PHARMACY

IN SILICO CLINICAL TRIALS: DREAM OR CERTAINTY?
continued
The huge cost of developing new
medical products has many
consequences. Countries with
universal healthcare struggle to
afford the best new products, and in
countries with private healthcare
only the wealthy can afford the best
treatments. Many conditions are
ignored by the biomedical industry
because they cannot return the
significant investment needed for
clinical trials – because the groups
of people affected by the conditions
are too small (e.g. Sanfilippo
Syndrome) or too poor (e.g. Chagas
disease).
The Avicenna Consortium
believes computer simulation is one
solution that will contribute to
revolutionising the clinical trials
process. In all other industrial
sectors, computer simulation plays
an essential role in the design and
assessment of new products. Given
recent advances in medical imaging
and other analytical technologies,
the Avicenna Consortium asked if
we have collected enough
knowledge to start using computer
simulation in the development of
medical products. Could we use the
computer simulation of individual
patients’ bodies in the development
or regulatory evaluation of a
medicinal product, medical device
or medical intervention? If we could,
what would be the barriers to its
widespread adoption?
In its conclusions, the Avicenna
Roadmap states that, in the opinion
of the Consortium and the
contributors to the Avicenna
Research and Technological
Roadmap, the use of individualised
computer simulation in the
development or regulatory
evaluation of a medicinal product,
medical device or medical
intervention (generally referred to
as “in silico clinical trials”) is one of
the most important strategic
priorities in biomedical and
technological research, if we want
to make the development and
assessment of new biomedical
products simpler, cheaper, faster
and safer, whilst at the same time
minimising those activities such as
animal or human experimentation
that pose ethical concerns. It
recommends that all public and
private research funding agencies
across the world do the following.
a) Acknowledge the significant
socioeconomic relevance that
research and technological
development, assessment and
adoption of in silico clinical trials
technologies pose. The
mounting needs of universal
healthcare provision in
developed countries exceed our
ability to innovate quickly and
efficiently, and in silico
approaches are the best
possible route to address those
needs.
b)Progressively increase the
expenditure in this area in the
next 5 years, so that by 2020 at
least 1% of the total public and
private expenditure in
biomedical research and
development worldwide
(estimated as US $268 billion in
2012) is dedicated to the
development and adoption of
in silico clinical trials
technologies used to translate
biomedical research discoveries
into new products and services
more quickly, safely and
efficiently. This should be
initiated with a dedicated
programme in the 2016/17
European Commission Work
Programme of the European
Union Horizon 2020
programme, with a budget of at
least €50 million per year.
16 european INDUSTRIAL PHARMACY September 2015 • Issue 26