Pre-IND Meetings: How To Achieve Success For 505(b)(2)

By Ken Phelps, Strategic Advisor, Angela Drew, Ph.D., Product Ideation Consultant, and Kristi Norris, PhD, Senior Scientific and Regulatory Manager

One of the greatest mistakes that the Sponsor of a 505(b)(2) can make is to have an unsuccessful Pre-IND meeting. Common errors occur at the Pre-IND meeting because Sponsors and CROs that are more familiar with traditional 505(b)(1) drug development programs fail to appreciate the different goals and the impact of a Pre-IND meeting on a 505(b)(2) program.

The goal of a 505(b)(1) Pre-IND meeting is to introduce the FDA to the novel drug, discuss standard toxicology study results, and propose a first-in-human study. In contrast, a properly prepared and conducted 505(b)(2) Pre-IND meeting presents the proposed strategy and the entire development program, including the justification for leveraging existing data in place of required studies. Therefore, the approval strategy presented in the 505(b)(2) Pre-IND meeting is paramount, requiring productive discussion and alignment with the FDA.

We cannot overemphasize that getting FDA feedback on the entire development program at the Pre-IND meeting is the critical path to success in 505(b)(2) drug development. The Pre-IND meeting must be successful.