Authored by Clarion, now part of Lumanity
The target product profile (TPP) has long been a quintessential planning tool in therapeutic product development, but too often it becomes a “check the box” activity and fails to serve its main purpose – to be the strategic ‘north star’ that defines the requirements to deliver a meaningful benefit to patients and achieve commercial success. An effective TPP is essential to ensure product development is aimed at demonstrating value to a diverse set of stakeholders in ever evolving and competitive markets.
What is a target product profile?
The TPP is a shared document that articulates an asset’s value proposition and describes key goals for product development through attributes such as desired efficacy, safety, addressable patient population, and economic metrics. A TPP should set an aspiration as well as establish criteria to evaluate the product as it progresses through development, and not only describe the likely product profile – a common misstep with TPPs. When done well, the TPP describes a product that will be differentiated in the anticipated future market landscape. More importantly, the cross-functional process to define a TPP supports strategic alignment across functions throughout development and commercialization.
Common pitfalls and best practices for TPP development
Most industry professionals can call to mind examples of assets entering late-stage clinical development, or worse yet, going to market with little hope of providing real benefit to patients or achieving the desired return on investment. What may have started as an exciting, novel scientific discovery progressed too far through development stage gates that failed to adequately consider commercial viability. A well-developed and managed TPP can mitigate many common issues such as underestimating competitive scenarios, neglecting to demonstrate value to key stakeholders beyond regulators, or executional missteps by individual functions. Here are some TPP best practices to keep in mind:
Ensure TPPs define minimum product requirements that are grounded in a robust, externally informed assessment of the future landscape (e.g., future standard of care, competition, new regulatory or reimbursement requirements). It is imperative the program team can articulate specific patient and/or system unmet needs, the drivers and barriers of stakeholder acceptance, and the associated expectations for substantiating evidence. This nuanced understanding is then translated into a TPP that describes a differentiated, value-creating product even if it only meets its minimally acceptable criteria and falls short of the most ambitious aspirations. It is also helpful to include ‘benchmarks’ in TPPs that explicitly outline the rationale for minimum requirements (e.g., future standard of care efficacy and proposed degree of improvement, requirements for product dosing or presentation expressed in HCP or patient interviews).
Establish a TPP early. An initial TPP or early articulation of the market opportunity and product concept should be put on paper by or during pre-clinical development. At this time there are many unknowns about the future dynamics in a disease area, especially in nascent markets, and markets in which organizations lack experience. However, don’t let this uncertainty be a deterrent to ‘put a stake in the ground’.
The TPP should act as a critical strategic tool that sets expectations from the start and should be referenced as the cornerstone of all development planning. It also supports effective option evaluation and scenario planning, which is often at the forefront of program team discussions early in development. While collaborating with R&D, allocating commercial resources and/or employing external support to conduct foundational insight generation provides a good starting point to establish the initial TPP.
Evolve TPPs with new insights, but ‘lock’ them ahead of critical decision points. TPPs should become focused over time as the program team continues to understand commercial viability and development feasibility (e.g., external stakeholder perspectives, market events, and emerging product data). TPPs should be reviewed and revised as changes to the external environment occur (e.g., new standard of care, regulatory guidance, and competitive pipeline additions/dropouts). Program teams must be disciplined in determining whether and how to iterate a TPP based on new clinical, economic, and/or other product data. More importantly, if new product data does not meet the minimum criteria previously defined for one or more TPP attributes, the company should critically assess whether to continue investment.
To avoid the temptation to ‘move the goal posts’ based on asset performance, it is useful to lock TPP minimum requirements based on the latest market understanding ahead of key data readouts (i.e., lock the TPP ahead of Phase 2 readout to inform go / no-go to pivotal study). Key functional and leadership stakeholders should be involved to ensure buy-in.
Lay the groundwork for effective TPPs with proactive guidance. Often there is organizational misalignment around the purpose of the TPP and its development process and governance, which can arise from individuals bringing disparate perspectives and experiences from prior companies (e.g., some think ‘target’ means the most likely product profile while others think its setting an upside aspiration). Organizations should level-set program teams on a TPP template, it’s lexicon (e.g., meaning of target vs. minimum case), the TPP creation and refinement process, and the function-specific/individual responsibilities. Companies can also establish a common enterprise-wide framework and guidance to provide consistency across program teams, which results in efficiency and facilitates asset and portfolio-level decision-making.
Extensive experience in TPP development and enterprise-wise business process design
By implementing these best practices across all stages of drug development, individual program teams and organizations can increase the likelihood of positive patient impact and commercial success. We have a deep expertise in TPP development, testing, and implementation throughout the asset development lifecycle with emerging as well as established pharma partners. Our perspectives come from extensive experience in the field, and are supplemented by in-depth interviews with various subject matter experts across a range of small to large pharma/ biotech companies.
Are you a biopharma leader that is looking to develop a robust TPP for your unique product or establish an effective TPP process for your organization? We offer extensive experience and expertise in helping clients build and manage successful TPPs. Contact us to learn how we can help you envision, craft, and enable your target product profile today.
