LeRoy LeNarz

MD, Vice President, Cardiovascular, Global Product Development

LeRoy has 27 years of industry experience across all phases of drug, device, and drug/device development prior to joining PPD in 2019. He brings leadership experience in the development of cardiovascular products from both large pharma and device companies, with indications targeting treatment of coronary lesions with both drugs and devices, and adjunctive pharmacology of antiplatelet drugs. Other cardiovascular targeted indications include alteration of lipids, structural heart and heart failure efforts, plus critical care therapies, to include teams working in the treatment of sepsis. Additionally, LeRoy has been involved with think tanks, working groups, and FDA initiatives to improve product development pathways. This includes adjudication standardization of clinical endpoints, safety assessments, and study design to enable practicing physicians to understand study output (e.g., ARC definitions, guidelines for drug eluting stents).

During his last several years at Eli Lilly and Company, LeRoy , as the global senior medical director, led teams completing studies with a marketed product, Prasugrel, approved for acute coronary syndromes in association with percutaneous intervention. Three of the studies led to iterative changes in the label and were published simultaneously with presentation in NEJM. Dr. Woodcock of the FDA recognized the DOVE study team with a Director’s Award for the ability to complete a sickle cell vaso occlusive endpoint study in patients ages 2-17, with zero lost to follow-up, requiring at least 9 months in the study and involving regions of the world not traditional for research. LeRoy also served as the Lilly representative to the unique Industry/FDA/Academia consortium study known as DAPT, for interpretation of the data and alignment with FDA to significance. This DAPT study involved four device sponsors and four drug manufacturers to help define the optimal duration of antiplatelet treatment following drug eluting stent implantation. While at Medtronic, LeRoy, as chief medical officer and vice president of clinical affairs for the vascular division, led the teams that completed studies allowing submission to the FDA of the Endeavor drug Eluting for approval, subsequently approval globally. The unique aspect to this drug-eluting stent is that the drug used, Zotarolimus, has no prior drug indication approval due to its physiochemical properties precluding IV, oral administration, but ideal for coating with a polymer on a stent. This required thoughtful negotiation with both drug and device divisions at the FDA for approval pathway with both FDA drug (CDER) and device (CDRH) represented at the FDA Advisory Panel for approval. LeRoy was also instrumental in the faster path for approval for the next generation of Medtronic DES known as Resolute, with negotiation with the FDA to allow an all-comers population from OUS to be the pivotal study for this DES approval. Additional experiences at Medtronic include meetings with Japanese regulatory bodies to define approval for Endeavor in Japan, including conducting a Japanese DES clinical study.

Beyond the clinical study design, completion, and registration efforts, LeRoy has been involved in negotiations with many regulatory bodies across the globe for both approval, label language, safety updates, and risk management efforts.

LeRoy is a graduate of the University of Arkansas Medical School (UAMS) in Little Rock, Arkansas, USA. He completed training in general surgery at UAMS allowing subsequent board certification in surgery while completing additional training in cardiovascular and thoracic surgery at the University of Texas Southwestern Hospitals in Dallas, Texas, USA. LeRoy is also board certified in CV and thoracic surgery.