Service to FDLI Award

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 publication, Top Food and Drug Law Cases 2019, and Cases to Watch, 2020. 

William M. Janssen, Professor of Law, Charleston School of Law
Moderated by August T. Horvath, Partner, Foley Hoag LLP

5:15 – 5:20 PM | Closing Remarks

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!