David G. Strauss, MD

David Strauss, MD, PhD, is Founder and CEO of CardiaCures, Inc., a cardiovascular drug company developing software-linked, precision-dosed medicines for inherited arrhythmia and atrial fibrillation. He also founded Translational Cures, the platform company behind CardiaCures’ model-informed drug development and precision-dosing architecture. Previously, Dr. Strauss served as FDA Acting Chief Scientist and spent 14+ years at FDA across CDER and CDRH, including as Director of CDER’s Division of Applied Regulatory Science, where he led programs to move emerging science, computational modeling, clinical pharmacology, and device-informed evidence into medical-product development and review. His work spanned drugs, devices, cardiac safety, biomarkers, in silico methods, and model-informed development. He served as FDA rapporteur for the ICH E14/S7B cardiac-safety guideline modernization effort, helping harmonize global regulatory expectations for QT/proarrhythmic risk assessment. He is an author of 100+ peer-reviewed articles and book chapters on drug/device safety, effectiveness, and individualized response. At BIO, he will present CardiaCures’ strategy to convert dosing- and monitoring-constrained cardiovascular medicines into two FDA-engaged, registration-enabling drug-device combination product programs.