OPEN BRIEF: A call to
accelerate human-focussed medical research
We are calling for a change of mindset and a clear timetable
for regulatory change to enable accelerated development of medicines which are
likely to be safer, more effective and cheaper, without the use of animals.
Investment in human relevant science offers a golden
opportunity to revitalise medical research, save money, create wealth and
improve public health.
We find ourselves in a time of global health emergency, one
that will challenge our healthcare, social fabric and economy for years to
come. Hard choices today have been borne out of great and immediate need. Yet
there are patterns emerging in the scientific response that will have far reaching
consequences for how we progress medical science in the future.
In March 2020, Moderna Therapeutics, one of the first
companies to begin research into COVID-19, trialled a vaccine in humans in
parallel to animals – a break from the linear process requiring animal trials
before clinical trials.
The University of Oxford also subsequently
trialled COVID-19 vaccines in humans without the usual preceding animal trials.
Given the urgency of the crisis and that both vaccines
contain components known to be safe to use in people, the opportunity to
fast-track trials straight into humans was approved in order to save lives.
Moderna Therapeutics Chief Medical Officer Tal Zaks stated, “I don’t think
proving this in an animal model is on the critical path to getting this to a
clinical trial.”
The International Coalition of Medicines Regulatory
Authorities (ICMRA) agreed that “it is not required to demonstrate the efficacy
of the SARS-CoV-2 vaccine candidate in animal challenge models prior to proceeding
to [first in human] FIH clinical trials.”
The European Medicines Agency and European Commission have
expressed their commitment to advancing animal free new approach methodologies
for drug development and safety assessment in the context of COVID-19.
Prioritising human relevant approaches in the search for a
COVID-19 vaccine sets a powerful precedent. The emergency has forced an
appraisal of what is truly necessary to deliver safe and effective medicines as
quickly as possible. Traditional animal-based tests are too slow and unreliable
to meet the ambitious goal of a vaccine or treatment within a year. As Dr
Francois Busquet and colleagues from the Center for Alternatives to Animal
Testing-Europe state, human relevant approaches offer crucial advantages of
speed and “much more robust and exacting data than any animal experiment could
deliver.
Myriad human relevant technologies are currently available
and increasingly used within basic and clinical research, such as 3D human
‘lungs-on-a-chip’ that more accurately reflect human biology and enable study
of the disease in real human tissue. There has never been a more pertinent
moment to embrace these new approach methodologies and to step up investment in
advancing technologies which are representative of the whole human system. This
is how we will save precious time, replace invasive animal experiments and
avoid the unreliability inherent in extrapolating from species with very
different immune systems.
We now need the vision to adopt this approach for all human
disease and illness – from COVID-19 to cancer, dementia to diabetes – as
outlined in the Alliance for Human Relevant Science White Paper, ‘Accelerating
the Growth of Human Relevant Life Sciences in the United Kingdom’.
Something good can come from the COVID-19 emergency.
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