Fit for Filing Academic Clinical Trials: An Industry Perspective
About this Event

Osteosarcoma Webinar Series: Elly Barry, MD, Chief Medical Officer at Day One Biopharmaceuticals and co-leader of the Accelerate Fit for Filing Working Group joins us on OsteoBites to share best principles guidelines (define elements of a data package) for filing, roles and responsibilities in collaborative studies, as well as resource needs to operationalise and deliver these types of trials.

For decades, academic clinical trials consortia have collaborated to optimize outcomes for childhood cancers through evaluating incremental improvements in conventional mutimodality treatment regimes. There are now increasing opportunities to partner with industry to test new medicines in academic-sponsored trials, but these collaborative studies rarely contribute to marketing authorizations. Under the auspices of the multistakeholder platform ACCELERATE, we convened a working group of representatives from clinical academia, pharmaceutical industry, European Medicines Agency, US Food and Drug Administration, and patient advocacy to explore why this is the case and to seek solutions to enable academic-sponsored trials to directly contribute to the licensing of new medicines. This presentation summarizes our findings and provides an industry perspective on how to move forward.

After a short presentation on this topic, she will take questions from attendees. Share your questions in advance with us at [email protected].