Nanomedicine - European Science Foundation

EXECUTIVE SUMMARY 9
lished. This would close the gap between molecular
and cellular technologies understudy, and allow
rapidly commercialisation of clinical diagnostic
nanotechnologies.
In the longer term, research should develop a
multimodal approach for nanoimaging technologies,
and assist the design of non-invasive, in vivo
analytical nanotools with high reproducibility, sensitivity
and reliability. Such tools would allow a paradigm
shift in pre-symptom disease monitoring, and
enable the use of preventative medicines at an early
stage. The simultaneous detection of several molecules,
analysis of all sub-cellular components at the
molecular level, and replacement of antibodies as
detection reagents are seen as particularly important
challenges for basic research.
Novel Therapeutics and Drug
Delivery Systems
Nanosized drug delivery systems have already
entered routine clinical use and Europe has been
pioneering in this field. The most pressing challenge
is application of nanotechnology to design of multifunctional,
structured materials able to target
specific diseases or containing functionalities to
allow transport across biological barriers. In addition,
nanostructured scaffolds are urgently needed
for tissue engineering, stimuli-sensitive devices for
drug delivery and tissue engineering, and physically
targeted treatments for local administration of therapeutics
(e.g. via the lung, eye or skin).
To realise the desired clinical benefits rapidly,
the importance of focusing the design of technologies
on specific target diseases was stressed: cancer,
neurodegenerative and cardiovascular diseases were
identified as the first priority areas.
Longer term priorities include the design of
synthetic, bioresponsive systems for intracellular
delivery of macromolecular therapeutics (synthetic
vectors for gene therapy), and bioresponsive or selfregulated
delivery systems including smart nanostructures
such as biosensors that are coupled to the
therapeutic delivery systems.
Toxicology
There is an urgent need to improve the understanding
of toxicological implications of Nanomedicines
in relation to the specific nanoscale properties
currently being studied, in particular in relation to
their proposed clinical use by susceptible patients.
In addition, due consideration should be given to the
potential environmental impact and there should be a
safety assessment of of all manufacturing processes.
Risk-benefit assessment is needed in respect of
both acute and chronic effects of nanomedicines in
potentially pre-disposed patients – especially in relation
to target disease. A shift from risk-assessment to
proactive risk-management is considered essential at
the earliest stage of the discovery, and then the development
of new nanomedicines.
Clinical Applications and Regulatory
Issues
As the technologies are designed based on a clear
understanding of a particular disease, diseasespecific
oriented focus is required for the development
of novel pharmaceuticals. In addition, it will
be important to establish a case-by-case approach
to clinical and regulatory evaluation of each
nanopharmaceutical. High priority should be given
to enhancing communication and exchange of information
among academia, industry and regulatory
agencies encompassing all facets of this multidisciplinary
approach.
Research Strategy, Policy
Organisation, Funding and
Communication
In terms of education, a need for more formal interdisciplinary
training courses in the area of Nanomedicine
was foreseen. At the undergraduate level these
would cover the basic scientific disciplines including
molecular biology, colloidal chemistry, cell physiology,
surface chemistry, and membrane biophysics.
In addition, new programmes at master’s or early
postgraduate level (preferably with combined
medical and scientific training) are needed to support
the rapidly developing field of Nanomedicine.
Encouragement of more interdisciplinary MD/PhD
degree programmes with some provision for
nanoscience would provide core scientific training
for both scientists and physicians. This will be essential
to ensure a trained workforce to oversee clinical
development of new nanomedicines.