Formal project framing is essential for the success of any project, as it sets the direction and parameters for the entire project from the beginning. It involves defining the project’s purpose, scope, objectives, timelines, resources, stakeholders, and potential risks and challenges. Formal project framing ensures that all team members are aligned and have a clear understanding of the project’s goals and expectations, minimizing the risk of misunderstandings, delays, or costly mistakes. Drug development projects are complex projects that require significant investment in time, resources, and capital. Formal project framing is crucial for drug development projects to ensure their success. Target Product Profile (TPP) answers this essential step.
What is a TPP?
In 1997, a working group composed of pharmaceutical sponsors and FDA representative started discussion on the way to improve interactions on new drug development. They created a template that summarize the drug expected characteristics named Target Product Profile (TPP).
The Target Product Profile (TPP) is a document that outlines the ideal characteristics of a new drug being developed by Healthcare companies. It is used to guide the development process by defining the desired product attributes and specifications that will ultimately lead to regulatory approval and commercial success.
The TPP provides a blueprint or guideline for development teams as well as regulators and potential investors.In industry, internal Target Product Profiles (TPPs) are used as planning tools to guide development towards desired features.In a regulatory context, the TPP is considered as a tool to shape developments related regulatory submissions.
How to prepare TPP
The TPP typically includes information such as the intended use of the product, the patient population it is intended to treat, the route of administration, the dosage form, the efficacy and safety endpoints, and other specific requirements such as stability, packaging, and labeling. An exhaustive list and associated recommendations are described in the FDA Guidance: “Target Product profile – A Strategic Development Process Tool”. The TPP is prepared early in the product development process and is periodically updated as new information becomes available.
Otherwise, the TPP requires multidisciplinary skills to be prepared. A cross-functional team must be assembled, including representatives from research and development, regulatory affairs, clinical development, marketing, and other relevant areas. The team should work together to identify the target indication, patient population, and clinical trial endpoints, its pharmacokinetic and pharmacodynamic properties, dosing regimen, route of administration, and safety profile.
By focusing on the final characteristics, it helps ensure that the final product meets the needs of patients!
Advantages of using TPP
- Patient oriented: By focusing on the final characteristics, it helps ensure that the final product meets the needs of patients, healthcare providers and regulatory agencies.
- Clear Roadmap: It provides a clear roadmap for the project and helps align all internal & external stakeholders involved in the process.
- Secure Project: By defining the desired product attributes and specifications early on, it can help prevent wasted resources and delays in development.
- Common Goal: TPP helps to ensure that all parties have a clear understanding of the product’s goals and objectives, and can work together to achieve them.
The TPP must be reviewed and updated throughout the development process to ensure that the project remains aligned with the latest scientific and market data. It should also be used as a reference point for decision-making throughout the development process.
First step of QbD methodology
The Target Product Profile (TPP) is a critical aspect of Quality by Design (QbD) methodology in the pharmaceutical industry. QbD is a systematic approach to product development that focuses on understanding the product and its manufacturing process to ensure quality throughout the product lifecycle. To incorporate the TPP outcomes into the QbD framework, a document named Quality Target Product Profile is written. It describes the quality attributes of the product allowing for a more efficient and effective design of the manufacturing process. Therefore, the TPP is an essential component of QbD, as it guides the design of the product and the manufacturing process to ensure that the final product meets the desired quality standards.
