Materials
Presentations
Introductory Remarks and Program Overview
Welcome, Introduction, Forum Updates, Program Overview and Acknowledgements
Session I: Updates and Setting the Stage
Update: Towards Accelerating HBV Clinical Research in Africa
Mitchell Leus, Forum for Collaborative Research
Veronica Miller, Forum for Collaborative Research
Participant Comments: Towards Accelerating HBV Clinical Research in Africa
Asgeir Johannessen, Hepatitis B in Africa Collaborative Network (HEPSANET)
Mark Sonderup, University of Cape Town
Wendy Spearman, University of Cape Town
EMA Proposed Update to HBV Guideline
Stephanie Buchholz*, European Medicines Agency
Open Discussion
All Meeting Participants
Session II: Gene Editing and Epigenetic Platforms for HBV Cure
Academic Overview Presentation
Fabien Zoulim*, INSERM - French National Institute of Health and Medical Research
PBGENE-HBV: ARCUS gene editing to eliminate the root cause of Hepatitis B
Cassie Gorsuch*, Precision BioSciences
Epigenetic Silencing of the Viral Genome as a Therapy for Chronic Hepatitis B
Kendra Congdon, Kendra Congdon, Tune Therapeutics
Regulatory Perspective
Vaishali Popat*, FDA/CBER Office of Therapeutic Products
Panel Discussion
Kendra Congdon, Tune Therapeutics
Emily Harrison, Precision BioSciences
Vaishali Popat*, FDA/CBER Office of Therapeutic Products
Thomas Tu, Westmead Institute for Medical Research, HepBCommunity.org, Hepatitis B Voices Australia
Fabien Zoulim*, INSERM - French National Institute of Health and Medical Research
Session III: Immune Checkpoint Inhibitors in HBV Clinical Development
Immune Checkpoint Inhibitor (ICI) Treatment and Immune-related Adverse Events (IrAEs): Lessons Learned from Oncology for its Potential Use for Chronic Hepatitis B (CHB) Patients
Agustina Crespi*, Toronto Center for Liver Disease
Mitchell Leus, Forum for Collaborative Research
Patient Perspectives
Su Wang, , Center for Asian Health, Cooperman Barnabas Medical Center, Global Health Advisor, Hepatitis B Foundation
Open Discussion
All Meeting Participants
Session IV: HDV Assay Development Project
HDV Assay Development Project Overview
Veronica Miller, Forum for Collaborative Research
Norah Terrault, Keck Medicine at USC
Panel Discussion
Maria Ines Garcia*, FDA Center for Devices and Radiological Health (CDRH)
Robert Gish, Hepatitis B Foundation
Scott Patterson, Gilead Sciences
Christian Voitenleitner, Roche Diagnostics
Heiner Wedemeyer, Hannover Medical School
Veronica Miller, Forum for Collaborative Research
Open Discussion
All Meeting Participants
* Indicates Remote Participation
