MARKHAM, ON, Sept. 16 /PRNewswire/ - Cytochroma today announced that it has appointed Steven I. Engel, M.S., Pharm.D., as Vice President, Regulatory Affairs and Quality Assurance. Dr. Engel brings to Cytochroma over 20 years of experience in regulatory affairs and quality assurance, and will be responsible for directing all of Cytochroma's regulatory activities, as well as ensuring that the Company has appropriate quality systems in place. He will be based in Cytochroma's Illinois office.
"Cytochroma's activities in the areas of clinical and regulatory affairs are increasing significantly as we advance three lead product candidates through clinical development," stated Charles W. Bishop, Ph.D., Cytochroma's President and CEO. "For this reason, we have named Dr. Joel Melnick as Vice President, Clinical Research and Development and assigned his former responsibilities in the areas of regulatory affairs and quality assurance to Dr. Steve Engel. Steve has a proven track record of successful new drug registrations and post-marketing support, and we are pleased to have an individual of this caliber helping us secure global regulatory approvals for our products."
Prior to joining Cytochroma, Dr. Engel was Vice President of Regulatory Affairs and Clinical Quality Compliance at Par Pharmaceutical, Inc. where he was responsible for the regulatory strategies of both branded and generic pharmaceutical programs. Prior to joining Par Pharmaceutical, Dr. Engel held regulatory positions at AlgoRx Pharmaceuticals, Vertex Pharmaceuticals, Baxter Healthcare, Abbott Laboratories, Otsuka America Pharmaceuticals, G.D. Searle, and American Cyanamid. He earned his Doctor of Pharmacy degree from the University of Florida, his Master of Science in Pharmacology from the University of North Carolina at Chapel Hill, and his Bachelor's degrees in Pharmacy and Biology from Drake University.
"Cytochroma's portfolio of therapies for chronic kidney disease has tremendous potential," stated Dr. Engel. "I look forward to working with such a skilled team to create a leading specialty pharmaceutical company."
Cytochroma has a diverse portfolio of vitamin D-based therapeutics designed to treat disorders related to abnormal or insufficient vitamin D metabolism in chronic kidney disease (CKD) patients. These new products will address target markets that are expected to grow significantly, reaching more than $1.4 billion annually by 2013 in the U.S. alone. Cytochroma has three product candidates in development for CKD patients: CTA018 and CTAP201 are being developed for the treatment of secondary hyperparathyroidism (SHPT), while CTAP101 is being developed for the treatment of vitamin D insufficiency.
Cytochroma is a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary products to treat and prevent the clinical consequences of vitamin D insufficiency and SHPT associated with CKD. The Company's vitamin D-based therapeutics are designed to safely and effectively treat patients with Stage 3, 4 or 5 CKD. In addition, Cytochroma is developing novel therapies to treat hyperphosphatemia in these same patients.
For more information, please visit http://www.cytochroma.com.
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