Our Impact
We have facilitated critical dialogue between the FDA and industry leaders. Key contributions include the “Benefit-Risk Framework” championed by Dr. Janet Woodcock and the “Precision Dosing Strategies” outlined by Dr. Robert Temple. These initiatives ensure that safety assessments evolve alongside modern pharmacology, providing a structured pathway for balancing therapeutic innovation with patient protection.
Standardizing Clinical Definitions
By establishing the 2012 Consensus Definitions for Myocardial Infarction (MI) and Heart Failure, we provided a universal language for clinical trials. This standardization is essential for comparing safety data across diverse drug development programs.
Our ECG Waveform Database (hosted in collaboration with Yale University) remains a gold-standard resource for validating algorithms and testing the sensitivity of reference compounds used in cardiotoxicity screening.
Advancing Pre-clinical Discovery
Supporting the Comprehensive in vitro Proarrhythmia Assay (CiPA), we advocate for early-stage safety testing. We emphasize the transition from simple hERG screening to a multi-channel approach that considers the integrated effects of various cardiac currents.
We continue to promote the use of high-purity ion channel inhibitors, specialized compound libraries, and mechanistic assays to predict toxicity before a drug ever reaches human trials. This "fail-early" philosophy reduces clinical risk and accelerates the development of safer therapeutics.
