Timely development of a product's/compound’s target product profile (TPP) is key to shortening a product’s development and regulatory approval timeline and thereby maximizing company returns. The TPP sets the clinical hurdles that must be met for a product to be competitive. Erosion of the minimum TPP is the single most important reason that products, once launched, fail to meet their financial forecasts. An effective TPP is developed based upon medical practices in each of the respective major markets around the world.
TPP development requires timely aggregation of information that enables the project team to develop the product profile. This data includes but is not limited to:
+ Characterizing and validating current and future treatment patterns and unmet needs + Assessing likely competitive threats + Segmentation and quantification of the target patient population for the product + Definition of the endpoints that must be met and at what level + Potential product indications and prioritization + Quantification of the range of realistic market opportunities.
This information is then utilized by the project team to develop the TPP which should contain:
+ Product Profile + Indications + Formulations + Side Effects + Dosage + Administration + Potential Drug Interations.
TIMING AND INVESTMENT
Preparation of information that leads to the TPP should begin as soon as a candidate for development is identified. However, the investment made on the initial study must be tempered against the total investment that will be made; first, to validate that the product/molecule should go into development and thereafter, to develop the TPP. To minimize the required investment, the project team, with guidance from market research, should develop a market research plan that will allow work efforts to flow so that they capitalize upon and do not needlessly duplicate prior research.