Joint Fellowship Training Program Fellows Haruhiko Murata, M.D., Ph.D. Phone:   301-827-6575. E-Mail:   Haruhiko.Murata@fda.hhs.gov Professional Background Dr. Murata received his M.D. and Ph.D. degrees from Washington University in St. Louis. He received an NCI-FDA Cancer Prevention Fellowship and subsequently earned an MPH degree in Epidemiology and Biostatistics from John Hopkins University. Research Interests</p> Dr. Murata's regulatory and research focus is on safety issues associated with vaccine cell substrates. The repertoire of cell substrates commercially available for the production of viral vaccines has been limited for many years by several safety concerns, foremost among them being the oncogenic risks perceived to be associated with the use of neoplastically immortalized cells. The theoretical oncogenic risks associated with using immortalized cell lines include the possibility that the final product may be contaminated with oncogenic DNA or latent or unrecognized oncogenic agents, both originating from the cell substrate. This issue remains a challenge for viral vaccine products, especially live viral vaccines, which by their inherent nature are administered in a relatively unpurified state. Dr. Murata is involved in the development of novel vaccine cell substrates that will be required to address the global effort to contain HIV infection, as well as effective responses to emergent threats such as SARS, pandemic influenza, and potential agents of bioterrorism, Fellowship Experiences "In addition to participating in the regulatory process, I am currently developing assays to identify oncogenes that are expressed in a particular cell substrate. The aim is to generate data that can be used to guide regulatory policy by allowing the functional classification of potential cell substrates according to the expression profile of oncogenes." Career Goals "After completion of my Fellowship, I hope to pursue a career in research or regulatory affairs."

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