06 July 2009 An Interview with Ted Gastineau - ICON plc

CWWeekly January 26, 2009 2 of 2
Special Profile Reprint: ICON Medical Imaging
nuclear medicine arena like PET, which has become
a big tool in functional imaging. Our challenge is
finding the right tool to apply to the right problem.
When a client comes to us, for example, in phase I,
and wants to understand, ‘Do I have a drug that’s
working?’, ‘How does it work?’, and ‘Is it worth
taking into phase II?’ These are different concerns
than those of a client who has a study in phase III
and says, ‘I think I have something here. We’ve
demonstrated proof of concept. Now I need to get
through the regulatory hurdles and get this drug
approved.’ One of the challenges is we have to
match up the right imaging application to the problem
that’s presented. Getting the science right and
the regulatory environment right is one part.
Working with FDA always provides opportunities
and challenges. FDA has been very interested, supportive
and articulate on how they would like medical
imaging to be used. Working with FDA to come
to agreement on what the right application is and
what the right inputs are and how you validate
those has been part of the challenge.
Multicenter clinical trials and the education of
our clients in the imaging space are also ongoing
challenges. If we have a multicenter trial with 50
sites, a minimum of 50 radiologists will be involved,
probably double or triple that, because whoever is
on call that day or whoever is reading the CT that
day is the one who is going to interpret the images
for your protocol. They aren’t necessarily trained in
the criteria. They don’t have the audit trails. In addition,
clinical practice is much different than clinical
trials. What we’re asking for is a little bit different
than managing a patient and treating a disease.
Managing variability is one of our challenges on a
day-to-day basis for complex, multicenter trials.
The last point, which is timely, is the financial environment
today. Many people are worried about trials
getting canceled, biotechs not getting funded,
research slowing and a new leader at FDA.All those
things will affect what’s going to happen with R&D.
At the same time, we have not seen slowdowns, our
bookings are good and our business is growing.We
have not seen an indication of trials being delayed or
being put on hold. Clearly, we’re all apprehensive.
For now, things remain strong. It’s to be determined
what will happen in 2009.
How has ICON Medical Imaging grown and
how will it grow?
The adoption of using imaging technology to
understand how drugs work—both anatomical
and functional imaging—has been growing
between 15% and 20% per year since 1997. We
see continued growth in the imaging space. Late
phase II/phase III have been the dominant areas
that companies have looked at in using imaging to
validate the efficacy of a product. Where we see
new growth areas and greater adoption more rapidly
is really around the outside of that, particularly
in the phase I arena, using some of the novel technologies
like PET and DCE-MRI. These are areas
where clients and project teams are looking to
understand how the drug works and whether they
have something that’s worth taking forward. Phase
I is an area where we are actively growing. One of
the nice things about being part of the ICON family
is that our IDS [ICON Development Solutions]
Group, which is the early drug development side of
ICON, has phase I units in Manchester, UK, and San
Antonio, Texas, that allow us to have access to
patients in a setting where we can also provide
medical imaging. We’ve done that successfully a
number of times in our Manchester, UK, office,
which is the largest phase I unit in the UK. That
allows us to do cardiovascular imaging, advanced
MR or advanced PET to look at drug areas.
We also use both imaging tools and the aggregation
of data to enable cardiac safety profiles for
data safety monitoring boards and cardiac event
committees. We have some academic partnerships
with people at Harvard, Cleveland Clinic, Brigham
and Women’s Hospital, UCSF and Oxford, UK, that
allow us to use thought leaders in the field in combination
with our technology to advance the cardiac
safety monitoring boards and the cardiac
events committees in a relatively simple way.
Finally, we are an industry leader in the development
of diagnostic imaging agents used for X-rays,
nuclear medicine, ultrasound, CT and MR. These are
injectable chemicals that make the images better
by enhancing special features that show the size of
a tumor, or brain function, or help detect targets for
a certain drug. We’ve had more than 15 years of
experience developing these agents, taking them to
the FDA and getting approval for them. We provide
everything from site selection and startup, clinical
monitoring, data management, blinded reads, statistics,
etc., a full-service integrated CRO offering
that’s specialized in imaging as a premier service
for the development of diagnostics.
Imaging is an important area and will continue
to grow and mature. We’re at a point today where
a whole-body, high-resolution scan can be done in
less than 10 seconds. The technology is incredible.
We certainly are excited and enthusiastic about
applying these tools to drug development. It’s an
area of science that really has the opportunity to
benefit the way drugs should be developed.
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