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In Critical Path Update, Novartis Official Said Industry Should Share Biomarker Data


A Novartis Pharmaceuticals official advocated sharing biomarker data among industry in a US Food and Drug Administration webcast discussing the agency's Critical Path Initiative — 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, Mathias Hukkelhoven, senior vice president and global head of drug regulatory affairs of Basel, Switzerland-based Novartis, said during the webcast.

Using the example of "genomic signature" data concerning nephrotoxicity — an important component of toxicology research — "much" information can be shared without endangering companies' proprietary holdings, he said.

Hukkelhoven's statements, which were made during a webcast in which biomarkers featured prominently, coincided with a broader biomarker debate swirling around the FDA's upcoming guidance for the use and submission of pharmacogenomics data. Many in the pharmacogenomics industry view the guidance as a potential boon for the use of existing tools, and the development of new technologies.

The webcast, produced by the FDA's Center for Drug Evaluation and Research, focused 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 Larry Lesko, chair of the FDA Pharmacogenetics Working Group and the Clinical Pharmacology Section of the Medical Policy Coordinating Committee of CDER; 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; and Debbie Henderson, director of the Office of Executive Programs at CDER.

"We're looking at a flat pipeline," with no growth in the rate of new drug applications, said Woodcock. The view was echoed 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 submitted to the agency has actually declined since 2000, and the number of medical device applications has also decreased.

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

The primary obstacle, according to the report, is that "the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences." A key message is that the FDA doesn't plan to address the challenges of post-genomic drug development on its own, but is "proactively" reaching out to academic researchers, the biopharmaceutical industry, and patient groups for assistance.

The report called for modernizing the tools used to assess the safety and effectiveness of potential new products and for manufacturing novel therapies.

In the service of this aim, the report announced an upcoming "National Critical Path Opportunities List," which will identify those areas of product development that could most benefit from innovative approaches and emerging technological advances.

The list was initially intended for release before the end of the year, but it has been delayed for release in "several months," said Woodcock.

— CW


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