Session – Regulatory Challenges and Opportunities for the Global Development of Gene Therapies Daniela Drago, Ph.D., RAC is Senior Director Regulatory Sciences at Biogen. Prior to joining Biogen, she has held senior positions in global regulatory and medical affairs at F. Hoffman-La Roche, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb. During her career, she was an Associate Professor at George Washington University’s School of Medicine and served as a Premier Consultant at NDA Partners. Daniela has significant global experience in the development of small molecules, biologics, and gene therapies in rare and common disease areas, including oncology, ophthalmology, and neuroscience. She received the TOPRA Award for Regulatory Excellence and the RAPS Community Leadership Award. She serves on the Regulatory Affairs Certification Board, is the former Chair of the RAPS DC/Baltimore Chapter, and is a member of the Advisory Council to the TOPRA Board of Directors.