Kincell Bio engineers cells into therapies. Headquartered in Gainesville, Fla., Kincell is a technology- forward contract development and manufacturing organization (CDMO) formed to streamline analytical development, process development, CMC consulting and early-stage GMP cell therapy manufacturing. Kincell’s initial focus is on manufacturing commercially viable immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK and CAR-M programs. For more information, visit www.kincellbio.com.

As the Sr. Scientific Director of the Fred Hutch Therapeutic Products Program (TPP), I was responsible for the scientific leadership of the process development and clinical manufacturing teams. The capabilities at Fred Hutch include a wide range of highly complex cGMP manufacturing for cell and gene therapy products (e.g., CAR-T, TCR, gene-modified stem cells, lentiviral vectors, plasmid DNA) and recombinant proteins and monoclonal antibodies, as well as process development activities including cell population selection (e.g., cell sorting and Miltenyi MACs selection), culture vessel optimization, vector-mediated gene transfer/transduction, cytokine-driven cell expansion, antigen presentation-driven expansion, and analytical characterization (e.g., high content phenotypic analysis, cytokine production and functional proliferation/killing assays).

My most recent experience in Pharmaceutical research was as a team leader in Pharmaceutical Sciences at Pfizer Global Biologics in St. Louis, where I was responsible for leading several interdisciplinary teams of scientists in the development of Pfizer pre-POC assets, including a recent focus on leading a team of scientists with a goal of developing a universal allogeneic CAR-T therapy. This included leveraging multiple international industrial collaborations and CMO relationships, as well as building internal expertise and knowledge. Previously, I was responsible for the development, qualification and validation of bioassay methods for release and stability testing of large molecules, including mAbs, vaccines (recombinant and conjugate) and other complex molecules. In addition, I've lead a team of analytical scientists in the development of a multi-component recombinant vaccine that is currently in Phase 2 clinical trials. I've gained expertise in statistical analysis, in vivo, cell-based and ELISA assay development, as well as experience in a GLP/GMP documentation, testing and investigations.