Rochelle, Virginia (April 18, 2018) – NDA Partners Chairman Carl Peck, MD, announced today that Dennis Fisher, MD, a highly regarded PKPD expert with more than 30 years of experience in clinical pharmacology, pharmacokinetic analysis, simulation of preclinical and clinical trials, pharmacodynamic models, and pharmacometric analysis in the pharmaceutical industry, has joined the firm as an Expert Consultant.
Dr. Fisher was a founder of NDA Partners and worked with the firm for 10 years before leaving to focus on his own business. He was previously Vice President of Medical Affairs and Medical Director at DURECT Corporation, where he was responsible for identification, evaluation, and implementation of compounds for development, and participated in meetings with regulatory agencies including the US Food and Drug Administration (FDA), Swedish Medical Products Agency (MPA), and Committee for Proprietary Medicinal Products in the European Union (CPMP), now the Committee for Medicinal Products for Human Use (CHMP).
Prior to his time at DURECT, Dr. Fisher was a faculty member in the Department of Anesthesia, University of California, San Francisco (UCSF), first serving as Assistant Professor of Anesthesia and Pediatrics, Associate Professor, and then as tenured Professor. During his tenure, he performed numerous clinical studies and pharmacokinetic analyses and served as a Special Government Employee at the FDA in the Center for Drug Evaluation and Research (CDER) as a Primary Reviewer for several New Drug Applications (NDAs). He was also an Editor of the journal Anesthesiology and a reviewer for many journals. He currently serves as Professor Emeritus in the Department of Anesthesia at University of California, San Francisco.
“Dr. Fisher’s expertise in clinical pharmacology, pharmacodynamic models, and pharmacometric analysis makes him an excellent resource for our clients in the preclinical and clinical drug development phases,” said Dr. Carl Peck. “We are very pleased to welcome him back to NDA Partners.”
Dr. Fisher received an MD from Yale University and earned both a Master of City Planning and a Bachelor of Science from the Massachusetts Institute of Technology. He is a member of the American Society of Anesthesiologists.
About NDA Partners
NDA Partners is a life sciences management consulting firm focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; 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, expert consulting, high-impact project teams, and management of client product development programs.
Earle Martin, Chief Executive Officer