CAC2 Webinar–“Fit for Filing”

We are pleased to announce the CAC2 January webinar, “Fit for Filing,” where our presenters will explore how research funders can encourage our academic and industry partners to design and conduct clinical trials that produce data suitable for regulatory filing.

The “Fit for Filing” webinar will explore designing and conducting academic or academic industry collaborative trials that produce data suitable for regulatory filing. This presentation will cover best practices and considerations for conducting trials ready to submit for regulatory approval. The panel will examine multiple perspectives, including academia, industry, regulatory authorities, funding organizations, and patient advocates.

Learn how the FDA evaluates clinical trials to determine if the treatment benefits outweigh potential risks. Regulatory approval of pediatric oncology drugs has increased since the implementation of the RACE Act, children with cancer still need new therapies to improve their outcomes and reduce the late effects of current options.

The speakers will emphasize 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 that the unmet medical needs of children with cancer remains a priority in drug development.