Bhavishya Mittal is the Senior Director of Formulation and Process Development at Kronos Bio (San Mateo, CA) where he is leading the strategy for drug product development for all small molecule oncology assets within the portfolio. Before Kronos, Bhavi worked at AbbVie (Irvine, CA), leading a global CMC team for a BLA-bound molecule. Bhavi has also worked at the US FDA (Silver Spring, MD), Takeda Pharmaceuticals (Cambridge, MA), and Astellas Pharmaceuticals (Norman, OK). Bhavi is also a former adjunct faculty at the Keck Graduate Institute’s Henry E. Riggs School of Applied Life Sciences (Claremont, CA). He has a Ph.D. in Materials Engineering from the Pennsylvania State University and a BS in Chemical and Bio Engineering from the National Institute of Technology, Jalandhar (India).Bhavi has 19+ years of industrial experience in the formulation design, process development, and project management of numerous drug products of small therapeutic molecules (oncology, inflammation, GI, and CNS indications) aimed for NDA, BLA, and ANDA filings. He is the past Vice-Chair for the Manufacturing Sciences and Engineering (MSE) section of AAPS and is currently the chair of AAPS’ Southern California Pharmaceutical Discussion Group (SCPDG). He is the author of 2 published books (with 17 combined chapters), 3 granted US patents, 11 peer-reviewed manuscripts, and numerous conference papers and posters published/presented in various international journals and conferences. He is also very active in organizing conferences and moderating technical sessions on cutting-edge topics related to compaction simulation and manufacturing sciences. His expertise includes product development strategy, project management, outsourcing management, phase-appropriate formulation design (immediate and modified release), process engineering, statistical process control, QbD implementation, FMEA/risk mapping, and process modeling/simulation of unit operations for solid oral dosages.
