Drs. Karthika Perumal and Heather Hatcher were invited to speak on legal and regulatory issues that impact commercialization of novel medical products at the annual Mayo Clinic Regenerative Medicine and Surgical Medicine Symposium that was held in Phoenix, AZ on November 4-7, 2021. Leaders at Mayo Clinic and Mayo Clinic’s Center for Regenerative Medicine strongly believe that regenerative science, medicine and surgery are vital pillars of tomorrow’s healthcare, and used to create new healthcare models and transform the practice of medicine and surgery. The unique character of Mayo Clinic’s Center for Regenerative Medicine is the expansive nature of its priorities with focus areas including oncology, orthopedics, cardiovascular medicine, neurosciences, and transplant. Karthika and Heather provided an overview of FDA’s Regulation of Biological Products as well as insight into Market Exclusivities, Intellectual Property, Orphan Drug Designations and Patent Protections for Increased Investment, and best practices for Clinical Trial Agreements and Meetings with FDA.
Womble Bond Dickinson was a sponsor of this year’s Symposium.