The Target Product Profile provides a structure for the scientific, technical, clinical, and market information, which is the basis for the product development strategy. The Target Product Profile (TPP) is the critical component of the Development Plan (DP), and its existence is necessary to achieve a desired commercial outcome for the particular product. TPP provides all stakeholders with a clear vision of the product objectives and guides for R&D actions and decisions. TPP is a dynamic document that should be reviewed and updated throughout the drug development process. The FDA has also published the guidelines on how to develop a TPP, and the agency encourages its use as a tool to better frame the technical details of the product at advisory meetings.
A precursor of the TPP in the discovery phase is called Target Candidate Profile (TCP) and is maintained by discovery team leaders. The Target Device Profile (TDP) is an equivalent of TPP used for Medical Devices.
The Development Plan (DP) is the drug development framework, focused on compound differentiation and incorporating appropriate investment, risks and opportunities and mitigation aimed at delivering maximum asset value for the pipeline.
Various TPP sections have to be populated, updated and governance approved before development decisions points or gates. Initial approval is usually required before the start of the FIH study. The organizational governance bodies agree on TPP and the updates according to pre-determined approval schedule and criteria.
Typical biopharmaceutical TPP includes following sections:
- Molecule (NBE/NCE) and General Product Information: Brief description of the molecule, product name, general information
- Mechanism of Action: The mechanism by which the product produces an effect on a living organism
- Clinical Pharmacology: Pharmacokinetic information, distribution, and pathways for transformation
- Indication for Use: Targeted disease and population
- Target Manufacturing Profile: Formulation, shelf life, storage conditions, delivery system
- Primary Efficacy Endpoints: The primary clinical outcome measures. Note: endpoints are usually proposed as 3 different scenarios: minimal, base, optimal
- Secondary Efficacy Endpoints: Additional endpoints that are not required to be met in a clinical trial.
- Expected Safety Outcomes: The primary safety outcome measures
- Contradictions: Known or expected contraindications
- Commercial Landscape: Description of the competitive landscape at launch time
- Regulatory: Expected BLA/NDA approval date
- R&D Go/No-Go: Criteria for upcoming decision points
The TPP article is the first in “Know the Pharma Basic” series. Hope you find this short post helpful. In case you wish to learn more, please use below references.
- Target Product Pro le Example for Drug Development, February 5, 2014, Ruben Rathnasingham, Target Product Profile
- Guidance for Industry and Review Staff: Target Product Profile – FDA