Challenge:
A pharmaceutical company with an established gene-therapy franchise wanted to expand its oncology pipeline through external licensing. Among several options, the deal team had identified an academic group’s proprietary vector platform for a solid-tumor indication. Alacrita was retained to provide an independent, science-driven assessment of the opportunity and to map out the critical steps needed before any formal partnering conversation.
Solution:
Alacrita assembled a focused, multidisciplinary team covering virology, translational oncology and CMC. Working to a tight, pre-agreed timetable, the consultants:
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Reviewed each in-vitro and in-vivo dataset, process-development document and research plan provided by the academic investigators.
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Benchmarked the package against current regulatory expectations and the data sets typical of IND filings.
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Rated scientific, pre-clinical, CMC and competitive risks in a qualitative “traffic-light” framework.
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Drafted a sequenced action plan of experiments and analyses that would strengthen the dossier or mitigate the key risks.
The assessment addressed five core areas: the strength of the scientific rationale, the robustness of pre-clinical proof-of-concept data, the completeness of the current development package, the realism of the forward research plan, and the asset’s competitive position in an increasingly crowded competitive landscape.
Findings were delivered in a concise written report that summarized the strengths, weaknesses and data-gap priorities without disclosing confidential data. Alacrita also outlined priority confirmatory studies and CMC activities to strengthen the dossier ahead of licensing discussions.
Armed with this analysis, the client was able to client set clear go/no-go criteria, aligned internal stakeholders on resource requirements and compared the candidate objectively with other assets under review, all without slowing its deal timetable. The structured approach provided the client with a clear framework for assessing this program and comparable opportunities.
Gene-Therapy Due-Diligence Services
Alacrita supports biopharma teams assessing external gene-therapy programs for licensing, option deals, or M&A. Our cross-functional specialists in biology, CMC, IP and commercial strategy rigorously benchmark datasets against current expectations and surface the risks that matter most to deal value. If you are evaluating an early proof-of-concept asset or technology outside your core domain, we provide the clear, evidence-based insight needed for confident, well-structured partnering decisions.