Advancing Cell Therapies: From IND to BLA with Scalable CMC Strategies

This webinar will explore how extensive scientific knowledge in CMC development can be applied to establish a strong foundation for cellular therapies during IND development. The featured speakers will discuss approaches to scaling and de-risking processes for later-stage clinical supply and ultimately commercialization.

From rapid development for IND submission to building robustness into commercial process, the speakers will describe their process, analytical development technologies and approaches used to advance cellular therapies to the clinic. With a manufacturing operations team that has produced clinical CAR-T products for the clinic for more than five years, they have experience in consistently delivering products for patients.

The speakers will also describe their path from IND to BLA and how they are expanding operational capabilities for commercial readiness to meet the needs of clients who are rapidly advancing to commercialization.

Register for this webinar to learn how to build scalable, compliant processes for cell therapies from IND to market.

Speakers

Bruce Thompson, PhD, Chief Technology Officer, Kincell Bio

Bruce Thompson brings more than 28 years of experience to his position as Chief Technology Officer. Bruce is the Founding CEO of Kincell, where he built the technical and operations team and launched Kincell’s tech-savvy CDMO offerings in the marketplace. Prior to his role with Kincell, Bruce was Vice President and Technical Lead for the Cell Therapy Franchise at Resilience, Inc., where he helped to build the development and GMP manufacturing capabilities and served as a technical advisor.

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Bruce has over 18 years of CMC strategy, product development and cell therapy manufacturing experience. As Vice President of Process Sciences at Lyell Immunopharma, he was responsible for Process and Analytical Development, as well as tech transfer of processes and methods to a newly built state-of-the-art cGMP facility. Before Lyell, Bruce served as the Senior Director of the Therapeutic Products Program at Fred Hutchinson Cancer Research Center (FHCRC), where he led GMP manufacturing of cell and gene therapy products. He supported more than 15 active clinical programs and contributed to the filing of six INDs for various cell therapy programs. Bruce also spent nearly 10 years at Pfizer in the Pharmaceutical Sciences division, where he gained expertise in analytical and process development.

Bruce received his BA in Biology and an MS in Biochemistry from The Ohio State University, and a PhD in Microbiology and Immunology from the University of Louisville.

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Stewart McNaull, PhD, Chief Commercial Officer, Kincell Bio

Dr. Stewart McNaull is the Chief Commercial Officer for Kincell Bio, where he leads the commercial organization, driving innovation for Kincell’s cell therapy service offerings to provide unique technical and business solutions that advance our clients’ products for patient impact.

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Prior to joining Kincell in November of 2024, Dr. McNaull served as CBO at Wheeler Bio, where he successfully launched and commercialized Wheeler’s Portable CMC antibody service offerings. Other commercial roles include Business Unit Head for Biologics and Vaccines at Resilience with global franchise responsibility for development and execution of sales and marketing strategy, network S&OP and franchise P/L responsibility for seven sites.

Previously, he held senior commercial roles in established CDMOs such as KBI Biopharma and Fujifilm Diosynth Biotechnologies. He has a track record of continually designing and executing CDMO sales and marketing strategies that deliver innovative solutions to the market.  As a Chemical Engineer by training, Stewart is known for driving innovation to the manufacturing floor, providing insightful integration of technology and business priorities to meet unique client needs. Stewart earned a BS in Chemical Engineering from North Carolina State University and a PhD in Chemical Engineering from the Georgia Institute of Technology.

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