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Target product profile (TPP) development and indication prioritization

A good target product profile defines the characteristics of your medicine product. This will include the targeted populations, your product’s target indication, treatment durations and regimens, as well as safety and efficacy characteristics.

Increasingly, early-phase development may revolve around the use of basket studies to identify safety and activity in patients with potentially different conditions. This is often the case with targeted therapies in oncology.

How we can help with your TPP

  • writing a TPP sets out a product’s minimum and desirable attributes, and
  • evaluating the regulatory and approval precedent which exists in different conditions.

We can help you identify which indications to prioritize and help to plan the development programme for an asset.

Roadmap

Download our roadmap to get a step-by-step guide to working with Somerville Development Partners.

FAQs

What is the TPP in medicine development?

According to the World Health Organisation, a TPP is a planning tool that guides medicine development to ensure a drug or biologic meets the minimum desired characteristics for its intended use and target population.

Why is the target product profile important?

Providing a detailed analysis of the regulatory landscape and potential TPP can be helpful in prioritizing the indication for registration and establishing the development pathway, duration and cost.

years of regulatory expertise

clients supported

agency interactions

orphan applications

marketing applications