Published on 1/1/2019 12:05:00 AM
David Strauss, MD, PhD, Division Director, FDA, Silver Spring, MD
The Director of the FDA's Office of Clinical Pharmacology, Issam Zineh, PharmD, referred Dr. Strauss to ASCPT in 2018. Dr. Zineh encouraged Dr. Strauss to join so he could connect with colleagues from around the world in industry, academia, and government agencies to advance clinical pharmacology and translational medicine.
The ASCPT Journal Family is Dr. Strauss's favorite aspect of his membership. Over the past 4 years, he has published five articles in Clinical Pharmacology & Therapeutics (CPT). These articles have focused on developing new translational approaches to assess the proarrhythmic risk of new drugs. Dr. Strauss feels that CPT and the broader ASCPT community is the ideal venue for communicating translational research that affects drug development and evaluation. His work has focused on using in vitro cell‐based assays that are combined in QSP computational models to predict arrhythmia risk in patients and then evaluating novel pharmacodynamic biomarkers in phase I trials. The two more recent articles that include the rationale and design of a prospective clinical study to verify this approach published in the January 2018 issue of CPT, and the validation study results of the in vitro ion channel and computational model‐based approach are currently in press with the journal.
Currently, Dr. Strauss directs the Division of Applied Regulatory Science in the FDA's Office of Clinical Pharmacology. The division was created to move new science into the drug review process, closing the gap between innovation and regulatory evaluation. He and his team perform mission‐critical applied research across the translational science spectrum, including developing and applying new in vitro, in silico, in vivo nonclinical models and clinical trials to improve assessment of drug safety and effectiveness. Their goal as a division is to develop and implement new tools, standards, and models to better evaluate safety and bring new medicines to patients faster.
Dr. Strauss was the 2018 recipient of the Leon I. Goldberg Early Investigator Award. He also serves on the CPT: Pharmacometrics & Systems Pharmacology (PSP) Editorial Board.