The most underutilised tool in drug development: Five reason to start an integrated evidence plan

Underutilised and misunderstood:

Integrated evidence plans (IEP) are the most misunderstood component of pharmaceutical strategy. This has unfortunately come about due to a vendor ecosystem that has morphed a brilliant forecasting and planning tool into an overly complex, tedious and woefully expensive set of PowerPoint slides of questionable utility.This sad state of affairs is compounded by the fact that IEPs have been demonstrated to reduce development timelines, reduce risks and optimise asset positioning from the earliest phases of development.

What is an IEP:

Put simply, an IEP is an agile tool that identifies what questions an asset needs to answer to address the needs of four key stakeholders: Regulators, Payers, Physicians and Patients.

Furthermore, the IEP becomes a roadmap guiding teams to what needs to be answered, by who and by when. Like any other map, if studied properly it can even guide teams to take much shorter routes to their destination and even highlight alternative destinations if particular roads are busy or obstructed.

For clarity an IEP is not a simple list of projects that are intended to be completed over the course of a year, nor is it something that is done only during the late phases of development – as a matter of fact, the most impactful IEPs are those started at the earliest point of drug development.

A development team or asset strategy team should never find an IEP process tedious or time consuming: Instead, it should be a highly valuable and productive process that not only brings strategic clarity but also reduces the anxieties and workloads of team members. ‍

‍What are the benefits of an IEP:

The IEP identifies the critical questions that need to be answered:

In drug development, IEPs carve out a sharp path by identifying the most pressing scientific, regulatory, and commercial questions. These aren’t just abstract inquiries, but targeted questions designed to shape clinical trials, regulatory filings, and market entry strategies. By pinpointing gaps in data and evidence early on, IEPs allow teams to anticipate hurdles that could slow or even derail a drug's development, ensuring that each step forward is based on sound, data-driven answers that matter.

The IEP is a tinderbox of innovative solutions for asset needs and challenges:

IEPs are far from static; they are dynamic frameworks that ignite innovation when addressing asset-specific challenges. From unique trial designs to personalised patient population strategies, the IEP becomes a toolkit for crafting bespoke solutions. It serves as a foundation for creative problem-solving, allowing teams to think outside conventional approaches. Whether navigating regulatory nuances or addressing unforeseen market barriers, the IEP is a hub for proactive thinking that matches the complexity of modern pharmaceutical development.

The IEP ensures the value proposition of the asset is always front of mind:

In an increasingly crowded pharmaceutical landscape, it’s not just about getting a drug approved—it’s about demonstrating its worth. IEPs keep the value proposition of the asset front and centre at every stage of development, weaving it through the clinical and commercial narratives. They help articulate the unique benefits of a drug—whether it’s addressing an unmet medical need, improving patient outcomes, or offering economic advantages—to stakeholders, regulators, and payers. This clarity in value proposition is essential for gaining traction in the marketplace post-approval.

The IEP identifies opportunities to accelerate and augment development strategies:

Speed is everything in pharma, but it can't come at the expense of quality. An IEP acts as a strategic radar, detecting opportunities to streamline development timelines without cutting corners. By continuously monitoring new regulatory guidance, evolving data, and shifting market dynamics, IEPs enable teams to recalibrate plans, integrate real-world evidence, or even seize fast-track designations. This flexibility not only accelerates development but also ensures that new, efficient strategies are employed to enhance the asset’s overall potential.

The IEP guarantees team alignment and reduces workload and stress:

With so many moving parts in drug development, team misalignment is a common source of inefficiency. IEPs function as a unifying process, keeping everyone—from development leads to commercial leads—on the same page. By establishing clear objectives and timelines, they reduce duplicative efforts and prevent last-minute scrambles. A well-executed IEP doesn’t just lower stress; it transforms team cohesion, ensuring every department is aligned with the end goal and empowered to execute its part effectively.

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