Scientific Due Diligence & Program Assessment

Scientific due diligence and program assessment evaluate whether an asset's data, rationale, and development plan hold up under licensing, acquisition, partnership, or internal portfolio review. Reviewers need more than a pitch deck: study quality, missing experiments, CMC feasibility, clinical design realism, and regulatory path risks all belong in the same picture. Inflated novelty language and missing negatives are common; a useful assessment calls those out with evidence.

Viltis conducts structured scientific assessments across nonclinical, clinical, bioanalytical, and CMC packages. We identify strengths, gaps, and red flags, estimate what it would take to de-risk the next stage, and write findings that investment or governance committees can use. The tone stays factual, with no invented benchmarks or fake comparator claims, so buyers and sellers argue from the same evidence base. Time-boxed reviews are designed to answer the deal question, not produce an encyclopedic monograph nobody reads.

Diligence should also stress-test the operating model: who owns the science after close, which vendors are single points of failure, and whether key know-how lives only in a few heads. Viltis includes those practical risks beside the data review so commercial and scientific leadership share one picture of what they are buying and what they must staff immediately. Competitive and precedent context is used carefully, only where it clarifies regulatory path risk, not as marketing color.

Due diligence assessments commonly cover

• Nonclinical and clinical data package review
• CMC and manufacturability risk screening
• Biomarker and bioanalytical readiness checks
• Development plan and timeline feasibility
• Regulatory path and precedent assessment
• Gap lists with practical remediation options
• Written findings for deal or portfolio teams

Good diligence shortens arguments and clarifies price-of-risk. Viltis delivers a clear scientific read: what is solid, what is thin, and what must be true before the next major spend or signing. When needed, we help the receiving team turn findings into a 90-day work plan so diligence insight becomes action instead of a forgotten PDF in the data room. If diligence timelines are compressed, we focus first on fatal flaws and expensive unknowns, then layer secondary risks for negotiation and integration planning.