Alok Bandyopadhyay
AB Consulting, USA
Biography
Alok Bandyopadhyay is a Senior Global Consultant at AB consulting. He started his scientific career working on immunoglobulin and received his PhD from University of Calcutta. Later he came to USA to work on molecular biology of proteins using Fulbright Travel grant. He took training as a Post-doctoral fellow from US universities. After training, he held several academic positions and worked in molecular biology of proteins. He published several scientific papers in various peer reviewed journals and received awards. In 1990s, he joined industry in drug development area and at the same time, he held Adjunct Faculty Position in Medicine at Thomas Jefferson Medical College, and subsequently Stony Brook University Medical College, NY. He worked with various famous people in the protein research. After joining industry, he gained experience in project management, advancing product innovation from conception through commercialization. He worked in various areas of drug development including Research, Quality and Regulatory. He was involved in various global submissions of IND, NDA, BLA, ANDA, pre-approval, and post approval. He worked in drug development of CNS, immunology, endocrinology, and oncology. He is a certified regulatory professional and proficient in US/EU regulations. He is successful interfacing with FDA reviewers. He is attached with several professional associations e.g. RAPS, DIA and AAPS.
Abstract
Abstract : Biosimilar of protein therapeutics¬