Target Product Profile
A Target Product Profile (TPP) is a blueprint for the development of therapeutic candidates that encapsulates key features of an intended commercial product. The target product profile is a planning tool that helps to guide the development of the product to reach the commercial design. It is a living document, often established at candidate selection, giving the status of the drug throughout development, and provides the overall aim of development.
The target product profile may also be used to provide information to regulatory agencies regarding drug development. Researchers found that the approved products that mentioned target product profiles had a more efficient review process through the FDA (Trends in Biotechnology). Improved communication with the FDA along with having established design criteria against which you are developing the product likely reduces the development time.
The target product profile should be a collaboration between the commercial, research and development teams to define the desired characteristics of the product. This includes the indication for use, mechanism of action, pharmacology, and clinical trial endpoints. It also lays out the clinical trial strategy and potentially provides criteria for ending development if critical aspects of the target product profile cannot be achieved.
The target product profile should be reviewed at each stage of development to ensure the modality and indication remain viable against competitors on the market or in development. Continually comparing to the standard of care guarantees the product will provide benefits, either in terms of cost, efficacy or safety. With each review arises the opportunity to update the target product profile in response to the current commercial/clinical landscape.
The target product profile links the drug labeling to the drug development process. The TPP typically contains the following information while providing a critical versus ideal state:
Indication
Patient population
Approach
Efficacy
Safety
Mechanism of action
Biological activity
Modality
Dosing and Administration
Indication
The target product profile should contain the primary conditions, diseases, or states for which a drug can safely and effectively be used to provide an unmet medical need. Additional indications for use may be provided as part of the ideal state.
Patient population
The target population for which there is a cohort of patients with an unmet medical need. The quantification of the need as well as any segments of the patient population that are untreated or undertreated should be described.
Approach
Describe if the drug will be used for the treatment of a disease or prevention. Define if the drug will be used as a monotherapy or if it must be used in a combination with other treatments.
Efficacy
Define objective efficacy endpoints with clear measures of success. Regulatory agencies provide guidelines around their expectations for which endpoints should be used when seeking approval for certain indications. Define primary versus secondary endpoints.
Safety
Define the required safety profile as it compares to the standard of care. Define any specific adverse effects that need to be addressed.
Modality
Describe the type of drug that will be used to treat the indication.
Dosage and administration
Various aspects of the dosage and administration should be described.
Treatment duration (acute vs. chronic)
Route of administration
Dosage form
Regimen
Summary
In summary, the benefits of the target product profile are as follows.
The TPP is a strategic tool providing objectives for the development of the product.
The TPP may be used to communicate to regulatory agencies the intent of the design of the product.
The TPP provides objective criteria to measure success against the current commercial/clinical landscape.
It potentially provides criteria for ending development if critical aspects of the target product profile cannot be achieved.