2013 CSRC Accomplishments

Overall Numbers

  • Over 600 Industry participants
  • 50 Professional Society participants
  • 220 Regulatory Agency participants
  • 250 Academic Faculty participants

42 Member Companies

Regulatory Collaborators

  • FDA
  • NIH
  • PMDA Japan
  • Health Canada
  • European Union

Society Collaborators

  • ACC
  • The Health and Environmental Services Institute (HESI)
  • SCAI
  • Heart Rhythm Society
  • Agency for Healthcare Research and Quality
  • Canadian Heart Association
  • Center for Business Intelligence
  • DIA
  • European Society of Cardiology
  • International Society of Cardioncology
  • Latin American Society of International Cardiology

 

Publications

  • 19 White Papers published in the American Heart Journal
  • 3 papers published in other journals- British Journal of Clinical Pharmacology and Annuls Noninvasive Electrocardiology, JACC Intervention
  • Press Publications: MedPage, Pink Sheet, FDA Registry, Oncology Today have all covered our meetings.

 Projects

  • ECG Warehouse with over 5 companies sharing placebo data to develop test datasets.  This database has been used by at least 4 companies to test algorithms etc.  –Cindy Green is co-chair of the Database Committee
  • DAPT Trial
  • SAFE PCI- Managed at DCRI
  • Development of CRF Forms for Non-Cardiovascular Trials
  • CSRC/IQ  Clinical Trial- Prospective Phase 1 Clinical Trial being managed by ICON
  • Development of Pediatric ECG Warehouse- work has begun.  Community Foundations, FDA, Lilly, GSK, Mortara, ERT currently involved.  Jennifer Li, Salim Iddress, Barry Magnum, and Danny Benjamin from Duke will also work on this project.

Meetings

  • 28 Scientific Thinktank Meeting
  • Content Provider for DIA Meeting and complimentary booth given 3 consecutive years Co- Sponsor Meetings with DIA and CBI

Thinktank Meetings 2013

  • CSRC/HESI Thinktank Meeting: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study – Over 200 participants
  • TREAT IV Meeting- Follow Up to SAFE PCI Meeting
  • CEC Adjudication Thinktank Meeting- about 100 participants
  • CSRC/ ICOS Annual Meeting- Over 200 participants

Thinktank Meetings 2014

  • CSRC Outcomes Thinktank
  • COPD Thinktank
  • Anticoagulation- Induced Bleeding and Reversal Agents Thinktank Meeting
  • CSRC/ IQ Meeting- Being planned
  • CSRC/HESI Thinktank Meeting: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study- Follow up Thinktank Meeting- Meeting being planned.

 

Other Important Facts

  • CSRC work has led to MDEpiNet being award to DCRI
  • Preferred agreement with American Heart Journal
  • Preferred agreement with DIA
  • Perosphere one of speakers at thinktank meeting which has furthered our relationship with this company.

Operational Finances

Cash on Hand-   507,046.19