5151 Pooks Hill Road

Bethesda, Maryland 20814

Presentations, agendas, and other material pertinent to the recently concluded 2009 CSRC Annual Meeting are provided below.

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Day 1 - Thursday 29 October 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

• FDA: Rachel Behrman (15 min)
• Academia: Ralph Brindis (15 min)
• Industry: Jonathan Fox

• International: Borje Darpo

09:00-09:30 CSRC: What is CSRC, How Does It Work and Why Have We Joined Together?

Moderators: Philip Sager, Norman Stockbridge

• History & Structure of CSRC: Mitchell Krucoff (10 min)

Why Have We Joined Together (5 min each)

• Pharma Industry: Theressa Wright
• Device Industry: Mark Mentzer
• FDA: Douglas Throckmorton
• Academics: Peter Kowey

09:30-09:45 Break

09:45-11:45 CSRC: What Have We Done and Where We're Going

Moderators: John Finkle, Cindy Green

• CSRC "Signature" Efforts: An Overview (QT Warehouse, Thinktank Incubators & White Paper Pre-competetive Collaborations): John Finkle (10 min)

QT Warehouse (10 min each)

• 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 (10 min each)

• 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 (10 min each)

• White Papers In Progress- 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

• Presentation (20 min) Overview of Key Issues in Public Access to Proprietary Data: Ralph Brindis
• Discussion Panel and Open Q&A (Benjamin Eloff, Daniel Bloomfield, Theressa Wright, Steve Grant, Paul Kligfield, David Buckles) (40 min)

14:00-15:00 Hot Topics II - Cardiac Safety in Product Development in Diabetics

Moderators: Theressa Wright, Colette Strnadova

• Presentation (20 min) Overview of Key Issues in Cardiac Safety Drug Development in Diabetics: Hylton Joffe
• Discussion Panel and Open Q&A (Theressa Wright, Colette Strnadova, Daniel Bloomfield, Andy Farb)

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

• Presentation (20 min) Overview of Key Issues in Drug Development: What is Normal?: Tom Marciniak
• Discussion Panel and Open Q&A (Mitchell Krucoff, Norman Stockbridge, John Finkle, Mark Mentzer, Paul Kligfield, David Buckles) (40 min)

16:15-17:15 Hot Topics IV - Non-QT Cardiac Safety in Product Development

Moderators: Daniel Bloomfield, Peter Kowey

• Presentation (20 min) Overview of Key Issuews in Non-QT Cardiac Safety in Product Development: Rick Turner
• Discussion Panel and Open Q&A (Daniel Bloomfield, Peter Kowey, Jean-Philippe Couderc, Philip Sager, Fabio Badilini) (40 min)

17:15 Adjournment

17:30-18:30 Networking Reception

Day 2 - Friday 30 October 2009

07:30-08:00 Registration & Continental Buffet

08:00-09:00 Hot Topics V - Cardiac Safety in Medical Product Development in Pediatrics

Moderators: Lawrence Satin

• Presentation (20 min) Overview of Key Issues in Cardiac Safety and Drug Development in Pediatrics: Victoria Vetter, CHOP
• Discussion Panel and Open Q&A (Lawrence Satin, Francesca Joseph, Hina Pinto, Victoria Vetter) (40 min)

09:00-10:00 Hot Topics VI - Late Phase & Post-marketing Assessment of Cardiac Safety

Moderators: Borja Darpo, Judith Racoosin

• Presentation (20 min) Overview of Key Issues in Infrastructure & Strategies for Long Term & Post-market Cardiac Safety Assessment Product Development: Shari Targum
• Discussion Panel and Open Q&A (Borje Darpo, Judith Racoosin, John Finkle, Mary Ross Southworth, Danica Marinac-Dabic, Lawrence Satin) (40 min)

10:00-10:15 Break

10:15-11:45 CSRC: Where Are We Going & What Do I See When I Look at CSRC

Moderators: Daniel Bloomfield, Mitchell Krucoff

• Panel (10 min): Daniel Bloomfield, Mitchell Krucoff, Philip Sager, Paul Kligfield, John Finkle, Benjamin Eloff, Theressa Wright, Norman Stockbridge
• Panel Comments and Open Q&A (80 min)