Pre-Conference Workshop Day | Monday October 24, 2022

8:00 am Morning Coffee & Networking

9:00 am Workshop A – Developing an Analytical Genotoxicity Package: From Preclinical Development Through Drug Product Release & Beyond


A new generation of gene modified TIL therapy is on the horizon for patients, with genome editing approaches now being commonly employed as means to enhance TIL activity and persistence in the hostile microenvironment of solid tumors. Since genome editing may increase genotoxicity risk, and due to the importance of complying with an evolving regulatory landscape, the development of new assays and criteria to address such concerns becomes increasingly important.

Join this collaborative session to:

• Understand the requirements for a pre-clinical data package on genotoxicity

• Outline analytical methods to address genotoxicity concerns

• Discuss setting release criteria on genotoxicity parameters

11:00 am Lunch Break & Networking

12:00 pm Workshop B – Cell Sorting to Manufacture TIL Products Enriched in Neoantigen-Reactive T Cells: What Are The Best Markers, Selection & Expansion Strategies?


There are more bystander than tumor-reactive T cells infiltrating solid tumors, as well as in most TIL products administered to patients after conventional polyclonal expansion methods. Clinical-grade cell sorting combined with a better characterization of the phenotype of neoantigen-reactive T cells provide opportunities to manufacture more tumor-specific TIL products.

Join this collaborative session to:

• Consider which cell surface proteins best characterize neoantigenreactive CD8+ and CD4+ TILs in resected tumors

• Discuss whether selected CD4+ and CD8+ TILs should be expanded together or separately

• Decipher beside direct TIL selection from tumors, what are other relevant time points for TIL selection?

• Explore whether selected-TIL products are less relevant for melanoma?

2:00 pm Afternoon Break & Networking

3:00 pm Workshop C – Optimizing Cryopreservation to Support the Development of TIL Therapies

  • Eduardo Davila Associate Director & Professor, University of Colorado Denver


Cryopreservation of TIL products poses a distinct set of problems and many constraints of a technical nature, but the successful development of approved cell therapies relies on the stability of finished products. As such, the importance of effective cryopreservation is paramount for successful development. The use of genetic modifications to TILs poses a variety of questions that merit further investigation to ensure the production of an optimally efficacious product. The aim is to develop cell therapies that have long term stability, ease of use and preservability to support patients.

Join this collaborative session to:

• Analyze how to support the survival of cryopreserved cells

• Discuss the impact that genetic engineering effects have on cryopreservation and the strategies surrounding engineered efforts

• Tackle key considerations pertaining to stability assays

5:00 pm Close of Pre-Conference Workshop Day