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 Research & Development within a US biopharmaceutical company focused on developing groundbreaking oncology drugs.

The Challenge

Initially aiming for a breast cancer indication with one of their novel agents, the company discovered a potential faster and better-defined development path for a different cancer indication. However, their existing preclinical data would not support an IND for the new cancer indication.

The Approach

Conducted a thorough preclinical gap assessment to identify the necessary evidence required to bridge the existing preclinical data to the newly targeted oncology indication.

The Outcome

Achieved a successful meeting with company funders, resulting in the company securing a substantial budget to conduct the bridging studies needed for the new cancer indication.

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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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.