Session Information
2007 BIO International Convention
Click here to go to the previous page
Exploratory INDs — Phase 0 Trials: New Tools Accelerating Drug Development
Track
:
Clinical Research/Clinical Trials
Program Code:
CLIN040
Date:
Monday, May 7, 2007
Time:
4:00 PM to 5:30 PM
Location:
258 A
CHAIR
:
Oxana Pickeral, PhD, MBA, Director, Strategic Alliance Management, Division of Cancer Treatment and Diagnosis, NCI/N
SPEAKER
(S):
Ed Tabor, MD, Executive Director; Head Regulatory Affairs and Medical Writing, Quintiles
James Doroshow, MD, Director, Division of Cancer Treatment and Diagnosis, NCI/NIH
Christopher-Paul Milne, DVM, MPH, JD, Associate Director, Tufts Center for the Study of Drug Development, Tufts University
George Mills, FASHE, CEM, CHFM, Vice President, Medical Imaging Consulting, Perceptive Informatics/PAREXEL, MA, United States
Description
Beginning with a brief overview of the FDA's Exploratory IND Guidance and the concept of Phase 0 trials and their application, this session will feature a point-counterpoint discussion among medical, government and industry experts on the merits of this new approach in drug development. The panel will explore the pros and cons of incorporating Phase 0 trials into existing drug development strategies and discuss scenarios where this option may produce the greatest impact on next-stage development, attrition rates, overall costs, time and productivity.
Objectives:
Educate attendees on the FDA's Exploratory IND guidance and its impact on drug development efforts.
Discuss the pros and cons of Phase 0 trials so that attendees will know when exploratory INDs should be considered as part of a product development strategy.
Inform participants of the resources, expertise and infrastructure required to conduct Phase 0 studies, and address the key points for patient communications.
Objectives:
Streaming Audio with
PowerPoint Slides
PowerPoint Slides
(Code: CLIN040)
This session is a part of: