Advancing Therapeutic Development For COVID-19 Treatment

Washington, DC, November 2, 2023

Meeting Materials

Agenda

Participant List

Presentations

Introductory Remarks

Welcome and Introduction from The Forum

Introduction from the FDA
Veronica Miller, Forum for Collaborative Research
John Farley, FDA
Stephanie Buchholz, EMA

Session I: Characterizing Risk Factors for Severe COVID-19 to Inform Participant Eligibility Criteria for Enrollment

Part A: Define Patient Populations

Introduction
Benjamin Lorenz, FDA

COVID-19 Epidemiology
Pragna Patel, CDC

Understanding Risk of Progression to Severe COVID-19: Lessons from a Large Integrated Health System
Jacek Skarbinski, Kaiser Permanente

The Impact of COVID-19 Treatments on Patient Outcomes: A Probabilistic View Based on the National COVID Cohort Collaborative (N3C)
Bradley Price, West Virginia University

Severe Outcomes of COVID-19 Among Increased-Risk Adults
Scott Dryden-Peterson, Brigham and Women’s Hospital

Part B: Possible Trial Designs for Targeted Populations: Issues and Feasibility

Ethical Considerations for Non-Hospitalized Patients with COVID-19
Benjamin Lorenz, FDA

Panel Discussion
Stephanie Buchholz, EMA
Jeffrey Murray, Forum for Collaborative Research
Jose Pablo Morales, FDA
Scott Dryden-Peterson, Brigham and Women’s Hospital
Michael Boeckh, Fred Hutchinson Cancer Center
Kai Lin, Aerium Therapeutics

Session II: Possible Trial Endpoints and Medically Attended Visits

Medically Attended Visits (MAVs): Is it Time to Expand the Primary Endpoint for Trials in Participants with Mild-to-Moderate COVID-19?
Aimee Hodowanec, FDA

Effect of Nirmatrelvir/Ritonavir vs Placebo on COVID-19 Related Hospitalizations and Other Medical Visits
Edward Weinstein, Pfizer

Considerations for Medically Attended Visits in COVID-19 Clinical Trials
Carisa De Anda, Merck

Panel Discussion
Aimee Hodowanec, FDA
Stephanie Buchholz, EMA
Edward Weinstein, Pfizer
Carisa De Anda, Merck
Ann Kwong, Kwong Pharma Consulting LLC
Annie Luetkemeyer, University of California San Francisco

Concluding Remarks

Next Steps
Veronica Miller, Forum for Collaborative Research
Jeffrey Murray, Forum for Collaborative Research
John Farley, FDA
Stephanie Buchholz, EMA