Mr. Dhananjay Marathe

New Jersey

Qualification - PhD

Mobirise

About -

Clinical Pharmacologist / Pharmacometrician

PhD Chemical and Biological Engineering: State University of New York at Buffalo

BS Chemical Engineering: University of Mumbai

About

*Professional work experience for drug development in the industry and the FDA (10+ years).

*Experience in applying Clinical Pharmacology and Physiology principles to drug development, approval and labeling decisions in a wide spectrum of therapeutic areas:
-Cardio-Renal, Oncology, Bone-Reproductive-Urological, Dermal, Antiviral/Anti-infective, Hematology, and Gastroenterology drug products as a pharmacometric reviewer at FDA.
-All products covered by CDER Office of New Drugs as the Scientific Lead for QT-Interdisciplinary Review Team (QT-IRT) at FDA.

*Worked on 300+ submissions encompassing NDAs, BLAs, INDs, Pre-INDs and Biomarker Qualification to guide decision making for benefit-risk, dose selection, clinical trial design, and cardiac safety issues.

*Received several individual and team level awards for work in FDA.

*Supervised and mentored several primary reviewers, post-doctoral fellows and interns.

Positions Held:

Principal Scientist, Quantitative Pharmacology & Pharmacometrics (QP2), PPDM: Merck Nov 2018 – Present

Scientific Lead, QT-IRT: FDA   Oct 2016 – Nov 2018

Senior Staff Fellow (Senior Pharmacometric Reviewer) FDA  May 2014 – Nov 2018