Basic principles of non-clinical development

4. Overview of non-clinical development

4.2. Project management and the Target Product Profile (TPP)

The non-clinical development programme is complex so it requires solid project management and communication skills. Project teams must be setup with specialists that have different expertise and they must understand the clinical plan in order to define the non-clinical plan and related activities.

The Target Product Profile (TPP) is a key document that describes the non-clinical development strategy. It defines the goals, risks, liabilities, metrics and Go/No-Go decision milestones.

The TPP usually contains:

  • Expected therapeutic indications and clinical use, key clinical trial endpoint.
  • Patient age range, dose route and form, frequency of administration.
  • Medicines target, mechanism of action, bioavailability, duration of action.
  • Safety, precautions and contraindications.
  • Chemistry, manufacturing and controls (CMC).
  • Market evaluation.
  • Patent status and conditions of exclusivity (e.g. orphan drug status).

The TPP will be updated and should be reviewed from time to time during the medicines development. For example, the project team should evaluate any results that may lead to concerns on safety or the ability to fulfil the criteria in the TPP. The team will also evaluate how the results may impact the success of the project. The TPP helps the project team to focus on key product criteria and to make 'Go/No-Go' decisions in due time. It will also help to reduce the overall project risk.