Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased and excited to announce that Dr. Ellis F. Unger has joined the firm as a Principal Drug Regulatory Expert. Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). While at FDA, Dr. Unger’s Office oversaw the approval and regulation of scores of new drugs for cardiovascular, renal, neurological, and psychiatric disorders.
Dr. Unger, who is a 1971 recipient of the Rensselaer Polytechnic Institute Mathematics and Science Medal, earned a Bachelor of Science (magna cum laude) in chemistry from Wright State University in Dayton, Ohio, and a Doctor of Medicine from the University of Cincinnati College of Medicine in Cincinnati, Ohio. He completed his cardiology training at The Johns Hopkins Hospital in 1987. While at Johns Hopkins, and as a Senior Investigator in the Cardiology Branch of the NIH National Heart, Lung, and Blood Institute, Dr. Unger led a translational research program on promotion of angiogenesis. From 1997 to 2003, Dr. Unger served as a medical officer, team leader, and subsequently branch chief in FDA’s Center for Biologics Evaluation and Research (“CBER”). After regulatory authority for therapeutic biologics was transferred from CBER to CDER in 2003, Dr. Unger joined CDER as the Deputy Director of the Division of Cardiovascular and Renal Products. Dr. Unger transitioned to the Office of Drug Evaluation-I in 2009, and became its Director in 2012.
As a Principal Drug Regulatory Expert, Dr. Unger joins HP&M’s growing and stellar Drug Development Team, which is composed of a host of attorneys and regulatory experts who assist companies on a multitude of drug and biological product legal, regulatory, and policy issues. “I am delighted to be joining HP&M in this role, and believe that my knowledge and experience will be synergistic with the amazing expertise of the Firm,” said Dr. Unger.
“We are thrilled and humbled that someone with Dr. Unger’s background has chosen to work with us. His experience at FDA and insights into the FDA approval process broaden and strengthen our capabilities in ways that will benefit our clients,” said JP Ellison, HP&M’s Managing Director. Drug development attorney (and guru) Frank Sasinowski commented: “We are honored to have Dr. Unger join us in aiding patients, researchers and sponsors bring new therapies to those in need of them. Dr. Unger’s decades of dedicated service to advance our public health should find here the opportunity to extend that illustrious career even and ever further.”