Dr. Melanie McBride has over twenty years of experience in drug development, specifically Regulatory Affairs. Melanie has diverse experience across the industry having held positions of increasing levels of responsibility at large CROs, two small biotech firms, and a large pharmaceutical company.
In these roles Melanie has provided guidance and regulatory strategy to cross-functional project teams. Her experience includes full-development programs from early stage through registration. She has been the primary regulatory point of contact to FDA as the authorized US Agent for various foreign sponsors and US companies. In this capacity she has been the regulatory lead for teams through the drug development process from pre-IND meetings through IND application and support of subsequent IND life-cycle maintenance activities. As the development programs progressed she facilitated and coordinated preparations of meeting requests, meeting briefing packages and rehearsals for End-of-Phase 1 meetings, End-of-Phase 2 meetings and Type C meetings as necessary to discuss and progress the development program. She has also provided additional regulatory strategic guidance for preparation and successful negotiation of special protocol assessments; preparation of product development plans and recommendations on development including regulatory strategy; and conducted regulatory due diligence review of products for potential in-licensing.
Her recent experience includes a strong background in oncology drug development; in addition to broader therapeutic area expertise including but not limited to neuroscience (Alzheimer’s disease and related syndromes); psychiatric disorders (anxiety and depression); endocrine and metabolic disorders (diabetes and osteoporosis); inflammatory and autoimmune disorders (rheumatoid arthritis, psoriatic arthritis/ankylosing spondylitis); osteoarthritis; pain and women’s health.
Melanie attended the University of Nebraska-Lincoln and received a Pharm. D degree from the University of Nebraska Medical Center-College of Pharmacy in Omaha, Nebraska.
Melanie joined Catalyst Regulatory Services in 2017.