Clinical, CMC regulatory & CMC manufacturing due diligence

Challenge:

An east coast biotechnology company had reached non-binding terms with an overseas company for development and commercialization rights to a novel anti-cancer product with a well-characterized mode of action. The asset was entering potentially pivotal trials, and the client commissioned Alacrita to undertake a multidisciplinary clinical, CMC regulatory and CMC manufacturing due diligence.  

Solution:

At short notice, Alacrita assembled a team of consultants who had extensive expertise in the relevant disciplines. Following our standard DD approach, the team assessed the contents of the client's virtual data room including:

• CMC documentation: drug substance (synthesis of API, manufacturing process, analytical method, impurities, scalability, stability data, inspection history), drug product (manufacturing process, analytical method and reports, comparability studies, extractables and leachables, formulation stability, scalability of DP process), device and/or packaging plans or specifications.
• IND package, including investigator’s brochure.
• Development plans or product strategy plans.
• Clinical trial protocols, statistical analysis plans, and clinical study reports.
• Regulatory agency correspondence, including meeting/virtual meeting minutes, letters, question and answer communications.

The target company proved reticent to supply all of the requested documentation and ultimately our client called off the deal.

Due Diligence Services

Alacrita's due diligence consultants have been a trusted DD source for more than a decade, 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.