PharmTech.com Bio/Pharma Outsourcing Innovation eBook 2023 Pharmaceutical Technology
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conventional systems and having a singular tracking
solution for monitoring real-time location and condi-
tions of an individual therapy, Sharif emphasizes.
"But there is a bigger opportunity here as well in that
these systems [can be used] to build advanced therapy
ecosystems and I think increasingly innovators [will
start to] think about not only how to get through a trial,
but what the experience is going to be like post launch,"
Sharif says. That is the direction of travel for ATMPs in
Sharif's opinion, where collaboration with outsourcing
providers will ensue to build solutions and platforms
that are not only scalable but will also provide post-ap-
proval value. "This [year] will be the 'make or break' year
for the supply chain—it's either going to fail and trials
will stop or slow, or we will move as an industry to plat-
forms that all providers can use," he states.
Shifting toward technology
"Innovation has provided big opportunities and empow-
ered the shift toward digital and decentralized clinical
trials; however, it also means there is a bigger gap in the
technological capabilities and the needs of many trials,"
Tian adds. "So, CROs are relied upon now in much more
diverse areas and especially so in the last three years."
As many small- to medium-sized sponsors are not
equipped with the in-house expertise or bandwidth to
search for innovative solutions and technologies—a fact
that has been intensified by the COVID-19 pandemic
when companies were put to the test of figuring out
how to continue trials or start new ones in a restrictive
situation—CROs have been tasked with providing these
options to sponsors in addition to providing their reg-
ular clinical and regulatory expertise, Tian confirms.
"With many siloed solutions not able to work with each
other, CROs are investing in connecting them together
because they need to be able to offer sponsors useable
and flexible solutions that are fit for the purpose of their
studies," she says.
"[Therefore], CROs have started shifting away from
massive human capital resources and more toward
using technologies that can capture, process, and ana-
lyze data," Tian summarizes. "A CRO today cannot just
rely on being operationally strong they must be techno-
logical strong as well."
References
1. ASGCT. Gene, Cell, and RNA Therapy Landscape Q4 2022
Quarterly Data Report. Report, Jan. 20, 2023.
2. Iglesias-Lopez, C.; Agustí, A.; Vallano, A.; Obach, M.
Current Landscape of Clinical Development and Ap-
proval of Advanced Therapies. Mol. Ther. Methods
Clin. Dev. 2021, 23, 606–618.
3. Research and Markets. Cell and Gene Therapy CRO Mar-
ket: Distribution by Area of Expertise, Scale of Operation,
Therapeutic Area, and Geography: Industry Trends and
Global Forecasts, 2022–2035. Report (September 2022).
4. FDA. Guidance for Industr y, Long Term Follow-Up
After Administration of Human Gene Therapy Products
(CBER, January 2020). ■
Contract research
organizations have
started shifting
away from massive
human capital
resources and
more toward using
technologies that
can capture, process,
and analyze data.
—Ching Tian,
Emmes
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