Challenge:
A mid-cap pharmaceutical company exploring licensing and co-development opportunities in women’s health identified a promising early-stage startup. With limited internal resources available for early screening, the company engaged Alacrita to conduct a pre-due diligence (pre-DD) assessment. The goal was to quickly evaluate the startup’s therapeutic concept, assess scientific and development risk, and determine whether the opportunity merited a full due diligence process. Key considerations included the strength of the scientific rationale, the quality of the preclinical data, estimated development timelines, and the scale of resources likely required to progress the asset to clinical stages.
Solution:
Alacrita deployed a cross-functional team led by a seasoned former Chief Medical Officer with deep experience in women’s health drug development. The team conducted a thorough analysis of the startup’s preclinical data package, including non-human primate (NHP) studies and proof-of-concept findings. Our review concluded that while the therapeutic concept had some potential, the current data did not support readiness for IND-enabling studies. Significant additional preclinical work would be required to validate the asset’s viability, which in turn implied long development timelines and substantial resource commitments. Based on this assessment, Alacrita advised against initiating full due diligence at this stage, allowing the client to preserve internal bandwidth for more advanced or de-risked opportunities.
Explore Our Due Diligence Services
Alacrita delivers expert, cross-functional support for due diligence engagements, especially where early-stage science intersects with clinical, regulatory, and development risk. Our teams include former CMOs, CSOs, and regulatory experts with deep therapeutic area experience - ensuring that each assessment is both rigorous and practical. Whether you're screening emerging biotech assets, evaluating preclinical data, or deciding whether to initiate full diligence, we provide the insight needed to make informed, confident decisions.