A pre-IND meeting is a Type B FDA meeting which occurs early in the therapy development process to help to guide trial strategies. These meetings can help facilitate faster therapy approval processes. Pre-IND meetings greatly increase the likelihood of a program’s success by allowing concerns to be addressed early in the trial process. Pre-IND meetings are also a great opportunity to build a relationship with the FDA, minimize costs, and identify preclinical studies that have already been conducted. They are especially important when the therapy is intended to treat a serious or life-threatening disease. 1
The Client
The Head of Regulatory Affairs, and Vice President of Clinical Development in an emerging pharmaceutical company focused on developing first-in-class agents for the treatment of moderate-to-severe ulcerative colitis.
The Challenge
The company has built their molecule using a scaffold that is based on a drug that has historically been associated with a high level of toxicity.
The Approach
Developed a compelling narrative to present the new molecule as a potential therapeutic that can tackle a major unmet medical need, while mitigating any safety concerns.
The Outcome
A productive meeting with regulators, resulting in a well-defined development pathway.
Sources:
1. NIH.gov – https://toolkit.ncats.nih.gov/module/prepare-for-clinical-trials/participating-in-initial-meetings-with-regulators/learn-about-pre-ind-meetings/
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