Dr. Mallikaarjun has over 33 years of experience clinical pharmacology and drug development in various therapeutic areas with a focus on CNS and tuberculosis. He started his career at the FDA as a Pharmacokinetic Reviewer responsible for reviewing clinical pharmacology applications from various clinical divisions. Where he served as a Clinical Pharmacology Reviewer, Division of Biopharmaceutics, FDA for five years. In 1993 he joined P&G Pharmaceuticals as a Senior Scientist, Clinical Pharmacology and Pharmacokinetics where he had significant contributions to the first approved treatment for H. pylori. In 1996, he joined Otsuka America Pharmaceuticals where he assumed positions of increasing responsibility and retired in 2020 as a Senior Director, Clinical Pharmacology.
Dr. Mallikaarjun has been involved in the development of numerous therapies in several therapeutic areas, i.e. Helidac®, Pletal®, Abilify®, Samsca®, Rexulti®, Deltyba® and several investigational drugs. He has given several invited lectures on early drug development and has in-depth experience in the utilization of clinical pharmacology in all stages of drug development, including extensive experience with INDs and NDAs. He is a diplomate of the American Board of Clinical Pharmacology and is a Fellow of the American Association of Clinical Pharmacology.
Dr. Mallikaarjun has broad experience in regulatory/scientific/medical communications, editing dossiers for regulatory review: INDs, CTAs, NDAs/BLAs/MAAs, regulatory communications. He has authored/co-authored more than 75+ publications, textbook chapters, posters, and abstracts. He obtained his B. Pharm degree from the Univ of Bombay and a PhD from Virginia Commonwealth University in Pharmacokinetics in 1987.
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