Advanced therapies, particularly cell and gene therapies, have the potential to transform global healthcare. The lack of an established regulatory framework in many countries for these unique, complex, and innovative modalities poses challenges for developers. Combatting the myriad of challenges that attend the worldwide commercialization of an advanced therapy will require companies to begin fomenting their global regulatory strategy early and adapting it for their specific goals.
Dr. Daniela Drago, whose distinguished career in pharmaceutical regulatory affairs has included work for companies such as Hoffmann-La Roche, Vifor Pharma, Bausch + Lomb, and Biogen, has long worked to overcome these regulatory challenges. Dr. Drago, who currently serves as the chief regulatory officer at Aurion Biotech, recently sat down with The Business of Biotech podcast to explore some of the intricacies of navigating international regulatory affairs, particularly for advanced therapeutics, which have experienced burgeoning growth in the last several years owing to their potential to surmount the limitations of more traditional modalities.