Life Science Investor Due Diligence
In brief
What does independent life-science due diligence assess?
It assesses whether a clinical development path, evidence package and medical value proposition are credible enough to support an investment, acquisition, partnering, portfolio or board decision.
- Best suited to
- Material decisions where enterprise value depends on clinical credibility, evidence quality, development feasibility and execution capability.
- Typical scope
- Clinical rationale, evidence gaps, endpoints, regulatory and payer considerations, development risk, team capability and the assumptions behind the value case.
- Expected outcome
- A decision-focused view of the important medical questions, remaining uncertainty and evidence required for the next value-inflection point.
Expert lead: Mogens Gisselbaek, MD, MSc, physician executive and founder of Gisselbaek Consulting.
Independent clinical and medical due diligence for investors, boards and executive teams assessing biotech, medtech and specialty-pharma opportunities in Europe. Gisselbaek Consulting provides senior medical input when investment, acquisition, partnering or portfolio decisions depend on the credibility of a clinical development path, evidence package or medical value proposition.
When independent medical judgement is valuable
Before committing capital, entering a partnering process, acquiring an asset, prioritising a portfolio or making a strategic reset, decision-makers may need a practical assessment of whether the clinical path is credible, feasible and capable of creating the value being assumed.
Due diligence questions addressed
- Is the clinical development path credible, feasible and value-creating?
- Are the endpoints, patient population, comparator and study design appropriate?
- What are the main medical, clinical, regulatory and adoption risks?
- Which evidence is required for the next financing, partnering or value inflection point?
- Does the data package support the claims being made to investors or partners?
Typical deliverables
- Independent medical and clinical assessment.
- Risk and evidence gap summary.
- Development-path and value-inflection review.
- Input to investment memo, board discussion or partner process.
- Practical recommendations for next-step evidence generation.
The output is designed to help decision-makers see the important medical and clinical questions, the uncertainty that remains and the evidence required for the next value-inflection point.
Discuss investor due diligence support.
View all five Core Services. Related service: Clinical Development Strategy / Investable Clinical Programme.