In CAC2’s “Fit for Filing” webinar, our speakers explored designing and conducting academic or academic industry collaborative trials that produce data suitable for regulatory filing. This presentation covered best practices and considerations for conducting trials ready to submit for regulatory approval. The panel examined multiple perspectives, including academia, industry, regulatory authorities, funding organizations, and patient advocates.
The speakers emphasized the importance of early, robust, and multi-directional partnerships among academic investigators, cooperative groups, regulatory agencies, and industry, and how funding organizations can help promote these collaborations that are crucial to ensure the unmet medical needs of children with cancer remains a priority in drug development.
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