Due Diligence/Asset Evaluation

Inform Go/No Go Drug Investment Decisions with Scientific Due Diligence/Asset Evaluation

Partnering with emerging biopharma companies and acquiring drug product candidates is an essential part of the pharmaceutical business ecosystem. Emerging companies are focused on drug discovery and early development. They often lack the funding or experience to manage the complex, expensive, and time-consuming path to regulatory approval. The go-forward path for their promising drug products requires working with venture capital, private equity, or established pharma companies.

Selecting the Right Investment Opportunities

As investments in promising drugs often involve several million dollars or more, per program, a disciplined process for evaluating each asset is critical. Certara’s scientific due diligence/asset evaluation program expedites the triaging of drug development plans and development of compelling data packages. This triage requires an integrated team comprising cross-functional drug development and commercial expertise to inform decisions to either acquire or invest in companies and their development programs.

Scientific due diligence identifies development and commercial risks; assesses those risks on development milestones and commercialization; and incorporates risk and risk mitigation strategies into deal structures and terms. It is a comprehensive evaluation that is valuable at all development milestones, including pre-GLP tox, first-in-human, early Phase 2, entry into Phase 3, and pre-commercialization.

Understanding Factors that Impact Probability of Success (POS)

Certara’s strategic and programmatic approach identifies potential R&D, regulatory, or commercial show-stoppers, creates a costed and stage-gated development plan incorporating risk mitigation strategies in alignment with the target-product-profile, and identifies clinical pharmacology and model-informed drug development technologies that can create value at the deal table by increasing speed, efficiency, and decision quality. Additionally, Certara can develop a competitive commercial assessment of the asset within its prospective drug class.

For each drug product or program, Certara assembles a bespoke cross-functional team of experienced drug development professionals, including due diligence leaders, regulatory strategists, clinical pharmacologists, quantitative modeling scientists, and clinical and commercial experts. Key areas that will impact POS are addressed, including toxicology, CMC, clinical pharmacology, clinical development, clinical safety, biostatistics, regulatory, and commercial. These analyses inform the recommended investment thesis and deal structure.

Certara’s due diligence offering is applicable to buy- and sell-side parties.

Contact us to learn how we can help you evaluate an opportunity or a target company, orient yourself for investment, and understand which development activities are likely to create value inflections in a transaction.

 

 

 

Certara provides integrated asset evaluation, scientific due diligence, and regulatory licensing guidance for venture capital, private equity, in-house pharma commercial teams, and government agencies. Our program stewardship and functional area expertise within development teams supports creating costed and stage-gated development plans.

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