Clinical Research: Phase 1 - Phase 4

Target Product Profiles: Turning Discoveries into Companies

One of the first steps in the development process is to create the target product profile (TPP) that defines the projected marketed product label. The TPP helps rule out any pharmacodynamic effects that are no more beneficial than current therapeutic treatments.

Developing a TPP is also an opportunity to evaluate intellectual property and ensure that the product has an appropriate patent strategy for the end game — commercialization.

Begin with the end in mind

Creating a TPP is one of the best ways to fine-tune your product development efforts so they remain focused on bringing your drug to market. From its inception through approval, the TPP serves as a living reference document containing the most current information on the product’s characteristics and use. Developing a TPP early in the project provides clear focus and a tangible vision of the final product. Better still, the TPP gives the development team its first glimpse of the end product in ways that bring within reach the goal of improving patient care.

There is considerable latitude in construction of a target product profile, but a TPP should always define the patients you wish to serve and the effects you want your product to impart. Even in the beginning, TPPs should provide information essential to the end product, such as:

  • A characteristics profile that includes a product description, formulation, volume, potency, dosage, and shelf life
  • A safety profile that specifies microbial assurance, manufacturing residuals, and cellular impurities
  • A use profile that lays out indications for use, treatment timing, and preparation
  • A businessprofile that describes clinical/commercial milestones, market projections, cost of goods, etc.

Converting discoveries into companies

TPPs have traditionally served as the industrial communication link from discovery through approval. Today, target product profiles can act as novel communication tools between academic discoverers and investors. As an operational document and a philosophical planning approach, a TPP prompts detailed brainstorming and planning that can help developers avoid missteps in later development.

It’s never too soon to develop a TPP

The details of many elements are often unknown at the earliest stages of clinical development, so there is a tendency to delay development of a TPP until more information can be gathered. But this can lead to regrettable development decisions, especially for elements of the business profile, which can be difficult to specify in the earliest stages of product development. For best results, develop an initial TPP draft early with the intent of editing some areas later on.

Early development of the TPP creates a rational development plan that starts with the end in mind. Developers can use the living document throughout molecule development to communicate current information with stakeholders and to keep the process focused on the intended target. TPPs also provide the right foundation for success when the cell therapy developer is ready to move into the contract development and manufacturing stages.