From lab to the clinic: Embedding Modeling to De‑risk CGT Scale‑Up and speed to clinic 

Why This Session Matters 

In her Future of CGT “Getting to the clinic” session, Olga will share on how over a decade of viral vector vaccine development informs gene therapy advancements getting fast into the clinic. 

In particular, focusing on how modelling techniques used in viral vector development can help in leveraging prior knowledge in early development of CGT and speeding up the early phase development activities. 

Despite the nature of viral vectors, viral-based products share similar challenges when it comes to formulation strategies, surface interaction, stability and storage conditions, manufacturability and scalability. 

When material availability is a constraint, modelling adds high value to increasing product understanding, reduces experimental burden, and informs risk‑based decision making. Central to her message is a clear principle she has adopted: “Invest on your knowledge and scientific rigor.” That means enhance knowledge on the product and process understanding, treating failures as data to refine models to quantify uncertainty, distinguish reversible from irreversible decisions, and define the minimal experiments required to close critical knowledge gaps. 

Applying models from analogous products throughout product development stages, provides important pre-manufacturing insights on the process, formulation, storage and stability profiling, scalability and manufacturability and helps speed development to the clinic, while improving resource efficiency for early development of cell and gene therapies (CGT) from promising science to a product that can be manufactured, approved, and delivered at scale.