The Supply Brain

Breakthroughs in immunotherapy, such as chimeric antigen receptor T cell (CAR-T) therapy  and checkpoint inhibition antibodies, have led to a rejuvenated interest in the human immune system. Insights from basic immunology research drive approaches and innovations in the exploding immunotherapy field (Figure 1). Studies of tumor-infiltrating lymphocytes helped shed light on the complex tumor microenvironment and the mechanisms of cancer immune evasion. Discoveries of neo-antigens, unique biomarkers, and optimization of combination immunotherapy (Figure 1) have led to improved efficacy and patient outcomes. However, we still don’t fully understand the complex relationship between immunity and disease, especially when it comes to cell activation, cytotoxicity, regulation, and memory.

De-Risking the Path to Cell & Gene Therapy Commercialization Part 1: You Need Access to a Robust and Reliable Donor Pool

When cell and gene therapy researchers step into the lab each morning, we envision transforming what may be an early stage experiment into a clinical success. Therapeutics developers spend years working tirelessly to generate pre-clinical data so that, when the time comes, their Investigational New Drug (IND) application (or equivalent outside the USA) will be accepted by the appropriate regulatory agency, allowing the therapy to enter clinical trials. However, IND approval is just the first of many significant hurdles that therapeutics developers face on the path to commercialization.