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Leveraging 505(b)(2): Real-World Evidence Rescues Program


A biotech company could not afford the time and expense of conducting studies recommended by another of its consultants and agreed to by the FDA.

The company had previously initiated product development discussions with the FDA based on existing 505(b)(1) guidance. The result of its first pre-IND meeting was a strategy, with concurrence from the agency, 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 Premier Consulting’s assistance to rescue the project.


Through analysis of the product’s scientific and medical viability, we identified a possible alternative solution. In its 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.


Following our 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 understanding of the nuances of published guidance, we helped reduce the client’s projected development cost by 90 percent versus the original $25 million estimate and reduce time to market by more than two years.


FDA reversed its original pre-IND decision based on our presentation and the sponsor was able to meet its desired development cost and timeline goals.