Challenge:

Our client, a global pharmaceutical company, was facing a short deadline to making an offer for a late stage gene therapy asset and was under considerable competitive deal pressure. This would be the client's first gene therapy asset and as such, the company did not have internally the specialized personnel required to conduct an expert due diligence of the opportunity. Alacrita was asked to conduct within a two week period, a deep dive due diligence focusing on clinical, CMC, regulatory and related issues.

Solution:

Alacrita assembled an expert DD team comprising a highly experienced medic, an ex-FDA gene therapy regulatory specialist, a gene therapy CMC specialist and a quality specialist. Over a very limited timeframe, the team assessed the target's dataroom and identified a number of critical issues including some where the target had yet to disclose the relevant documentation. This complemented the work that our client's internal, although not gene therapy-experienced, team had done, and the combined team reached the appropriate conclusion that informed the client's deal team over how to proceed.

Gene Therapy Consulting

Alacrita frequently supports client programs in the gene therapy space, with our expertise spanning a range of therapeutic areas and functional disciplines.