Senior Clinical Consultant, Biologics Consulting
Julia Barrett, MD, MPH, joined Biologics Consulting as a Senior Clinical Consultant in December 2004 and had served as an affiliate to our group for several years prior to joining.
Dr. Barrett’s 24 years of clinical regulatory experience, combined with her training in Internal Medicine and Public Health, enhances her ability to consult in a number of clinical and regulatory areas including vaccines, protein therapeutics, cell and gene therapy, small molecules, biosimilars, combination products, allergenics including immunotherapies, live biotherapeutics and other microbiota products.
Dr. Barrett’s drug development experience covers a wide range of indications including infectious disease, gastroenterology, allergy, pulmonary, genitourinary, gynecology, orthopedics, rheumatology, neurology, metabolic and rare diseases.
Dr. Barrett received a BA in Biology from Smith College in 1982; an MD from Northwestern University School of Medicine in 1987; completed an internship and residency in Internal Medicine at the University of Minnesota in 1990; and completed a Fellowship in General Internal Medicine and Master’s Degree in Public Health from George Washington University in 1992. From 1992-1997 she was a Senior Clinical Reviewer in the Division of Vaccines and Related Products Applications, Center for Biologics Evaluation and Research (CBER), FDA.
As a Senior Clinical Reviewer at CBER, Dr. Barrett was responsible for the comprehensive review of clinical protocols for Phase 1, 2, and 3 clinical studies, including assessment of the rationale, safety, and design of proposed trials for bacterial, viral (including HIV), and DNA vaccines as well as several biologic therapeutic products. While at CBER, Dr. Barrett reviewed clinical data submitted to over 80 INDs and BLAs, contributed to decisions regarding the licensure of several vaccines, made presentations before FDA advisory committees, and participated in a variety of special FDA projects and committees.