Q. Melody Dai, PhD, PMP, RAC

Dr. Dai is an accomplished industry leader with 23+ years of experience in global strategic development for biopharmaceuticals, instrumental in securing regulatory approvals and product life cycle management. With a diverse scientific background, she specializes in oncology, hematology, ophthalmology, and rare diseases.
As Executive Director of Regulatory Affairs at Adverum and Director at AbbVie, Melody drove regulatory strategies and led IND/IMPD global submissions for innovative treatments like gene therapy and antibody drug conjugates. At Amicus, she led submissions for global phase III studies, as well as BLA/MAA that paved the way for crucial therapies and addressed regulatory challenges in gene therapy programs. Melody holds a BS in Chemistry from Peking University and a PhD in Biophysical Chemistry from Rutgers University, with post-doctoral training at the University of Pennsylvania.