One of the best ways to focus your technology and product development efforts is to use a Target Product Profile (TPP). In a series of articles that will be posted on this blog, we will provide templates and examples of TPPs relevant for drugs, medical devices and diagnostic products. In this article, you can download Part 1 of our version of a simple TPP for drug development.
The TPP can become a living reference document for the most current information on the intended product characteristics and use. The benefit of using the TPP with your research and development team early in your project, is that it provides clear and tangible vision and focus. The TPP gives the core team a glimpse of what could be a real product. It brings some clarity to the development path ahead and makes the goal of improving patient health more real.
In Part 1 of the example TPP for drug development, we highlight a number of key initial entries:
- Product description: Brief description and/or current product name
- 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: Target disease or manifestation of a disease and/or population.
- Primary efficacy endpoints: The most important clinical outcome measure. Ideally should be easy to interpret and sensitive to treatment differences.
- Secondary efficacy endpoints: Additional criteria that may be met during a clinical trial, but that are not required to obtain a successful positive clinical trial result
Download Part 1 of the Therapeutics TTP example and template. Part 2 will follow and will include information on other expected efficacy and safety outcomes, as well as contraindications and dosage information.
The FDA has also published a draft guidance document on how to develop a TPP and the agency encourages its use as a tool to better frame the technical details of the product at advisory meetings.
Let us know what you think of our version of the TPP. We hope you find it useful.