DIA 48th Annual Meeting
Click here to go to the previous page
Integrating Pharmacogenomics and Companion Diagnostic Development into the Integrated Clinical Development Plan
Track
:
Track 02: Project/Portfolio Management and Strategic Planning
Program Code:
303
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Michelle Smith, Eli Lilly and Company, United States
PRESENTER
(S):
Michelle Smith, Eli Lilly and Company, United States Christopher Harbison, Bristol-Myers Squibb Company, United States
Diane Yen, Merck Research Laboratories, United States
Description
By integrating pharmacogenomics (PGx) and companion diagnostics (CDx) into the clinical development plan in the early stages of drug development, the clinical team can maximize their opportunity for tailored therapies and minimize the risk of a CDx registration holding up drug approval.
Learning Objectives:
Describe processes and methods for the successful integration pharmacogenomics (PGx) and companion diagnostics (CDx) into clinical planning and timeline development
Identify integration points for PGx and CDx in the drug development life cycle
Discuss what is required for PGx subgroups to be in the label and when a CDx is needed.
Learning Objectives:
Describe processes and methods for the successful integration pharmacogenomics (PGx) and companion diagnostics (CDx) into clinical planning and timeline development
Identify integration points for PGx and CDx in the drug development life cycle
Discuss what is required for PGx subgroups to be in the label and when a CDx is needed.
This session is a part of:
Handout Online
