Marriott Pooks Hill
5151 Pooks Hill Road, Bethesda, Maryland 20814
Presentations, agendas, and other material pertinent to the recently concluded 2009 CSRC Annual Meeting are provided below.
(All files are in Adobe Acrobat PDF format. Download the free Acrobat Reader program by clicking here.)
Day 1
Thursday, October 29, 2009
07:30-08:00 Registration & Continental Buffet
08:00-09:00 The Critical Path & Cardiac Safety 2009: Plenary Presentations
Moderators: Mitchell Krucoff, Daniel Bloomfield
09:00-09:30 CSRC: What is CSRC, How Does it Work, and Why Have we Joined Together?
Moderators: Philip Sager, Norman Stockbridge
Why Have We Joined Together?
- Pharma Industry: Theressa Wright
- Device Industry: Mark Mentzer
- FDA: Douglas Throckmorton
- Academics: Peter Kowey
9:30-9:45 Break
09:45-11:45 CSRC: What Have We Done and Where We’re Going
Moderators: John Finkle, Cindy Green
QT Warehouse
- QT Warehouse Structure, Acquisition, Vetting, and Use: Paul Kligfield
- CSRC QT Warehouse – A Vendor’s View: Sam George
- Panel (John Finkle, Cindy Green, Mark Mentzer, Paul Kligfield, Sam George, Mike Li, Wendy Sanhai)
- Open Q&A
Thinktank Incubator Programs
- Optimal Duration of Dual Anti-platelet Therapy after DES Study: Bram Zuckerman
- Atrial Fibrillation Ablation Safety National Registry: Marcia Yaross
- Panel (John Finkle, Cindy Green, Benjamin Eloff, Mitchell Krucoff, Philip Sager, Ruey Dempsey)
- Open Q&A
White Papers
- White Papers In Progres – An Update: Ignacio Rodriguez
- Panel (John Finkle, Ignacio Rodriguez, Colette Strnadova, Peter Kowey)
- Open Q&A
11:45-13:00 Networking Lunch
*Afternoon Sessions: Hot Topics*
13:00-14:00 Hot Topics I – Public Access to Proprietary Cardiac Safety Data
Moderators: Benjamin Eloff, Daniel Bloomfield
- Overview of Key Issues in Public Access to Proprietary Data: Ralph Brindis
- Discussion Panel (Benjamin Eloff, Daniel Bloomfield, Theressa Wright, Steve Grant, Paul Kligfield, David Buckles) and Open Q&A
14:00-15:00 Hot Topics II – Cardiac Safety in Product Development in Diabetics
Moderators: Theressa Wright, Colette Strnadova
- Overview of Key Issues in Cardiac Safety Drug Development in Diabetics: Hylton Joffe
- Discussion Panel (Theressa Wright, Colette Strnadova, Daniel Bloomfield, Andy Farb) and Open Q&A
15:00-15:15 Break
15:15-16:15 Hot Topics III – What is “Normal” in Cardiac Safety Monitoring and Product Development?
Moderators: Mitchell Krucoff, Norman Stockbridge
- Overview of Key Issues in Drug Development: What is Normal?: Tom Marciniak
- Discussion Panel (Mitchell Krucoff, Norman Stockbridge, John Finkle, Mark Mentzer, Paul Kligfield, David Buckles) and Open Q&A
16:15-17:15 Hot Topics IV – Non-QT Cardiac Safety in Product Development
Moderators: Daniel Bloomfield, Peter Kowey
- Overview of Key Issues in Non-QT Cardiac Safety in Product Development: Rick Turner
- Discussion Panel (Daniel Bloomfield, Peter Kowey, Jean-Philippe Couderc, Philip Sager, Fabio Badilini) and Open Q&A
17:15 Adjournment
17:30-18:30 Networking Reception
Day 2
Friday, October 30, 2009
07:30-08:00 Registration & Continental Buffet
08:00-09:00 Hot Topics V – Cardiac Safety in Medical Product Development in Pediatrics
Moderator: Lawrence Satin
- Overview of Key Issues in Cardiac Safety & Drug Development in Pediatrics: Victoria Vetter, CHOP
- Discussion Panel (Lawrence Satin, Francesca Joseph, Hina Pinto, Victoria Vetter)
09:00-10:00 Hot Topics VI – Late Phase & Post-marketing Assessment of Cardiac Safety
Moderators: Borje Darpo, Judith Racoosin
- Overview of Key Issues in Infrastructure & Strategies for Long Term & Post-market Cardiac Safety Assessment Product Development: Shari Targum
- Discussion Panel (Borje Darpo, Judith Racoosin, John Finkle, Mary Ross Southworth, Danica Marinac-Dabic, Lawrence Satin) and Open Q&A
10:15-11:45 CSRC: Where Are We Going & What Do I See When I Look at CSRC
Moderators: Daniel Bloomfield, Mitchell Krucoff
- Panel: Daniel Bloomfield, Mitchell Krucoff, Philip Sager, Paul Kligfield, John Finkle, Benjamin Eloff, Theressa Wright, Norman Stockbridge
- Panel Comments and Open Q&A
11:45-12:00 Final Comments and Adjourn