Paresma (Pinky) Patel, Ph.D. is a Division Director in CDER’s Office of Pharmaceutical Quality, Office of Product Quality Assessment III. In this role, she leads groups responsible for the evaluation of chemistry, manufacturing, and controls (CMC) information with a focus on drug substance quality throughout clinical development to submission of marketing applications. She served as a Branch Chief, supporting the oncology and anti-viral clinical divisions, prior to transitioning to her current role. Prior to FDA, she worked as a medicinal chemist at the National Institutes of Health. Dr....Read more
Olga currently leads a Takeda Pharmaceuticals development team responsible for establishing robust and scalable biotherapeutic purification processes in support of late-stage pipeline programs along with bioconjugation processes for early and late stage projects. Olga’s prior experience includes oversight for development of upstream, downstream, and bioconjugation processes for antibodies and antibody-derived products spanning pre-clinical stage through launch (along with life-cycle management). She holds a BS in Chemical Engineering from UC Berkeley and a PhD in Chemical Engineering from...Read more
Karthik Narsimhan is a Sr. Development Engineer III in the Antibody Drug Conjugate Process Development under Biologics Development & Launch in AbbVie. He has supported early phase to commercial programs such as the validation and BLA filing of Pivekimab Sunirine drug substance and product and the post-commercial development and optimization of the Elahere drug substance manufacturing process. Before coming to AbbVie, Karthik was a member of Small Molecule Process Research & Development at Merck. As a member of the Flow Chemistry Group and Reaction Engineering Lab, he built data-...Read more
Prof. Morgan obtained his Ph.D. from Rice University where he studied producing anti-cancer drugs in plant tissue culture. He then did postdoctoral training at the University of California, Berkeley, where he studied biocatalysts in organic solvents. He is currently a Professor and Director of Graduate Studies in the Davidson School of Chemical Engineering at Purdue University. Prof. Morgan’s research program focuses on the production of valuable compounds in photosynthetic organisms and understanding metabolic pathways for sustainable production of biochemicals. He received the NSF CAREER...Read more
Ning Liu currently serves as the Executive Director of Global TSMS in Manufacturing at Eli Lilly and Company. She holds a PhD in Chemical and Biomolecular Engineering from Ohio State University. In her current role, she leads the innovation strategy for Global TSMS at Eli Lilly and Company.
Previously, Dr. Liu was the Director and then Senior Director of the Bioproduct Upstream Development Department at Eli Lilly. In this capacity, she directed efforts in cell line generation, cell culture process development and optimization, process scale-up and characterization, technology...Read more
