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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