Approximately 25% of late phase trials fail due to commercial and strategic issues. A more robustly developed Target Product Profile (TPP) could reduce this risk and result in a stronger business case, forecast and basis for clinical trial design decisions.
Target Product Profile
The purpose of a target product profile is to provide a format for discussions between a sponsor and the regulatory agencies that can be used throughout the drug development process. […]. The TPP embodies the notion of beginning with the goal in mind. By beginning with the end in mind, you can identify all the critical properties of the product. It is an essential tool for all therapeutic developers (small molecules, biologics, cell and gene therapies, …) and the concept within can be applied to medical device and diagnostic development.
The TPP is a living, planning tool. Used properly, the TPP can play a central role in the entire drug discovery and development process. This role includes effective optimization of drug candidates, decision-making within an organization, design of clinical research strategies, and constructive communication with regulatory authorities.
Some possible sections of the TPP include the following:
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Warnings and Precautions
- Adverse Reactions
- Drug Interactions
- Use in Specific Populations
- Drug Abuse and Dependence
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
Generally, when starting a development program, it’s good to create at least two TPPs and compare them directly against profiles of the existing market leaders. One is a TPP with ideal criteria, and the second is the minimum acceptable profile, in which some elements may not be the best, but are still enough to support development and commercial feasibility. For example, the target may be once-monthly dosing, but the minimally acceptable dosing regimen may be twice monthly.
Below is a screenshot of a part of 3Biotech’s template for TPP. The columns can change with regards to the product under development, but what you see here actually fits most of the projects we managed. You can see that for the product attribute “formulation”, we considered as best an IV solution with no preservative but considered it would be acceptable to reformulate the product in Phase II or Phase III. The difficulties forecasted were considered high and are listed in the third column. The fourth and last column shows what studies are planned to meet the best case and otherwise the base case.
A detailed Target Product Profile, when created early in the development program and updated as new information becomes available throughout the drug development process, can be extremely helpful in mapping out the strategic marketing and scientific pathway. The TPP can not only facilitate interactions with regulatory agencies, but also help in the strategic planning of your clinical and nonclinical programs and provide a valuable tool in the assessment of the market value of the product.