HCV Drug Development Workshop - Last few weeks left for registration!
Please visit the conference website for more information:
http://ubsconnect.com/umctm2012.html
Here are the speakers and their presentation topics for the plenary session on
Day 1.
Dr. Wendy Carter, FDA: FDA is in the process of revising the Guidance for
Industry to provide the current perspective on development of direct acting
antiviral DAA products for treatment of chronic hepatitis C infection. This
talk will highlight considerations for Phase 1 through Phase 3 development for
DAA products. Additional points to be covered will include efficacy endpoint
considerations, histologic considerations, safety database, longer term
follow-up, documentation of prior response for trial population and
considerations for special populations.
Dr. Lucy Perez, McKinsey: Hepatitis C is a growing and evolving market. The
near term growth is driven by a new generation of protease inhibitors,
boceprevir and telaprevir. The pipeline is getting increasingly crowded with
assets representing numerous mechanisms of action across all phases of
development. In an environment in which biopharmaceutical companies are
investing heavily in this disease area, thoughtful pipeline investment
decisions are the key to outperforming the crowd.
Dr. David Nelson, UFL: The new era of direct acting antiviral agents (DAA) is
upon us after a decade of interferon-based regimens and offers new hopes for
HCV infected patients. Two oral protease inhibitors, telaprevir and boceprevir
have shown the opportunities/challenges of DAAs. For naïve, genotype 1
patients, higher cure rates and shorter duration of therapy can be expected,
but partially offset by new issues of resistance and increased adverse events.
As other classes of HCV agents are approved, a new era of interfron-free
regimens will likely transform the HCV landscape.
[cid:[email protected]]
Joga Gobburu, PhD, FCP, MBA | Professor | School of Pharmacy | School of
Medicine
Executive Director |Center for Translational Medicine
N407, 20 N Pine, Baltimore, MD-21201
Office: (410) 706-5907 | E-mail:
[email protected]<mailto:[email protected]>
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