In today’s drug development world it still amazes me to find companies that don’t have an overall drug develop life cycle plan in place, especially when there is a baseline tool endorsed by FDA that could be used. In March 2007, the FDA released a draft guidance entitled, “Guidance for Industry and Review Staff Target Product Profile – A Strategic Development Process Tool”. The Target Product Profile (TPP) template format described in the guidance is a summary of a drug development program presented in terms of labeling concepts. The guidance describes the purpose of a TPP, its advantages, and its optimal use. It also provides guidance on how to complete a TPP and relates case studies that demonstrate its usefulness.

The TPP serves as the “road map” for current and future drug development programs. It reflects the realities of the drug development program, global regulatory and clinical requirements, as well as essential components and messages for commercial development. The TTP should be written keeping in mind what possible claims will be made on the commercial label, e.g.  therapeutic indication (s), dosage form(s), patient populations( adult, pediatric, adolescent, elderly). Knowing where you want to end will help you develop the “road” to get to the destination. For example, if you want to treat both adult and pediatric populations, market research may tell you that you need two different formulations. Your TPP would list what type of nonclinical studies needs to be done to support the two formulations.

Key elements of the TPP:
• Defines key scientific/medical, regulatory and commercial elements of the development program
• Becomes a living document linked to planned and completed scientific studies as part of the product life cycle
• Guides nonclinical, clinical, manufacturing and commercial planning
• Becomes a communication document for internal and external use

Preparation of information that leads to the TPP should begin as soon as a drug candidate is identified for development. The team creating the TPP should be cross functional, consisting of marketing, clinical, regulatory, quality, and development scientists. The TPP is a living document and will be change as the development program and market forecast change.

In the FDA guidance you will read that one of the suggested uses of the TPP is to voluntarily share the TPP with the FDA review team starting at the pre-IND stage. This is so Agency can see what you want to claim in your commercial label  and provide feedback on the adequacy of  your develop plan to meet your claims. To some of you this will be a scary idea, but having real-time experience with sharing the TPP with the FDA on three different new medical entities (NME)  has really worked for  companies as far as shortening timelines, reducing cost and getting the Agency review team “excited” about the NMEs. For example one of the NMEs was for an Orphan Drug for both adult and pediatric treatment populations. The Agency pharmtox reviewer looked at the nonclinical studies that were planned for supporting the dosage form in the two populations and suggested combining some of the studies and dropping others.  We had presented a stripped down nonclinical package and were totally surprised by the feedback. This got the drug into the clinic six months earlier and cut over $350,000 out of the budget.

In summary, if you start off with the TPP in hand, you should be able to “get there from here” and not have to keep asking for directions to get to commercialization.

Taylor Burtis

Tags: Business Strategy, Drug Development, FDA

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