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FDA to be Flexible on Microarray Standards; Novartis Exec Suggests Pooling Biomarker Data

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The US Food and Drug Administration will likely be flexible on microarray standards in the drug-development process, said Larry Lesko, chair of the FDA Pharmacogenetics Working Group and the Clinical Pharmacology Section of the Medical Policy Coordinating Committee of CDER, on Friday.

He suggested that the agency is wary of producing rules that would stifle innovation in the industry. His comments echoed earlier statements by agency officials that because the use of microarrays in the drug-development process is quickly evolving, the FDA must be flexible in its approach (see BAN 8/4/2004).

Lesko’s comments came during the question-and-answer session in a webcast produced by the FDA’s Center for Drug Evaluation and Research focusing on the agency’s Critical Path initiative, a set of proposals intended to streamline drug development and evaluation by implementing new technologies throughout the drug development pipeline.

Held in a panel format, the webcast featured Lesko; Bob Temple, director of the CDER Office of Medical Policy and acting director of the Office of Drug Evaluation I; Doug Throckmorton, acting deputy director of CDER; Janet Woodcock, acting deputy commissioner for operations at the FDA; Mathias Hukkelhoven, senior vice president and global head of drug regulatory affairs of Basel, Switzerland-based Novartis; and Debbie Henderson, director of the Office of Executive Programs at CDER.

Also during the webcast, Novartis’ Hukkelhoven advocated sharing biomarker data among industry — a development that could help increase the use of pharmacogenomics technologies. Providing that pharma can protect its IP, it would be advantageous for industry to pool biomarker data, he said during the webcast.

Hukkelhoven’s statements coincided with a broader biomarker debate swirling around the FDA’s upcoming guidance for the use and submission of pharmacogenomics data. Many industry observers view the guidance as a potential boon for the use of existing tools, such as microarrays, and the development of new technologies.

“We’re looking at a flat pipeline,” with no growth in the rate of new drug applications, said Woodcock. That view was supported by several other panel members in their assessment of the need for the FDA’s Critical Path. Despite the rise of genomics, proteomics, bioinformatics, and other new technologies, the FDA noted in a 2003 white paper entitled “Innovation or Stagnation? — Challenge and Opportunity on the Critical Path to New Medical Products,” that the number of new drug and biologic applications, as well as medical device applications, submitted to the agency has actually declined since 2000.

Hukkelhoven suggested that sharing biomarker data among industry players could help fill the pipeline.

— EW, CW

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