Challenge:
A lean pharma company reached out to Alacrita for due diligence support regarding three oncology assets of interest, prior to entering into licensing negotiations. The client requested an initial “triage” assessment for two of the assets, which were small molecules, to evaluate whether or not more detailed due diligence evaluations would be necessary. For the third asset, a bispecific antibody for immuno-oncology indications, we were asked to proceed directly to a full technical DD.
Solution:
Drawing from our core team and our expert network, we fielded a highly-experienced project team with significant expertise in oncology in each required area, including medicinal chemistry, pharmacology, manufacturing/CMC, regulatory affairs, clinical development and market analysis.
We then first provided a “triage” due diligence assessment of the non-confidential materials provided by the owners for the first two assets, which involved reviewing any published scientific literature, patents, and review articles. From this, we highlighted any obvious red flags with the assets. The client elected to proceed with a full technical due diligence of all three assets.
Each full due diligence assessment included reviewing confidential documents relevant to the following areas:
- Chemical structure (where appropriate)
- Pharmacology and toxicology
- Preclinical efficacy
- Strategic assessment of IP position and documentation
- CMC documentation, including manufacturing strategy and plans
- Medicinal chemistry
- Regulatory correspondence
- Future development plans and timelines
- Assessment of the competitive landscape
We then compiled our findings and detailed any red flags, the overall level of risk associated with each molecule, mitigation strategies, and final recommendations.
Due Diligence Consulting
Alacrita due diligence consultants have been a trusted DD source for close to fifteen years, conducting assignments for large pharma, biotech, universities and investors. Every due diligence we perform is underpinned by our ability to incorporate individuals into each project who have the exact matching expertise required for a complete, thorough and accurate assessment.