Tag Archives: Medicine

Guess who invented the Target Product Profiles…

By Itziar Escudero, Ph.D., M.B.A. Partner at Insights in Life Sciences (ilS).

A Target Product Profile (TPP) is a planning tool for therapeutic candidates based on FDA guidelines.

The TPP defines the minimal and ideal profile of the final marketed product and shows the ultimate goals of the proposed therapy development effort such as disease indication, patient population, delivery mode, treatment duration, treatment regimen, and standards for clinical efficacy.

Target-product-profile-template (1)

Fig1. Standard TPP (you can download a template here)

The TPP concept was used for the first time more than 20 years ago (in 1997), when FDA representatives and pharmaceutical sponsors were looking for ways to improve sponsor and FDA interactions during the drug development process.

The purpose of a TPP is to provide a format for discussions between a sponsor and the FDA that can be used throughout the drug development process, from pre-investigational new drug application (pre-IND) or investigational new drug application (IND) phases of drug development through postmarketing programs to pursue new indications.

The TPP embodies the notion of beginning with the goal in mind. That is, the sponsor specifies the labeling concepts that are the goals of the drug development program, documents the specific studies intended to support the labeling concepts, and then uses the TPP to assist in a constructive dialogue with the FDA.

The use of the TPP has evolved and nowadays does not only facilitate the dialogue between the sponsor and the FDA, but with other stakeholders (such as physicians and payers) as well.

In fact, at ilS we help Companies assess how those stakeholders (physicians and payers) “react” to the different TPP presented, including the minimally acceptable and the desired scenarios. For this purpose we count with a network of life sciences experts (ilS NetworkSM) from all over the world, including physicians and payers, with whom we conduct in-depth phone interviews and collect their perspective around the TPP.

Ideally, the TPP provides a statement of the overall intent of the drug development program, and gives information about the drug at a particular time in development. Usually, the TPP is organized according to the key sections in the drug labeling and links drug development activities to specific concepts intended for inclusion in the drug labeling.

The TPP is a dynamic summary that changes as knowledge of the drug increases. For optimal use, it is recommended to update regularly the TPP to reflect new information about the product.

Early TPPs can be brief depending on the status of the sponsor’s development process.

A well-organized TPP is also useful for updating quickly sponsor personnel who join the program for the first time.

The is part of the proprietary IND file. Nevertheless, a TPP does not represent an implicit or explicit obligation on the sponsor’s part to pursue all stated goals.

According to the FDA, sponsors have seen advantages of using a TPP at meetings early in the drug development process. Use of a TPP can facilitate the efficiency of sponsor-FDA interactions and communications. A TPP can help address issues early on in the drug development process thereby preventing late stage drug development failures and decreasing the total time involved with drug development.

In the same way, we at ilS, have seen advantages of using TPPs for Companies (sponsors) that seek stakeholder input. This tool allows physicians and payers to comment on the product profile in an organized manner and to evaluate different scenarios. We have observed that this tool is useful not only in later stages of drug development, but also in early stages where there is still so much room for change for the sponsors.

Interestingly enough, we have also found this tool useful for evaluating in vitro diagnostics (IVD) devices, adjusting the TPP template.

References:

https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/CREATE-Bio-Example-Target-Product-Profile-TPP

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf.

The CBER Office of Cellular, Tissue and Gene Therapies (OCTGT) web page for industry education also has a Webinar on TPP

 

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