What is Target Product Profile (TPP)?
In the high-stakes world of drug development, clarity and alignment can make or break a product’s journey to market. This is where the Target Product Profile (TPP) shines—a tool that ensures everyone is working toward the same end goal.
What is TPP?
A Target Product Profile (TPP) is a strategic planning tool/document introduced by the FDA to be used in the early stages of drug development. It acts as a roadmap for the development process and outlines the desired attributes of a drug product, from clinical development through to regulatory approval. Think of this like a dream plan – what your ideal results look like in the entire development process.
The TPP offers a structured template summarizing crucial drug labeling details including intended use, target populations, and safety/efficacy-related characteristics. This information changes as you go deeper in the development stage, and it becomes more clear towards the later stages. It serves as a guiding framework that aligns the development team and stakeholders on the end goal for the product and its positioning in the market. Even though it is not an FDA requirement to use this tool, it is highly recommended. It’s a tool that is constantly updated as the company moves forward in the drug development process.
According to WHO, in-house target product profiles (TPPs) are used as planning tools that guide development towards desired characteristics in the industry.
Important Features of a TPP:
- The TPP organizes the key information related to the drug’s development, including proposed claims, clinical data requirements, safety profiles, and product characteristics. It aligns these details with the key sections of the product’s label (also known as the package insert) which will be submitted to the FDA.
- Here is the list of product targets that are typically included in a TPP:
- Primary Product Indication
- Patient Population
- Treatment Duration
- Delivery Mode
- Dosage Mode
- Regimen
- Efficacy
- Risk/Side Effect
- Therapeutic modality
- For all of these product properties, the TPP typically includes a range of scenarios, from the ideal outcome (where the drug achieves the maximum therapeutic benefit and meets all regulatory and safety requirements) to acceptable alternatives (where certain goals might be adjusted based on real-world data, limitations, or unforeseen challenges).
- Here is the list of product targets that are typically included in a TPP:
- According to FDA guidance, the TPP represents the ideal version of what the drug sponsor hopes to claim on the product label. It is based on the vision for the drug’s potential use and characteristics. The FDA describes it as a “beginning with the goal in mind” approach, which helps to focus the development program on meeting the necessary requirements to achieve the desired product claims.
- The TPP is a dynamic, evolving document that changes as the drug progresses through the development stages. As new data from preclinical studies, clinical trials, and regulatory feedback becomes available, the TPP is updated to reflect these changes and adapt the development strategy.
- The TPP is an excellent planning tool for drug developers. It provides a clear vision and strategy for what the drug will look like when it reaches the market. It helps ensure alignment among different departments (clinical, regulatory, manufacturing) and external stakeholders, including investors and regulatory agencies.
- While the TPP is highly recommended and valuable for organizing the drug development process, it is not a mandatory requirement by the FDA. However, the FDA encourages sponsors to create a TPP early in the development process to help streamline the regulatory submission and approval process.
Role in Drug Development:
The TPP plays a critical role in preparing for regulatory submissions. It aligns the clinical development goals with the expectations of the regulatory agencies, ensuring that the drug’s clinical trials are designed to meet the necessary requirements for product approval. It also helps identify potential risks and challenges early on, allowing the development team to proactively address them.
Summary:
The Target Product Profile (TPP) is an essential document in drug development that helps guide the entire process from initial planning to regulatory approval. While it’s not a regulatory requirement, it provides a framework for achieving the desired product claims and positioning. By anticipating the final product’s characteristics and therapeutic benefits, the TPP helps drug developers navigate the complex journey toward market approval.
Furthermore, the TPP is used as a guidance in making important decisions throughout the drug development journey with all stakeholders involved. See below for examples of the questions to answer when filling out the TPP document:
- Indications: which disease or diseases?
- Patient population: Who are the patients and where do we find them?
- Efficacy: Is it clinically effective?
- Safety and tolerability: Is it safe? What types and numbers of adverse events are expected?
- Stability: How is it stored and for how long?
- Administration: What route of administration is best; oral, injectable, transdermal, other?
- Dosing: How frequently is it given to patients and for how long?
- Cost: Will it be affordable to the target population, will it be reimbursable?
- Time: How long will it take to develop?
When answering these questions, it’s important to review and assess the competitive landscape, unmet medical needs, existing products, and regulatory guidelines. When this is done right, TPP can be an asset in the drug’s life cycle.
References
https://seed.nih.gov/sites/default/files/2023-12/Creating-Target-Profile-for-New-Drug-Products.pdf
https://neuroscienceblueprint.nih.gov/sites/default/files/documents/Example_TPP_508C.pdf
https://www.iconplc.com/solutions/consulting/asset-development/target-product-profile
