Close
The Camargo Way Case Studies FDA Product Development and Regulatory Consultant Case Study

Real World Evidence Saves Project

Challenge: A biotech company could not afford the time and expense to conduct studies recommended by its consultant and agreed on by the FDA.

Background

The biotech company had previously initiated product development discussions with the FDA based on existing 505(b)(1) guidance. The result of their first Pre-IND meeting was a strategy with concurrence from the FDA to conduct significant clinical trials estimated to cost $25 million and take more than three years. The company couldn’t afford the plan and sought our assistance to rescue the project.

   

Solution

Through analysis of the product’s scientific and medical viability, we identified a possible alternate solution. In their previous FDA meeting, the client had not made sufficient use of data from outside sources—a unique possibility in the 505(b)(2) pathway. Using our proprietary search methods, our researchers identified key publications to support the 505(b)(2) development plan. After arming the sponsor with this new information and following our recommendations on how to approach the FDA, the company contracted us to request and conduct another Pre-IND meeting with the FDA.

   

Outcome

Following our thorough and detailed presentation and scientific argument, the FDA reversed its decision and required only a bioequivalence study, which reduced the initial three-year clinical trial plan to just months. Through our unique understanding of the nuances of published guidance, we helped reduce the client’s projected development cost to within 10% of the original $25 million estimate, and increased the speed to market by more than two years.

Page 3 of 4

Get Our Diverse Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our Solutions or Contact Us.


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


Contact
Headquarters
9825 Kenwood Road,
Suite 203
Cincinnati, OH 45242
Durham Office
2505 Meridian Parkway,
Suite 150
Durham, NC 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights