LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016
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are more about scope and flexibility.
Sponsors need flexibility to make scope
changes in requested project activities
as data is obtained and analyzed. Results
obtained in the sponsors' facilities or the
CMOs can narrow, expand, or refocus the
subsequent activities required to move
the project along. Results from safety,
pharmacology, clinical trials, or market-
ing assessments can impact the scope of
activities at the CMO. Flexibility may also
mean speed of progress needed, changes
in batch sizes, amount of testing required,
inability of CMOs to be more flexible and
accommodate schedule change requests.
For example, the inability to obtain
material on time may be costing the
sponsor in lost revenue, in extra costs
for back-up options, or in marketing
losses even before production starts. On
the other side, the production facility
tries to schedule six months to a year
out so that it can more efficiently plan
personnel and equipment needs to lower
its costs and raise operating margins.
To accommodate the sponsors' schedule
changes for whatever reasons, CMOs
have to maintain idle capacity, perhaps
expand to a seven-day week to then
shorten a production run, take on the
expense of storing larger inventories of
raw materials, and mess up the queue for
analytical work.
Moreover, where production is all
about scheduling, development projects
etc. It may mean changes in process or
formulation definitions that call for less
frequently used equipment, and at a vari-
ety of operating scales, e.g., for isolation
and drying, purification, granulation, or
testing. Oh, and of course, through it all
the sponsors will demand their project
remains prioritized over competing
activities at the CMO.
SPOILED OR SUCCESSFUL BEHAVIOR?
Having been on the side of the sponsor, I
know that all the above are not necessarily
What becomes important in an
outsourcing relationship is how to ensure
the two parties effectively contribute to
the business goals of each company.
In an industry where regulatory compliance is just the
starting point, WellSpring is committed to quality beyond
compliance. With WellSpring as your formulation,
development, manufacturing and packaging partner for
solid, semi-solid and non-sterile liquid products, you'll
get the kind of scientific expertise and technical support
that result in consistently high product quality and
complete fulfillment of your to-market goals.
Any CDMO can make it.
If you want it made better, choose WellSpring.
Your product can
be manufactured,
TRUST CAN'T.
made better
MEET US AT:
DCAT – March 14-17 | INTERPHEX – April 26-28
www.wellspringcmo.com