Brian E. Harvey, MD, Ph.D

Asoke Mukherjee, Ph.D

Asoke Mukherjee has been a consultant since 2015. He has over 30 years of biopharmaceutical industry and regulatory experience. He has comprehensive management experience and a solid track record of accomplishments in regulatory strategy and non-clinical development.  Asoke joined FDA and spent almost three decades on regulatory development of products on immunological modulation. He contributed to the regulatory approvals of several products that gained major market share among pharmaceutical portfolios. His proven strengths include IND/NDA/BLA development, protocol design and development.  Asoke has through knowledge in FDA and ICH regulatory guidelines, issues to assist biotechnology companies plan, research and execute for marketing approvals. Asoke possesses excellent interpersonal skills with the ability to select, mentor, and lead teams to achieve objectives successfully. Prior to FDA, Asoke was with Smith Kline and French conducting feasibility research on respiratory diseases and leukotriene antagonists



Asoke has B.S. degree in Pharmacy from Jadavpur University and MS, Ph. D. from All-India Institute of Medical Sciences.  Asoke completed postdoctoral fellowships at The Ohio State and Yale Universities. 

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