Joint Fellowship Training Program Fellows Arindam Dhar, M.B.B.S., M.D, Ph.D. Phone:   301-827-3656  E-Mail:   Arindam.dhar@fda.hhs.gov Professional Background Dr. Dhar received his M.B.B.S. degree from the University of Calcutta, and his M.D. (Pharmacology) and Ph.D. (Biotechnology) from the All India Institute of Medical Sciences, New Delhi, India. His postdoctoral work was at the University of Oklahoma Health Science Center (Gynecologic Oncology Research) and at NCI's Laboratory of Cancer Prevention. Research Interests Dr. Dhar has prior experience in molecular targets for cancer therapeutics and prevention. His postdoctoral work at OUHSC was on modified retinoids (heteroarotinoids) and cancer therapy. Subsequently, he worked at NCI-Frederick on transcription factors (NF-?B and AP-1) as molecular targets for cancer prevention. He has active research on nitric oxide-donors as anti-cancer agents. As an NCI-FDA Fellow, Dr. Dhar combines research on targeted cancer therapeutics with regulatory training on oncology product review.. His research at NCI's Nanotechnology Characterization Laboratory (NCL) is on liposome and dendrimer based delivery systems (http://ncl.cancer.gov/about_staff.asp#dhar). The projects are part of the process to establish the potential of nanomaterials and nanoplatforms for human cancer diagnostics and therapeutics. This includes structure activity relationship (SAR) and preclinical studies for IND applications using the NCL assay cascade. Dr. Dhar initiated a liposome-mediated targeted delivery project in collaboration with the Nanobiology Program and the Laboratory of Cancer Prevention. Fellowship Experiences "I have benefited from FDA's didactic training courses and supervised review of regulatory submissions. Training received includes CBER Reviewer Training and Biologics Law, FDA Food and Drug Law, and CDER IND and NDA Regulations courses. I have reviewed pre-IDE, BLA (CMC) and INDs (oncology, cellular product), and attended sponsor meetings. This has enabled me to better understand the essential aspects of preclinical and clinical development of cancer therapeutics. With a special interest in nanomedicine regulation, I am an active participant in the FDA-wide and CBER Nanotechnology Interest Groups (NTIGs) and have successfully initiated a CBER-NTIG seminar series with participants from government, academia, and industry." Career Goals "My major career focus is on targeted cancer therapeutics and the developing area of nanomedicine regulation."

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