While a TPP puts commercial goals at the forefront. It should, however, be balanced and assure that the drug development process provides the required relevant medical, technical and scientific information. Essentially, it provides the overall intent of the drug. While not being a mandatory document per se, the TPP is highly useful and can facilitate dialogue with regulatory authorities, stakeholders, and within your development team.
Content of the TPP
The TPP includes the ideal product description (your best-case scenario) and the minimally acceptable product description (your worst-case scenario). While the content varies from case to case, some sections that often appear are:
- Population: Which patients are you aiming at?
- Indications: Which disease(s) are you aiming at?
- Dosage: How much and how often will it be given?
- Clinical pharmacology: How is the drug absorbed, metabolized, distributed, excreted.
- Non-clinical toxicology program: Is the drug safe?
- Adverse effects: What side effects would limit use?
Moreover, TPP might contain the studies necessary to support your targets. This also is context-dependent.
Benefits of a target product profile
- Supports strategic decisions for the drug developer.
- A tool for communication between drug developers and regulatory bodies, as well as investors and other stakeholders.
- The TPP can make Scientific Advice meetings more efficient by, for example, bypassing a discussion about the history of the drug development program.
- Having clear milestones helps in assessing the progress of the development process.
- It helps to prevent failures in the latter stages of the development process.
- The TPP provides a clear picture of the outcome of the drug development process (ie. where you are going with the product, its characteristics, target indications and so on)
Pro-tip: Keep it dynamic
Change your mind when new information comes to your desk. A rule of thumb as good as any. And by that logic, the TPP should be dynamic. You see, updating the document regularly as the process progresses and new knowledge appears is one of the most crucial aspects for creating a TPP that increases the value of your project.
How to begin? A first meeting is a good start 👇