The HBV Forum Stopping NUCs in Drug Development Webinar was held on July 14, 2021.
Materials
Presentations
Jessica Weber, Forum for Collaborative Research
Overview of Stopping NUCs in Current Clinical Practice
Grishma Hirode, University of Toronto
Overview of Recommendations and Current Industry Strategies for Stopping NUCs: Lessons Learned
Considerations for stopping NA in HBV finite treatment
Maria Beumont-Mauviel, Janssen
Lessons Learned from Phase 2 Studies 201 and 211
Luisa Stamm, Assembly Biosciences
Stopping NUC therapy in Piranga
Anna Maria Geretti, Roche
Gilead: Stopping NUCs in HBV Cure Trials
Susanna Tan, Gilead Sciences, Inc.
Regulatory perspectives on trial design (flares and mitigating risk)
Trial Design (Flares and Mitigating Risk): FDA Perspective
Poonam Mishra, FDA
Stopping NUCS - Regulatory considerations for clinical trial design for novel combination therapies
Stephanie Buchholz, BfArM
Stopping NUCs- How to move forward? (with incomplete knowledge)
Kosh Agarwal, King's College London
When to retreat after stopping Nrtl
Marion Peters, Northwestern University