Interview with: Dr Milen Vrabevski, Chief Executive Officer, Comac Medical, a contract research organisation attending the marcus evans Evolution Summit 2013 in Europe and the Evolution Summit 2014 in North America, on what is essential for a seamless clinical trial.

1. Interview with: Dr Milen Vrabevski,
Chief Executive Officer, Comac
Medical
Chief Medical Officers (CMOs)
sometimes fail to acknowledge what is
essential for seamless clinical
operations, according to Dr Milen
Vrabevski, Chief Executive Officer,
Comac Medical. “Successful trials are
primarily dependent on the physician’s
devotion to the concept of a potential
benefit to the patient and his or her
willingness to commit time. These
factors, in conjunction with a support
staff of experienced coordinators and
regulatory personnel, are essential for a
seamless effort. The “nuts and bolts” of
daily queries, Contract Research
Organisation (CRO) monitoring visits
and vigilance over accumulated data
still require physician oversight.
Nonetheless, the benefits outweigh the
time required,” he details.
Comac Medical is a CRO attending the
marcus evans Evolution Summit
2013 in Europe and the Evolution
Summit 2014 in North America.
How is the landscape of clinical
operations changing today? What
challenges and opportunities is it
presenting to CMOs?
CMOs are operating in an environment
that is constantly changing and with
various regulatory requirements. Many
companies conduct trials in developing
or emerging markets to reduce costs
and take advantage of their services.
For example, the Balkan and Baltic
regions are a highly attractive market
for conducting trials. They are non-
s a t u r a t e d , h a v e e x p e r i e n c e d
investigators and flexible logistics.
However, it is important to work with
CROs that are experienced and able to
manage in an unstable regulatory
environment.
What would help accelerate drug
development and delivery/time to
market?
It is not surprising that as development
costs have increased, the absolute
number of newly approved drugs has
constantly been decreasing for several
years. Together with the greater
scrutiny of the approval process, this
has created a growing problem both for
the drug industry and for patients who
are desperately waiting for new drugs.
It is therefore timely to consider how
new technologies (namely functional
genomics, proteomics and the related
field of toxicogenomics) can help speed
up drug development and make it more
efficient.
Ultimately, it will be market forces that
decide whether the pharmaceutical
industry will start using the large-scale
“-omics” approaches. If it leads to cost
savings, as we believe it will,
pharmaceutical companies will
inevitably adopt them. Secondly, by
removing the considerable cost and
delay of waiting for approval between
stages, we can widen the pool of viable
treatments and accelerate drug
development.
There is a desperate need for capital
efficiency and reduction of risk in
clinical development. We are
watching the adaptive clinical trial
design technologies that are available,
as they give CMOs the opportunity to
move forward and work faster. We see
that as a good opportunity to tap into.
What is unique about Comac
Medical’s approach?
We strongly believe that the time and
effort spent in planning a product’s
clinical development program directly
correlates with the chance of success.
Clinical Strategy Planning is the vital
innovation needed to survive today’s
challenges, includ ing financial
constraints, the high cost of execution
and competition. The right strategy
improves the decision’s quality. Our
personnel are highly experienced and
trained, and clearly comprehend the
cultural and professional peculiarities of
sites and investigators. They are able to
track and manage tools that encompass
the entire clinical trial process, providing
broad oversight capabilities.
What is key to clinical trial success?
What do Chief Medical Officers
overlook?
Better understanding the processes by
which drug candidates affect the human
body and identifying the cellular factors
and processes with which these
compounds interact will be the key to
improved therapeutics.
Improving clinical practice using clinical
decision support systems: a systematic
review of trials to identify features
critical to success.
Working with
experienced
CROs that are
able to manage
a diversified
regulatory
environment and
are committed to
timely delivery of
results is a key
success factor
Ensuring a Seamless Clinical Trial

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About Comac Medical
Comac Medical Ltd. founded in 1997 by Dr. Milen Vrabevski, CEO operates as a boutique full-service clinical research/site
management organization via own network of offices with more than 250 full-time employees.
14 CEE countries / 100 million population incl. Romania, Poland, Bulgaria, Georgia, and others.
Key achievements:
Certificate of Recognition by USA NIH
3 FDA inspected Sites (NAI letters)
EMA inspected Sites
Certified by French Govmnt Hospital-based EU CA-inspected Clinical Research units
ISO 9001:2008
DIA partner
CDISC partner
www.comac-medical.com
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To view the web version of this interview, please click here: www.pharmaceuticalseries.com/MilenVrabevski