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In Critical Path Update, Novartis Official Says Industry Should Pool Available 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.

Providing that pharma can protect its intellectual property, 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.

Hukkelhoven’s statements, which were made during a webcast of panel discussion that included: 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.

Despite the rise of genomics, proteomics, bioinformatics, and other new technologies, the FDA noted in a 2003 white paper “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 declined since 2000.

The report concludes that, in addition to basic and translational research, new research is required to focus on creating effective products from new scientific discoveries.

Chris Womack, Pharmacogenomics Reporter editor


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