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Personalized Medicine

Personalized medicine gaining ground

Federal regulators continue to work with Biotechnology Executives to develop momentum for the Critical Path Initiative, according to an industry association.

Jim Greenwood, president and CEO of the Biotechnology Industry Organization, lauded the Department of Health and Human Services and the Food and Drug Administration in March on the release of FDA’s “Critical Path Opportunities” white paper.

“FDA is taking a significant step toward working with us to transform the vision of personalized medicine into a reality. Today’s report cited substantial opportunities for better diagnoses, more efficient drug development, and safer and more effective therapies, such as the identification and qualification of new safety and efficacy biomarkers,” Greenwood said.

“These advances will play an essential role in helping industry, regulators, and other stakeholders deliver on the promise of personalized medicine. For people living with unmet medical needs, overcoming road blocks to getting new products developed, approved, and utilized can be matter of life or death.”

The Critical Path Initiative is the result of the FDA’s investigation into the downward trend in applications for drugs, biologics, and medical devices. The first report of the series, released in March 2004, studied the slowdown in innovative medical therapies reaching patients.

“Biotechnology companies are leaders in modernizing the product development sciences that turn biomedical discoveries into breakthrough products. These companies are also advancing research that will enable better health care through personalized medicine. In this report, the FDA is acknowledging that personalized medicine will revolutionize health care in the future,” Greenwood said.

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