SlideSource’s new system enabled the first-ever, full-day virtual FDA approval AdComm
It appears that, for the foreseeable future, FDA Advisory Committee meetings (AdComms) will be conducted virtually. Remote participation adds a number of complex logistical and communication challenges to a process that can already be fraught with pitfalls for an unprepared sponsor.
One of the biggest of these challenges is replicating the complex interplay that takes place between the sponsor team members while responding to the committee’s questions. Providing the committee members with the data they need to come to a well-informed decision quickly and efficiently is critical to a sponsor’s success.
SlideSource recognized early on that we are all inevitably moving toward a more virtual world. To address this trend, even before the current pandemic, SlideSource augmented and extended the capabilities of its industry-leading technology platform. This means that sponsors can now hold virtual mock rehearsals and, more importantly, participate in virtual AdComms without needing to be in the same physical location.
This system has been extensively tested at mock rehearsals over the past year and was used successfully for the Cardio-Renal Drug Advisory Committee (CRDAC) meeting that took place on July 15, 2020. This was the first fully virtual, full-day drug approval AdComm.
All features and benefits of SlideSource’s live, in person Q&A response technology have been incorporated into this virtual platform. SlideSource worked with the FDA to test the system and ensure tight integration with their webcast software.
The SlideSource virtual platform enabled the drug’s sponsor to access thousands of data slides to quickly locate, preview, and then display the ones that supported their responses to panel member questions. Like the committee members, the sponsor’s responders and support team members were located in many locations around the world but were all linked seamlessly and were able to perform at the same level they would have if they were all in the Great Room on the FDA campus.
To learn more about our proprietary virtual mock and adcomm platform, contact us to schedule a live demonstration.