When it comes to IND submission, do you have any tips for a successful submission? Are there any things that you would recommend including or any preparatory work you could recommend?

Answer

The single best recommendation I have for a successful IND submission is to make sure that you have communicated with the FDA throughout the development process. This can be accomplished by communicating with the agency via a pre-pre-IND meeting, which is an informal discussion focused primarily on preclinical issues (and always handled by teleconference). The pre-pre-IND dialogue can help ensure that the IND proceeds and mitigate the risk of a clinical hold; however, the focus of the pre-pre-IND is only preclinical and sometimes very preliminary CMC, and for this reason, a standard pre-IND is still highly recommended.

The pre-IND discussion is a key venue to communicate with the FDA where critical issues are raised, addressed, clarified, and resolved prior to the IND filing. There is one pre-IND meeting available to sponsors and sponsors should prepared with the questions and data the FDA will need to review to answer their questions.