If polled, most executive teams would say they don’t want to take the time to do a Pre-IND meeting before submitting an initial investigational new drug (IND) application. I get it, it takes time, and time is money. But consider it can take MORE time to get your IND through the Food and Drug Administration (FDA) if they place you on a Full Clinical Hold (FCH) and give you a long list of things to complete before they will let you proceed. Common FCH items include the following:
- Submit data from repeat-dose toxicology studies of appropriate length to support the proposed clinical trial.
- Submit data from an adequate battery of safety pharmacology studies.
- Submit batch release data on your drug product including a comparison of batches used in toxicology studies and those intended for clinical trials.
- Include adequate subject and trial stopping criteria in your clinical protocol.
- Because this is a first-in-human trial, update your inclusion criteria to include only patients who are not amenable to standard of care.
Some items including revision to inclusion/exclusion (I/E) criteria and stopping criteria in the clinical protocol are fast and easy. On the other hand, a nonclinical (animal) study that was not yet performed and/or one that was not performed adequately, can take a year or more to complete. Spending a relatively small amount of time with a regulatory strategist before you start your IND-enabling nonclinical studies can save your program months of time and tens of thousands of dollars.
AO Regulatory Consulting can walk you through the steps of a Pre-IND meeting no matter where you are in the development process. Even if you have already started or completed your nonclinical studies, a Pre-IND meeting can confirm you are on the right track, or help you make a small course correction that can save time and money.