Decisional tools for end-to-end value chain analysis of cell and gene therapies

This project will focus on predictive cost modelling across the whole cell and gene therapy (CGT) portfolio of interest to Roche (such as autologous and allogeneic gene-modified cell therapies, somatic stem cell therapies, in vivo gene therapies, personalised RNA cancer vaccines). The focus of this project is the development of various different cost models in accordance with the end-to-end (E2E) Value Chains and product lifecycle and ultimately the combination of the different cost models to a business feasibility assessment framework.

The goal will be to create an advanced E2E cost modelling decisional tool for CGTs that comprises the following elements:

Detailed CGT cost of goods models for current and emerging cell and gene therapies. This will enable identification of more cost-effective technologies and scale-up/out solutions for each product and each stage of the process.

CGT Project lifecycle models that will capture the trade-offs when implementing manufacturing changes to achieve cost reduction and the consequences on CGT lifecycle costs that include the cost of development (process development, assay development, tech transfer, comparability, validation, site licence), clinical attrition rates and speed to market for the different modalities.

Commercial supply chain models that explore centralised versus decentralised manufacturing scenarios.

Risk analysis tools to determine the robustness of solutions to cope with process and source variability.

E2E Portfolio cost modelling tool that integrates the above models and links them to an optimisation algorithm to identify the optimal portfolio composition for different scenarios.

A set of industrially relevant case studies will be devised to illustrate the capabilities of the models and to provide insights into the specificities of each modality's value chain that enable strategic decision- making.