Views from the
regulatory cockpit

Catalyst CEO, Nancy Myers, had the opportunity to address CBER leadership during OTP’s September 18th public listening meeting titled “Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies.” Though a PDUFA VII commitment and a required action, meetings like this one provide a critical space for industry and the Agency to share ideas and deliver better outcomes for patients.

Multistakeholder collaboration, led by Catalyst Healthcare Consulting, to Recommend Data-Informed Optimization of CAR T-Cell Therapy Long-Term Follow-Up (preprint).