Scientific innovation in Cell & Gene Therapy (C>) is advancing rapidly, sparking hope for patients with rare diseases, cancer, and other debilitating conditions. The key is knowing where the advances may come from. To stay at the cutting edge of the C> space, ARM commissioned Catalyst Healthcare Consulting to conduct a comprehensive industry-based horizon scan that identified the top emerging C> technologies poised to impact the industry, patient lives, and regulatory thinking in the next 3-10 years. The horizon scan culminated in a white paper that highlights the scientific background, latest innovations, and regulatory considerations of each of the top technologies. Check it out below.
Multistakeholder collaboration, led by Catalyst Healthcare Consulting, to Recommend Data-Informed Optimization of CAR T-Cell Therapy Long-Term Follow-Up (preprint).
Understanding the patient experience with CAR-T long-term follow-up (LTFU) is essential for building a sustainable model. Catalyst...
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).