Home' Australasian BioTechnology : Vol 27 No 3 Contents Australasian BioTechnology | Volume 27 | Number 3
Clinical vs Commercial
INTEGRATING THE CLINICAL
AND THE COMMERCIAL
Biopharmaceutical companies must navigate
a complex and fluid clinical development
pathway. Commercial surprises come in the
form of fast-changing payer landscapes,
changes in standard of care and new forces
impacting the valuation of a company
In the past, a traditional contract research organisation
(CRO) provided research and development (R&D) services.
Separately, contract commercial organisations (CCOs), or
standalone commercial solutions organisations (advertising,
communications, consulting), provided commercialisation
and life cycle management services. The separation of
these services on the supply side mirrored the separation
of these functions at biopharmaceuticals. As CEOs of
biopharmaceutical companies are learning, cross-talk
between the clinical and commercial organisations during
product development has become a business necessity.
It helps important medicines build in the necessary
components for a robust and thorough approval to treat
patients with high unmet needs.
Real-world evidence in development planning
Real-world evidence (RWE) can capture all the means to
anticipate possible obstacles at the earliest opportunity, and
generate the appropriate target product profile (TPP). It is
important that, at the Phase II/III planning stages, there is a
multi-stakeholder validated TPP and an integrated evidence
plan that positions the product appropriately in the
treatment paradigm ‘at launch’. It is also crucial to identify
the evidence gaps for not only the regulator, but also
payers, patients and physicians, to remove impediments to
reimbursement and maximise return on investment (ROI).
RWE is data derived from medical practice through
sources such as insurance claims, patient registries and
past clinical data. RWE could substitute for randomised
controlled clinical trials in support of a regulatory decision.
Recently, a panel of Federal Drug Administration (FDA)
and industry experts convened at the June 2017 Drug
Information Association (DIA) conference to discuss this
very topic. RWE based on
Medicare data is being used
in cardiovascular outcomes
trials, with some trials costing
significantly less than a
trial. RWE is also useful for
drugs with breakthrough
designation where the
treatment effect is expected
to be high. Here, RWE could
substitute for confirmatory trials for
drugs under accelerated approval.
Industry is taking the lead on RWE and the prize for
biopharmaceutical companies is reduced cost and
complexity of clinical trials, and potentially the broadening
of labels for approved drugs. But, as with any novel, fast-
moving standard, biopharmaceutical companies need
to be current on the appropriate methodologies and
analytics and, most importantly, on the indications, trial
designs and types of treatments for which RWE will be
appropriate in early product-development planning.
Pros and cons of product strategies
Fully integrated biopharmaceutical solutions can
support smaller companies in monetising their assets.
Traditionally, small companies have faced the decision
to proceed with funding support and/or partner their
assets. What is the right strategy and when is the right
time to implement it? The solutions are complex and
attentive to rapidly changing funding trends, product
development and pricing challenges, a competitive
landscape, and regulatory and policy-rich environments.
Long-term planning during product development
maximises opportunities and avoids pitfalls. A fully
integrated biopharmaceutical solution could model
all of the partnering scenarios to help a company
understand and attain the best option to progress
good science and medicines.
Jill McGuinn has more than 19 years of experience in the global
pharmaceutical industry, specialising in various aspects of business
development licensing and drug development.
BY JILL MCGUINN, VICE PRESIDENT, BIOTECHNOLOGY STRATEGY,
INC RESEARCH/INVENTIV HEALTH
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