www.biopharminternational.com May 2022 eBook BioPharm International 23
PARTING THOUGHTS
As parting thoughts, Mahler expresses
his belief that "outsourcing and the
development and commercialization
of medicines in genera l should be
more a 'system thinking' approach.
Companies or outsourcing services may
be getting so specific about one given
part of the product, that the inter-
connectivit y and dependency of all
the components of a drug product are
being forgotten: a sterile product can
only be reliably and reproducibly man-
ufactured if the formulation, primary
packaging, and processing parameters
are wisely chosen in its entity."
Furthermore, Mahler stresses the
importance of focusing on 'people'—
patients and employees—as well as the
planet. "We, at ten23 health, hence
embed considerations of fairness and
sustainability in all we do. There is
only one Planet," he adds.
Pretorius also points to the larger
operating system, observing that out-
sourcing can also prove beneficial in
t he a rea of reg u lator y operat ions
through a id ing w ith submissions,
product registration, tracking agency
interactions, and so on. "This [ser-
vice] requires working in tandem with
partner internal regulatory teams and
carefully defining roles and responsi-
bilities to assure alignment," he says.
"At Parexel, our regulatory outsourc-
ing teams consist of former regula-
tors from FDA, European Medicines
Agency, National Medical Products
Administration, among others with
specialized knowledge and first-hand
experiences of regulatory expectations."
While there is much to weigh and
evaluate, the uptick in outsourcing
appears well founded on benefits and
advantages. This has led to what might
be termed a 'run' on available sched-
uled slots within CMOs and CDMOs.
Currently, not only must one place a
large cash down payment but also the
requesting company must now face
wait times of around 12 months to
get their place in the que. However, in
this case good things take time, and
time taken pays dividends at the (pun
intended) finish line.
REFERENCE
1. PWC, Current Trends and Strategic
Options in the Pharma CDMO
Market, PriceWatershoueCoopers,
November 2019.
BP
Partnerships for Outsourcing Development
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www.medicalworldnews.com
While there is
much to weigh and
evaluate, the uptick
in outsourcing
appears well
founded on benefits
and advantages.
