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Blog & Resources Camargo Blog July 18th, 2018

The Importance of the Target Product Profile in 505(b)(2) Development

The Importance of the Target Product Profile in 505(b)(2) Development

Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What does the Target Product Profile have to do with the development program for my 505(b)(2) Project?

Read the transcript of the video podcast below or click play to watch the discussion:

Ken:

In a number of our webinars and educational programs, we stress the importance of the Target Product Profile, or the TPP in terms of the effect of the TPP and the effects on labeling. Let’s talk about how the Target Product Profile informs our development programs.

Dr. Stevens:

The Target Product Profile for 505(B)(2) products, you want to look at the attributes early on. What are the characteristics of your product that will help make it a commercial success? As well as what do you know about the safety and efficacy of the product compared to what is already known about the drug substance. The TPP starts to lay out what your drug development program is going to look like. You may have to conduct clinical or nonclinical studies. When you’re looking at conducting these studies, what types of endpoints do you want to collect? What type of safety data do you want to collect that support the great attributes and characteristics of the product you are developing. The Target Product Profile leads to a strong labeling that informs the physicians and patients about the product they are prescribing and taking.

Ken:

The TPP is essential to guide the entire development program. The FDA actually requests the Target Product Profile. How do you think the FDA uses the TPP when they work with a sponsor?

Dr. Stevens:

The 505(b)(1) development program, the Target Product Profile isn’t looked at until later on, until Phase 2. The TPP with 505(b)(2) development needs to be earlier on, because when we go to the FDA, we are outlining our drug development program. That TPP informs the FDA of our vision of getting a 505(b)(2) program to the NDA.

Ken:

The FDA uses the Target Product Profile to figure out whether the studies we are proposing are sufficient to meet our target goals.

Dr. Stevens:

That is correct. The FDA wants to know the type of public literature we are relying upon, therefore to make sure that the clinical and nonclinical sections are outlined appropriately.

Ken:

It also helps the FDA to understand why we are requesting certain endpoints in the trial, correct?

Dr. Stevens:

Yes, endpoints are very important. The safety and efficacy study that is conducted determines what the indication will be. The endpoints are critical to support the indication.

Ken:

The data from the endpoints is what gets on the labeling. That is what the physicians and payers use to justify the prescribing of this drug.

Summary:

We have written about the Target Product Profile and different aspects of it. To read more about TPPs, click here. To access the rest of the series of common questions in 505(b)(2) development discussed by Dr. Stevens and Ken Phelps, click here.

Every 505(b)(2) development program is unique and different. To learn more about ways Camargo can help you evaluate your program and create a Target Product Profile to support your project, contact us.



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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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