Challenge:
A developer of live biotherapeutic products (LBP) derived from stool donations had a lead product in phase 2 clinical trials for metabolic pathology secondary to hepatic pathology. An investor for whom Alacrita had previously worked on several assignments requested a due diligence focusing on the scientific rationale, the novel production technology, the regulatory position and commercial prospects.
Solution:
We deployed a team with experience of microbiome-based products across a variety of technologies and indications. The team reviewed all key documentation including:
- Business plan including budgets;
- Key research reports, scientific advisory board minutes, etc;
- Regulatory correspondence including the application to conduct clinical trials;
- Clinical trial protocols, investigator brochures and data where available;
- Manufacturing process and analytical approach/validation status;
- Plans for scale up to commercial scale and timing vs. clinical development milestones.
Our conclusions were that this company had successfully established a class-leading manufacturing technology coupled with state-of-the-art quality and analytical systems. The team had proven itself capable of overcoming several significant technical hurdles and was exceptionally well-placed considering the relative "youth" of the company.
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.
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