Beginner's Guide To Pre-IND Meetings

By Sharon Ayd, MBA, PhD, VP & Principal, Regulatory CoE

New to the process of helping to bring a drug to market? As intimidating as the Food and Drug Administration (FDA) might seem, they do a lot to support research sponsors. One example is the pre-investigational new drug (IND) meeting.

The pre-IND meeting is usually a drug sponsor’s first formal meeting with the FDA as they begin the process of bringing a drug to market. The meeting provides sponsors the opportunity to discuss their IND plans prior to the full IND submission. This interaction is where the drug sponsor can receive insight into the FDA’s current thinking. Sponsors who factor this valuable input into their drug development efforts early on may benefit by receiving fewer FDA requests for changes.

The pre-IND meeting is designed to address questions related to the initial clinical study design, as well as answer other important questions potentially affecting the IND application. Discussion topics usually include adequacy of nonclinical data to support the duration of the clinical study, and current good manufacturing practice (cGMP) issues relating to manufacturing for and product quality of the IND.