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.

Standardizing Clinical Definitions

By establishing the 2012 Consensus Definitions for MI and Heart Failure, we provided a universal language for clinical trials. 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.

Advancing Pre-clinical Discovery

Supporting the Comprehensive in vitro Proarrhythmia Assay (CiPA), we advocate for early-stage safety testing. We emphasize the use of high-purity ion channel inhibitors, compound libraries, and mechanistic assays to predict toxicity before a drug ever reaches human trials.