GAITHERSBURG, Md., Aug. 5 Panacea Pharmaceuticals, Inc.today announced the appointment of Suzanne Sensabaugh as Vice President,Regulatory Affairs. Ms. Sensabaugh will assume responsibility for formulatingstrategies and managing all U.S. and foreign regulatory filings for theCompany's therapeutic and diagnostic products. This role is of criticalimportance as the Company prepares to file applications with the U.S. Food andDrug Administration for approval of its prostate and lung cancer diagnostictests, and to begin clinical trials of its cancer and neuroprotectanttherapeutic products within the next 12 months.
"We are very pleased to welcome Suzanne to the team at Panacea", commentedHossein Ghanbari, Ph.D., Chairman, CEO and Chief Scientific Officer at PanaceaPharmaceuticals. "Suzanne brings a breadth of regulatory experience relatedto therapeutic products and particularly monoclonal antibodies, in industryand with the FDA. Her experience is particularly important as we progressPAN-622, our lead cancer therapeutic which is an all-human sequence monoclonalantibody, toward Phase I clinical trials in early 2009."
Just prior to joining Panacea, Ms. Sensabaugh held the position of VicePresident, Biopharmaceutical Development, MDS Pharma Services, where she wasresponsible for managing and directing the consulting group in Development &Regulatory Services and providing professional guidance to clients. She hasmore than 10 years of experience with the Center for Biologics Evaluation andResearch (CBER) within the U.S. Food and Drug Administration as a researcher,product reviewer, and inspector for biologics. She also was involved in thedevelopment and implementation of SOPs, guidance, regulations, and laws. Ms.Sensabaugh began her industry career as Associate Director, RegulatoryAffairs, at Genzyme Corporation where she directed, planned, and implementedglobal regulatory activities. She has held senior positions as Vice President,Regulatory Affairs & Quality, at SICOR Inc., Biotechnology Division, where shewas responsible for global regulatory affairs, quality assurance and control,and Vice President, Regulatory Affairs, and Senior Director for GlobalBiogenerics, at Teva Pharmaceutical Industries Ltd., where she developedregulatory strategy and submissions for biotechnology products. Ms.Sensabaugh received her MBA from Duke University, MS in Biotechnology fromJohns Hopkins University, and BS in Zoology from the University of Maryland.She teaches clinical development of drugs and biologics at Johns HopkinsUniversity.
"I am excited to add Suzanne to our team. Her expertise and experiencewill be critically important as we move toward clinical development of ourcancer and CNS therapeutic products," commented Stephen N. Keith, MD, MSPH,President and Chief Operating Officer. "We will continue to strengthen ourmanagement team, looking to add scientific and managerial staff withexperience in biotechnology and pharmaceuticals. I am confident that Suzannewill play an important role in facilitating the success of our therapeutic anddiagnostic products."
About Panacea's Oncology Platform
In addition to the cancer therapeutic PAN-622, Panacea offers: PCDetect(R), a diagnostic test used in conjunction with PSA and digital rectalexam to identify patients with prostate cancer; LC Detect(sm), a diagnostictest to aide in the detection of patients with lung cancer; BC Detect(sm), adiagnostic test to aide in the detection of recurrence of breast cancer; CCDetect(sm), a diagnostic test to aide in the detection of colo-rectal cancer;and TK Sense(R), which determines whether white blood cells from patients withchronic myelogenous leukemia (CML) are sensitive or resistant to imatinib, thetherapy of first choice for CML patients, prior to initiation of therapy.Each of these tests is offered as a laboratory service performed by PanaceaLaboratories (www.pa