LSHC Horizons Brochure 2024 - Flipbook - Page 28
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Cell, Tissue, and Gene Therapies
The convergence of high-tech emerging technologies in precision
medicine: Human organ chip systems
Organ-on-a-chip technology (OoC) emerged as
a powerful tool to model human physiology and
disease by merging microfluidic and in vitro
cell culture techniques to create microscale
models that mimic the structure and function
of human organs. OoC shows promise in drug
discovery, nonclinical testing, and disease
modeling. Traditional development approaches
rely on animal testing before human testing;
however, differences in human physiology
and animal welfare considerations have
advanced approaches in modeling human
biology and diseases in vitro to accelerate drug
development and personalized medicine.
Animal models are not fully reflective of human
physiology, which means drugs shown to be
safe and effective in animals may be harmful
or ineffective in humans. Advanced therapies
including monoclonal antibodies, vaccines and
cell and gene therapies, account for nearly half
of all drugs in development. There is a critical
need for human-relevant preclinical models
because some advanced therapies are specific
to human target molecular sequences such
that non-human models do not translate
to humans.
OoC shows potential as an ethical and feasible
alternative to the traditional approach. While
OoC technology is not new, technological
advances and recent legislation could
transform OoC’s use in nonclinical testing.
Through the FDA Modernization Act 2.0,
Congress expanded the requirement that
new drugs undergo preclinical animal testing
Lowell M. Zeta
Partner
Washington, D.C.
to a requirement that new drugs undergo
“nonclinical tests”, including OoC. This
represents a significant step forward for OoC
development, which could reduce the risk of
drug development failure, accelerate the drug
development timeline, and lead to faster access
to more effective and safer drugs for patients.
Advances in artificial intelligence (AI)
provide improvements for the design (higherthroughput) and data processing of OoC. As
described in FDA's discussion paper on AI in
drug development as technology that could be
leveraged for evaluating toxicity or exploring
mechanistic models in nonclinical research,
OoC platforms require standardization and
validation to ensure reproducibility and
reliability of the data, and developers should
understand FDA’s expectations with respect
to safety studies that are intended to support
applications for research or marketing of
regulated products, including applicable
Part 11 and Good Laboratory Practice
(GLP) requirements.
In addition, OoC is a focus area for the
Administration, stated in the March 2023
goals for implementing Executive Order 14081.
Although questions remain over the quality
and reliability of OoC biological data, FDA
provides numerous engagement opportunities,
including discussion forums and grant
programs, including its Innovative Science
and Technology Approaches for New Drugs
(ISTAND) Pilot Program.
Ashley Grey
Associate
Washington, D.C.
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