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Neil Nelson, President and Chief Services
Officer
R&D outsourcing is becoming not just a
trend, but a way of life — and survival — for even the
largest pharmaceutical companies. The following text is
taken as an excerpt from an article published in
PharmaVoice magazine entitled “Outsourcing: A Vital
Clinical Strategy.” To download the complete article click here.
Is it more effective to outsource
certain R&D activities to an innovative organization
than to acquire that organization?
Yes. If the innovative organization is
acquired, then its inventiveness will over time become
stifled by the controls that are inherent to larger
organizations. The regulatory controls are the same for
all firms involved in the manufacture of pharmaceutical
products. Smaller, innovative organizations save a great
deal of time in areas such as purchasing, HR, and
communications because decisions are usually made
quickly, and action is taken that results in shortened
cycle times.
Are larger pharmaceutical
companies more capable of cGMP compliance than smaller,
innovative organizations?
No. Compliance with cGMP is actually
easier to achieve in smaller, innovative organizations.
Once alignment has been achieved regarding compliance
deliverables, the innovative organization will quickly
organize to achieve these deliverables.
Is it true that smaller,
innovative firms can do things faster because they are
willing to take risks that large, established
pharmaceutical firms will not take?
Yes. But these should not be regulatory
exposure risks.There are risks that can be taken that do
not compromise cGMP compliance. Employees at smaller,
innovative firms are often encouraged and empowered to
both propose and take risks that close the gap between
scientific soundness and compliance with cGMP. The
culture and modus operandi are effective in decreasing
the time required to move a compound through the R&D
process.
Does acquisition (compared with
outsourcing) provide more control of proprietary
information?
No. Firms that provide outsourcing
services are highly motivated to protect their
customers’ information. It is in their interest to do so
to protect their reputation and secure future business.
Is in-sourcing a team of
innovative people as effective as outsourcing to a
similarly innovative organization?
No. Although in-sourcing can work in a
highly disciplined and well championed environment, in
reality the in-sourced group will tend to lose its
innovative edge as influenced by even limited sponsor
management and QA oversight.
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