Jason Cataldo

WORK HISTORY

EDUCATION

ABOUT JASON CATALDO

Executive Clinical Development Physician with over 17 years of experience with extensive expertise in clinical trial drug development and rare disease/orphan drug development within several therapeutic areas of Internal Medicine, Hematology, Metabolic Disorders, Immunology, Musculoskeletal, Neurology, Endocrinology, and Cardiology utilizing AAV gene therapy, mRNA-LNP technology, enzyme and substrate replacement, biologics, and ASO (antisense oligonucleotides). Key accomplishments•Medical Lead for a new drug application (NDA) resulting in approval of Ultragenyx’s Dojolvi®/LC-FAOD program. •Active member and SME for a new biological license application (BLA) resulting in approval of Alexion’s Soliris®/PNH Program•Successful approval of Ultragenyx’s investigational new drug (IND) application for a gene therapy AAV liver directed therapy for Wilson Disease utilizing a novel seamless Phase 1/2/3 study design.•Co-lead for Ultragenyx\'s lead asset of GTX102, an ASO, for the treatment of Angelman•Co-directed with business development a signed collaboration agreement with Daichi Sanko for an AAV directed therapy for Propionic Acidemia.•Proposed and developed concept of new asset target using mRNA-LNP for hemochromatosis/secondary iron overload disorders and incorporated into translational/preclinical pipeline.