16.04.2012 14:30:00
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Array BioPharma Names Howard Holden, Ph.D., Vice President of Regulatory Affairs and Quality Assurance
Array BioPharma Inc. (NASDAQ: ARRY) today announced that Howard Holden, Ph.D., has joined the Company as Vice President of Regulatory Affairs and Quality Assurance. With over 25 years of experience in regulatory affairs and compliance in the pharmaceutical / biotechnology industry, Dr. Holden will lead regulatory affairs and quality assurance for Array's pipeline of targeted small molecule drugs to treat cancer and inflammatory diseases.
"Howard’s lifetime of regulatory experience will help Array navigate the FDA approval path for our proprietary programs,” said Kyle Lefkoff, Executive Chairman, Array BioPharma. "He will make an immediate contribution as we move our pipeline into registration studies, and we’re all excited to have Howard on the Array team.”
During his career, Dr. Holden has built and led regulatory and compliance functions for programs from Investigational New Drug (IND) applications to New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA); developed and implemented regulatory drug development and compliance strategies; and obtained approval for several products in the U.S., Europe and Canada. From 2005 until 2012, Dr. Holden was Senior Vice President of Regulatory Affairs and Compliance at Nereus Pharmaceuticals. Prior to joining Nereus, Dr. Holden was Vice President of Regulatory Affairs and Compliance at Stressgen Biotechnologies and Ligand Pharmaceuticals, Senior Director at Parke-Davis/Warner-Lambert, Director at Centocor and Senior Investigator at the National Cancer Institute. Dr. Holden has over 120 publications on tumor immunology and natural host resistance. Dr. Holden received his bachelor's degree from Drew University and his Ph.D. in microbiology from the University of Miami, School of Medicine.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Array has four core proprietary clinical programs: ARRY-614 for myelodysplastic syndromes, ARRY-520 for multiple myeloma, ARRY-797 for pain and ARRY-502 for asthma. In addition, Array has 10 partner-funded clinical programs including two MEK inhibitors in Phase 2 clinical trials: selumetinib with AstraZeneca and MEK162 with Novartis. For more information on Array, please go to www.arraybiopharma.com.
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