Cardiac Safety Research Consortium Annual Meeting
Thursday, December 12, 2013
Introduction
· Welcome and Agenda Overview: Philip Sager, MD
· CSRC Mission, How We Work, and Major 2013 Accomplishments: John Finkle, MD
· ICOS Mission: Creating a Consensus for CardiOncology: Daniel Lenihan, MD
Using Personalized Medicine Approaches to Identify Drug-induced Individual Patient Risk during Development
Moderators: Philip Sager, MD / John Finkle, MD
Utility of pharmacogenomics to identify and limit CV risk: Chris Granger, MD
The role of genomics and proteinomics (with specific examples) to identify molecule-specific patient risk related to therapy: Michael Pacanowski, MD
What is the optimal approach to develop in 2014, utilizing the fact that individual patients will respond differently from an efficacy and safety standpoint
o Academic Viewpoint: Dan Roden, MD
o Regulatory Viewpoint: Douglas Throckmorton, MD
Biomarkers and Risk Identification in lieu of large clinical trials
Moderators: Robert Blaustein, MD, PhD /Peter Kowey, MD
The pathway to biomarker acceptance: Marc Walton, MD
Use of Troponins to identify potential oncologic drug cardiotoxicity during clinical development: Kristin Newby, MD
Does serial troponin measurement help identify acute ischemia/ischemic events?: Alan Jaffe, MD
PLENARY SESSION : Critical Issues in Drug Development
Moderators: Mitchell Krucoff, MD / Norman Stockbridge, MD, PhD
Richard Moscicki, MD (Deputy Center Director for Science Operations, FDA)
Robert Califf, MD ( Vice Chancellor for Clinical and Translational Research, Director, Duke Translational Medicine Institute) Vice Chancellor Clinical Research, Duke University Medical Center
Panelist: Colette Strnadova, PhD (Health Canada) and Kaori Shinagawa, MD, PhD (PMDA)
Hot Topic Session: Replacing the Thorough QT Study: Is it Time?
Moderators: Borje Darpo, MD, PhD / Gary Gintant, PhD
The utility of Phase 1 QT data to replace the Thorough QT Study: Christine Garnett, MD
The new paradigm for proarrhythmia assessment without the TQT study: Philip Sager, MD / Gary Gintant, PhD
Overall Perspective of the New Approaches and New Paradigm Next Steps: Norman Stockbridge, MD, PhD
HESI Perspective and Ongoing Efforts: Syril Pettit, MEM
Additional Efforts and CSRC Future Directions
Moderators: Ignacio Rodriquez, MD/Theressa Wright, MD
CRF Forms for Non- Cardiadc Studies: Impact and Use: Mary Beth Sabol, MD
Abstracts Presentations
DBP Warehouse and ABPM in Oncology Drug Development: Jeff Heilbraun
Drug Induced Cardiac Abnormailities in Premature Infants and Neonates: Luana Pesco Koplowitz, MD, PhD
EXERCISE, CANCER SURVIVORSHIP AND CARDIAC RESERVE
Lee Jones, PhD