Catherine Kessler joined Citius with more than 25 years of experience in the life sciences industry. For over 20 years, Ms. Kessler focused on regulatory affairs supporting early and late-stage product development in multiple therapeutic areas. Ms. Kesesler’s expertise extends to regulatory research and surveillance, developing regulatory paths to market for unique products, and effectively engaging health authorities through complex stages of product clinical development. She has supported development, U.S. marketing approvals, and/or post-marketing approvals of multiple FDA-approved products including: Mektovi®, Koselugo™, Tukysa®, Enbrel®, Remicade®, Humate-P®, Mononine®, Albuminar®, and a broad range of investigational products (small molecules, chemical solutions, medical devices, protein therapeutics, cellular therapies; oral capsules/tablets/drinks, intravenous injections, intrauterine devices, biologic/device combination products) in various phases of clinical development (pre-Phase 1 through Phase 3). These products have spanned numerous therapeutic indications including oncology (solid and liquid tumors), cardiovascular disease, inflammatory disease, and reproductive women’s health.
Ms. Kessler is a seasoned pharmaceutical executive who has held positions of increasing responsibility at SmithKline Beecham Pharmaceuticals, Centocor, Aventis Behring, Amgen, Array BioPharma, Clinipace Worldwide, and Imvax. She received a Master of Science in Quality Assurance and Regulatory Affairs from Temple University and a Bachelor of Science in Biochemistry from the University of Delaware.