Bhavishya Mittal

Bhavishya Mittal is the Vice President of Product Development and Manufacturing at BioDuro-Sundia (Irvine, CA), where he leads the strategy and operations for drug product development of all small molecule client-owned assets within the portfolio. Before BioDuro-Sundia, Bhavi worked at Kronos Bio (San Mateo, CA), AbbVie (Irvine, CA), US FDA (Silver Spring, MD), Takeda Pharmaceuticals (Cambridge, MA), and Astellas Pharmaceuticals (Norman, OK). Bhavi is also an 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 21+ 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 Vice-Chair for AAPS’s Manufacturing Sciences and Engineering (MSE) community and is currently the chair of AAPS’ Southern California Pharmaceutical Discussion Group (SCPDG). He is the author of 3 published books (with 25 combined chapters), 4 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.

An avid sports enthusiast and a history buff, Bhavi is a passionate supporter of continuing education and firmly believes in the noble tradition of passing knowledge forward to younger generations.