Agenda and Slides July 29, 2013

Trans-Radial Education and Therapeutics (TREAT) IV

Fourth Thinktank on Novel Research Infrastructure To Study Access Site & Bleeding Safety of Anti-Thrombotic Drugs

Monday July 29, 2013

FDA Headquarters

White Oak, Maryland

07:30-08:00  Arrival & Continental Breakfast

08:00-08:15:  Welcome & Introductions

08:15-10:00:  Plenary Session:  Novel Infrastructure for Clinical Trials & Innovation

·         Pre-competitive Collaboration Through Public-Private Partnerships:  The Key to Novel Research Infrastructure- Mitchell Krucoff, MD

·         Infrastructure & Innovation:  An Pre-Market FDA View- Bram Zuckerman, MD

·         Infrastructure & Innovation for Patient-Centered Device Surveillance- Danica Marinac-Dabic, MD, PhD

·               Embedding Clinical Interventions Into Observational Trials:  An NHLBI View- Larissa Aviles Santa, MD 

 ·         Leveraging Operational Cardiovascular Registries:  An ACC View- Ralph Brindis, MD

·         Competitive Industry Needs & Research Infrastructure:  Is Partnering Possible?- Robert “Chip” Hance, MD

·         Open Discussion

Lead Discussants 

10:00-10:30  Break

10:30-12:00:  SAFE PCI For Women

·          Update on SAFE PCI for Women- Sunil Rao, MD

·         SAFE PCI for Women:  ACC-NCDR View- Fran Fiocchi, MPH

·         SAFE PCI for Women:  Investigator View- Prashant Kaul, MD, FACC, FSCAI

·         SAFE PCI for Women:  FDA OWH View- Helen Barr, MD

·         SAFE PCI for Women:  Device Industry View- David Rutledge, PharmD

·         SAFE PCI for Women:  Pharma Industry View- Mark Effron, MD

·         Open Discussion

Lead Discussants

12:00-13:00  Lunch Break

13:00-14:45  SAFE STEMI for Seniors

·          STEMI, Bleeding & Outcomes in Seniors:  What Are the Issues?- Ron Waksman, MD and Joshua P, Loh, MD

·          TRI vs. TFA in STEMI:  Should We Randomize?- Ajay J. Kirtan, MD, SM

·          SAFE STEMI for Seniors:  NIH Application- Sunil Rao, MD

·         Open Discussion

Lead Discussants

14:45-15:15  Break

15:15-16:45  Operational Challenges for Novel Research Infrastructure

·           Data Quality & Monitoring Using NCDR for IDE:  – ACC View- Kathleen Hewitt, MSN, RN, AACC

·           Data Quality & Monitoring Using NCDR:  FDA View- Andrew Farb, MD and Dorothy Abel, BSBME

·           Accelerating CMS Outcomes Data to Near Real Time:  Challenges & Solutions- Rosemarie Hakim, PhD

·          Validating CMS Outcomes for IDE and IND Clinical Trials –J Matthew Brennan, MD, MPH

·          Open Discussion

Lead Discussants

Closing Comments