With an updated agenda this year, join us to learn the essentials of drug and device law and how to engage with FDA to better support your organization’s advocacy efforts.

For this two-day virtual program, FDLI brings together law, industry, and FDA experts with deep advocacy experience to equip patient organizations with an understanding of the legal tools and strategies available for interacting with the agency. Case studies will illustrate the opportunities for engagement and legal challenges facing patient organizations. Watch several prerecorded sessions for background information and to prepare for the live sessions, with ample opportunity to get your questions answered.

Agenda Highlights Include:

  • Foundations of FDA Organization and Regulations
  • Overview of Review Pathways
  • Incorporating Patient Experience into Drug Development and FDA Policy
  • Patient Access to Treatments, Other Agencies, and Lawmakers
  • Engagement Opportunities with FDA Offices
  • Lessons Learned from COVID-19
  • Hot Topics to Stay Up-to-Date

Partners

Apply

This course is offered for staff and volunteers of 501(c)(3) patient or disease organizations. Applications are considered on a case by case basis. Registration for this two day program is $49

Apply Now

A special thanks to the FDLI Patient Organization Engagement Committee:

David M. Fox, Hogan Lovells US LLP
Ryan M. Hohman, Friends of Cancer Research 
Peter Pitts, Center for Medicine in the Public Interest
Kristin Schneeman, FasterCures
Deborah M. Shelton, Arent Fox LLP
Ami E. Simunovich, Becton Dickinson (BD)
Joshua Soreth-Harman, Sanofi
Kathryn Spates, The Joint Commission
Eva Temkin, King & Spalding
David R. Zook, Faegre Drinker Biddle & Reath LLP

Agenda

subject to change
All Times are in Eastern Time

Prerecorded

Prerecorded
FDA 101
David L. Chesney, Principal and General Manager, DL Chesney Consulting

  • FDA Organization
  • Regulatory Documents
  • Enforcement
  • The Basics of FDCA, PHSA, and PDUFA
  • FDA Regulations
  • FDA’s Relationship with Other Agencies
  • Congressional Oversight

Prerecorded
Overview of Review Pathways
Lee H. Rosebush, Partner, BakerHostetler

  • Drugs: NDA, ANDA, BLA and 351(k) BLA
  • Devices: PMA, de novo, and 501(k)
  • Expedited Programs: Breakthrough, Fast Track, and Priority Review

Prerecorded
Technology and Patient Healthcare
Shelby Buettner, Principal Legal Counsel, Medtronic
M. Jason Brooke
, Attorney &Managing Member, Brooke Consulting, LLC

  • Medical Devices
  • Digital Health
  • Combination Products
  • The Use and Regulation of Artificial Intelligence 

Tuesday, December 14

11:30–11:40 AM
Welcome and Announcements

11:40 AM–12:40 PM
Incorporating Patient Experience into Drug Development and FDA Policy (Part 1)
David R. Zook, Chair, Faegre Drinker Consulting

  • FDA Advisory Committees
  • Testifying as a Patient
  • Patient Representatives
  • Role of Patient Advocates

12:40–1:40 P
Incorporating Patient Experience into Drug Development and FDA Policy (Part 2)
Kerry Jo Lee, Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA (invited)

  • How Patient Perspectives are Submitted to FDA
  • Patient Experience Data Policy
  • Patient Reported Outcomes
  • Patient/Caregiver Perspective in the Drug Review Process
  • Real-World Evidence to Support Drug, Biologic, and Device Approvals

1:40–1:50 PM
Break

1:50–2:50 PM
Engaging with FDA: Opportunities and Boundaries
Susan Chittooran, Patient Listening Session Program Manager, Office of Patient Affairs, Office of the Commissioner, FDA
Sadhna Katri, Associate Director of Operations, Professional Affairs and Stakeholder Engagement, Center for Drug Evaluation and Research (CDER), FDA
Michelle Tarver, Director, Patient Science and Engagement, Center for Devices and Radiological Health (CDRH), FDA

  • Patient Initiatives
  • FDA Patient Engagement Activities
  • Patient Focused Drug Development
  • Resources for Patients

2:50–3:00 PM
Break

3:00–4:00 PM
Patient Access to Other Agencies and Lawmakers
Corinne Alberts, Associate Director of Policy, National Organization for Rare Disorders
Cara Tenenbaum, Principal, Strathmore Health Strategy

  • Legislative Jurisdiction and Oversight
  • The Relationship Between NIH, FDA, and CMS
  • CDC’s Impact on Vaccine Regulations
  • The Relationship Between Industry and Agencies

4:00–5:00 PM
Accelerated Approval
Marian J. Lee, Partner, Gibson Dunn & Crutcher LLP

  • History and Development of Accelerated Approval Pathway
  • Approvals Based on Surrogate and Immediate Endpoints versus Direct Evidence of Clinical Benefit
  • Confirmatory Studies and Postmarket Authorities
  • FDA: Regulator of and Partner with Industry
  • June 2021 Accelerated Approval of Alzheimer’s Drug

Wednesday, December 15, 2021       

12:00–12:45 PM
Cell/Gene Therapy
Eva A. Temkin, Partner, King & Spalding LLP
Elaine H. Tseng, Partner, King & Spalding LLP

  • Overview of Product Regulation
  • Increasing Role of Targeted Therapies and Immunotherapies
  • Stem Cell Therapies: Overlap and Differences
  • RMAT Designation
  • End of Enforcement Discretion Period

12:45–1:00 PM
Break

1:00–2:00 PM
Patient Access to Treatments
Richard Klein, Director, Expanded Access Programs & Policy, GE2P2 Global Foundation

  • FDA Guidance and Changes for Clinical Trials
  • gov: Overview and How to Navigate
  • Diversity and Inclusion in Clinical Trials
  • Traveling for Patient Access to Therapies
  • Informed Consent
  • Safety Reporting
  • Expanded Access and the Right to Try
  • Withdrawn Drugs
  • Off-Label Use

2:00–2:10 PM
Break

2:10–3:10 PM
Lessons Learned from COVID-19
Ami E. Simunovich, Executive Vice President, Chief Regulatory Officer, Becton Dickinson (BD)
Brad Spring, VP, Regulatory Affairs, Strategic Planning and Policy & Regulatory Intelligence, Becton Dickinson (BD)

  • EUA Process and Vaccines
  • Device Clearance Process during Public Health Emergencies
  • Remote Inspection Tools
  • Patient Advocacy through Remote Clinical Trials
  • Post-COVID Plans and the Potential for Upcoming Legislation

3:10–4:10 PM
Hot Topics
Remy L. Brim, Principal, BGR Government Affairs LLC
Kate Rawson, Senior Editor, The RPM Report: Regulation, Policy and Market Access and “The Pink Sheet,” Prevision Policy LLC
Moderated by: Ryan Hohman, Vice President – Public Affairs, Friends of Cancer Research

  • CURES Act, PDUFA, other policies that are moving
  • Executive Order on Promoting Competition in the American Economy
  • Valid Act
  • FDA Inspection Backlog: Possible Approval Delays and Supply Chain Capability
  • Patient Registries
  • The Role of FDA and State Initiatives in Transformative Medicines
  • R. 3: Lower Drug Costs Now Act

4:10 PM
Course Adjournment

Sponsors

Sponsorship opportunities are available. Please let us know if you would like more information.

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.