Avenues to Early and Better Regulatory Access was presented at the 2025 Mayer Brown Utah Life Sciences Summit on November 12, 2025, in Salt Lake City.
Presented by BioUtah, Chris Phillips, RAPS, served as moderator with panelists including Kai Kadoich, FDA / CDRH / TAP Program, TAP Advisor; Kelli Oborn, BSI Group, Senior Technical Specialist; and Heather Murphy, BSI.
Pathways to early regulatory approval in the life sciences industry include leveraging expedited programs like Breakthrough Designations, engaging in early and frequent communication with regulatory bodies, designing clinical trials with clear endpoints from the outset, and building a strong foundation with solid preclinical data. The FDA is also speeding the approval process with AI and a new Commissioner’s National Priority Voucher Program. This panel will explore the pathways that lead to earlier and better regulatory access.
