FDA expedited programs, such as FDA Fast Track, Breakthrough Therapy, FDA Accelerated Approval, and FDA Priority Review, have become essential tools for oncology drug developers seeking to bring new therapies to patients faster. In this interview, Josh Taylor, PhD, RAC, Senior Director of Regulatory Affairs at Allucent, explains how these FDA programs differ from traditional processes and why they are especially critical for small and mid-size biotech companies working to compete in a crowded oncology market.
Dr. Taylor highlights how these expedited programs can streamline communication with FDA, shorten review timelines, and in some cases, such as under FDA Accelerated Approval, allow sponsors to pursue approval based on surrogate endpoints while confirmatory trials are still ongoing. He also shares how enhanced collaboration with the agency under FDA Breakthrough Therapy designation can help biopharma companies make program-critical decisions earlier and avoid costly delays.
For biopharma teams planning oncology development strategies, understanding the nuances of each of these expedited programs, including eligibility requirements, clinical data expectations, and the role of biomarkers and companion diagnostics, is key to maximizing opportunities. From enabling rolling submissions under FDA Fast Track to securing faster patient access through FDA Accelerated Approval, these programs not only impact timelines but can also influence fundraising and strategic prioritization for emerging biopharma companies.
Watch the interview to learn how early engagement with FDA, clear data packages, and thoughtful program design can help oncology innovators leverage FDA expedited programs to advance effective therapies faster for patients who need them.
Request a Proposal
Share This
