Iftekhar Mahmood, PhD

Senior Advisor, Clinical Pharmacology

Dr. Mahmood holds a Bachelor of Pharmacy degree and a Ph. D. degree in Pharmaceutical Sciences (specialization in Pharmacokinetics) from University of Missouri at Kansas City. Dr. Mahmood has more than 25 years of FDA experience in clinical pharmacology related to small and large molecules and worked both in Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). During this period Dr. Mahmood worked on anesthetics, analgesics, and neurological products (9 years), therapeutic proteins (antibodies and non-antibodies) (4 years), coagulation factors, and immunoglobulins (12 years). Dr. Mahmood helped in establishing a robust clinical pharmacology program in the Office of Blood Review and Research (OBRR) and the Office of Tissue & Advanced Therapeutics (OTAT), CBER. In CBER, he led a team of clinical and preclinical pharmacologists for two years.

Dr. Mahmood was the member of several working groups in CDER and CBER which wrote guidance for industry.

Dr. Mahmood received three research grants from CDER for conducting research in the area of anti-epilepsy drugs, pediatric clinical pharmacology, and drug-drug interaction.

At the FDA, Dr Mahmood besides his reviews of INDs, NDAs, and BLAs was heavily involved with clinical pharmacology research (both small and large molecules) and published more than 125 research papers in peer-reviewed scientific journals. His research works mainly focused in Pharmacokinetics/Pharmacodynamics of small and large molecules, Pharmacokinetic allometric scaling, pediatric drug development, population pharmacokinetics, and drug-drug interaction studies. He also edited and wrote several scientific books.

Since September, 2019, Dr. Mahmood has been an independent clinical pharmacology consultant.