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A crucial step in adding
market value to a IMP/NCE is providing evidence
that the compound actually works (Proof
of Concept). A "proof of concept"
study is needed to answer that crucial question,
does it work, before the drug development
process can move forward. |
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The traditional drug
development paradigm calls for Phase I studies
in human volunteers with doses up to the
maximum tolerated dose without measurements
of pharmacodynamic effects. Our ability
to accurately measure the in-vivo response
to a drug allows us to demonstrate the pharmacological
effects in a smaller number of individuals
and at lower doses. This forms the basis
for the Proof of Concept trials that aim
to confirm and describe the desired pharmacodynamic
effect in a small number of healthy volunteers
or patients |
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Pharmacodynamic markers
can often be shown in healthy volunteers.
These same markers correlate with a therapeutic
response when the drug is administered to
an affected individual. This allows valuable
drug-response information to be obtained
from Phase I studies. Such information can
play an important role in the design of
Phase II trials and in giving an early go-no
go answer to IMP/NCE development. . |
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Some useful
questions to ask before embarking on a POC
include: |
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Is the underlying science sound? |
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What constitutes
‘proof of concept’ for
this IMP/NCE? |
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What outcomes
are needed in order to continue on
the desired commercialisation pathway?
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What sort of
experimental and/or trial design will
maximise the value of the technology
to a third party? |
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