|
Activity Number:
|
14
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Sunday, July 29, 2007 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #310401 |
|
Title:
|
Optimizing the Manufacturing of Phase III Material During Phase II Trials
|
|
Author(s):
|
Nitin Patel*+ and Francoise Vandenhende
|
|
Companies:
|
Cytel Inc. and Eli Lilly and Company
|
|
Address:
|
675 Massachusetts Ave, Cambridge, MA, 02139,
|
|
Keywords:
|
|
|
Abstract:
|
We will describe a Bayesian decision analysis model developed for late stage Phase II trials. The aim of the model is to explore the opportunity to reduce the time to market for a drug in a Phase II clinical trial by triggering the Compound Manufacturing and Control (CMC) process before completion of the trial. Since the CMC effort for a drug often lies on the critical path to release, early triggering has the promise of increasing revenues over the life of the drug. The risk is that the CMC work may be fruitless as there is a chance that the drug will fail on the Phase II trial. The model optimizes this trade-off and is currently being actively investigated for application to a Phase II trial of a cancer drug.
|
