Overall, you can consider an INTERACT meeting if you have begun the development process for your asset but have not yet reached the stage of Pre-IND meeting readiness.
You should have proof-of-concept data from in vitro and in vivo pre-clinical studies to demonstrate preliminary evidence of efficacy and safety for discussion at the INTERACT meeting – it would be premature to request a meeting if you do not – but you should not be as far along as having conducted your pivotal pre-clinical studies (e.g., definitive toxicology studies) – in fact, this would be considered too advanced for INTERACT. [2]
Please see below for a checklist to guide you in assessing if you are at the appropriate timing for an INTERACT meeting.
Pro tip:
Note that these are best practice recommendations for when an INTERACT meeting would be most useful to a Sponsor. The FDA denies about two-thirds of all INTERACT meeting requests, with the most common reason being that the meeting request is submitted too early or too late in development. In order to increase the likelihood of securing a meeting, do your best to check off as many items on this list to ensure you are at the optimal stage of readiness!
INTERACT Meeting Readiness Assessment Checklist | |
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Minimum pre-clinical |
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Minimum CMC |
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Clinical |
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Patient Engagement |
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Prior to proceeding, let us do one final check to ensure you are ready to initiate the INTERACT meeting preparation.
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Accessible description of the flowchart
Flowchart with decision points and actions related to INTERACT readiness assessment requirements. It starts with the question "Have you checked all readiness assessment requirements?" If "No," it suggests "Consider completing these requirements before trying." If "Yes," it asks, "Do you have more ready at this current stage than what is listed in the checklist?" If "Yes," it suggests taking the Pre-IND readiness assessment. If "No," it advises proceeding to INTERACT meeting preparation.