Integrated Asset Evaluation for Go/No Go Drug Investment Decisions
Partnering and acquisition of drug product candidates is an essential part of the pharmaceutical business ecosystem. While emerging companies are focused on drug discovery and early development, they often do not have the funding or experience to manage the complex, expensive, and time consuming path to regulatory approval. The go-forward path for these promising drug products is to work with venture capital, private equity, or established pharma companies.
Selecting the Right Investment Opportunities
As investments in promising drugs often involve several million dollars, a disciplined process for evaluating each asset is critical. Certara’s scientific due diligence/asset evaluation program is essentially the triaging of a drug development plan and data package in fast forward. This requires an integrated team comprising cross-functional drug development and commercial expertise to be rapidly assembled to inform decisions to either acquire or invest in companies and their development programs.
Scientific due diligence involves the identification of development and commercial risks; the assessment of those risks on development milestones and commercialization; and the incorporation of appropriate risk and risk mitigation strategies into deal structure and terms. It is a comprehensive evaluation that is valuable at all key 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 has developed a strategic and programmatic approach that 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, drawing from a broad range 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. The outcomes of these analyses inform the recommended investment thesis and deal structure.
Certara’s due diligence offering is applicable to buy- and sell-side parties. The offering supports a life-science investor in evaluating an opportunity or a target company, orienting themselves for investment, and seeking to 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. We provide program stewardship and functional area expertise within development teams, including the creation of costed and stage-gated development plans.