3. Begin with the end goal in mind: Perfect the Target Product Profile
The project team you assemble is also critical to the success of your program because it will guide the development of the Target Product Profile (TPP).
The ultimate goal of an effective development program is to identify and gather the data needed to support a marketing application that contains all desired prescribing information for the planned indication. The TPP is a means to communicate the primary indication, delivery mode, dosage form, and patient population that the compound may treat. It should also communicate the route of administration and dosing regimen, safety profile of the product, and efficacy. The TPP then becomes the roadmap for the development program – it guides which studies will need to be conducted to support the ultimate approval of the product.
Developing a TPP can be used to facilitate early discussions with FDA regarding the nonclinical and clinical programs that will be needed to support the labeling. For companies looking for funding and/or partnering opportunities, the TPP also serves as a concise document that can be used to communicate the development pathway for the program.