Program
| Wednesday 22 June 2011 |
| 08:45 - 09:15h |
Opening Lecture: Health Economics of Hepatitis Therapy |
| Session 1 | Round Table Discussion |
|
Regulatory requirements for early clinical testing of novel HCV antiviral drugs |
|
| 09:15 - 09:45h |
The US (FDA) regulatory perspective |
| 09:45 - 10:15h |
The EU (EMA) regulatory perspective |
| 10:15 - 10:45h |
Discussion |
| 10:45 - 11:45h |
Break |
| Session 2 |
Clinical Pharmacology - Special Patient Populations |
| 11:45 - 12:15h |
Issues for HCV drug development in Special Populations |
| 12:15 - 12:30h |
Abstract driven presentation |
| 12:30 - 13:00h | Drug Interaction Studies in Special populations invited speaker: Jennifer Kiser PharmD |
| 13:00 - 14:00h |
Lunch |
| Session 3 |
Clinical Pharmacology - Novel Compounds (I) |
| 14:00 - 14:30h |
Translating Molecular Virology into Novel therapies for Hepatitis |
| 14:30 - 16:00h |
Abstract driven presentations and discussion |
| 16:00 - 16:30h |
Break |
| Session 4 |
Clinical Pharmacology - Novel Compounds (II) |
| 16:30 - 17:00h |
Impact of aging in Liver on HCV progression |
| 17:00 - 18:00h |
Abstract driven presentations and Discussion |
| Thursday 23 June 2011 | |
| Joint Session | with 6th Int. workshop on Hepatitis C - Resistance & New Compounds |
| 08:45 - 09:15h | Overview on Clinical Trials with Protease Inhibitors Invited speaker: Stefan Zeuzem MD |
| 09:15 - 09:30h | Discussion |
| 09:30 - 10:00h | Overview on new classes of HCV Inhibitors (other than Protease and Polymerase Inhibitors) Invited speaker: Ira Jacobson MD |
| 10:00 - 10:15h | Discussion |
| 10:15 - 10:45h |
Break |
| 10:45 - 11:15h | Viral dynamics and Resistance; Implications for HCV drug development Invited speaker: Robert Schooley MD |
| 11:15 - 11:30h | Discussion |
| 11:30 - 12:00h | Influence of IL28B and other genetic markers on treatment outcome Invited speaker: John McHutchison MD |
| 12:00 - 12:15h | Discussion |
| 12:15 - 12:45h |
Interferon Responsiveness to Bridge PegInterferon Ribavirin Treated and Untreated Subjects |
| 12:45 - 13:00h | Discussion and Closure of the joint session |
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Robert Branch MD
Impact of Aging in Liver on HCV Progression
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Raymond Chung MD
HCV Drug Development in Special Populations
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Jeffrey Glenn MD, PhD
Translating Molecular Virology into Novel Therapies for Hepatitis
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Filip Josephson MD, PhD
Regulatory Requirements for early clinical testing of novel HCV antiviral drugs, The EMA perspective
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Jennifer Kiser PharmD
Drug Interaction studies in Special Populations
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Sarah Robertson PharmD
Regulatory Requirements for early clinical testing of novel HCV antiviral drugs, The FDA perspective
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John Wong MD
Health Economics of New HCV Therapies
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Speakers Joint Session
Ira Jacobson MD
Overview of the new classes of HCV inhibitors (other than Protease and Polymerase Inhibitors)
...
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Pravin Jadhav PhD
Interferon Responsiveness to Bridge Treatment Naive and Experienced Patients
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John McHutchison MD
Influence of IL28B and other genetic markers on treatment outcomes
...
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Robert Schooley MD
Modeling / New Therapies: Implications of viral dynamics and resistance considerations for optimizing Hepatitis C therapies
...
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Stefan Zeuzem MD
Overview on the Protease inhibitor trials / Clinical Implications
...