ICON_Jan2021_CellandGeneTherapy - 7

Cell and Gene Therapy Clinical Trials - The Promise and Complexity of Living Therapies

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This is especially true since, for many sponsors, the

opportunity to work on multiple trials with unique

CGT trial they are embarking on is their first.

requirements. The lessons we learn in executing

CROs play a critical role in both the growth

across therapeutic areas and technologies provides

and demand for resources for these trials and in

a lens of foresight we can offer our sponsors. We

capturing lessons learned and best practices in an

sometimes refer to it as our ability to see around the

area of clinical research that has no handbooks and

corner and know where the pothole is. Our role is to

few standards to follow.

steer around the pothole! "

" It is hard to know what you don't know. I think

" ICON has been working with CGT trials from the

this is the biggest 'boogeyman' for sponsors, " says

beginning, starting with CAR-T trials in oncology. "

Brandon Fletcher, Ph.D., Principal, Clinical Project

states Tamie Joeckel, Global Business Lead for the

Management, ICON plc. " They are stepping into

Cell and Gene Therapy Center of Excellence. " We joke

something, and they don't know if it is a few things

internally that our best practices are all based on the

that they don't have the skillset and workforce to do,

mistakes and the stumbling blocks we've encoun-

or if it is hundreds of things. As a CRO, we have the

tered over the years, learning this new environment
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ICON_Jan2021_CellandGeneTherapy

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