FDA’s New Pre-Pre-IND Process Allow Early Strategic Discussions for Biologics

Last week, the Center for Biologics (CBER) announced a new kind of meeting with the FDA reviewers aimed at exploratory discussions prior to initiating significant development work. These meetings are expected to primarily provide an opportunity to discuss the preclinical studies and manufacturing issues related to first-in-human trials with new biological products. These meetings seem very similar to the Biosimilar Initial Advisory meetings and the Informational meetings held by the Center for Devices (CDRH) in terms of the scope of such meetings. Although the announcement for these meetings did not contain much details about these meetings, the potential applicants are advised to email CBER for more details. FDA also promised more detailed instructions soon. These pre-pre-IND meetings, called the INTERACT Meetings (INitial Targeted Engagement for Regulatory Advice on CBER producTs) should be popular with biologics developers. These meetings are in addition to the other opportunities to meet with the FDA starting with the pre-IND meetings so seems like a no-loss proposal for the developers, although it should be expected for developers to have clear defined questions for discussions with FDA. The developers should still plan to doing reasonable homework prior to the meeting to have a productive discussion. FDA has not mentioned the criteria for granting these meetings but a review of the processes for other similar meetings with FDA should be a good place to start for instructions. Overall, another effort by FDA to get more involved with the industry to help speedy product development.