The clinical supply of cell and gene therapy drugs: Challenges ahead

Cell and gene therapies (CGT) are becoming an increasingly important modality in the pharmaceutical space. CGT has demonstrated an impressive CAGR of 25% over the last decade with more than 3,000 on-going clinical studies today. As CGT requires mastery of a multitude of new capabilities in both manufacturing and distribution, we deployed a questionnaire-based assessment to evaluate the level of industry readiness for this new modality. We have surveyed 23senior clinical supply chain executives from the largest global pharmaceutical companies to assess their current level of capabilities and to identify their biggest expected challenges in large-scale deployment of CGT for manufacturing and distribution. The results indicated that essential capabilities around the planning and logistics which are fundamental to ensuring rapid vein-to-vein times are not yet broadly established amongst industry players. Most importantly, participants reported little expertise in managing ultra-low temperature logistics – an integral capability for successful CGT deployment. These findings also extend to the broader industry ecosystem of CROs and CDMOs with 80% of the participants stating that their vendors are equally lacking basic capabilities for CGT.