www.biopharminternational.com Partnerships for Outsourcing eBook May 2023 BioPharm International
®
11
Early
DE
vElopmEnt
"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 platforms 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 Industry, Long Term Follow-Up After
Administration of Human Gene Therapy Products (CBER,
January 2020). ■
Rhonda Henry
is the president of Emmes'
BioPharma Group.
Adam Mendizabal, PhD
is the VP and director of
Emmes' Cell and Gene
Therapy Center.
How CROs Adapt Themselves in
the Ever‑Changing Landscape of
Cell and Gene Therapies
In this episode of BioPharm International
®
's sister
publication, Pharmaceutical Technology
®
's, Drug Solutions
Podcast, Felicity Thomas, European/senior editor, talks to
Rhonda Henry, president of Emmes' BioPharma Group,
and Adam Mendizabal, vice-president and director
of Emmes' Cell and Gene Therapy Center, about the
role contract research organizations (CROs) play in the
development of cell and gene therapies. Key factors and
solutions that are driving growth in the CRO market are
of particular focus during the discussion, along with some
of the challenges pertaining to cell and gene therapy
development facing service-providers.
For more podcast episodes,
visit PharmTech.com!
SCAN
ME
