06 July 2009 An Interview with Ted Gastineau - ICON plc
06 July 2009 An Interview with Ted Gastineau - ICON plc
06 July 2009 An Interview with Ted Gastineau - ICON plc
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CW<br />
Special Profile Reprint: <strong>ICON</strong> Medical Imaging<br />
<strong>ICON</strong> Medical Imaging, Warrington, Pa.<br />
<strong>An</strong> interview <strong>with</strong> <strong>Ted</strong> <strong>Gastineau</strong>, president<br />
Tell me about <strong>ICON</strong> Medical<br />
Imaging’s background.<br />
<strong>ICON</strong> Medical Imaging comprises a core group of<br />
people who have been working together for 10 to<br />
15 years in medical imaging for drug development.<br />
In 2000, we established Beacon Bioscience.Then, in<br />
2004, we entered into a partnership <strong>with</strong> <strong>ICON</strong> <strong>plc</strong><br />
when it acquired a 70% stake in Beacon Bioscience.<br />
Since then, we have operated essentially as <strong>ICON</strong>’s<br />
imaging division. In 2007, we changed our name to<br />
<strong>ICON</strong> Medical Imaging. Recently, <strong>ICON</strong> acquired the<br />
remaining 30% stake. <strong>ICON</strong> Medical Imaging typically<br />
works directly <strong>with</strong> pharmaceutical and biotech<br />
companies as independent providers of imaging<br />
services, but we also bundle our services for things<br />
like oncology, cardiovascular and CNS [central nervous<br />
system] <strong>with</strong>in the <strong>ICON</strong> family to provide full<br />
service opportunities and integrated services.<br />
What differentiates <strong>ICON</strong> Medical Imaging<br />
from other imaging companies?<br />
In the commercial space, we differentiate ourselves<br />
in three areas: people, technology and science.We<br />
have the most experienced people in the industry.<br />
We’ve been imaging for drug development continuously<br />
since 1991.We also hire and train people from<br />
the imaging environment for our project management<br />
team.The value-add we offer clients is really<br />
our expertise in imaging for use during drug development.<br />
All our project teams are led by imaging<br />
experts.When clients call, wanting to know what is<br />
happening at a particular site, the project manager<br />
doesn’t have to walk down the hall to get the information<br />
but clearly understands what’s happening in<br />
the radiology department.<br />
The second area that differentiates us is technology.<br />
We use a technology platform that’s built around<br />
a system called MIRA. Our MIRA platform is an<br />
image management/project management system.All<br />
of our data that we collect, whether these are medical<br />
images or SAS data sets or other PDF information,<br />
come into us electronically.We offer an end-toend<br />
digital package integrated <strong>with</strong> the sites.They<br />
can submit images and supporting information to us<br />
in a digital fashion, and it goes into our MIRA system.<br />
We manage the images and data, provide realtime<br />
quality assurance, manage timelines and workflows,<br />
and we generate the resulting efficacy data<br />
through blinded reads or quantitative analysis out of<br />
our MIRA system. Our project teams use MIRA to<br />
manage the trials. It’s also available 24/7 to our<br />
clients, which is an important feature. MIRA allows<br />
clients to understand where they are in the study,<br />
where any given image is in the process or where<br />
any given patient or study is in terms of submissions.<br />
They can access the same systems that our project<br />
teams use at any given time.This really enables them<br />
to best understand the study. In addition to that, if<br />
Year founded: 2000<br />
Year entered partnership<br />
<strong>with</strong> <strong>ICON</strong> <strong>plc</strong>: 2004<br />
Employees: 185<br />
Contact: Mark Eberhardt<br />
Tel: (267) 482-6336<br />
Email: mark.eberhardt@icon<strong>plc</strong>.com<br />
Web site: www.iconmedicalimaging.com<br />
they have a medical director, a scientific advisor or a<br />
safety board that needs access to a set of images to<br />
understand an adverse event or to understand how<br />
an early trial is going, they can access the images<br />
online and review those as well. Our technology<br />
offers image management, information management<br />
and data management that is digital and enables<br />
our clients.<br />
The third thing that differentiates us is the science.<br />
The core background of most of our staff<br />
comes out of the science of medical imaging. Our<br />
job is to help our clients understand how best to<br />
use medical imaging tools in the regulatory environment<br />
and develop those so that they have the<br />
best opportunity to put their drug through their<br />
protocols and get the best data possible out of it.<br />
We come to that <strong>with</strong> strong scientific input both<br />
from the therapeutic area and, importantly, from<br />
the imaging aspect of that application.<br />
What challenges do you face?<br />
Medical imaging is advancing very rapidly. We can<br />
do advanced MRI techniques like dynamic contrastenhanced<br />
imaging. We can also do things in the<br />
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From Volume 13, Issue 04. January 26, <strong>2009</strong>. Copyright © <strong>2009</strong> by CenterWatch. All rights reserved.
CWWeekly January 26, <strong>2009</strong> 2 of 2<br />
Special Profile Reprint: <strong>ICON</strong> Medical Imaging<br />
nuclear medicine arena like PET, which has become<br />
a big tool in functional imaging. Our challenge is<br />
finding the right tool to apply to the right problem.<br />
When a client comes to us, for example, in phase I,<br />
and wants to understand, ‘Do I have a drug that’s<br />
working?’, ‘How does it work?’, and ‘Is it worth<br />
taking into phase II?’ These are different concerns<br />
than those of a client who has a study in phase III<br />
and says, ‘I think I have something here. We’ve<br />
demonstrated proof of concept. Now I need to get<br />
through the regulatory hurdles and get this drug<br />
approved.’ One of the challenges is we have to<br />
match up the right imaging application to the problem<br />
that’s presented. Getting the science right and<br />
the regulatory environment right is one part.<br />
Working <strong>with</strong> FDA always provides opportunities<br />
and challenges. FDA has been very interested, supportive<br />
and articulate on how they would like medical<br />
imaging to be used. Working <strong>with</strong> FDA to come<br />
to agreement on what the right application is and<br />
what the right inputs are and how you validate<br />
those has been part of the challenge.<br />
Multicenter clinical trials and the education of<br />
our clients in the imaging space are also ongoing<br />
challenges. If we have a multicenter trial <strong>with</strong> 50<br />
sites, a minimum of 50 radiologists will be involved,<br />
probably double or triple that, because whoever is<br />
on call that day or whoever is reading the CT that<br />
day is the one who is going to interpret the images<br />
for your protocol. They aren’t necessarily trained in<br />
the criteria. They don’t have the audit trails. In addition,<br />
clinical practice is much different than clinical<br />
trials. What we’re asking for is a little bit different<br />
than managing a patient and treating a disease.<br />
Managing variability is one of our challenges on a<br />
day-to-day basis for complex, multicenter trials.<br />
The last point, which is timely, is the financial environment<br />
today. Many people are worried about trials<br />
getting canceled, biotechs not getting funded,<br />
research slowing and a new leader at FDA.All those<br />
things will affect what’s going to happen <strong>with</strong> R&D.<br />
At the same time, we have not seen slowdowns, our<br />
bookings are good and our business is growing.We<br />
have not seen an indication of trials being delayed or<br />
being put on hold. Clearly, we’re all apprehensive.<br />
For now, things remain strong. It’s to be determined<br />
what will happen in <strong>2009</strong>.<br />
How has <strong>ICON</strong> Medical Imaging grown and<br />
how will it grow?<br />
The adoption of using imaging technology to<br />
understand how drugs work—both anatomical<br />
and functional imaging—has been growing<br />
between 15% and 20% per year since 1997. We<br />
see continued growth in the imaging space. Late<br />
phase II/phase III have been the dominant areas<br />
that companies have looked at in using imaging to<br />
validate the efficacy of a product. Where we see<br />
new growth areas and greater adoption more rapidly<br />
is really around the outside of that, particularly<br />
in the phase I arena, using some of the novel technologies<br />
like PET and DCE-MRI. These are areas<br />
where clients and project teams are looking to<br />
understand how the drug works and whether they<br />
have something that’s worth taking forward. Phase<br />
I is an area where we are actively growing. One of<br />
the nice things about being part of the <strong>ICON</strong> family<br />
is that our IDS [<strong>ICON</strong> Development Solutions]<br />
Group, which is the early drug development side of<br />
<strong>ICON</strong>, has phase I units in Manchester, UK, and San<br />
<strong>An</strong>tonio, Texas, that allow us to have access to<br />
patients in a setting where we can also provide<br />
medical imaging. We’ve done that successfully a<br />
number of times in our Manchester, UK, office,<br />
which is the largest phase I unit in the UK. That<br />
allows us to do cardiovascular imaging, advanced<br />
MR or advanced PET to look at drug areas.<br />
We also use both imaging tools and the aggregation<br />
of data to enable cardiac safety profiles for<br />
data safety monitoring boards and cardiac event<br />
committees. We have some academic partnerships<br />
<strong>with</strong> people at Harvard, Cleveland Clinic, Brigham<br />
and Women’s Hospital, UCSF and Oxford, UK, that<br />
allow us to use thought leaders in the field in combination<br />
<strong>with</strong> our technology to advance the cardiac<br />
safety monitoring boards and the cardiac<br />
events committees in a relatively simple way.<br />
Finally, we are an industry leader in the development<br />
of diagnostic imaging agents used for X-rays,<br />
nuclear medicine, ultrasound, CT and MR. These are<br />
injectable chemicals that make the images better<br />
by enhancing special features that show the size of<br />
a tumor, or brain function, or help detect targets for<br />
a certain drug. We’ve had more than 15 years of<br />
experience developing these agents, taking them to<br />
the FDA and getting approval for them. We provide<br />
everything from site selection and startup, clinical<br />
monitoring, data management, blinded reads, statistics,<br />
etc., a full-service integrated CRO offering<br />
that’s specialized in imaging as a premier service<br />
for the development of diagnostics.<br />
Imaging is an important area and will continue<br />
to grow and mature. We’re at a point today where<br />
a whole-body, high-resolution scan can be done in<br />
less than 10 seconds. The technology is incredible.<br />
We certainly are excited and enthusiastic about<br />
applying these tools to drug development. It’s an<br />
area of science that really has the opportunity to<br />
benefit the way drugs should be developed.<br />
Copyright © <strong>2009</strong> CenterWatch. Duplication of this publication is prohibited.<br />
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