Udayanath Aich, Ph.D.Director at Bristol Myers SquibbSpeaker
Profile
Dr. Uday Aich has more than 16 years of diverse experience in the pharmaceutical organization as a matrix and people leader in analytical technical and CMC strategy. Over six years working at Bristol Myer Squibb as Director, Dr Aich has been leading several key biologics and small molecules for overseeing day-to-day CMC-related analytical technical, strategic, and operational elements, including control strategy, specification, and comparability, Global Regulatory filings, and response, change control, and quality analytical investigation and implementation., budget and resources, drive various Tech transfer for validation and transfer, filing readiness and analytical life cycle. Before this, Uday was a principal scientist at Sanofi, leading early and late-stage biologic products for HTP and PAT technology innovation, managing the analytical testing lab, and leading the business process related to analytical WoW and harmonization. Uday has acted as Chair of the BPOG cross-industry forum for ILM-RTR innovation to develop a technology roadmap, white paper, and business case for implementing novel analytical, Upstream, and Downstream process technologies. At GSK, Uday led the Analytical Characterization lead for Biologic and ATL for a late-stage Program. At Johns Hopkins School of Medicine, Dr Aich leads various anti-cancer drug development and Stem cell engineering activities using a novel approach to Metabolic cell engineering. Dr Aich holds a Ph.D. in Biochemistry from the Indian Institute of Technology Madras and recently completed an executive leadership program certification from Wharton School.
Agenda Sessions
Overview of Analytical Control Strategy and Life Cycle Management for Biologics Products
, 11:45amView Session