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International Clinical Trials
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Maria V Lopez-Bresnahan of
PharmaNet/i3 speaks to ICT about her experience in the industry and how
she envisages the future of clinical research
ICT: What was your entry point into the clinical trials industry?
Maria V Lopez-Bresnahan: I joined the pharmaceutical industry from
academic medicine, where I had been involved in clinical trials as an
investigator. I worked fi rst at Astra, and then Serono, which gave me
the experience of consolidation in the industry as they merged to become
AstraZeneca and Merck Serono. They both gave me a great sense for the
global nature of the drug development process. From there I joined the
CRO industry, i3 Research, which is now part of PharmaNet/i3, an
inVentiv Health Company, and found that this industry provides a unique
vantage point for what’s happening across drug development and
commercialisation.
Which part of your current job do you most enjoy?
Understanding a client’s problem and providing them with a solution that
solves that problem is very gratifying. They come to us, as the service
provider, with a sometimes quite urgent need that we can fi x. It’s
great to partner with clients and be part of achieving their goals.
Which part is the most challenging?
Because drug development is complex and engaging, it’s easy to become
overly involved in a client’s programme, and hard to draw rigid lines
around the scope of work. That can create a business challenge.
How would you describe your business philosophy?
Innovation rules the day. It’s a cliché, but if you can think of a way
to solve a problem in a different way, that can save resources, then you
will win. This concept holds for small things and big things and it’s
accretive, but it means you have to let go of preconceived notions of
how things have to work. If someone pushed back on innovation, they’d
better have a very good rationale.
What drives you?
The sense of a trajectory in the business: we’re here now and we will
get over there. That sense of objectives and goals is motivating and
drives individuals, but more importantly, it drives the enterprise.
When are you happiest?
When I am busy and intellectually engaged addressing a challenge. Our
business has so many facets that draw you in,whether it’s leading a
team, building or revamping the organisation, or thinking of
innovations. There is always something happening and if there isn’t,
then you can make something happen. That’s fun.
What keeps you awake at night?
The global economy; that sounds grandiose, but it’s pretty remarkable
how this recession has impacted and permeated all of business – from
lack of funding for start-ups and biotech to restructuring of Big
Pharma. No one has been immune to this situation, which is still labile
and creates a challenge in forecasting.
What do you think the clinical trials sector needs to focus on over the next year?
Technology. We have wrung out many inefficiencies in clinical trials
already, so what can we do that will be more radical? We need to exploit
the technologies that we already have more effectively and more
broadly, and subsequently to implement business technologies in clinical
trials that we don’t already use and haven’t thought of using. This
will allow us to make leaps in productivity, not just incremental steps.
How do you think the industry will change over the next 10 years?
The business models will become more fl exible and much more
interesting. As mergers continue, there will be internal ‘boutique’
organisations within large companies to serve particular client needs,
with specialists to address the unique questions of programmes in
particular therapeutic areas.
What is the most important lesson you have learnt?
As a leader, never give up on your vision within the enterprise. Your
vision is what sustains you and the organisation. If you believe in it,
you will make it happen.
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