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The FDA
has approved the first phase of a biomarker study to be
conducted by BG Medicine and the FDA’s
National
Center
for Toxicological Research (NCTR). Funded by a group of
seven pharmaceutical companies, the Liver Toxicity
Biomarker Study (LTBS) hopes to discover biomarkers of
human hepatotoxicity in the pharmaceutical companies’
standard pre-clinical test.
BG
Medicine and the NCTR will jointly conduct the study at
their
Massachusetts
and
Arkansas
laboratories. The first phase will last approximately nine
months.
BG
Medicine’s president, Peter Muntendam, is excited about
the project and its potential implications for drug
discovery, but he’s also pleased with the collective
approach to discovery. “This is a very serious attempt
to find a solution,” he said. “You have to work
together to solve projects like these collectively.”
The
project brings together BG Medicine, the NCTR, Pfizer,
Johnson & Johnson Pharmaceutical Research, Mitsubishi
Chemical, Orion, UCB, Sankyo, Eisai, and Applied
Biosystems. The seven pharmaceutical companies provided
funding and sit on the project’s Scientific Advisory
Board. Applied Biosystems will provide biomarker discovery
systems based on mass spectrometry and other support.
“It’s
a good model whereby you get their input and design
research projects that address their needs,” said
Muntendam of the partner companies.
Liver
toxicity is one of the primary obstacles to safely and
efficiently developing new drugs. As the most common
biological reason for drug failure in the development of
new drugs, liver toxicity affects one in six drugs in
development. The 40-year-old tests currently used for
toxicity often don’t reveal problems until the late
stages of clinical development.
With
such a widespread need for better toxicity data, it’s
not surprising that there are so many interested parties.
“After we’d identified the need and the basic
structure, we had to recruit the companies to fund it,
Muntendam explains. “There’s no Critical Path funding
for projects like these. We had to get all the companies
aligned.”
After
gathering their partners, BG Medicine went through the
remaining FDA approval and review process. “It takes
time,” says Muntendam. “But from concept to being
ready to start with seven [pharmaceutical] companies, we
did well.”
“This
model of collectively funding and designing research is
one that really works.”
Copyright
2007, Cambridge Healthtech Institute, All Rights Reserved.
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