Kelly Creighton

Kelly joined Citius from Clinipace Worldwide, a leading global contract research organization, where he served as Vice President of Regulatory and Strategic Development. As a senior-level regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, and combination products, he has provided comprehensive regulatory strategy assessments, development plans and regulatory dossiers for programs across a wide range of therapeutic areas. As head of a global CMC regulatory activities for investigational products, he has led teams throughout North America, Europe and the Asia Pacific region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has directed the implementation of multiple CMC development plans including: contract manufacturing organization selection, product manufacturing, analytical development, product characterization, specification establishment, container closure systems and stability requirements. Additionally, his substantial product development experience extends to biologics/biosimilars, small molecule, gene and cellular therapies, cancer immunotherapies, live oncolytic biotherapeutics, and microbiome therapies. Twenty products for which he prepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in the US and EU. Additionally, he has performed internal and external quality assurance audits for drug products, drug substance, and tissue and cell therapy products. Kelly earned his BS from New Mexico State University and his MSc and PhD from the University of Nebraska.