Boris Reznik of BioRASI LLC, a solution provider at the marcus evans Evolution Summit 2013, on the latest trends in the pharmaceutical industry. Interview with: Boris Reznik, Chairman, BioRASI LLC

1. What the Future of the Pharma Industry Holds
Interview with: B o r i s R e z n i k ,
Chairman, BioRASI LLC
Maximizing the probability of clinical
trial success is key, as pharmaceutical
companies are increasingly pressured to
reduce the time and cost of clinical
development, without compromising on
quality, says Boris Reznik, Chairman,
bioRASI LLC.
A contract research organization (CRO)
joining the marcus evans Evolution
Summit 2013, in Palm Beach, Florida,
May 8-10, as a solutions provider,
bioRASI LLC’s Reznik highlights the
latest trends in the industry.
What trends do you see in the
pharmaceutical industry globally?
The growth of emerging consumer
markets worldwide is prompting
pharmaceutical companies to take
deliberate steps for adhering to
regulatory requirements of not only the
US Food and Drug Administration (FDA)
and the European Medicines Agency
(EMA) but also other jurisdictions even if
rollout to those markets is not
immediately planned. For example,
including Russia into pivotal trial
geographies assures eligibility of the
drug for future registering there.
The industry is also experiencing
mounting pressure to reduce overall
costs of bringing new drugs to market.
With clinical development being one of
the most expensive components of this
process, the accepted paradigm of
outsourcing specialized services to CROs
continues to climb. CROs are now
accountable for maximizing the
probability of trial success and
maintaining high service levels while
minimizing both the time and cost of
development. This trend is causing the
pharma industry to re-evaluate their
exclusive relationships with multi-billion
dollar CROs and in certain cases to shift
alignment to small and mid-size CROs
who might be better at fulfilling the
entire spectrum of these requirements.
Additionally, sponsors are increasingly
looking to CROs to provide a scientific
angle, not only in development of
protocols or clinical trial designs, but
also in running them with the aim of
optimization. Agile CROs are responding
to this challenge by augmenting their
professional talent pool with MDs and
PhDs trained in particular areas of
specialty.
Leading CROs are progressing beyond
mere global presence to fully integrating
their geographic capabilities, the best
worldwide medical facilities, supply chain
management and e-clinical technologies.
Strong partnerships between pharma
companies and CROs optimize the
fulfillment of global regulatory
requirements eliminating the necessity
to duplicate trials.
Another trend is associated with an
increasing number of expiring
blockbuster drug patents. This is
opening up new areas of opportunities
for pharma and biotech companies.
Building upon existing successful small
molecule drugs, companies are
delivering to the market both generic
drugs and enhanced 505(b)(2) versions.
Similarly, biologics going off patent
create tremendous opportunities with
follow-on biologics, from biosimilars to
bio-betters and soon to inter-
changeables. Pharma companies are
searching for CROs that have
demonstrated experience in these areas
to avoid pitfalls that have been known to
derail biosimilar development. Not
surprising, companies are eager to
pursue simultaneous approvals from
FDA, EMA and other jurisdictions for
costly biosimilar drug developments.
In the wake of this trend some CROs are
emerging as experts in follow-on
biologics. The concept of inter-
changeability presents even greater
potential; biosimilars would require a
direct-to-physician sales force, which is
expensive. Interchangeable biosimilars,
however, can be sold directly to major
distributors and pharmacy chains,
because they can be substituted at those
levels, providing a far more cost-
e ffe c tive s trate gy f or ma rke t
penetration.
How can pharmaceutical companies
achieve the highest probability of
success?
Trial success requires a close partnership
between the sponsor and CRO in
advance of project design. With
collective focus on optimization, they can
determine the relative importance to be
placed on crucial trial variables. Focusing
on factors as if they are independent
leads to unintended consequences, for
example increasing the number of
patients naturally increases the trial
power, but also increases costs and
time. Since all program requirements
are in fact interconnected, solutions
must be developed with simultaneous
multidimensional considerations in mind.
This demands using a more scientific
approach when designing studies and
leads to a higher probably of success.
For example, selecting precise endpoints
measurements and reducing trial-
induced variability provides for a study
with a given number of patients having
higher power, or for the same trial
power but with fewer patients. This is
where novel principal investigator (PI)
interactive training reduces intra- and
inter-rater variability. Taking that a step
further, you can apply similar techniques
for training study subjects to minimize
inter- and intra-subject variability.
These types of scientifically designed,
and more importantly validated
methods, are exactly what the industry
leaders use.
Any final comments?
Billions of dollars have been needlessly
wasted on trials that have failed to reach
success or need to be repeated for
approvals in different jurisdictions. The
industry is moving toward leveraging
appropriate expertise, normally
associated with CROs, in the areas of
trial design and conduct to increase the
overall probability of success and
eliminate rerunning the studies.
Many
billions
of dollars
have been
wasted
on trials

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About BioRASI LLC
As a full service global CRO, bioRASI delivers “Clinical Research Optimized”. bioRASI provides expertise in the design and execution
of large complex clinical trials, supporting Specialty, Innovative and Biopharmaceutical companies bioRASI accelerates drug
development by optimally leveraging global resources and proficiency across a broad range of therapeutic indications, maximizing
quality, service levels, regulatory and industry acceptance, while minimizing time and cost.
www.biorasi.com
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