ICON_Jan2021_CellandGeneTherapy - 12

The Critical Role of a CRO in Cell and Gene Trials

critically important. " The thing that I find the most

order the courier. We order the shipper and collection

challenging about monitoring CGT studies is that

kits that get packed out and overnighted via air

there are multiple moving pieces, as many as 10 to

to the manufacturing facility, which needs to start

15, " says Sarah Allenson, Senior Clinical Research

the manufacturing process as soon as they receive

Associate with ICON. " Picture a clock with gears and

it. And if a patient becomes ill or cannot make the

how they work together. If you move this gear it

appointment, which is often the case in CGT, we're

affects another gear and that changes another gear.

rearranging everything from end to end. "

And if something gets stuck in the gear, it can wreak

With so much riding on the timely pickup and

havoc all down the line. That's pretty much what we

delivery of the cells and proper handling, it is not

live and breathe every day in a CGT trial. It's all about

surprising that the COVID-19 pandemic has further

the details. "

challenged sponsors and their CRO partners to

Allenson notes, " The cohorts of CGT trials are
typically not large, perhaps only a dozen or a couple
dozen participants, and can be spread among

ensure the collection, packing, and delivery of cells
continues to go off without a hitch.
" This became very evident during the Covid

multiple trial sites. That means arranging apheresis

pandemic. We have to pay close attention to staffing

for the participants in multiple locations, all on the

changes and reassignments to ensure anyone

day before the cleanroom is available. We schedule

handing the IP is properly trained. Training and

the patient for the apheresis. We collect the cells. We

reminders have become a standard practice, " says

12 |

ClinicalOMICs.com
http://www.ClinicalOMICs.com
ICON_Jan2021_CellandGeneTherapy

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