As CAR T cell therapies continue to lead innovation and revolutionize disease treatment, with several approved CAR T cell therapies and many more advancing through the clinical pipeline, the significance of effective tech transfer is undeniable.
This webinar will uncover the essential lessons learned from past experiences and define the core principles of successful CAR T tech transfer, highlighting the importance of strategic infrastructure, communication, and readiness. We will demonstrate how to navigate common challenges including CDMO selection, ensuring material and equipment suitability, documentation generation and knowledge transfer, and analytical method transfer. Real-world experiences will be shared illustrating how best practices can ensure a smooth transition to GMP manufacturing, and preparing you for product approval, ultimately accelerating your path to market.
- Share typical obstacles encountered in tech transfer and how to proactively address them
- Discover how to master the CAR T cell therapy tech transfer process
- Learn from a real-world case study showing how to achieve seamless transition to GMP manufacturing
Sara Mills
Senior Principal, Head of Cell Therapy CMC at Dark Horse Consulting Group
Sara Mills is a Senior Principal and Head of the Cell Therapy CMC Department at Dark Horse Consulting Group. She entered the cell & gene therapy industry over 14 years ago by way of UCSF, where she was in the neurosurgery department studying glioblastoma, epigenetics, and pluripotent stem cells. Mills joined Dark Horse Consulting Group in 2017 and enjoys leading a team of cell therapy and gene-modified cell therapy subject matter experts in supporting small, academic through large and late-stage programs developing CMC strategies. This work includes a minimum of 110 clients and over 120 unique products in nine different regulatory jurisdictions.
Neil Blackburn
Senior Director, Process and Analytical Development at OmniaBio
Neil earned his PhD from the University of Guelph and focused on protein biochemistry and immunology. His post-doctoral training at Eli Lilly and Company focused on dendritic cell tolerization and the interaction of immune cells with novel TLR ligands.
Neil next led the development and commercialization of immunochemical-based clinical assays and companion medical devices (Siemens Healthineers) before spending 14 years at Sanofi, in their vaccines division. Holding roles of increasing responsibility at Sanofi, Neil was ultimately accountable for leading transversal CMC teams tasked with ensuring the successful transfer of candidates from early development into late-stage pilot and final launch commercial facilities.
He has experience developing tech transfer and PPQ strategies that take full advantage of the QbD design space established in earlier phases of CMC development. Prior to joining OmniaBio, his most recent role was in the small biotech CGT space focused on the development of two complementary assets targeting solid tumours (TILs and oncolytic viruses). Neil has comprehensive experience designing phase-appropriate CMC strategies that meet global regulatory requirements and currently works as a senior director of process sciences and analytical development and is a co-lead of the cell immunotherapy platform.
Dan Miskimin
Director of MSAT at Brainchild Bio
Dan Miskimin has been in the biotech industry for over 25 years, and working in cell therapy for 7 years. He has led dozens of tech transfers on three different continents while working for five different companies, both big and small. These tech transfers have included clinical and commercial stage cell therapy products, and he has helped design multiple cell therapy manufacturing facilities which are actively serving patients.
