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Genomics Hasn t Solved Pharma s Pipeline Problem, But FDA Proposes a Solution

NEW YORK, March 16 (GenomeWeb News) - A new white paper from the US Food and Drug Administration outlines a new FDA initiative to translate the promise of biotechnology into improved healthcare by driving recent technological advances in early discovery through the later stages of the drug development pipeline.

Despite the rise of genomics, proteomics, bioinformatics, and other new technologies, the FDA notes 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. The primary problem, 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 in the report, "Innovation or Stagnation? -- Challenge and Opportunity on the Critical Path to New Medical Products," 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. 

"With so much promising technology in development in the clinical labs, ranging from engineered tissues to new kinds of biologicals and genomics-based treatments, we need to turn the process of bringing these technologies to patients from a costly and time-consuming art form to a well-understood science," said FDA commissioner Mark McClellan in a statement. "FDA intends to launch a new effort with our public and private partners in improving the public health to turn the critical path of product development into a fast, certain, and more affordable process, to improve access to better treatments for all Americans."

The report concludes that in addition to basic and translational research, a third type of research is required that will focus on creating effective products from new scientific discoveries. The report calls for modernizing the tools used to assess the safety and effectiveness of potential new products and for manufacturing novel therapies. "Often, developers are forced to rely on the tools of the last century to evaluate this century's advances," the report notes, "and the situation does not appear to be improving."

The report suggests the collaborative development of a "National Critical Path Opportunities List," which will identify those areas of product development that could most benefit from innovative approaches and emerging technological advances.

FDA said that the next steps in its initiative include a series of workshops and meetings, development of the National Critical Path Opportunities list, and realignment of its internal project emphasis.

Lester Crawford, FDA deputy commissioner, said that the agency's upcoming April Science Board meeting "will be devoted to this topic."

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