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