LIFESCIENCELEADER.COM
45
MARCH 2015
goals and measurements before engaging
suppliers.
CATALYSTS: FDASIA, AND AN OIL SHOCK?
Xavier Health hosts two annual confer-
ences: PharmaLink for biopharma and
MedCon for medical device. Discussions at
both identified the need for the Integrity
of Supply Initiative. Lowndes of Shire
sits on the governing board. "The overall
initial driver and why I got personally
interested was because of FDASIA [Food
and Drug Administration Safety and
Innovation Act of 2012]. Embarrassingly
for our industry, the FDA has
legislated
for us to pay more attention to our own
supply chains," he says.
He adds, "It was important when the
FDA came out with a clear message
regarding what they saw as the issues,
and their desire to work with us. I think
back to the PharmaLink conference when
we talked about why FDASIA was being
put in place, specifically Title 7 for the
safety and quality of supply and Title 10
for drug shortages."
Both Lowndes and Phillips bring up
another seminal scene that unfolded dur-
ing a 2014 meeting of Initiative leaders.
Norman McLennan, VP of supply chain
at Sasol Petroleum International (U.K.),
presented on his industry's best practices
for working with suppliers.
"He brought the whole upside-down
nature of the way we look at our suppli-
ers to light," Lowndes explains. "Here's oil
and gas saying they treat their suppliers
as if they are dependent upon them and
need to look after them. Meanwhile, we
often behave as though the opposite is
true, as if they should be glad to have us
as customers even while we are depen-
dent on their performances to meet the
profound needs of our patients."
READY FOR A NEW ATTITUDEā¦
AND MODEL?
Lowndes presides over a fully outsourced
supply chain for some Shire products.
PharmaLink was a vehicle to interface with
the FDA and fellow biopharma compa-
nies, and a way to share best practices. He
also wants to change the entire supplier-
manufacturer business model.
According to Lowndes, the current
model was created by "Big Pharma mov-
ing late life cycle products out of their
plants to make space and harvest as much
residual value as possible. The process is
frequently led by a part of a procurement
organization. CMOs get negotiated down
to small margins for large quantities."
Unfortunately, this leads to a need to
standardize production and relationships
to drive efficiency. It might have worked in
the past with high-volume products, but
with the increasing demand for specialty