Scientific advances have spurred on major changes across the biopharmaceutical industry, accelerating the speed and complexity of therapy and portfolio development. These innovations include the growing range of biomarkers, diagnostics, delivery mechanisms, novel modes of action, and subsequent combinations—all of which have driven complexity and the need for evolved internal consideration of the challenges this complexity presents and creates externally.
Landscapes are also rapidly becoming more competitive, with regulatory and clinical mechanisms established to enable faster development. This is fueled in part by a greater ability to focus on more targeted patient populations, meeting high unmet needs, which can then lead to accelerated regulatory approval.
As a result, external stakeholders (regulators, payers, clinicians, patients) are at times facing an ambiguous treatment paradigm that is challenging to determine the optimal therapy option and sequence.
Biopharmaceutical teams need to think about solving for this complexity from as early as preclinical stages, ensuring continuation of the strategy. This means looking beyond regulatory approval and considering the broadest requirements for commercial success, building the infrastructure to deliver the therapy and achieve business goals.
THE FOUR PRINCIPLES OF EARLY‐STAGE STRATEGY
Four key principles underpin the evolution required within early‐stage strategy development. These key principles are intrinsically linked and should be considered when determining your early‐stage strategy fitness and which processes to evolve.
01) INTEGRATED APPROACH AND GOALS
As early as the preclinical stage, it is essential to bring in understanding of what is needed to be commercially successful in its broadest sense—at launch and beyond, and for each stakeholder. This includes building a process and team governance structure that ensures ambitious, achievable, commercial goals are defined and the team, regardless of function, is motivated by the same goals.
Siloed internal structures, limited cross‐functional experience across the lifecycle, or lack of consistent cross‐functional involvement can lead to myopic goals and a suboptimal approach. This problem is often exacerbated in the preclinical stage, where teams are small with few dedicated people. A great example of this is the historic one-page target product profile, which is often dominated by clinical endpoints that may only satisfy regulators’ needs, rather than the needs of a range of stakeholders.
Setting consistent long‐term goals and individual functional milestone goals early on facilitate the development of a clear roadmap to success, which all can work to simultaneously, as well as ensuring that the primary goal of improving patient outcomes is achieved with any therapy.
02) BROADER PERSPECTIVE
Experience is a key limiting factor, as most teams are normally involved in the development of one or two assets over several years. Other limiting factors include team size, cost, and effort involved.
Lack of relevant broad experience can lead to personal bias, resulting in views and perceptions of the external future market that may be heavily weighted to one stakeholder and not consider others, or even worse, be grossly inaccurate and fail to reflect evolution in the market that is likely to occur. Obtaining unbiased insight, counsel, and broader external input as early as the preclinical stage are essential to ensuring teams’ perceptions and assumptions are challenged and to maximize the chance of success in the future market.
03) RIGOR WITH PURPOSE
Regardless of therapy area, therapy, or the team’s prior experience, the sheer volume of questions to answer from the preclinical stage through to Phase 3 can be daunting. As a result, questions and data points are deprioritized as they do not align to team functional goals at the time.
Teams not only need to understand the relevant questions to ask and when, but also the depth of information required to accurately plan for the future and prevent drowning in irrelevant data with limited material impact.
Implementing the same activities found later in the lifecycle (eg, during brand planning) will generate unnecessary detail. Asking highly specific questions will lead to highly specific directional answers that provide a clear strategic choice, ensuring data are not generated for data’s sake.
04) FLEXIBLE APPROACH AND MINDSET
The early‐stage strategy development at all steps should follow an iterative agile approach and require cross‐functional collaboration. The approach starts with assumptions, where necessary, and incorporates new insights as they become available. Fundamental to this is building flexibility into the processes and the team mindset to ensure iterative improvements are made as new insights are uncovered.
Both aspects (approach and mindset) can be just as challenging as each other to alter, but both need to be fully addressed so the value of the therapy can be fully realized. Teams that have explicitly documented processes to evolve their thinking and approach can easily incorporate the other three pillars within their strategy and adapt to the shifting market requirements. More importantly, they can pivot and incorporate insights to change plans without impacting pace or the level of effort required.
Get in touch with the team at Fishawack Health to learn how they can support your early-stage strategy.
This is an extract from the report “Reinventing Product and Portfolio Value” by Fishawack Health. Download the report for advice on uncovering clinical and economic value for a complex network of stakeholders.