Diabetes Mellitus and Cardiac Safety: A CSRC Thinktank

Agenda & Meeting Presentations

Diabetes Mellitus and Cardiac Safety: A Cardiac Safety Research Consortium Thinktank

Wednesday, April 13, 2011

FDA Headquarters, White Oak Facility

Silver Spring, Maryland


Thinktank Goals: Discuss concrete collaborative projects that would positively impact the development of diabetes medications. It is recognized that these efforts may be informative to other chronic use therapies when CV risk assessment is important to the drug’s profile.

Deliverables: Two to three concrete collaborative proposals that are actionable and can be progressed forward.

Part I: 8:00am-2:20pm


·   Introduction to Meeting: Philip Sager, MD, Consultant (5 min)

·   The Use of Large Databases for Drug Development: An FDA Perspective: Vicki Seyfert-Margolis, PhD, FDA (15 min)

·   Key Developmental Needs to a Collaborative Approach to Diabetes Mellitus Drug Development and Risk/Benefit Assessment: Anders Svensson, MD, PhD, Roche (15 min)

·   Current State of Diabetes Drug Development – Challenges & Opportunities: Mary Parks, MD, FDA (15 min)


Effort #1: Phase 3 and 4, Pre- and Post-Marketing Continuum Models for Cardiovascular Safety with Diabetic Drugs. 

·   Statistical Issues:

o Regulatory Perspective: Todd Sahlroot, PhD, FDA (10 min)

o Academic Perspective: Mitchell Krucoff, MD, Duke (10 min)

o Pharma Perspective: Fred Yang, PhD, GSK (5 min)

o Pharma Perspective: Deborah Shapiro, PhD, Merck (5 min)

o Discussion (30 min) Lead Discussant: Brenda Gaydos, PhD, Eli Lilly

·   Key Operational Issues:

o Pharma Perspective: Shamik Parikh, MD, AstraZeneca (10 min)

o Operational Perspective: Thomas Todaro, MD, Medpace (10 min)

o Discussion (25 min) Lead Discussant: Philip Sager, MD, Consultant

·   Summary (5min)

11:00-11:15 am: BREAK

11:15 am-12:30pm

Effort #2: How to Leverage Large Databases For Prospective and Retrospective Safety & Benefit Analyses? Is a CV Safety Warehouse Feasible?  Moderator: Mitchell Krucoff, MD, Duke

o  Regulatory Perspective: Norman Stockbridge, MD, PhD, FDA  (10 min)

o Academic Perspective: Sanjay Kaul, MD, Cedars-Sinai (10  min)

o FDA Sentinel Effort: Melissa Robb, BSN, FDA (5 min)

o Pharma Perspective: Murray Stewart, MD, GSK (5 min)

o Discussion (40 min) Lead Discussant: Mitchell Krucoff, MD, Duke

12:30-1:00pm: LUNCH

1:00 -2:15pm

Effort #3: New approaches to Benefit analysis; Equipoise of Benefit versus Risk in Diabetes Mellitus Drugs.  Moderator: Ralph DeFronzo, MD, UTHSCSA

o Academic Perspective: Ralph DeFronzo, MD, UTHSCSA (10 min)

o Regulatory  – Benefit:Risk Perspective:Robert Temple, MD, FDA (10 min)

Regulatory  – Benefit:Risk Perspective:Patrick Frey, MD, FDA (10 min)

o Academic Perspective: Kevin Schulman, MD, Duke (5 min)

o Pharma Perspective: Barry Goldstein, MD, Merck (5 min)

o ADA Perspective: David Kendall, MD, ADA (5 min)

o Patient Group Perspective: Rebecca Killion, BA, MA (5 min)

o Payers: Mark Grant, MD, Blue Cross Blue Shield (5 min)

·         Discussion (30 min) Lead Discussant: Mary Parks, MD, FDA


Introductions to Break-out Sessions: Philip Sager, MD

Break-out Session Goals:

o Specific Goal(s) that is/are practical in a 2 year time frame

o The impact of the opportunity

o The challenges and their mitigations

o What resources are needed; can they reasonably be obtained; How can they be obtained?

o A suggested research plan with clear deliverables and an approximate timeline with suggested next steps.

Part II: 2:20-4:00pm

·   Effort #1 Break-out Chairs: Shamik Parikh, MD, AstraZeneca

Brenda Gaydos, PhD, Eli Lilly

·   Effort #2 Break-out Chairs: Sanjay Kaul, MD, Cedars-Sinai

Norman Stockbridge, MD, PhD, FDA

·   Effort #3 Break-out Chairs: Orville Kolterman, MD, Amylin

Ralph DeFronzo, MD, UTHSCSA

Part III: 4:00-5:40pm Moderators: Mitchell Krucoff and Philip Sager

Report of Break-out Sessions & Discussion/Next Steps:

·   Effort #1 Presentation (10 min) and Discussion (20 min)

·   Effort #2 Presentation (10 min) and Discussion (20 min)

·   Effort #3 Presentation (10 min) and Discussion (20 min)


Summary and Conclusion