Julia Barrett, MD, MPH

Senior Clinical Consultant

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. Julia Barrett’s 27 years of clinical regulatory experience, combined with her training in Internal Medicine and Public Health, enhances her ability to consult across many clinical and regulatory areas including cell and gene therapy, protein therapeutics, vaccines, small molecules, biosimilars, combination products, immunotherapies, live biotherapeutics and other microbiota products.
Dr. Barrett’s drug development experience covers a wide range of indications including infectious disease, gastroenterology, allergy, genitourinary, gynecology, orthopedics, rheumatology, neurology, dermatology, cardiopulmonary, ophthalmology, metabolic and rare/orphan 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.

At Biologics Consulting, Dr. Barrett utilizes her clinical, regulatory, and public health expertise to assist clients in the following areas of clinical drug development:

• Clinical development plans for the US licensure of biologics, drugs and combination products
• Gap analyses of products under development (often in conjunction with CMC and nonclinical colleagues)
• Clinical regulatory strategy
• Design of Phase 1, 2, and 3 clinical trials and clinical protocol development
• Comprehensive “FDA style” review of clinical data
• Orphan drug applications
• Fast Track, Breakthrough Therapy and RMAT designation requests
• Strategy/writing/review of clinical sections for pre-IND, IND, BLA, and NDA submissions
• Briefing packages for FDA meetings (Type A, B and C)
• Clinical study reports
• Clinical review of statistical analysis plans (SAPs)
• Oversight of medical writing (e.g., FDA submissions, clinical protocols, white papers)
• Prepare/rehearse clients for FDA meetings and advisory committees
• Participate in FDA meetings on behalf of clients
• Product development roundtables with key opinion leaders
• Mock FDA advisory meetings

Education

MPH, (Master’s in Public Health) George Washington University, Washington D.C. (1992)

MD, Northwestern University School of Medicine, Chicago, IL (1987)

Non-Degree Program, Violin Performance, Trinity College of Music, London, England (1982-1983)

BA, Biology, cum laude, Smith College, Northampton, MA (1982)