DIA 48th Annual Meeting
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Product Candidate to Proof-of-concept: An Integrated Approach to Accelerate Programs
Track : Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Program Code: 246
Date: Tuesday, June 26, 2012
Time: 1:30 PM to 3:00 PM  EST
CHAIR :
 John Shillingford, Independent Consultant, Germany
PRESENTER (S):
 John Shillingford, Independent Consultant, Germany
 Sergei Leonov, Vertex Pharmaceuticals, United States
 Joachim Vollmar, ICDC LLC, United States
Description
This session will look at the Early Phase Team's decision-making processes, use of adaptive designs to facilitate studies, and reduction of study times. An integrated approach with the aim to facilitate rapid development go/no-go decisions.

Learning Objectives:
Analyze the decision making processes used to determine Early Phase Drug Development with study designs to facilitate drug development go/no-go decisions
Identify strategies to facilitate the acceleration of studies from the volunteer phase into patients for proof-of-concept.