PET projects
How can early and effective decision making be
made easier with novel imaging of biomarkers
and high-quality quantitative imaging trials?
Pharma and medical device companies have been
answering this question with the support of GE
Healthcare’s Imanet, an imaging solutions
business, for the past ten years.
Since 2001, one of Imanet's core efforts has
been
conducting exploratory phase Positron Emission
Tomography (PET) imaging studies to aid in drug
development for the pharmaceuticals industry since
2001. From
PET micro-dosing to dose-occupancy profiles, PET
imaging
assists decision makers to select the best drug
candidate,
monitor treatment response and make informed portfolio
management decisions. To be really successful,
the company also
believes that imaging in support of pharma and
device trials
needs to address a number of specific issues about
quality,
choice of imaging sites, novel imaging and analysis
methods.
Imanet combines PET imaging with their second
area of
emphasis: broad clinical R&D imaging capabilities.
This covers
everything from imaging protocol development to
analysis of the
image data using dedicated methodology and software
tools. The
in-house team can deliver blinded read hosting
and operates out
of centres of expertise in six countries worldwide.
Imanet's PET imaging services for drug development
have
emerged as both tactical and strategic methods
to evaluate drug
candidates in specific trials and drug programs.
Radiotracers for
PET have been used extensively for product and
dosage selection
in micro-dosing to Phase II studies. The in vivo
monitoring of
treatment response at a molecular level using
PET is also well
suited for molecularly targeted therapeutic drugs
in development.
De novo tracer development or radiolabelling of
therapeutic
candidates allows for subsequent down-selection
of molecules in a
drug portfolio via in vitro, ex vivo, and in vivo
preclinical methods.
The success of our clients' use of PET imaging
solutions
is critically dependent on the most effective
study design.
As an imaging solutions business, Imanet provides
a comprehensive imaging trial management service,
which encompasses the initial design through to
reporting endpoints.
Our comprehensive imaging trial services include
the following:
- Protocol development and integrated electronic
Case Report
Form (CRF) production
- Imaging site set-up including safety evaluations,
imaging
procedures and hands-on training of personnel,
and
alignment to local practices, ensuring the right
combination of
clinical expertise, patient population and imaging
equipment
- Submissions to regulatory authorities and
ethics boards, including documentation that
ensures regulatory compliance with the Imaging
Manual, Image Quality Control Manual and
Image Transfer Manual.
- Image transfer, automated anonymisation, effective
real-time
quality control checks and site feedback to
reduce the
number of non-evaluable image datasets
- Qualitative and quantitative analysis of results
(safety,
dosimetry and efficacy)
- Blinded reads, statistical analysis and endpoint
reporting.
Imanet has insight into the challenges of
PET in drug trials and
experience of providing solutions using PET
imaging in clinical
trials worldwide
|
 |
Company profile
Imanet
For further information, visit: www.imanet.com
imanet@ge.com
|
