Julie DiStefano-Pappas is a Principal Research Associate with more than 20 years of experience in project and data management for clinical research studies. DiStefano-Pappas serves as Director of the Children’s Hospital of Philadelphia (CHOP)/Westat Biostatistics and Data Management Core. She oversees clinical data managers, senior data research assistants, and data research assistants and serves as the main liaison between CHOP leadership and Westat, focusing on business development strategy. She also collaborates with Dr. Jonathan Spergel at CHOP to form the Data Coordinating Center (DCC) for Food Allergy Research Education (FARE). The FARE DCC supports critical activities for the design, development, execution, monitoring, and data analysis of translational research. Her experience at CHOP has led her to develop partnerships with multiple biopharmaceutical companies where she has managed phase 1-3 studies in rare disease. She was the project manager for the pivotal phase 3 study for Spark Therapeutics that led to FDA approval of Luxturna®, the first gene therapy approved for an inherited disease.
Earlier in her career, DiStefano-Pappas worked as a clinical data manager at a leading pharmaceutical company on global and North American phase 3, 3b, and 4 studies of cardiovascular therapies. As a clinical data manager, she was responsible for case report form tracking, data review and validation, query generation and resolution, and reconciliation of adverse experience and serious adverse experience reports.
- BA, Psychology, University of Pennsylvania
Areas of ExpertiseClinical Research Clinical Trials Innovative Tools for Data Collection and Management
Journal ArticleNovel mobility test to assess functional vision in patients with inherited retinal dystrophies
Clinical and Experimental Ophthalmology
D.C. Chung, S. McCague, Z.F. Yu, S. Thill, Julie DiStefano-Pappas, J. Bennett, D. Cross, K. Marshall, J. Wellman, K.A. High
Journal ArticleEfficacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65-mediated inherited retinal dystrophy: A randomised, controlled, open-label, phase 3 trial
O.U. Elci, X. Zhu, J. Bennett, K.A. Marshall, S. McCague, D.C. Chung, J.F. Wright, B.P. Leroy, F. Simonelli, K.A. High, A.M. Maguire, S. Russell, J.A. Wellman, Z.F. Yu, A. Tillman, J. Wittes, Julie DiStefano-Pappas, D. Cross, J. Walshire, T.L. Kehoe, H. Re
Journal ArticleSafety and durability of effect of contralateral-eye administration of AAV2 gene therapy in patients with childhood-onset blindness caused by RPE65 mutations: A follow-on phase 1 trial
O.U. Elci, J. Bennett, J. Wellman, K.A. Marshall, S. McCague, M. Ashtari, Julie DiStefano-Pappas, D.C. Chung, J. Sun, J.F. Wright, D.R. Cross, P. Aravand, L.L. Cysckowski, J.L. Bennicelli, F. Mingozzi, A. Auricchio, E.A. Pierce, J. Ruggiero, B.P. Leroy