1. [name of file], 1 From Cardiac Safety To SAFE PCI Mitchell W. Krucoff, MD, FACC Professor, Medicine/Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Co-Director, CSRC Duke Clinical Research Institute Cardiac Safety Research Consortium

2. Cardiac Safety Research Consortium (CSRC): A Critical Path Public Private Partnership FDA-Duke Memo Of Understanding 2005 http://www.fda.gov/oc/initiatives/criticalpath/ http://www.cardiac -safety.org http://www.fda.gov/oc/initiatives/criticalpath/ http://www.cardiac -safety.org  Pre-competitive focus  Multi-stakeholder perspectives  Regulatory/public health landscape  “Thinktank-incubator” processes: 1.Barrier identification 2.Prioritization 3.Partnered solutions 4. Proof-of-concept projects

3. [name of file], 3 Trans-Radial Education, Assessment &Training The TREAT Initiative Obligatory Device-Drug Safety Interaction: Impact of device technique on drug safety www.cardiac-safety.org *CSRC SOC Approved Research Project *

4. The TREAT Initiative Launch 2010 www.cardiac-safety.org

5. TransRadial Education, Assessment & Therapy: June 2010 Regulatory n FDA: l CDER l CDRH l OC OWH Regulatory n FDA: l CDER l CDRH l OC OWH Academia n Duke n Harvard n Cleveland Clinic n Columbia n Emory n Johns Hopkins n Mayo Clinic n Wash Hrt Ctr Academia n Duke n Harvard n Cleveland Clinic n Columbia n Emory n Johns Hopkins n Mayo Clinic n Wash Hrt Ctr Industry n Abbott n Medtronic n Terumo n Cordis/J&J n The MEDCO n Eli Lilly (Daichi) n Sanofi/BMS Industry n Abbott n Medtronic n Terumo n Cordis/J&J n The MEDCO n Eli Lilly (Daichi) n Sanofi/BMS Societies n ACC n SCAI n ESC n SOLACI Societies n ACC n SCAI n ESC n SOLACI Federal n NIH n AHRQ Federal n NIH n AHRQ www.cardiac-safety.org

6. http://www.clinicaltrials.gov/ct2/show/NCT01406236?term=safe+pci+for+women&rank=1  Fruit of pre-competitive PPP (cardiac safety FDA-Duke critical path program)  First & only USA PCI study of women  Unique public health concern  POC for unique research infrastructure

7. CSRC Consensus White Papers www.cardiac-safety.org

8. NIH-NCRI: Linking to the ACC-NCDR for SAFE RCT Efficiency in a “River” of E-Information  Index hosp:  Pt descriptors  Medications  Procedural details  Adverse events  65% workload reduction

9. Building on SAFE PCI for Women: SAFE STEMI for Seniors n Public health: Radial vs. Femoral Intervention l Women l Seniors n Regulatory: l OWH l IDE extension n RCT operations: linked registry efficiencies l Short term F/U: NCRI-NCDR Cath PCI Index hosp: descriptors, meds, procedure, SAEs Index hosp: descriptors, meds, procedure, SAEs l Long term F/U: CMS Claims Data (Seniors) 1 year death, MI, stroke 1 year death, MI, stroke n Collaborating Partners: l ACC, CSRC, DCRI, FDA-OWH, NIH, Medical Device & Drug Industry l ACC, CMS, CSRC, DCRI, FDA-CDRH, NHLBI, NIA, Medical Device & Drug Industry

10. http://www/fda/gov/MDEpiNetMDEpiNet  Dr. Danica Marinac-Dabic (FDA)  Dr. Arthur Sedrakyan (Cornell)  Dr. Sharon-Lise Normand (Harvard)  Dr. Mitchell Krucoff (Duke)

11. Overview of Today’s Agenda n Plenary: Partnered Approaches to Improving Data Quality & Efficiency n SAFE PCI for Women n Lunch n SAFE STEMI for Seniors l Scientific issues l Operational issues

12. [name of file], 12 From Cardiac Safety To SAFE PCI Mitchell W. Krucoff, MD, FACC Professor, Medicine/Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Co-Director, CSRC Duke Clinical Research Institute Cardiac Safety Research Consortium