ICON_Jan2021_CellandGeneTherapy - 6

The Critical Role of a CRO in Cell and Gene Trials

The Critical Role
of a CRO in
Cell and Gene Trials

I

n the eight years since Carl June, M.D. treated

globally, encompassing therapeutic areas such as

Emily Whitehead, the first pediatric patient to

hematology/oncology, genetic disorders, central

receive chimeric antigen receptor (CAR) T-cell

nervous system, cardiovascular, infectious diseases,

therapy for acute lymphoblastic leukemia (ALL), the

ophthalmology, and others.

fields of immunotherapy and cell and gene therapies

Still, the field of cell and gene therapy is in its

(CGT) have experienced exceptional growth. Emily's

adolescence. The growing pains of this research

path to remission was neither easy nor without

sector relate to the significant fundamental differ-

complications, yet today she is a healthy teenager

ences between traditional clinical trials and CGT trials

and her story underscores the emergence of a pivotal

that require exacting methods and protocols in order

new frontier in medicine. Today, according to reports

to collect, ship, engineer, manufacture, and admin-

from the Alliance for Regenerative Medicine, there

ister " living therapies. " In short, running any clinical

are over 1,026 companies engaged in CGT research-

trial is difficult-but running a CGT trial adds a level

with more than 1,109 clinical trials underway

of complexity that few sponsors have considered.

According to reports from the Alliance for Regenerative Medicine, there are

1,026+
companies engaged
in CGT research

6|

ClinicalOMICs.com

1,109+

in multiple

clinical trials underway

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

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