PRINCETON, N.J. -- (BUSINESS WIRE) -- Celator Pharmaceuticals today announced the appointment of Lisa DeLuca, Ph.D., as vice president, regulatory affairs. Dr. DeLuca will be responsible for ongoing interactions with global regulatory bodies, including the U.S. Food and Drug Administration (FDA), and leading the registration strategy for CPX-351, now in Phase 3 clinical development for untreated, high-risk acute myeloid leukemia (AML).
"Lisa has a track record of success in guiding development programs through registration, with considerable experience in oncology," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "I've worked closely with her in this capacity in the past and know she will be instrumental in maintaining a close working relationship with FDA and other agencies, while ensuring that we've identified an efficient registration pathway and that our eventual regulatory submissions are of high quality."
Dr. DeLuca joins Celator having recently worked at Sanofi-Topaz, Inc. (formerly Topaz Pharmaceuticals). As vice president, regulatory affairs and quality assurance, she was a key member of the management team responsible for the development of the company’s lead drug product (0.5% ivermectin lotion) through clinical development, manufacturing optimization, NDA submission, launch, commercialization, and acquisition of the company by Sanofi Pasteur Inc. She led the successful NDA submission process achieving FDA approval within a single review cycle. Prior to that, she served as vice president, global regulatory affairs, for YM BioSciences (formerly Eximias Pharmaceuticals), leading registration activities for oncology and pain therapeutics, and as director, regulatory affairs, for AstraZeneca, where she led the IRESSA™ regulatory team and developed the regulatory strategy for the prostate cancer and pain portfolios. Dr. DeLuca was part of a company formed by Centocor called Apollon Inc., where she was responsible for the regulatory strategy for gene therapies for several types of cancer, infectious diseases, and allergies. She began her career in regulatory affairs at Centocor contributing to the company’s first successful NDA filing for ReoPro® and the initial IND filing for Remicade®. She also held research positions at the Upjohn Company and SmithKline Beecham. Dr. DeLuca holds undergraduate and master's degrees in biology from Eastern Michigan University and earned her Ph.D. in biology from the University of Toledo.
"After the results of registration trials, nothing is more important to the approval of a new therapeutic than the efficiency and quality of the regulatory process itself," said Dr. DeLuca. "I am very excited to be joining the Celator management team at this key moment for the CPX-351 program and for the Company."
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Princeton, NJ, and Vancouver, BC, is a privately held pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex®, the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two clinical stage products; CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage product, CPX-571 (a liposomal formulation of irinotecan:cisplatin); and multiple research programs, including the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. Based on the applications of CombiPlex and the proprietary nanoparticle prodrug delivery platform, Celator is positioned to advance a broad pipeline of cancer therapies involving both previously approved and novel drug agents. For more information, please visit the company's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.