Citius Pharmaceuticals Expands Management Team with Appointment of Kelly Creighton, PhD as Executive Vice President of Chemistry, Manufacturing and Controls

 

Source:  Citius Pharaceuticals, Inc. 11/5/2021

Seasoned regulatory and manufacturing executive with 20 approved market applications in the US and Europe and 50 regulatory submissions worldwide joins Citius management team

Strategic expertise in regulatory and chemistry, manufacturing and controls development spans multiple therapeutic areas including oncology, infectious diseases and cell therapy

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, today announced the appointment of pharmaceutical industry veteran Kelly Creighton, PhD as Executive Vice President of Chemistry, Manufacturing and Controls (CMC). Mr. Creighton will be responsible for the global strategic regulatory and manufacturing development plans for Citius's five pipeline programs.

"With two late Phase 3 trials nearing completion, we continue to prepare the organization for commercial success. Kelly is a seasoned pharmaceutical veteran whose accomplishments include more than 50 investigational new drug (IND) submissions and 20 approved market applications spanning multiple therapeutic areas including oncology, infectious disease and cell therapy. Kelly has been a longstanding advisor to the Citius team on all aspects of the regulatory pathway for Mino-Lok^® and we anticipate a seamless transition into this newly created in-house role. He brings an ideal blend of strategic thinking, leadership skills and deep global regulatory and product development expertise, which he will apply to our entire clinical program as we continue to develop the Citius pipeline," stated Myron Holubiak, Chief Executive Officer of Citius.

Kelly Creighton, PhD joins 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.

About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company has two late-stage product candidates, Mino-Lok^®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma (CTCL), which has completed enrollment in its Pivotal Phase 3 trial.  Mino-Lok^® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on acute respiratory distress syndrome (ARDS) associated with COVID-19.