Margaret joined NDA in 2015, as a Medical Advisor. A former FDA Deputy Division Director and industry Medical Director. Her expertise lies in rheumatology, clinical immunology, and inflammatory conditions with special emphasis on requirements from US FDA. She applies her extensive knowledge of the FDA approvals process to successfully support companies from early product development through to license approval.
Key Areas Of Expertise
- Extensive knowledge of the FDA drug and biologics approval processes
- Clinical documentation requirements, development plans, scientific strategy, and design, supporting US regulatory applications:
- Investigational New Drug (IND), Biologic License (BLA) and New Drug (NDA) applications
- Preparation of paediatric investigational plans for submission to FDA and European Medicines Agency (EMA) paediatric committees
- Advised on regulatory strategy for FDA Fast Track, Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations, and accelerated approval submissions
- In-depth knowledge of the development of medicinal products, therapeutic proteins for the treatment of autoimmune and inflammatory diseases
- Provided clinical and regulatory support for the development of products for rare diseases;
- Advised on regulatory strategy for FDA orphan drug designation
Before Joining The NDA Advisory Board
Margaret held various senior positions at the FDA, she was the Deputy Director Division of Vaccines and Related Product Applications, Medical Officer Division of Vaccines and Related Product Applications at the Center for Biologics Evaluation and Research & Medical Officer, Hematologic Products Branch within Division of Biological IND’s. She also served as medical director in big pharma companies.
Furie R, Mitrane M, Zhao E, et al. Efficacy and tolerability of repository corticotropin injection in patients with persistently active SLE: results of a phase 4, randomised, controlled pilot study. Lupus Science & Medicine 2016; 3:e000180. doi:10.1136/lupus-2016- 000180.
Furie RA, Mitrane M, Zhao E, Becker P. Measures of Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus (SLE): Results from a Two-Part 52 Week Pilot Study of Repository Corticotropin Injection (H.P. Acthar® Gel) [abstract].Arthritis Rheumatol. 2016; 68 (suppl 10).
Furie RA, Mitrane M, Zhao E, et al. Repository corticotropin injection in patients with persistently active SLE requiring corticosteroids: post hoc analysis of results from a two-part, 52-week pilot study. Lupus Science & Medicine 2017; 4:e000240. doi:10.1136/ lupus-2017-000240.
Dr Margaret Mitrane