Dr. Grant’s FDA and industry experience in clinical development and regulation of drugs, biologics, and combination products, in addition to his extensive knowledge of the cardiovascular therapeutic area, make him a valuable resource to our clients.
ROCHELLE, Va. (PRWEB)
May 05, 2021
NDA Partners President Earle Martin announced today that Stephen Grant, MD, former FDA Deputy Director, Division of Cardiovascular and Renal Products, has joined the firm as an Expert Consultant. Throughout his more than 20-year career at FDA, he also served as Acting Associate Director, Medical and Scientific Affairs in the Office of Compliance in CDER, in addition to Clinical Reviewer in the Office of Therapeutics Research and Review and as Team Leader in the Office of Cellular, Tissue, and Gene Therapies in the Center for Biologics Evaluation and Research (CBER), and as Clinical Reviewer and Team Leader in DCRP.
Dr. Grant is a board-certified Cardiologist with expertise in pre-market development of drugs, biologics, and combination products. He has extensive experience in the design, analysis, and interpretation of clinical efficacy and safety studies of investigational and marketed drugs and devices, and in the FDA regulation of therapeutic and diagnostic products. In addition to his FDA career, he was Chief Medical Officer of Celladon Corp. and a practicing physician in general cardiology.
According to Dr. Carl Peck, Manager of NDA Partners’ drug development practice, “We are pleased to welcome Dr. Grant to NDA Partners as an Expert Consultant. His FDA and industry experience in the clinical development and regulation of drugs, biologics, and combination products, in addition to his extensive knowledge of the cardiovascular therapeutic area, make him a valuable resource to our clients.”
Dr. Grant received his medical degree from Harvard Medical School and bachelor’s degree from Yale College. He completed his residency in Internal Medicine at The George Washington University Medical Center. He is a Diplomate of the American Board of Internal Medicine and Cardiovascular Subspecialty Board and former cardiology fellow at The George Washington University Medical Center and medical fellow at the National Heart, Lung and Blood Institute, National Institutes of Health in Bethesda, Maryland.
About NDA Partners
NDA Partners, part of The Planet Group (https://theplanetgroup.com), is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
Contact
Earle Martin, President
Office: 540-738-2550
MartinEarle@ndapartners.com
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