WASHINGTON -- FDA Commissioner David Kessler on Thursdayannounced that Kathryn Zoon, a career government scientist,has been appointed to fill the long-vacant director's job at theCenter for Biologics Evaluation and Research.
"Dr. Zoon was the driving force in the licensing of the firstinterferon product and in the licensing of other productsderived from biotechnology. She has represented the agencyglobally on issues involving biotechnology," Kessler said in aspeech to the Massachusetts Biotechnology Council.
Zoon, a 12-year FDA scientist, takes charge of overseeingbiotechnology review after having served as director of thedivision of cytokine biology since 1988. She received adoctorate in biochemistry from Johns Hopkins University andwas a postdoctoral and staff fellow at the National Institutes ofHealth for five years.
At the NIH, Zoon worked with Nobel laureate ChristianAnfinsen on the purification of human interferons. In 1980 shejoined the FDA as a senior staff fellow in the Center for Drugsand Biologics.
She told BioWorld that the CBER will conduct a review of itsoperations to identify ways to streamline the drug reviewprocess. She also said she intends to involve CBER scientistsmore actively in the process of designing clinical trials.
Zoon said she intends CBER "to be very proactive andinteractive with industry."
Industry leaders praised Zoon, emphasizing their confidence inher strong scientific background. "She was a pioneer indeveloping many of the guiding concepts of CBER today," saidJames Fenno, senior director of regulatory affairs at WinthropPharmaceuticals' immunoconjugate division.
"Our company has had extensive dealings with her, and Ibelieve that she has demonstrated real capacity for performinga variety of roles," said Steven Duzan, chairman and CEO ofImmunex Corp. and chairman of the Industrial BiotechnologyAssociation.
"There are an enormous number of drugs in clinical trialsmoving toward approval," Duzan noted. "How can a portion ofthe FDA that, like the rest of the agency, is underfunded copewith this enormous amount of products? It will require astreamlining of procedures."
Duzan said that another area that requires attention isestablishment licensing for drug manufacturing facilities.Current licensing procedures can impose very high costs thatare difficult for small biotechnology companies to absorb, hesaid.
-- Steve Usdin BioWorld Washington Bureau
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