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Fujirebio Diagnostics Chief Scientific Officer Named to Immunology Devices Panel Of the Medical Devices Advisory Committee; Committee Offers Independent Professional and Technical Advice to U.S. FDA
Business Wire, May 2, 2006
MALVERN, Pa. -- Fujirebio Diagnostics, Inc. (FDI), a world-leader in in-vitro diagnostics, today announced that its vice president and chief scientific officer, Dr. W. Jeffrey Allard, has been named as an industry representative to the Immunology Devices Panel of the Medical Devices Advisory Committee, a group of outside experts that gives independent professional and technical advice to the U.S. Food and Drug Administration (FDA). Allard will provide diagnostics oncology expertise to the Immunology Devices Panel over a four-year term.
"Jeff's considerable experience in diagnostics oncology has been a great asset for Fujirebio Diagnostics as we develop and launch new diagnostic technologies that may improve care for cancer patients," said Paul Touhey, FDI president and chief operating officer. "Jeff will provide the Immunology Devices Panel of the Medical Devices Advisory Committee insightful recommendations regarding the safety and efficacy of in-vitro diagnostic devices."
The Medical Devices Advisory Committee consists of 18 panels, each addressing a different medical device specialty. The panels, which typically meet one to three times per year, review and evaluate data on the safety and effectiveness of marketed and investigational In-Vitro Diagnostic Devices (IVDs) and make recommendations to the FDA regarding regulation. The FDA considers these recommendations when it makes its final decisions. Five panels of the Medical Devices Advisory Committee cover IVD specialty areas, including the Immunology Devices Panel.
Dr. Allard is a biochemist and immunologist with more than 25 years of industry experience. As vice president and CSO at FDI, Dr. Allard is responsible for evaluating new product candidates, expanding FDI's global network of in-licensing institutions and promoting the company's relationships with research organizations. Prior to joining FDI in 2004, Dr. Allard held positions at Immunicon Corporation, where he served as vice president of clinical research and development; Bayer Corporation, where he was director of clinical and regulatory oncology; and E.I. du Pont de Nemours, where he was a diagnostics researcher. Dr. Allard holds eight patents for key diagnostic processes, has authored nearly 100 scientific papers and abstracts, and has received numerous scientific awards. He holds a Ph.D. in biochemistry from Dartmouth College, an M.S. in immunology from Idaho State University and a B.S. (cum laude) in pre-veterinary medicine from the University of New Hampshire.
About FDI
Fujirebio Diagnostics, Inc. (FDI) is a premier diagnostics company and the industry leader in tumor marker assays. FDI specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. In November 1998, Fujirebio, Inc. of Tokyo, Japan, acquired the company, formerly known as Centocor Diagnostics. FDI utilizes its worldwide distribution network to enable access by physicians and patients to its diagnostic products. For more information about FDI, please call 610-240-3800 or visit www.fdi.com.
Forward-Looking Statement
Any statements in this press release about future expectations, plans or prospects for the Company, including the Company's expectations and its plans to complete the FDA approval process for MESOMARK constitute forward-looking statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. FDI undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect FDI's business.
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