Agenda and Slides Day 1 (CSRC Annual Meeting and Dr. Lee Jones)

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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