In any project development program an understanding of the program goal is critical to finding the shortest path to the final result. Generation of a Target Product Profile early in a development program facilitates reaching the goal of a marketed drug product. It provides a focus for the development team and typically incorporates the extreme targets that could be expected outcomes of the development program. A commercially viable drug product can mean many different things to different companies. Often a development plan starts with a target product profile in mind such as a competitor product already on the market or the ideal drug product for an unmet medical need. This process of building a target product profile typically starts with a high level concept of the drug product goal, as more details become available a more complete target product profile evolves.
In the table below I provide examples of some components that are helpful in defining the potential commercial drug product goal. The example provided could be a 505(b)(2) candidate provided an argument to use some of the safety documentation available on the commercial product can be put forward to the agency. In the example below the right hand column under “Description” should include the key attributes of the drug product that you are striving for. This is not an exhaustive list of attributes, but should include the most important for the intended therapy; you might review the package insert of a drug product that would be a competitor for other key points. The next three columns below demonstrate one way to lay out the profile, each heading describing the product characteristics. The “Nominal” would be the base level requirements for a viable product anything less would not be marketable. Next is the “Target” or most achievable product characteristics that would be a commercially marketable product, and finally the last entry below is “Commercial Product”, this allows you to see how your product measures up to the current commercially available drug product or products. You could include a column for a product that “Exceeds the Target” list of attributes defining the highest mark you can imagine could be achieved with this drug product.
In the example below, the Therapeutic Area varies from the Commercial Product which is for joint pain to the Nominal Product which is to manage symptoms for a new disease state. The Therapeutic Area for the Target Product is for prevention of symptoms in a new disease state. Prevention is always a steeper hurdle than management of symptoms from a clinical study standpoint.
In each of the next two entries Safety and Warnings for the Nominal Product, achievement of the same label text as the commercial product is the goal. Again, the Target Product has a higher hurdle of achieving improvements to the current market label.
The last five entries are all about the product, dosage form, daily dosage, any important assumptions, input on the formulation and concentration of the active pharmaceutical ingredient.
The more detail that can be entered into a Target Product Profile early in the development program, the more clearly the development pathway forward can be mapped out. This is a helpful tool to focus the team efforts on the project priorities early in the process.
Lynn Gold, Ph.D.
Vice President, CMC