CSRC COPD Initiative Think Tank Round Table Meeting March 6, 2014
A unique Patient Population CSRC COPD Initiative: • There is a widely accepted link between COPD and Cardiovascular Diseases due to both diseases share common risk factors A unique Drug Class: Broncodilatators • With potential direct and indirect Cardiovascular effects • Most broncodilatators are Inhaled and Long acting compounds
Unmet Needs CSRC COPD Initiative: • How to characterize those direct and indirect Cardio Vascular effects (shall we be pleased with HR, BP, Cardiac Arrhythmias …) • How to collect Cardio Vascular data Phase 2 and Phase 3 • Need of consistent Cardio Vascular Safety data suitable for pooling
CSRC COPD Initiative Session 1: What is Specific in COPD Population Session 2: How to characterize CV Effects? Session 3: How to collect CV data during development Conclusions – Remarks Can we agree on a reasonable standard approach?