For biotech companies advancing oncology therapies, regulatory speed can be critical to achieving key milestones and getting new therapies to patients faster. In a recent interview, Josh Taylor, PhD, senior director of regulatory affairs at Allucent, discussed how biotech companies can leverage the FDA’s expedited programs—Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review—to shorten development timelines. These programs don’t replace traditional regulatory steps but can improve communication with the agency, streamline processes and provide strategic advantages, particularly for small and mid-sized biotechs.
Taylor emphasized the importance of early planning and frequent engagement with the FDA. He also noted that the thoughtful use of biomarkers or companion diagnostics could strengthen a product’s eligibility for accelerated review. These designations can improve a company’s ability to secure funding and increase the likelihood of delivering new therapies to market faster. Watch the full interview to learn how a proactive regulatory strategy can make a difference in oncology drug development.