Leveraging academic partnerships to advance adoptive cell therapies

Background & Aim The field of Adoptive Cell Therapies (ACT) is a an ever-evolving, fast-paced environment. In order to quickly advance translational research into viable commercial products, industry will need to partner closely with academic centers. Organizations such as Fred Hutch are well positioned to support these partnerships in a manner that quickly enables these products and technologies to rapidly advance from bench to bedside. By ensuring robust Process Development, Process Transfer, Clinical Manufacturing and Analytical Development, academic centers are able to provide the services and support required to quickly enable Phase I and II clinical trials. By leveraging existing infrastructure such as manufacturing cleanrooms and state-of-the-art clinics, industry partners are able to test a number of targets in order to identify the best candidates to bring forward to commercialization without the need for significant capital investments. Methods, Results & Conclusion This presentation will focus on the key aspects required for successful industry/academic partnerships. Starting with exploratory business development activities, academic centers must review the overall portfolio of IP existing within the academic center to best determine whether there is an opportunity to leverage existing technology or if a more traditional contract manufacturing and development opportunity would be a better solution. From there, the agreements, contracts, etc., help define the relationship and establish the method(s) of communication while also developing the key metrics used to determine success. We will explore the value of Process Development and Technology Transfer using the role of Process Engineers to ensure a robust manufacturing process is identified. Key attributes will be highlighted that ensure a successful partnership both within manufacturing and the clinic. Finally, an often-overlooked area of focus is the transfer of the technology back out to a Phase III or commercial manufacturer where registrational activities and future commercial manufacturing will take place.