Medical Design Briefs - June 2023 - 38

Extending the
Commercial
Life of Mature
Products with
Strategic
Outsourcing
W
ith pharmaceutical companies
constantly innovating in search
of the next life-changing drug,
it can be challenging to stay on
top of the ones they already have on the
market. It is a crucial part of business, however,
as mature products by their very nature
are well established as effective treatments
for medical conditions and are still
sold in substantial volumes.
These products have also often established
the reputation of the companies
concerned (think Aspirin for Bayer, or
GSK and vaccines, for example), a reputation
they can ill-afford to be dented by
taking their eye off the ball.
The challenge for pharma is how to extend
the commercial life of mature products
while keeping maintenance costs
low and ensuring they adhere to everchanging
regulations across the globe -
all while juggling the innovation for new
products. While the high costs of bringing
a new drug to market are well known,
the pressures to support existing ones are
not insignificant, either.
38
Companies must perform pharmacovigilance
activities, maintain regulatory
dossiers and labels, and conduct ongoing
benefit-risk analyses to maintain
licenses. Another significant impost is
the need to uphold regulatory requirements.
With unique rules and varied outcomes
according to the market or region,
the regulatory maze can be tough
to navigate. But noncompliance can result
in regulatory action and poses considerable
financial risk if companies do
not meet requirements. It is, therefore,
imperative that pharmaceutical companies
explore models that will safeguard
mature products while enabling them to
invest in new product innovation.
The Second Wave of Outsourcing
Marketing authorization holders
(MAHs) should assess existing operating
models for the maintenance and management
of their mature products in
light of a growing awareness of the benefits
of integrated outsourcing. Rather
than the lift-and-shift outsourcing modwww.medicaldesignbriefs.com
el,
which relied on low-cost, largely offshore
staffing models to support mature
products, companies are now seeking a
more tailored approach with trusted
third-party providers. This integrated
model incorporates local support from
expert teams in mature markets, as well
as near and offshore capabilities.
The so-called second wave of outsourcing
is not just about reducing costs,
either. The incremental benefit for companies
that partner with external providers
is the knowledge wealth at their disposal,
with
fully
fledged
specialists
available
across the safety, regulatory,
and quality domains. When assessing
current operating models, MAHs should
consider the following:
* Location of target markets. Do you
have the local expertise to undertake
the work required in a cost-effective
way? Even if you have teams in key target
markets, you need to determine
whether they have the capacity to manage
mature products, as well as support
new launches.
Summer 2023 Resource Guide
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Medical Design Briefs - June 2023

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