Speaker
Description
Translating biotherapeutics into clinical practice is essential for enhancing patients' quality of life and reducing therapy costs, ultimately democratizing access to treatments for all. This overview highlights the Mayo Clinic Center for Regenerative Biotherapeutics, dedicated to clinical translation of novel therapies into early-phase clinical trials. With facilities in Minnesota, Florida, and Arizona, our center features 20,000 square feet of clean room space and a team of 140 staff members collaborating with over 50 investigators on approximately 30 investigational INDs across cancer immunotherapy, immune-mediated diseases, organ regeneration, and more.
We emphasize our robust clinical trial infrastructure, with internal teams managing trials supported by project management, grant administration, and business development through collaboration with Mayo Clinic Ventures. Engaging the FDA early through INTERACT opportunities allows us to discuss pilot data and receive critical feedback, while pre-IND interactions enable us to outline our definitive studies, moving toward first-in-human trials. Our approach ensures we align with regulatory expectations, which will be a focus in this presentation as we explore pathways to support late-phase clinical trials. Ultimately, our commitment to translating laboratory discoveries into clinical practice aims to enhance patient care and outcomes.
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