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Thursday, September 08, 2016 - 8:00 am to Friday, September 09, 2016 - 12:00 pm

AASLD/EASL HBV Treatment Endpoints Workshop: From Discovery to Regulatory Approval

Note: This event was held September 8-9 in Alexandria, VA.

AASLD and EASL possess the expertise in chronic hepatitis B and D to bridge the current knowledge gaps that regulatory and pharmaceutical industry has identified as important issues hampering development of novel therapeutic agents for chronic hepatitis B and D.

This workshop brought together the academic, regulatory, and pharmaceutical communities to discuss therapeutic endpoints, trial designs. appropriate patient populations, and safety concerns with regards to novel therapeutic approaches for treatment of chronic hepatitis B and D.

Session I: Current Landscape

Thursday, September 8
Moderators: Marc G. Ghany, MD, FAASLD; Averell H. Sherker, MD, FAASLD; and Filip Josephson, MD, PhD

  • 8:00 am - 8:10 am
    Goals of the Workshop
    Anna S. Lok, MD, FAASLD and Fabien Zoulim, MD
  • 8:10 am – 8:30 am
    HBV: Natural History
    Maria Buti, MD, FAASLD
  • 8:30 am - 8:50 am
    HBV: Approved Therapies
    Pietro Lampertico, MD, PhD
  • 8:50 am - 9:10 am
    HDV: Natural History and Approved Therapies
    Heiner Wedemeyer, MD
  • 9:10 am - 9:30 am
    Panel Discussion 
     

Session II: Future Landscape

Thursday, September 8
Moderators: Geoffrey M. Dusheiko, MD; Norah Terrault, MD, MPH; and Debra B. Birnkrant, MD

  • 9:50 – 10:10 am
    Desired Future HBV Treatment
    Marc G. Ghany, MD, FAASLD
  • 10:10 am - 10:30 am
    In Vitro Models for Evaluating New HBV Treatment
    Stephen Locarnini, MD, PhD 
  • 10:30 am - 10:50 am
    Animal Models for Evaluating New HBV Treatment
    Maura Dandri, PhD
  • 10:50 am - 11:10 am 
    Assays for Assessing Endpoints
    Thomas Berg, MD
  • 11:10 am - 11:40 am 
    Panel Discussion 
  • 11:40 am - 1:10 pm
    Lunch (Poster Session)

Session III: Novel Antiviral Therapies

Thursday, September 8
Moderator: Rajen Koshy, MD; Timothy M. Block, PhD; and Stephen Locarnini, MD, PhD

  • 1:10 pm - 1:30 pm
    HBV Biology: Replication Cycle, Potential Antiviral Targets
    T. Jake Liang, MD, FAASLD
  • 1:30 pm - 1:45 pm
    Entry Inhibition
    Stephan Urban, PhD
  • 1:45 pm - 2:05 pm
    cccDNA Silencing and HBx Inhibition
    Massimo Levrero, MD
  • 2:05 pm - 2:25 pm
    HBV Kill Strategy: cccDNA Pool Clearance and Transcription Inhibition
    Ulrike Protzer, PhD
  • 2:25 pm - 2:40 pm
    Capsid Assembly Modulators
    Adam Zlotnick, PhD
  • 2:40 pm - 2:55 pm
    Assembly / HBsAg Secretion Inhibitors
    Ju-Tao Guo, PhD
  • 2:55 pm - 3:10 pm
    HDV Specific Targets
    Jeffrey Glenn, MD
  • 3:10 pm - 3:30 pm
    Break
  • 3:30 pm - 4:00 pm
    Panel Discussion 

Session IV: Immunomodulatory Therapies

Thursday, September 8
Moderators: T. Jake Liang, MD, FAASLD; Fabrice Carrat, MD, PhD; and Veronica Miller, PhD

  • 4:00 pm - 4:20 pm
    HBV Immunology Overview
    Carlo Ferrari, MD
  • 4:20 pm - 4:35 pm
    Cytokines
    Barbara Rehermann, MD
  • 4:35 pm - 4:50 pm
    Therapeutic Vaccines
    Kyong-Mi Chang, MD, FAASLD
  • 4:50 pm - 5:05 pm
    T Cell Functional Recovery and Check-Point Modulation
    Antonio Bertoletti, MD
  • 5:05 pm - 5:25 pm
    Panel Discussion

Session V: Clinical Trials for Future HBV and HDV Treatment

Friday, September 9 
Moderators: Jordan J. Feld, MD; Fabien Zoulim, MD; and Anna S. Lok, MD, FAASLD

  • 8:00 am - 8:30 am
    Traditional and New Endpoints of Therapy for Hepatitis B
    Geoffrey M. Dusheiko, MD
  • 8:30 am - 9:00 am
    Endpoints for Phase 2 and 3 Trials of Novel Antiviral and Immunomodulatory Therapies
    Harry L.A. Janssen, MD, PhD
  • 9:00 am - 9:30 am
    In Vivo Effects of Novel Antiviral and Immunomodulatory Therapies
    Joerg Petersen, MD
  • 9:30 am - 10:00 am
    Assessment of Safety of Novel Antiviral and Immunomodulatory Therapies
    Henry L. Chan, MD
  • 10:00 am - 10:15 am
    Break
  • 10:15 am - 10:45 am
    Target Patient Populations and Trial Design
    Norah Terrault, MD, MPH
  • 10:45 am - 11:45 am
    Panel Discussion