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Pharmacoeconomics
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evidenced by the promising results achieved in its technology
validation studies, HµREL
will enable researchers to achieve experimental toxicity, metabolism/bioavailability,
and efficacy endpoints of dramatically improved concordance
with, and predictive relevancy to, the in vivo performance
of drug candidates in both animals and humans. HµREL’s
predictive accuracy will afford greatly improved selectivity
in promoting preclinical candidates into both animal studies
and subsequent human clinical trials; as such HµREL
will become an important new technological substitute for animal
testing. The consequences of HµREL’s
improved predictive accuracy are projected to include:
• reducing the number (per FDA approval)
of animals committed to animal testing;
• increasing throughput (i.e., success rates) in human
clinical trials;
• reducing the average time-length of the R&D investment
carrying period (per FDA approval), and therefore reducing
the drug development firm’s aggregate cost of capital;
• accelerating time-to-market and product revenues;
and
• preserving proprietary patent life.
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Of the roughly $800 million average, fully-burdened cost of
developing a new drug*, the Company
estimates the potential aggregate economic benefit of the
above-listed impacts to be on the order of $100 million, or
more, for each drug that ultimately wins FDA marketing approval.
* Tufts Center for the
Study of Drug Development, Boston |
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