Hycor Aims for Autoimmune Testing Market; Tenet Elects CEO’s Slate
Developing new products is one of the overweening concerns in the biomedical and medical device industries. The University of Southern California’s School of Pharmacy will examine the issue during a late October conference in Irvine.
“Clearing Roadblocks in the New-Product Path” is scheduled from 8 a.m. to 5 p.m. Oct. 27 at USC’s Orange County center, 2361 Campus Drive. The conference is intended for regulatory managers, product development managers and others who are interested in speed-to-market issues.
A program flier for the conference says delays in medical-device development result in shortened patent life, disappointed customers, lost sales revenue and investors either disappearing or filing lawsuits against the company.
Four “obstacle” sessions will be presented. Dean Baker, director of the Alfred E. Mann Institute and Dr. Gerald Loeb, a USC biomedical engineering professor, will present the first, “Technology Transfer Between Groups With Different Cultures.” “New Regulations for Design History and Risk Analysis” will feature James Kozick, Los Angeles district director of investigations for the U.S. Food and Drug Administration, and Al Hans of Hans and Associates.
“Designing and Implementing Animal Trials” features Paul Rudko, staff toxicologist, and John Brand, staff scientist with the Irvine office of NAMSA. NAMSA provides non-clinical testing services to ensure medical device safety and compliance. “Clinical Trials Impediments” speakers are Elaine Messa, a 30-year FDA veteran who now works for Quintiles Consulting’s Irvine office, Laurie Scheuch of Quintiles and Lucy Pearson of the University of California, San Diego.
Conference objectives include identifying key points at which product development can lag; exploring case studies illustrating the impact of lags; presenting strategies to anticipate and remove roadblocks and accelerate time to market. The Life Science Industry Council and the Orange County Regulatory Affairs Discussion Group are co-sponsoring the event.
Hycor Expects Boost from New Test
The chief executive of Hycor Biomedical Inc., Garden Grove, said the FDA’s recent decision giving it clearance to market a new autoimmune test in the United States gives it a good chance to “seize” what he characterizes as a multi-million dollar market for such testing.
“We intend to seize leadership of the autoimmune sector of the diagnostics market by offering the broadest disease-testing line available anywhere in the world,” J. David Tholen said in a news release announcing the FDA action. “The allergy- and autoimmune-testing markets, with annual potential of $675 million in revenue, are not currently served by a single major diagnostics manufacturer. Our strategy is to seize that significant opportunity.”
Hycor discovers, develops, manufactures and markets diagnostic products for various medical conditions. Its new test, called Anti-MPO (p-ANCA) ELISA complements Anti-Pr-3 (c-ANCA), a test that was previously cleared by regulators. Medical professionals use both tests to differentiate between various forms of vasculitis. Vasculitis is an inflammation of the blood vessels that results in reduced blood oxygen. Vasculitis also leads to damage of certain vital organs in the body because of restricted blood flow.
Bits and Pieces:
Shareholders of Tenet Healthcare Corp., which operates nine Orange County hospitals, elected a slate of directors put forth by company management to serve three-year terms on the board, according to a preliminary proxy count. Tenet’s slate, which includes Chairman and Chief Executive Jeffrey Barbakow, defeated a slate put forth by Dr. M. Lee Pearce, a dissident Tenet shareholder … Advanced Sterilization Products, Irvine, signed a partnership agreement with ican, a provider of online resources for infection-control professionals. Advanced Sterilization Products is a Johnson & Johnson unit … Wedbush Morgan Securities initiated coverage of Radiance Medical Systems, Irvine, with a “buy” rating and 18-month price target of $19 a share. Radiance develops site-specific radiation-delivery catheters used to prevent complications after interventional treatment of atherosclerosis … GKK Healthcare, Irvine, received a contract from Casa Colina Hospital for Rehabilitative Medicine in Pomona to design and build a replacement facility for Casa Colina’s rehabilitative hospital, adult day health center, children’s center and outpatient facilities. The project is valued at $29 million and will replace the current facility, which has 66 beds … Care Solutions, Newport Beach, formed a partnership with EBC Administrators, a workers’ compensation pharmacy network. Care Solutions, which primarily provides bill-review services for workers’ compensation medical claims, said that the EBC partnership would provide payers access to a discount pharmacy network … Trimedyne Inc., Irvine, said its Cardiodyne subsidiary received favorable results in a study of pigs. Pigs that were injected with Cardiodyne’s angiogenic “cocktail” grew new blood vessels … Techniclone Corp., Tustin, held investor road shows this month in Atlanta, Raleigh, N.C., and Fort Lauderdale, Fla. Techniclone develops cancer treatment technologies … Bristol Park Medical Group, Orange, received the Pacific Business Group on Health’s 2001 medical group blue ribbon award for patient care. Bristol Park is a St. Joseph Health System business unit.
