Pre-Conference Workshop Day
Tuesday, January 25, 2022
Streamline development from discovery through to the clinic, by rationalizing different functionalities to target solid tumors and utilizing reliable analytical strategies to overcome manufacturing and regulatory bottlenecks
8.30 - 4.00 EST | 5.30 - 1.00 PST - All Timings Below in EST. For PST, download the full event guide here.
WORKSHOP A
8.30-10.30
Investigating the Types of Functions Required to Formulate an Effective Multi-Functional Cell Therapy
While success in solid tumors in still limited, clinical results from other diseases shows that cell therapies have the potential to provide life-changing benefits to patients. As the industry innovates by combining anti-tumor functions, it is more important than ever to clarify the different roles these can provide, to weaponize them effectively against solid tumors.
This session will discuss:
- Considering the rationale for building in different functionalities to target solid tumors, such as homing, logic gating, persistence, checkpoint inhibition and arming
- Strategizing the best criteria to ensure appropriate function selection and improve efficiency of the clinical development pipeline
- Discussing novel engineering approaches to factor in multiple functions at one time and the impact of this on regulatory requirements
Workshop Leaders
Barbara Sennino
Senior Director, Tumor Immunology
PACT Pharma
Marcela Guzmán
Associate Director
Senti Biosciences
WORKSHOP B
11.00-1.00
Developing Reliable Analytical Strategies to Support Robust Manufacturing Regimes for Cancer Cell Therapies
With the cell therapy industry constantly producing innovative engineering and targeting approaches to enable success in solid tumor indications, it is only a matter of time before clinical approval. However, the manufacturing bottlenecks remain an ongoing challenge.
Developing robust, standardized and scalable manufacturing processes which align with regulatory requirements must be considered at this stage to bring any success at clinical trials to the wider patient population.
This session will discuss:
- Mapping out robust CMC & manufacturing methods for different cell types and targeting functions
- Overcoming the challenges of automating manufacturing processes to standardize cell therapy development for consistency of cell product, minimization of operating times and decrease chance of human error
- Discussing future manufacturing technologies and solutions to maximize targeting of solid tumors
Workshop Leader
Hemant Dhamne
Head of Processs Development
Immuneel Therapeutics
Austin Bigley
VP of Research & Development
Indapta
WORKSHOP C
2.00-4.00
Making Sense of the Regulatory Path to Accelerate Therapies to Approval & Treat Patients with Solid Tumors
Despite over a decade of research, clinical translation of cell therapies has been slow, partly due to a lack of a pre-defined regulatory pathway. As we utilize new innovations and engineer techniques to devise cell therapies which are better at treating solid tumors, there is a growing need for clarification of the regulations required for clinical approval.
This session will discuss:
- Elucidating the regulatory pathways to utilize safe gene editing for multi-functional cell therapy development
- Leveraging the correct safety, purity, translocation and potency tests required to characterize cell therapies and speed up the approval process
- Understanding the challenges in defining efficiency and safety of multiple edits & impact on clinical development
