Investor-ready evidence planning: Why a robust strategy matters to funders

Outside funding is critical to the work of a biotech company. To attract venture capitalists or strategic partners, you’ll need a compelling investment thesis built on evidence you’ve already generated and expect to generate throughout development.  

Because investors’ confidence depends on the quality of your evidence, we strongly recommend that you implement an integrated evidence generation plan (IEGP) for all assets in your drug development pipeline. This plan encompasses a comprehensive strategy for meeting the evidentiary needs of all stakeholders, including investors. Created through cross-functional consensus, the IEGP outlines the evidence that’s essential to your program and how that evidence can best be generated. The IEGP provides a clear link between the overall asset value proposition, asset strategy, and development strategy, and provides the justification for clinical development to investors.

Figure 1. Integrated evidence generation planning as part of overall asset strategy and evidence delivery 

What investors want from an IEGP

Ahead of our recent webinar on integrated evidence planning to maximize commercial opportunity, we connected with EQT Life Sciences, one of Europe's largest life-sciences investors.* The EQT team told us that they “like to see proactive planning, with companies performing balanced and stage-appropriate market analysis, even before they’re in the clinic.” They called out opportunities for entrepreneurs in the evidence space, which include:

• Exploring creative and flexible trial designs, while retaining the fundamentals expected in the indication. 
• focus on patient awareness and early engagement, particularly in rare diseases 
• Use an expert network to devise a regulatory strategy early on and actively explore opportunities for early approvals 
• Increasingly validate commercial attractiveness of indications, while going through development
• Approach market estimates in a balanced way, avoiding overly optimistic projections
• Thoughtfully evaluate pricing strategies, with increasingly sophisticated approaches

Expect a potential investor to scrutinize your evidence strategy throughout their diligence process. To make this process as frictionless as possible, ensure that your IEGP:

• Clearly articulates your asset value proposition as well as an understanding of the unmet need your asset will address. This includes knowing the likely prescribers, the intended patient population, and whether evidence is being generated within that specific population. 
• Demonstrates evidence-based decision-making across your entire development path. This includes presenting a detailed rationale for choices at all key milestones and the trade-offs that were considered.
• Highlights your hypothesis-driven approaches for verifying both the therapeutic impact of your asset and its likely success in the market.
• Includes clinical trial designs that reflect the likely real-world use of the product.
• Offers market access strategies informed by a nuanced understanding of probable reimbursement rates for product use. Your team will need to detail the types of health-economics data required for making a compelling case for product pricing.

The IEGP demonstrates that you’ve understood and integrated the requirements of regulators, payers, prescribers, and patients. This key stakeholder coverage will be reassuring to investors. Additionally, it allows your management team to demonstrate the scientific and strategic rigor with which it is undertaking development – while reducing risk of duplicate research to drive an integrated, cost-effective approach. 

Communicating value

Along with articulating development milestones, your IEGP should outline a communication strategy for your asset. Effective communication is essential to a successful launch and serves as another avenue for earning investor confidence in your asset and management team.

For the first step in any communication strategy, we recommend establishing relationships with key opinion leaders (KOLs). Input from researchers, clinicians, and prominent patient advocates and patient advocacy groups are incredibly valuable in shaping both your evidence plan and the ways in which you communicate your evidence. Engaging with KOLs gathers valuable advice to strengthen scientific integrity and credibility.

Your communication strategy should strive to present a consistent narrative to all stakeholders. This narrative can be delivered through:

• Peer-reviewed articles that demonstrate the rigor of your science and your commitment to transparency, data integrity, and evidence-based medicine.
• Tailored education to the medical community and development of field medical tools to drive awareness of unmet need and potential clinical value of your asset.

In addition, your communication plan should guide your engagement with investors. 

• Build trust through transparent communication with investors, engaging KOLs for regular advice and feedback, and sharing these updates proactively.
• Develop a strategic communications roadmap with clear decision points, including publications co-authored with KOLs and regular, scheduled investor updates.
• Create visually appealing, well-structured data release presentations with clear messaging for investor communications.
• Anticipate the questions that investors may raise, proactively address these, when appropriate, and have prepared responses

How an IEGP can guide your investment strategy

While an evidence strategy matters to investors, it will also be a critical tool for your company as you decide which investment opportunities best serve your asset. The IEGP allows you to consider and evaluate your goals stage by stage. By following an incremental plan, you can pursue and allocate capital efficiently based on your progress within the development continuum. Remember to consider both short-term and long-term objectives, including funding objectives, as the evidence necessary for winning seed funding may not be the same evidence that supports a case for clinical proof-of-concept funding or an initial public offering (IPO).

The IEGP is foundational to both your asset’s value story and the investment thesis of any potential funder. In our experience, a comprehensive evidence strategy is the most efficient, cost-effective way to build confidence with potential investors. By enabling you to differentiate your asset in a crowded market, an IEGP puts you in the strongest possible position to win the funding you need to move your development forward.

Implementing an integrated approach to evidence planning is not a step you have to take alone. Connect with the team at Parexel to learn how we can support you in developing, executing, and validating IEGPs. 

*Parexel is co-owned by EQT; EQT Life Sciences is part of the EQT group. 
 

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