Presented in collaboration with Be The Match BioTherapies®
This session will provide an overview of cell and gene therapy product development from proof-of-concept to an FDA (Food and Drug Administration)- approved clinical therapy. Speakers will address technology transfer from the academic or industry research lab to the clinical manufacturing facility. Key strategic contracts and agreements will be described. Steps required for translation to a clinical grade product including scale-up or scale-out, closed manufacturing processes, transition to clinical grade reagents and supplies and assay development will be discussed. Finally, refining the manufacturing process for IND (Investigational New Drug) submission including validation, lot release testing and stability studies will be demonstrated. Examples will include contemporary cell and gene therapy products currently progressing through clinical trials. The speakers are Principal Investigators from three of the five cell processing facilities contracted by The Production Assistance for Cellular Therapies (PACT) Program - a National Heart, Lung, and Blood Institute (NHLBI) funded resource initiative created to provide support for cell therapy-based IND-enabling translational research.
Identify the optimal team for successful cell and gene therapy product development.
Describe how to leverage the skills of your staff to drive the process.
Establish realistic time lines and budgets.
Plan for hurdles and pitfalls with appropriate contingency plans.