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.

1. NIH.gov – https://toolkit.ncats.nih.gov/module/prepare-for-clinical-trials/participating-in-initial-meetings-with-regulators/learn-about-pre-ind-meetings/

Contact us

If you would like to find out more about this topic, please contact us.

A free audit of your pre-IND plan with one of our regulatory experts can increase the potential for a successful outcome on first-time submission – contact us to learn more.