Slides and Agenda March 2014

CSRC Introduction:Philip
Sager, MD

 

Overview of Key Concepts: Pierre Maison Blanche, MD, Antonio Ferrari,
MD
 

 

Session 1:  What
is Specific in COPD Population

 

Session Chairs: Sherahe Fitzpatrick MD, Stefano Petruzzelli, MD 

 

·      The Burden of CV Disease in COPD
Population and the Unmet Medical Needs:  Stephen
Rennard, MD

 

·      The direct and indirect CV effects of
current COPD drugs and those in development: Heribert
Staudinger, MD

 

·
Guidances
and White Papers available or in preparation that have an impact on the
assessment of CV safety in COPD populations:  Krishna Prasad, MD

 

·
Critical
Cardiovascular Safety Issues in COPD drug development Industry
Perspective:  Tjark Reblin, MD

 

o
Regulatory
Perspective (FDA):  Sally Seymour, MD

 

o
Regulatory Perspective (PMDA): AyakoMikami, MD

 

Discussion: Eric Michelson, MD


Session II:  How
to characterize CV Effects?

Session Chair: Antonio Ferrari, MD

 

·      Are heart rate increases a meaningful CV
Safety issue associated with COPD drugs and implications of dosing
frequency?  If so, how should this be
assessed/categorized and what constitutes a safety signal? Ihor Gussak, MD

 

·    Are ECG
interval changes (QRS, QTc, PR) and arrhythmias a meaningful CV Safety issue
associated with COPD drugs?  If so, how
should this be assessed/categorized and what constitutes a safety signal? Jay Mason, MD

 

·      Are BP increases a meaningful CV Safety
issue associated with COPD drugs? If so, how should this be
assessed/categorized and what constitutes a safety signalMichael Weber, MD

 

·   Is COPD Drug-induced Ischemic risk a
meaningful CV Safety issue?   If so, how
should this be characterized and what constitutes a safety signal? Pierre Maison Blanche, MD

 

Discussion: Jay Mason, MD

 

Session III: Which and how to collect CV data during
development?

 Session Chair: Philip Sager,
MD

·
What level
and types of CV safety data acquisition should be considered during development
to sufficiently characterize a drug’s benefit/risk assessment at the end of
Phase 3? Are there innovative approaches that should be
considered?

Clinical Development:
William White, MD

 

·      What are the best methodological
techniques to capture the critical CV data during development? Norman
Stockbridge, MD

·      Are there COPD MACE-specific endpoints
that should be considered?  Michael Durheim, MD

 

Discussion:
Sherahe Fitzpatrick, MD

 

Session III: Which and how to collect CV data during development

 Session Chair: Pierre
Maison-Blanche, MD

·   The use of modern pharmaco-epidemiology studies to
assess post-approval risk. Jennifer
Lund, PhD

·   What is the role of outcome studies in
pulmonary drug development and what data can be collected during development to
sufficiently characterize an agent so that an outcome study is not necessary?

 

o  Pharma/academy
viewpoint:  Peter Kowey, MD

Regulatory
viewpoint:  Sally Seymour, MD

 

Discussion: Philip
Sager, MD

Conclusions – Remarks

 

·
Can we
agree on a reasonable standard approach for the determination of CV safety of
COPD drugs?  Summary of key points, areas
of consensus, and next steps:  Antonio
Ferrari, MD, Pierre Maison Blanche, MD,  William White, MD, Philip Sager, MD