Kumkum Saxena

Lead strategic direction and operational execution for preclinical research, process development, analytical sciences, and CMC across vaccine and biologics programs, including a universal influenza vaccine leveraging a novel outer membrane vesicle (OMV) platform. Drive seamless integration of scientific, manufacturing, quality, and regulatory functions to accelerate clinical readiness and IND approval. Directed end-to-end preclinical development and GMP manufacturing scale-up, advancing programs from discovery through IND clearance and Phase I readiness. Built and governed scalable expression and purification processes, Master Cell Bank generation, and tech transfer of 35+ analytical methods with CDMOs to ensure regulatory compliance and product quality. Spearheaded CMC strategy and authored critical IND components, enabling regulatory approvals and supporting clinical protocol development. Fostered cross-functional partnerships to align preclinical strategy with clinical and translational objectives, de-risking portfolio and accelerating timelines.

At Jakevia Consulting LLC, I led strategic consulting in Protein Sciences and early-stage biologics R&D, helping clients accelerate discovery programs and maximize scientific impact. Developed scientific strategies and designed experiments to drive innovation and advance research goals. Built and aligned early scientific teams, fostering collaboration and talent development. Streamlined workflows to improve operational clarity and prioritize key development milestones.

As Director of Protein Sciences at Vertex Pharmaceuticals, I provided enterprise-level leadership for protein expression, purification, characterization, biophsical/mechanistic studies and X-ray crystallography, overseeing a high-performing team of nine scientists supporting multiple therapeutic programs. I was accountable for strategic deployment of bacterial, insect, and mammalian expression platforms to ensure robust, scalable protein supply aligned with portfolio priorities. Built and governed integrated protein production and biophysics platforms, driving implementation of SPR, ITC, DSF, and CETSA to enable rigorous target validation, mechanism-of-action elucidation, and quantitative decision-making across discovery programs. Partnered closely with Chemistry, Biology, and Translational teams to align protein and biophysical strategy with program objectives, ensuring data-driven lead optimization and efficient advancement through key discovery and preclinical milestones. Enabled crystal structures of multiple novel targets via X-ray crystallography, accelerating target validation and hit-to-lead progression. Established standards for protein quality, biophysical rigor, and operational excellence, accelerating timelines, reducing technical risk, and strengthening portfolio-level decision confidence.

Played a pivotal leadership role in advancing early-stage research initiatives by guiding a multidisciplinary team of scientists. Led target identification efforts for key drug development programs, including the Influenza virus polymerase PB2, top epigenetic targets in oncology, and a novel kinase target for multiple sclerosis. Directed target prioritization for high-throughput screening and crystallography campaigns, ensuring efficient progression of discovery projects and alignment with strategic objectives.

I contributed significantly to protein purification and optimization processes. I effectively supervised research associates and collaborated with external CROs to enhance large-scale insect cell production. My work focused on developing automated purification methods and optimizing strategies for challenging proteins, enabling high-throughput screening for drug design.

At Dana-Farber Cancer Institute, I honed my expertise in structural biology and protein tyrosine kinases as a Postdoctoral Fellow. My role involved developing recombinant protein production strategies to facilitate structural studies, contributing to the understanding of critical biological processes. This experience allowed me to deepen my knowledge in protein engineering and collaborative research within a leading cancer research institution.

At Brigham and Women's Hospital, I engaged in cutting-edge research as a Postdoctoral Fellow in the Laboratory of Dr. Eva Neer. My focus was on cell biology and signal transduction, where I established an SF9-baculovirus expression system and conducted detailed analyses of beta-propeller proteins, Sec13 and Gbetagamma. This role allowed me to deepen my expertise in biochemical and structural analysis within a prestigious research institution.