Power of partnerships
Positron emission tomography has become an important
way to monitor therapies, but the
trend towards molecular technologies has forced
companies to expand their remit to maintain
customer satisfaction. Eric Agdeppa, GE Imanet,
explains how partnerships have created
new competencies in anti-body fragments and non-imaging
biomarkers.
In 2001 GE Imanet established a market-leading
imaging
service for the global pharmaceutical industry.
At first, the
networks focus was on small-molecule tracers,
used for
imaging the central nervous system during studies
into dose
optimisation and neuroreceptors. A decade later,
the network
plans to maintain its prominent position by partnering
with
outside companies to create new competencies for
its clients.
According to Eric Agdeppa, imaging solutions
manager at
GE Imanet, the new services that the network can
deliver
to the pharmaceutical industry constitute major
changes.
Weve gone from having all our internal
capabilities offered
to pharma to partnering external companies to
complement
the core capabilities were missing,
he says. For example,
we can provide clients with the antibodies and
antibody
fragments from ImaginAb, and the non-imaging techniques
from Neuroimage. Those are just two examples of
how we
are broadening our capabilities by recognising
that our core
competencies in small-molecule PET need to be
enhanced
with outside capabilities.
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"Partnerships have
reduced the amount of money that Imanet
would have spent on an internal development
programme."
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Partnership keeps pace
Imanets partnership with ImaginAb, for example,
has given it the capacity to supply recombinant
antibody fragments as PET tracers, something that
has kept it up to date with the new molecular
wave.
The genomic proteomic revolutions have
created new
molecular targets for diagnostic and therapeutic
purposes
in recent years, Agdeppa explains. Pharma
is now reducing
its reliance on small molecules and antibody therapies
are
outpacing the growth rates of small molecules,
therapeutic
proteins and vaccines.
The company has increasingly leant towards the
needs
of the oncology function, previously partnering
contract
research organisations such as Quintiles, HMR
and
CDST, but now extends to other imaging technologists.
Imanets new partner Neuroimage enables
clients to
link non-imaging biomarkers with PET data in proof
of
mechanism, proof of concept and proof of principle
studies.
Likewise, its relationship with VirtualScopics
will leverage the
formers portfolio of tracers with the latters
advanced image
analysis and modelling capabilities for the oncology
facility.
Agdeppa believes that his field has changed in
terms of
increasing emphasis on using biologic targets,
the use
of biologics as therapeutics and the popularity
of using
macro rather than small molecules.
The best way for us to provide our service
is to partner
those companies that already have expertise in
macro
molecules as opposed to spending lots of money
and
time ramping up our own know-how, Agdeppa
explains.
Were trying to be more nimble.
Sourcing these technologies from third parties
rather than
in-house R&D keeps costs down for Imanets
customers.
Overcoming challenges
The company has spent ten years making PET trials
less
taxing for its customers, overcoming three main
challenges:
PET ethics, regulation and tracer stability. PET
not only needs
a radiation safety approval from each institution,
according to
Agdeppa, but also an institutional ethics review
for the centre
running the trial. Imanets three centres
in the UK, Sweden
and Finland have a strong working relationship
with the
radiation committees that regulate their work.
Theyre familiar with us weve
done hundreds of trials
that needed reviews, so many that the process
has almost
become trivial, says Agdeppa.
In human trials, PET tracers require government
approval
to be used in combination with therapeutic drugs.
In the US,
tracers need exploratory investigational new drug
status and
in Europe they need a PET micro-dosing package.
Another
reason that the company has become a preferred
partner
in drug trials is its established portfolio of
over 40 PET tracers.
Furthermore, the radiotracers are produced using
an automatic
system rather than a manual synthesiser, which
is, as Agdeppa
explains, almost like miniature chemical
engineering.
The use of a computerised system reduces the
number
of lost or failed runs and stabilises the yield
and purity
of the tracers for the duration of the trial.
For ten years, the PET arm of GEs Healthcare
unit has
built up experience and product range for its
clients and,
even during a period of intensive biotechnical
change, this
year is no different. This innovative service
delivery model
is just the thing to sharpen Imanets competitive
edge.
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