Target product profile

The Target Product Profile (TPP) defines the end goal for product development and establishes a framework for the execution of the development strategy. KLIFO ensures that the TPP stands out as a beacon for the development and acts as a decision-governing document that aligns clinical, regulatory, and CMC strategy from early development through late-stage planning. The TPP is a living document that should be revisited and updated as new data becomes available, and the strategy is fine tuned.

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Klifo, Glostrup. 07/10-2025

When a Target Product Profile becomes critical

The TPP is a core document that should be in place as early as possible in the development process and becomes critical when development decisions start carrying long-term regulatory and commercial consequences. This is often the point where external scrutiny increases, and internal assumptions are no longer sufficient.

Clients most often seek KLIFO advice for TPP development or update when:

  • early clinical or preclinical data requires strategic interpretation
  • clinical study design decisions need to be anchored to a clear end-label ambition
  • regulatory interactions require a coherent, defensible product narrative
  • investor discussions demand clarity on positioning, differentiation, and feasibility
  • portfolio or board decisions depend on explicit trade-offs between speed, risk, and value

In these situations, the TPP acts as a unifying reference point across development functions and stakeholders.

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What KLIFO delivers

The TPP is a core document that should be in place as early as possible in the development process and becomesIn close collaboration with the client, KLIFO delivers the asset-specific Target Product Profile, developed as a living, decision-ready document. 

The client receives a structured TPP that:

  • defines minimum and preferred product attributes
  • aligns intended use, target population, and indication strategy
  • integrates clinical endpoints, safety and tolerability expectations
  • incorporates CMC, manufacturing, and quality-critical attributes
  • reflects regulatory intent and anticipated authority expectations
  • supports both internal decision-making and external communication

The TPP provides a core development document that governs and actively supports program planning, regulatory dialogue, and investor or partner discussions.

How the TPP functions in development

During the entire drug development process, the TPP governs several parallel functions that must remain internally aligned and consistent. KLIFO will make sure the TPP enables the following:

Strategic guidance

The TPP clarifies what success looks like and which compromises are acceptable. It supports prioritization across formulation strategy, regulatory and clinical development strategy, clinical trial sequencing and study designs

Regulatory blueprint

The asset profile outlines the intended labeling logic, claims, and benefit-risk positioning, providing a stable basis for regulatory interactions in Europe and in the US.

Technical and operational alignment

By explicitly defining attributes related to dosing, administration, stability, and process-derived risks, the TPP ensures that clinical ambition remains aligned with manufacturing and quality realities.

Decision and governance support

As data evolves, the TPP is revisited and refined, ensuring that development decisions remain anchored to a coherent end goal rather than drifting through incremental compromises.

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Minimum versus preferred attributes

A core strength of an effective TPP is the explicit distinction between minimally acceptable and preferred attributes. This structure enables disciplined decision-making rather than aspirational ambiguity.

Typical attribute areas include:

  • target indication and patient population
  • clinical efficacy and primary endpoints
  • safety and tolerability thresholds
  • dosing strategy and regimen
  • route of administration and usability
  • stability and in-use requirements
  • manufacturing considerations and impurity control
  • affordability and access assumptions where relevant

By structuring attributes in this way, the development team can evaluate new data against clearly defined success criteria and understand the regulatory and strategic implications of falling short of or exceeding expectations.

Reducing regulatory and scientific risk

Regulatory risk rarely stems from missing document sections. It arises from misalignment between ambition, data, and execution. KLIFO’s approach to TPP development is designed to prevent such misalignment.

KLIFO is determined to reduce risks by:

Articulating a clear end-profile anchoring clinical trial designs

Ensuring endpoints, populations, and claims are internally coherent

Identifying and exploring implicit assumptions before they become regulatory liabilities

Aligning CMC feasibility with clinical and commercial intent

Stress-testing positioning against evolving competition and regulatory landscapes

This approach creates clarity for the internal teams, the board, and external stakeholders and not least for the authorities.

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How KLIFO works with the TPP

The TPP is developed in a close collaboration with the client involving highly experienced KLIFO senior profiles across medical, regulatory, clinical, and CMC disciplines. In this way, the work is integrated directly into the client’s development reality rather than delivered as a detached stand-alone service.

TPP development usually encompasses:

  • structured review of available non-clinical and clinical data
  • assessment of prior regulatory feedback and applicable guidelines against regulatory strategy
  • Evaluation of expected future regulatory feedback
  • alignment workshops across development functions
  • iterative refinement as new data or strategic constraints emerge

Because KLIFO combines strategic advisory with operational execution, the TPP is developed with a clear understanding of how it will be used in practice, not just how it should read on paper.

Klifo, Glostrup. 07/10-2025

A living document, not a static deliverable

The Target Product Profile is most valuable when it governs and evolves as the development programme progresses. KLIFO supports the TPPs as a living document that is updated as new data becomes available, development milestones are reached, or strategic direction change.

This ensures that the TPP continues to function as a governing reference document and beacon for the entire drug development process.

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Why companies choose KLIFO

Companies engage KLIFO when they need clarity under pressure. The value lies not in producing documentation, but in translating complex scientific ambition into regulatory-ready development decisions.

KLIFO is chosen because:

  • work is led by highly experienced senior specialists
  • strategic intent and operational execution are handled together
  • regulatory expectations are addressed proactively, not reactively
  • development decisions are made explicit, structured, and defensible

The result is a Target Product Profile that supports confident decision-making, withstands external scrutiny, and provides a credible basis for progression toward approval.

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