Dr. Dontabhaktuni is the Founder and CEO of PHARMAPRO CONSULTING. She has 25 years’ experience in the Pharmaceutical industry including corporate and academic research in the United States, U.K., and India. In the past 6 years, she has consulted for many Pharmaceutical and Biotech companies in Clinical Pharmacology, DMPK, and Regulatory, across all phases of drug development. Dr. Dontabhaktuni has served as DSMB Scientific Board Member for ContraFect Corporation and as a subject matter expert in Clinical Pharmacology for over two years.
Prior to this she was a Director at Imclone/Lilly and headed the PK, Pharmacometrics Department there, which she built from the ground up. She helped manage all aspects of the operation, overseeing 11 clinical compounds and 90+ protocols across the world at various stages of development from FHD to BLA submission. Some of her key accomplishments were, she served as clinical pharmacology & pharmacometrics project leader for the ramucirumab and necitumumab programs, was responsible for authoring the BLAs and recommending the clinical doses of these compounds; both these compounds have been approved by the FDA. She also authored the Breakthrough Designation application for olaratumab in patients with sarcoma which has also been approved by the FDA.
In her career, Dr. Dontabhaktuni has supported 60+ assets in various therapeutic areas, authoring/reviewing various eCTDs modules; 2.7.1 and 2.7.2, Biologics License Applications (BLA), New Drug Applications (NDA), Investigational New Drug (IND) applications, Breakthrough Therapy Designations applications, and briefing books.
Dr. Dontabhaktuni has shown unrivaled expertise as a research scientist in many pharmacological areas, including many of the most cutting-edge advances of modern Clinical Pharmacology such as population pharmacokinetics. She has authored 45+ peer-reviewed publications. She has been invited to numerous national and international conferences as a Keynote Speaker and Plenary Speaker. In 2019 she received “The Pharma Ratna Award” as Youngest Female Scientist for Extraordinary Scientific Achievement by Rab Di Meher, an international organization. Dr. Dontabhaktuni obtained her BS Pharmacy from Karnataka Pharmacy Collage, Gulbarga University India and her PhD in pharmaceutical sciences specializing in Pharmacokinetics from Long Island University, Arnold & Marie Schwartz College of Pharmacy, New York.the
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