統合型開発プランが今、重要な理由とは

Small biotechs often struggle with limited resources. They may lack both funding and manpower.

These constraints make developing a comprehensive plan a formidable task. This includes navigating regulatory requirements, selecting appropriate animal models, optimizing dosing, and identifying the right patient populations. These decisions must occur while continuously aligning and informing an often fragmented network of functional experts.

The stakes are incredibly high, as early-stage decisions can significantly impact the trajectory of the program. Consequently, small biotech firms must leverage meticulous planning and robust communication to mitigate risks and ensure the efficient advancement of their drug assets from candidate selection through clinical phases.

As my colleague Rajesh Krishna indicates in the blog Understanding the Role of Your Discovery Asset’s Target Product Profile, developing a TPP is the foundation of drug development and an opportunity to establish decision criteria as your asset advances through development.

The TPP will help your team align on the desired characteristics and provide a tool to evaluate tradeoffs. However, taking the next step to establish a comprehensive development plan is often a daunting task. This is especially true for small companies that rely on a network of independent functional experts.

Sponsors often perceive keeping all experts aligned, informed, and productive as burdensome tasks. This can result in underappreciation of the utility and value of IDPs. This tool, if used properly, supports effective communication and program management. The discussions to shape an IDP facilitate alignment on the strategy, plan, functional line interdependencies, and budget.

Developing a strategy that enables decision-making is key to an efficient program. An IDP should reflect how collecting necessary data will inform key programmatic decisions linked to the criteria established in the TPP. It should also provide a historical reference of how and why stakeholders made previous decisions.

The IDP is a tool to facilitate discussions and document the strategy and plans. It should be referenced and updated throughout development as data are generated to revalidate the plan or course correct if needed.

Other key components of an IDP are:

• End-to-end integrated timeline with key gated decision points
• Program level go/no go decision criteria
• Integrated high-impact risk registry with mitigation plans
• Planned or previous regulatory correspondences
• Detailed program budget

An IDP is a critical tool for stimulating healthy discussions, especially for programs in early development when confidence in decision-making is most critical (candidate selection through Phase 1).

The purpose of a high-level timeline is to understand the overall time frame of the program, milestones/key decision points and potential linkages between functions.

A CDP is one important element within an IDP. This plan is a roadmap for the clinical data required to deliver the TPP. At the minimum, it should detail the number and preliminary design of all planned clinical studies. In addition, it should articulate important scientific, medical, and regulatory submission considerations for asset registration.

Start-ups or small biotech companies often lack the necessary technical expertise in-house. It’s time-consuming to identify consultants with the appropriate breadth of technical experience needed to view a program in a holistic manner working in an integrated fashion.

There are multiple benefits to having the right development strategy.

1. It illustrates your confidence as your asset progresses to achieve your financial goals of continuing development or divesting.
2. Having your team use an IDP will facilitate critical discussions, achieve alignment with stakeholders, and aid in navigating the complexities of early clinical development.
3. It will serve as a tool to avoid common drug development pitfalls.

Our early development model allows clients the flexibility to access a team of experts with 25+ years of experience across all drug development functions. We combine strategic and scientific excellence in bespoke development designs in the context of tech-enabled decision-making.