Joint Fellowship Training Program Fellows Ashutosh Rao, Ph.D. Phone:   301-827-4487 E-Mail:   Ashutosh.Rao@fda.hhs.gov Professional Background Dr. Rao received his Ph.D. in Molecular Pharmacology at the Department of Experimental Therapeutics, The University of Texas M.D. Anderson Cancer Center in Houston. He conducted post-doctoral research in Molecular Pharmacology of DNA damage mechanisms and investigational drugs at the Laboratory of Molecular Pharmacology, National Cancer Institute in Bethesda, Maryland. Dr. Rao began the NCI-FDA Oncology Product Research/Review Fellowship program in September 2006. Research Interests The major areas of Dr. Rao's current research interests are directed towards the development of novel targeted therapeutic agents and the identification of clinically-relevant biomarkers. His extensive background in DNA damage mechanisms gives him insight into potential targets and biomarkers. Translational research carried out towards Dr. Rao's doctoral dissertation provided a proof-of-concept rationale for combination therapy of a nucleoside analog with a DNA repair-inhibitory agent in the clinic. His post-doctoral research has provided significant contributions towards understanding the mechanism of topoisomerases and BLM helicase. Dr. Rao discovered a previously unknown mechanistic understanding of how repair proteins sense, interact, and signal following replication blockage by cancer drugs. He identified a new biomarker within the DNA repair pathway and generated one new technology which is pending for patenting or licensing. He also dissected the mechanism of cytotoxicity for an investigational anticancer drug currently undergoing Phase 0/I clinical trials at the NCI and provided validation studies for using histones as biomarkers of activity. "The NCI-FDA Fellowship has provided me an excellent learning experience that merges both basic cancer research and FDA regulations on drug products. Situated on the NIH campus, I have benefited from the many seminars and courses that are offered year-round. In addition, FDA offers courses to train scientists on why and how to conduct product review. I found the "Introduction to Drug Law and Regulations" as well as "FDA Review of Biologics from A to Z" to be very applicable to my current review work in FDA's Division of Therapeutic Proteins. The review of biologics has introduced a wider perspective of the pharmaceutical/biotech industry from just understanding drug discovery to drug manufacture, in which the safety and efficacy through quality of the product has very direct consequences." Fellowship Experiences "My participation in the NCI-FDA fellowship program has been an exceptionally informative and empowering experience. It is truly unique in its opportunity to continue lab research under the mentorship of senior scientists who know what it takes to get a drug from the laboratory to the clinic. At the same time, this fellowship gives me direct access and understanding of the logistics of drug development from an FDA regulatory perspective. The drug review process and real-world training programs have helped me develop a multidisciplinary appreciation of how to develop and implement a scientifically-strong and logically-sound strategy for a promising new drug." Career Goals "I aspire to use my multidisciplinary training to continue growing as a scientist with an overall career goal of helping cancer patients benefit from the outstanding current research in cancer and therapeutics. My goal for the next few years is to leverage my skills and experiences in research and review to facilitate optimal drug development."

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