AM25-TU-16-L - Building a Translational Arm to Your Cellular Therapy Laboratory

Proposed Session Description: Many transfusion services oversee cell therapy (CT) labs working with standard-of-care products, such as hematopoietic progenitor cells and commercial chimeric antigen receptor T-cells (CAR-T). Some of these labs, along with the clinical teams they serve, are exploring opportunities to expand into the broader biotherapies space. This may involve working with modified NK cells, mesenchymal stromal cells, and other investigational products—necessitating the development of a translational program focused on manufacturing cell therapies for clinical trials.

While existing transfusion/CT services and quality systems provide a foundation, the path to establishing a translational research program can be daunting. Where does one even start? Is it feasible for a given program to enter this space? This session will address key considerations for CT programs looking to take the next step in manufacturing investigational products.

Building and maintaining a translational CT research program is a highly multidisciplinary effort, requiring medical, scientific/technical, operational, regulatory and quality expertise. The session will bring together speakers from these diverse fields to explore critical questions. Are there promising product candidates to advance into clinical trials? What are the financial and logistical costs of launching such a program? What does the product development process entail? How must we adapt our quality systems to accommodate investigational products?

Rather than focusing on a specific product type, this session will outline the structural and strategic considerations necessary for establishing a translational CT program. While no single session can offer a complete blueprint, attendees will gain a solid foundation for future discussions and collaborations in this rapidly evolving field.