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 multi-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.

Agenda Highlights Include:

  • New Drug Development and Clinical Trials Regulation
  • Submission of Marketing Applications and the FDA Approval Process
  • Expanded Access
  • Implementation of the 21st Century Cures Act
  • New Device Development
  • The 510(k) Process and De Novo Review for Devices
  • Interacting with Drug and Device Development Industries and FDA

Partners

Apply

This course is open to staff and volunteers with a leadership role of 501(c)(3) patient or disease organizations. Applications will be considered on a case by case basis. Registration for this program is $49.

Apply Now

2020 Agenda

Subject to Change
Speakers to Be Announced

 

Wednesday, November 18

12:00–12:15 PM
Welcome and Announcements

12:15–1:15 PM
Introduction to FDA Organization and Other Agencies

David L. Chesney, Principal and General Manager, DL Chesney Consulting

  • The U.S. Drug Regulatory Process
  • FDA Organization
  • Types of FDA Regulatory Requirements and Pronouncements
  • Congressional Oversight
  • The FDA’s Relationship with Other Agencies

1:15–2:00 PM
FDA in the Headlines and the Impact to Your Communities

Remy L. Brim, Vice President Regulatory Policy and Strategy, BGR Group  Committee
Ryan Hohman, Vice President-Public Affairs, Friends of Cancer Research

  • Overview of FDA’s Jurisdiction and Its Role During the Pandemic
  • Relationship Between HHS, FDA, White House Task Force
  • Impacts on Patient Organizations

2:00–2:15 PM
Break

2:15–3:15 PM
New Drug Development Under an Investigational New Drug Application (IND)

Heidi Gertner, Partner, Hogan Lovells US LLP

  • What is a “Drug”?
  • What is a “New Drug”?
  • Other Drug-Like Products
  • Who Decides Whether a Product is a “New Drug”?
  • The IND Process
  • IND Application

3:15–3:30 PM
Break

3:30–5:00 PM
The FDA Approval Process for Drugs

  • Submission & Filing of NDAs/BLAs
  • Approval Standards
  • The Review Process
  • Expedited Review

5:00–5:30 PM
Networking Session: “Applying the Law to My Organization”

Thursday, November 19

12:00–1:00 PM
Approval and Clearance Pathways for Medical Devices—Part 1

Allyson B. Mullen, Director, Hyman, Phelps & McNamara, PC
Ami E. Simunovich, Executive Vice President, Chief Regulatory Officer, Becton Dickinson (BD)

  • What is a “Device”?
  • Medical Device Amendments of 1976
  • Predicate Devices and Substantial Equivalence
  • Who Decides Whether a Device Needs Premarket Approval (PMA) or a 510(k) Clearance?

1:00–1:10 PM
Break

1:10–2:00 PM
Approval and Clearance Pathways for Medical Devices—Part 2

  • Laboratory-Developed Tests and In-Vitro Diagnostics
  • De Novo Requests for Classification
  • Medical Devices, Combination Products, and EUAs
  • Real World Examples and Practical Applications
  •  

2:00–2:15 PM
Break

2:15–3:30 PM
Post-Market Considerations for Drugs and Devices

Elizabeth Mulkey, Associate, Goodwin Procter, LLP
Steven Tjoe, Associate, Goodwin Procter, LLP

  • Recalls / Safety Communications
  • Post Market Surveillance 
  • Post Approval Changes and Supplements to NDA, ANDA, PMA And When a New 510(k) Must Be Filed
  • Risk/Benefit Health Risk Assessments 

3:30–3:45 PM
Break

3:45–4:45 PM
Expanded Access to Investigational Therapies for Drugs and Medical Devices

Richard Klein, Director, Expanded Access Programs & Policy, GE2P2 Global Foundation

  • Expanded Access
  • Federal Right-to-Try Legislation and Effect on Current FDA Expanded Access Framework

4:45–5:15 PM
Networking Session: “Applying the Law to My Organization”

Wednesday, December 2

12:00–1:00 PM
Conduct of Clinical Trials for Drugs and Medical Devices and Human Subjects Protections

Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative

  • Clinical Testing/Investigation and “Good Clinical Practice” (GCP)
  • Clinical Trials Registration and Results Reporting (clinicaltrials.gov)
  • Human Subjects Research Protection
  • Bioresearch Monitoring (BIMO)
  • Investigational Device Exemptions
  • Adverse Event Reporting

1:00–1:15 PM
Break

1:15–2:15 PM
How Data Informs the Safe Use of Drugs and Device and What You Need to Know

  • Clinical trial data
  • Efficacy
  • Data Review DSMBs
  • Patient Organization’s Role in Communicating Data
  • Diagnostics

2:15–2:30 PM
Break

2:30–3:30 PM
Calculating the Benefit/Risk Assessment for Your Organization

James E. Valentine, Associate, Hyman, Phelps & McNamara, P.C.
Melissa Goetz, Co-Founder, FCS Foundation

3:30–4:00 PM
Networking Session: “Applying the Law to My Organization

Thursday, December 3

12:00–1:00 PM
Intellectual Property and Regulatory Incentives to Protect Innovation
Ryan Kaat, Senior Director, Law, PhRMA

  • Patent Term Restoration/Extension
  • Five- and Three-Year Exclusivity
  • 180-Day Exclusivity
  • Pediatric Exclusivity
  • Orphan Drugs
  • Priority Review Vouchers (PRVs) (Tropical Disease, Rare Pediatric Disease, and Medical Countermeasures)
  • Biosimilars: Intersection of Regulatory Exclusivity and Patent Exclusivity

1:15–2:15 PM
Stakeholder Interactions in the Drug Development Community

  • Sponsor-Patient Group Engagement
  • Payor Communications Post-Cures Act
  • Ways Non-Profit Patient Groups Can Effectively Engage with FDA
  • The Role of PRO Data and How Can Patient Advocacy Groups Influence the Use of PRO Data in FDA Decision Making

2:15–2:30 PM
Break

2:30–3:30 PM
Engaging with FDA: Opportunities and Boundaries

Tracy Gray, Patient Engagement Lead, Patient Science & Engagement Program, Center for Devices and Radiological Health (CDRH), FDA
Sadhna Khatri, Associate Director of Operations, Professional Affairs and Stakeholder Engagement, Center for Drug Evaluation and Research (CDER), FDA
Susan Chittooran, Patient Engagement Project Manager, Patient Affairs Staff, Office of the Commissioner, FDA

  • FDA’s Patient Engagement Offices
  • FDA’s Patient Engagement Programs
  • Participating in FDA Policymaking

3:30–4:00 PM
Networking Session: “Applying the Law to My Organization”

A Special Thanks to the FDLI Patient Organization Engagement Committee

Ryan Hohman, Friends of Cancer Research
Kristin Schneeman, FasterCures
Maureen M. Japha, Eli Lilly and Company
Debra Lappin, Faegre Drinker Biddle & Reath LLP
Katherine Maynard, Peterson Wilmarth and Robertson, LLP (PWR)
Lisa Pieretti, International Hyperhidrosis Society
Ami E. Simunovich, Becton Dickinson (BD)
James Valentine, Hyman, Phelps & McNamara, PC
Laura D. Wingate, Crohn’s & Colitis Foundation

Sponsors

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