Scientific and Practical Requirements for Drug Candidate Substances Targeted by Companies
~Target Product Profile (TPP) description
To promote mutual understanding between academia and companies, specific details and ideas of TPPs in companies are disclosed.
Scientific and Practical Requirements for Drug Candidate Substances Targeted by Companies
Medical progress always begins with basic research discoveries. However, it is a long and complex path for great discoveries to reach patient care. In this process, the concept of Target Product Profile (TPP ) is commonly utilized in drug development as a guideline to clarify the product image to be aimed for.
TPP is a very important tool in drug research and development. It clarifies issues that need to be resolved, enables effective risk management, and allows for objective, data-based decisions on whether to continue development (Go/No Go). In addition, by continuously updating and refining (brushing up) the TPP as R&D progresses , the product image to be aimed for becomes clearer and more specific.
There is a lack of mutual understanding between academia and industry regarding the requirements for drug candidate substances, which is one of the factors preventing the practical application of excellent basic research results. Although teams of experts in various fields in companies use TPPs to share their R&D goals, there have been limited opportunities to widely share the specifics and ideas of TPPs. Mutual understanding of these development tools is crucial in "drug discovery.
The materials shown here are an overview of TPPs actually utilized by pharmaceutical companies in their drug R&D (each company has its own arrangement). We hope that this will be used as a common language between industry and academia and help bridge your research results from "interesting discoveries" to "drugs that reach patients. Let us work together to create the next generation of innovative medicines for the future of patients.
This document provides an overview of general TPPs prepared by pharmaceutical companies. Since each company has different target levels in TPPs, it is essential to discuss and reach a consensus on the target level.
The FDA and others have also provided draft guidance on the preparation of TPPs, but please note that the content of this document is slightly different because it summarizes information necessary for companies to conduct research and development of pharmaceutical products.
In addition, this document covers "pharmaceutical products" such as small molecule drugs and antibody drugs, and does not cover regenerative medicine products such as gene therapy, cellular and regenerative medicine, and vaccines.