Challenge:
A well-capitalized US biotechnology company was considering entry into the CAR-T space through a license and research collaboration with a leading US university with a distinguished and prolific track record in the field. The client had no internal expertise in the cell therapy space and hire Alacrita to conduct a due diligence and product development planning exercise on its behalf.
Solution:
Alacrita deployed an expert team led by a former CAR-T CEO who had spun out an academic venture in the field and had a close understanding of the issues and challenges in transferring academic cell therapy assets into the private sector. Alacrita assessed the research data and found that it supported the case for industrial development, but the university only had rudimentary plans for a first-in-human trial and no comprehensive development plan. Alacrita worked with the client team, the university and a range of potential service providers to map out alternative scenarios for the development plan. Ultimately the decision came down to a tradeoff between a rapid FIH trial to secure proof-of-principle or a delayed FIH trial, with upfront investment in commercially scaleable CMC arrangements, that would ultimately reach BLA sooner than the original strategy.
Due Diligence Services
Alacrita's due diligence experts have conducted over 200 major assignments for large pharma, biotech, universities and investors, underpinned by our ability to ensure each due diligence exercise is supported by individuals with the precise expertise required for a complete, thorough and accurate assessment.