ICON_Jan2021_CellandGeneTherapy - 11

on the ground " running these trials is a great way to
capture new challenges and talk about how problems
were solved. This " live " shared knowledge transfer
has proven to be a critical element of risk mitigation
during the pandemic. Having these weekly calls-

to as 'the most complex supply chain in the history
of medicine', in CGT trials logistics orchestration is

where our teams were encountering issues with every-

critical. Regardless of whether the program is an

thing from canceled shipments, deliveries, site access,

autologous, allogeneic cell therapy or a gene therapy,

and reassigned site resources to patient scheduling

we're working with living cells that are always time-

and cancellations-provided us the awareness that
allowed us to be proactive in developing solutions. "
Allenson says that for her, the fact that the calls are not

and temperature-sensitive. Product safety is directly
related to patient safety. " Joeckel adds, " This is a key
focus in our ICON CGT Training Academy curricula.

recorded allows everyone to be more candid-to air

We've developed procedures, proprietary tools, and

concerns, problems, challenges, and opportunities.

resources for managing the chain of condition and

" It's an open dialog of what is happening out in the

chain of custody from end to end. Our colleagues are

field right now, and that is very helpful, " she concludes.

trained in overall CGT best practices in addition to
protocol-specific requirements. "

" The fact that ICON has invested in these
resources-this dedicated infrastructure-to support

A key focus of best practices in logistics

these trials is an advantage for both our sponsors and

orchestration is at the sites. " As we've gained more

our teams. At ICON, we've internalized the importance

experience in CGT, we are confident in the capabil-

of this line of research and we want everyone set up

ities of specialty couriers and shipper technologies

for success. Just the fact that we provide our clinical
operations team weekly access to scientific and
operational experts like Brandon is a huge testament

in handling the cells. It's really a level playing field
with the service providers that manage the actual

to ICON's commitment. It's actually one of the key

transportation of the starting materials and final

reasons I joined the organization! " says Joeckel.  

doses, " says Joeckel. " The 'blindspots' we find in the
product journey are in the site procedures prior to
shipment and after delivery. Cell and IP handling are
critically important to avoid temperature excursions
and ensure product safety. Another key complication
is that every site has their own interdepartmental
processes that must be followed. Mock shipments
and validation of the detailed processes captured in
the IP manuals are very important in risk mitigation. "
For complex clinical trials such as these,
everything needs to move like a finely-tuned
orchestra, each part relying on the other. Lessons

Rost-9D / iStockphoto

from the field-the " feet on the ground " -are
ClinicalOMICs.com

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ICON_Jan2021_CellandGeneTherapy

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