Nikolas Burlew

Nikolas Burlew, EVP, Quality Assurance

Nik Burlew joined Citius from Clovis Oncology, Inc. where he served as Vice President of Quality Assurance. Prior to joining Clovis, Nik was the Executive Vice President of Regulatory and Strategic Development at Clinipace where he spent 15 years providing quality and CMC consulting counsel to clinical and commercial biologics and pharmaceutical companies. As a senior-level quality assurance expert with over three decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, natural products, live-biotherapeutics and combination products, Nik has provided quality and development plans for programs across a wide range of therapeutic areas. As the global head of QA for commercial and clinical stage companies, he has led teams throughout North America, Europe and Asia Pacific overseeing the application of quality programs in Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP) and Good Distribution Practice (GDP). Nik has successfully engaged with Health Authorities around the world in a variety of GxP inspections and negotiations including: FDA, EMA, MHRA, HPRA, BfArM, ANVISA, AEMPS, AIFA, PMDA, and Swissmedic. Additionally, his substantial product development experience extends to biologics, small molecules, natural products, gene and cellular therapies, cancer immunotherapies, live oncolytic biotherapeutics, and the microbiome. Mr. Burlew earned his B.S. in environmental, population and organismic biology from the University of Colorado Boulder.