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Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside

Audio conference highlights


New Chemical Entities (NCEs) that increase the percentage of sustained viral response with current standard treatment for hepatitis C have great marketing potential. Protease inhibitors, polymerase inhibitors, interferons, enzyme inhibitors, viral entry blockers, TLR agonists and oligonucleotides all seek to be included in the future armamentarium. Whether these different classes of compounds can fit together and lead to a successful combination treatment is still unknown. Registration of these NCEs is a long and arduous path, with no guarantee of success.


Drawing on his expertise and 19 years of experience, in this audio conference Dr. van Vliet provides an inside look at opportunities and obstacles when developing a hepatitis C compound, and discusses the critical steps necessary to optimize the chances of the NCE -- condensed Phase I development programs, subsequent proof of concept studies to verify efficacy, and competition for patients versus Phase III trials.


This audio conference covers:


  • Choosing the right formulation for your NCE
  • Value of in vitro data
  • Differences between species
  • Preclinical PK
  • Impact of FDA and EMEA restrictions with direct acting antivirals in treatment-naïve patients
  • PK in healthy humans as a predictor of PK in patients and inhibition of viral replication in treatment-naïve or treatment-experienced patients


About the speaker:


Dr. Andre van Vliet is the VP of Medical Affairs Early Development Services (EDS) with PRA International in the Netherlands, and is a Board Certified Internist with expertise and training in oncology and clinical pharmacology. For 19 years Dr. van Vliet was involved in patient care while working as an internist in the Netherlands Cancer Institute, the Free University of Amsterdam and the University of Groningen. He published a PhD thesis on diuretic resistance in liver and heart disease. He joined PRA’s EDS group in 1995 and supervised all aspects of Phase I and IIa drug research of approximately 850 studies in the last 13 years.


Since 2000, Dr. van Vliet has served as a qualified tutor for clinical pharmacologist registration. Recent publications include “Rapid Decline of Viral RNA in Hepatitis C Patients Treated With VX-950: A Phase Ib, Placebo-Controlled, Randomized Study” (Gastroenterology, 2006 Oct; 131(4):997-1002).


Who should attend?


  • Chief Medical Officers
  • Heads of Feasibility and/or Patient Recruitment
  • Program Directors
  • Therapeutic Area Leaders
  • Directors of Clinical Operations


This audio conference is rated General Interest.


*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.

Product Details

Dr. Andre van Vliet, PRA International
Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside
Title: Vice President of Medical Affairs, Early Development Services
Duration: 60 minutes
Discount: Buy 2 items, get 25% off your order using coupon code FX25%OFF
Event Type: Previously recorded on 2009-04-14
Item #: ac20090414
14 Apr 2009 
Registration Price:
$249.00

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Average Rating: (based on 2 reviews)

Showing 2 Reviews:

by L.B.
Director, Clinical Operations
A good presentation showing how umbrella protocols can speed the the development timeframe to obtaining POC data.
by C.C.
Head of Clinical Operations
Very informative talk.
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