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Every startup requires capital to fuel ambitious ideas. While funding catalyses progress, it is the experience of the team, the quality of the asset and the available data, along with strong clinical-regulatory strategies and their successful communication that carry the asset through development. Along with many roles, the CEO acts as an interpreter between the science, development teams and external stakeholders including capital markets to successfully communicate the mission of the company.
To attract investment into an early-stage asset, a CEO will address three overarching themes:
1. Potential value of the asset
Funding probability increases when assets are clearly positioned and a credible path to Phase 1 studies is laid out and communicated.
- Does the asset fit into the potential investor’s interest? (business model, value proposition, market opportunity, therapeutic area)
- Does the asset have a clear ownership and what is the life of its IP?
- Is the IP well-protected and legally sound?
- Can the asset address a high-value market gap, an unmet need?
- Are the asset’s scientific data and MoA sufficiently exciting?
- Are potential risks identified and ways to mitigate them identified?
- What is the company’s medium-long term strategy for the asset? (partnership, licensing, acquisition)
- Can a commercially viable manufacturing and supply chain be produced?
2. Clinical Development Plan
The CEO should be able to provide a capital-efficient and robust plan for clinical development, offering a clear line of sight to value inflection.
- Is the clinical plan anchored on good preclinical data?
- Does the plan have clear milestones that correspond to value inflection points?
- Which adaptive approaches might improve learnings, safety and speed of asset development, helping the drug to reach patients more quickly?
- Could enrichment strategy be applied to the patient population to optimize early phase efficacy signals?
- Which translational biomarkers could add value for early proof of mechanism and efficacy detection?
- Do surrogate endpoints offer a path to accelerated regulatory approval?
- What theoretical and practical operational insights can be offered to align timelines, patient enrolment, budget and cash runway?
3. Regulatory Strategy
A robust, concrete regulatory strategy is a critical component to develop and signal the value of an opportunity.
- Early input into indication selection, TPPs, clinical study designs and supporting non-clinical programs and ensure they align
- Early engagement with regulatory agencies for advice and feedback and use of regulatory designations and appropriate pathways.
- Provide sufficient evidence to support the intended approval pathways.
- Justify flexibility, design choices and accelerated timelines to mitigate investor concerns.
- Tracking and linking of regulatory milestones with data and funding requirements.
To raise capital, a CEO may prioritize knowledgeable investors who have prior experience in the modality of interest and can recognise and appreciate an ambitious, robust clinical and regulatory strategy. The CEO will build an accomplished senior management team with appropriate expertise and execution capabilities, which may include fractional or interim team members. For successful fundraising, the CEO will communicate a competitive product profile supported by a well thought through development plan which de-risks development and reaches key value inflection points efficiently.
Expertise from Adnovate Clinical
Adnovate Clinical is a science-led clinical development consultancy, servicing the life sciences sector. Our expert drug developers have partnered with many CEOs to identify development strategies that give their assets the best chance of regulatory and commercial success. We complement the skill sets of internal teams, providing trusted leadership and expertise to unlock the full potential of assets and maximise value creation throughout the clinical development life cycle to commercialization.
For more information, please get in touch: https://www.adnovateclinical.com/contact-us/
