DIA 48th Annual Meeting
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Pre-competitive Public Private Partnerships: The Changing Model of Pharmaceutical R&D
Track : Track 03: Innovative Partnering Models and Outsourcing Strategies
Program Code: 156
Date: Monday, June 25, 2012
Time: 3:30 PM to 5:00 PM  EST
CHAIR :
 Ruth Tal-Singer, GlaxoSmithKline, United States
PRESENTER (S):
 Ruth Tal-Singer, GlaxoSmithKline, United States
 Luca De Nigro, Italian Medicines Agency (AIFA), Italy
 Nancy Kline Leidy, United BioSource Corporation, United States
Description
This session will focus on an emerging approach to R&D using specific examples for public-private partnerships in chronic obstructive pulmonary disease and oncology. The role of biomarkers and patient-reported outcomes in research and development of new medicines, the current regulatory environment for biomarker and endpoint qualification, and key success factors for public-private partnerships will be discussed.

Learning Objectives:
Describe the role of biomarkers in R&D of new medicines
Discuss the current regulatory environment for biomarkers and PRO qualifications
Discuss the use of health care web-based registers for clinical research Identify key success factors for public-private partnerships using an example of COPD and oncology.