Nano Medicine

EUROPEAN
SCIENCE
Marine
FOUNDATION Board
Nanomedicine
An ESF – European Medical Research Councils (EMRC) Forward Look report
ESF focuses on science driven collaboration between the best European researchers in all disciplines.
We promote the identification and advancement of leading edge science in Europe in close co-operation
with our Member Organisations. We bring together leading scientists, scholars and funding agencies
to explore new directions in research and to plan and implement European level research collaboration
in a global context. Our main instruments include conferences, scientific foresights, collaboration
programmes and support to outstanding young researchers. ESF also manages COST, an
intergovernmental framework for European co-operation in the field of Scientific and Technical Research.
Integrative Biology is currently a hot topic in the Life Sciences. The potential applications of Integrative Biology will
contribute significantly to maximizing the value of knowledge generated in the biomedical field and the outcome
expected for the public health care system. In this context, the strategy developed by the European Medical
Research Councils (EMRC), one of the five Standing Committees at ESF, aims to:
• foster an interdisciplinary approach towards the Functional Genomics domain embracing all the –omics disci-
plines (including the DNA, RNA, protein and other macromolecules world) and their integration into Systems
Biology;
• focus on biomedical applications emerging from these and related domains, such as Nanomedicine and
Structural Medicine; Molecular Imaging, Genetic Epidemiology and Pharmacogenetics in order to advance the
promising field of Personalized Medicine also qualified as Individualized pharmacotherapy;
• develop translational research to overcome boundaries between basic research/science and clinical applica-
tions (e.g., application of cell and gene therapies in Tissue Engineering and Regenerative Medicine, identifica-
tion and validation of biomarkers and therapeutic/diagnostic tools that will allow the transfer of innovation
through a collaborative public-private process of research and development, etc.). In this respect, special atten-
tion will be paid to therapeutic domains identified as a burden for European citizens1:
– cardiovascular and respiratory diseases
– cancer
– allergic, immunological and infectious diseases
– neurodegenerative diseases including neurosciences and mental health
– diabetes, digestive and renal diseases
– rheumatic diseases, musculoskeletal disorders and skin diseases
– rare diseases for instance through its sponsorship of The European Rare Diseases Therapeutic Initiative
(ERDITI), and specific patient populations like children, the elderly and women.
• gather expertise and advance the methodology for the evaluation of the socio-economic value of research in
the above-mentioned fields.
In addition, further attention has been paid on the identification of related regulatory and ethical issues and to the
promotion of biomedical research to the European general public and political stakeholders. In this respect EMRC
is a permanent observer of the Comité directeur pour la Bioéthique at the European Council and is being involved
in further developments brought by the WHO and EMEA to its recommendation to build an open international reg-
istry for clinical trials.
• develop new partnering to support and leverage these activities, i.e. with European Agencies, intergovernmen-
tal organizations (EMBO), charities, pharmaceutical and biotechnological industries, etc.
Due to the progressive character of these scientific fields, the EMRC portfolio will provide flexibility to cover
newly emerging trends in science in a timely manner.
1. WHO Report on “Priority Medicines for Europe and the World” (The Hague, NL, 18 November 2004) commissioned by the Government of the Netherlands.
Cover picture: An image of one selected gas-filled polymer-stabilized microcapsule obtained by electron microscopy. The “magic bullet” is spherical with a diameter of about 1.7µm and the substructure
made of polymer nanoparticles is clearly visible. In order to indicate that the particles are in fact gas-filled, an imperfect capsule with a bump has been carefully selected.
These kinds of particles are the basis for Ultrasound Theranostics: Antibody based microbubble conjugates as targeted in vivo ultrasound contrast agents and advanced drug delivery systems.
A. Briel, M. Reinhardt, M. Mäurer, P. Hauff; Modern Biopharmaceuticals, 2005 Wiley-VCH, p. 1301
© Modern Biopharmaceuticals. Edited by J. Knäblein, 2005 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, ISBN: 3-527-31184-X
© Schering AG
1
ESF Forward Look on Nanomedicine

2005
2
Participants at the European Science Foundation’s Forward Look on Nanomedicine

Consensus Conference, Le Bischenberg, 8-10 November 2004
3
Sponsored by the
European Science Foundation
and organised by its Standing Committee, the
European Medical Research Councils (EMRC)
Steering and Organising Committee

Chair:
Ruth Duncan, Welsh School of Pharmacy, Cardiff University, UK
Deputy-Chair:
Wolfgang Kreyling, GSF National Research Centre for the Environment, and Health, Germany
Members:
Patrick Boisseau, CEA-Léti, France
Salvatore Cannistraro, INFM, Università della Tuscia, Italy
Jean-Louis Coatrieux, Inserm, Université de Rennes 1, France
João Pedro Conde, Instituto Superior Técnico, Portugal
Wim Hennink, Utrecht University, The Netherlands
Hans Oberleithner, University of Münster, Germany
José Rivas, Universidad de Santiago de Compostela, Spain
EMRC:
Clemens Sorg, University of Münster, Germany (Chair)
Thomas Bruhn, University of Münster, Germany (Assistant to the Chair)
ESF/EMRC Office:
Carole Moquin-Pattey, Head of Unit
Hui Wang, Science Officer
The Steering Committee would particularly like to thank the following persons
for their valuable contributions:
Alberto Gabizon, Israel
Mauro Giacca, Italy
Rogerio Gaspar, Portugal
Thomas Kissel, Germany
Bert Meijer, The Netherlands
The Steering Committee would also like to thank Philips Medical Systems and Schering AG
who co-sponsored the Consensus Conference held at Le Bischenberg, November 2004.
5
Contents
Foreword 6
Executive Summary 7
1. Nanomedicine: A New Opportunity for Improved Diagnosis, Prevention and Treatment for Disease 11
1.1. Definition of Nanomedicine 11
1.2. Position of Nanomedicines within the Healthcare Portfolio 11
2. Current Status of Nanomedicine Research and Forward Look 13
2.1. Science and Technology 13
2.1.1. Workshop on Analytical Techniques and Diagnostic Tools
2.1.2. Workshop on Nanoimaging and Manipulation
2.1.3. Workshop on Nanomaterials and Nanodevices
2.1.4. Workshop on Drug Delivery and Pharmaceutical Development
2.1.5. Workshop on Clinical Use, Regulatory and Toxicology Issues
2.2. Research Strategy and Policy 21
2.2.1. Organisation and Funding
2.2.2. Commercial Exploitation
2.2.3. Interdisciplinary Education and Training
2.2.4. Communication
3. European Situation and Forward Look – SWOT Analysis 25
4. Recommendations and Suggested Actions 29
4.1. General Recommendations 29
4.1.1. Priority Areas in Nanomedicine for the next 5 years
4.1.2. Priority Areas in Nanomedicine for the next 10 years
4.2. Scientific Trends 29
4.2.1. Nanomaterials and Nanodevices
4.2.2. Nanoimaging and Analytical Tools
4.2.3. Novel Therapeutics and Drug Delivery Systems
4.2.4. Clinical Applications and Regulatory Issues
4.2.5. Toxicology
4.3. Research Strategy and Policy 30
4.3.1. Organisation and Funding
5. Bibliography 32
5.1. Key Reports on Nanotechnology and Nanomedicine 32
5.2. Key Literature on Nanotechnology relating to Medicine 33
5.3. Websites and General Information 35
6. Appendices 37
Appendix I. ESF Forward Look Workshop Participants 37
Appendix II. ESF Forward Look Consensus Conference Participants 39
Appendix III. Projected Market for Nanomedicines 43
Appendix IV. European Projects and Networks Undertaking Nanomedicine Research 43
Appendix V. Nanomedicines in Routine Clinical Use or Clinical Development 45
Appendix VI. European Companies Active in Nanomedicines’ Development 47
6
Foreword
Recent years have witnessed an unprecedented growth in research in the area

of nanoscience. There is increasing optimism that nanotechnology applied
to medicine will bring significant advances in the diagnosis and treatment
of disease. However, many challenges must be overcome if the application of
Nanomedicine is to realise the improved understanding of the patho-physiological
basis of disease, bring more sophisticated diagnostic opportunities and yield
more effective therapies. Both the optimism and the challenges have prompted
governmental science and funding organisations to undertake strategic reviews
of the current status of the field1, their primary objectives being to assess potential
opportunities for better healthcare as well as the risk-benefit of these new
technologies, and to determine priorities for future funding.
In early 2003, the European Science Foundation launched its Scientific Forward
Look on Nanomedicine. I am pleased to see the successful conclusion of this
foresight study, which has been the first such exercise focused on medical
applications of nanoscience and nanotechnology. The Forward Look involved
leading European experts and led to a definition of the current status of the field
and debates on strategic policy issues. The recently published Policy Briefing
summarised the recommendations made2.
Here the discussions and recommendations are presented in full. Implementation

of these recommendations should ensure continuing European leading-edge
research and development in the field of Nanomedicine, resulting in reduced
healthcare costs and the rapid realisation of medical benefits for all European
citizens. ESF will commit itself to taking the initiative and facilitating the relevant
bodies, including ESF Member Organisations and the European Commission,
for actions based on these recommendations.
Bertil Andersson
ESF Chief Executive
1. Commission of the European Communities Communication: (2004) Towards a European Strategy

for Nanotechnology, EU, DG Research, Brussels, (www.cordis.lu/nanotechnology).
ftp://ftp.cordis.lu/pub/era/docs/3_nanomedicinetp_en.pdf
NIH Roadmap: Nanomedicine (2004), NIH, USA (http://nihroadmap.nih.gov)
(http://www.capconcorp.com/roadmap04)
UK Royal Society and Royal Academy of Engineering (2004) Report on Nanoscience
and nanotechnologies: Opportunities and uncertainties, (www.nanotec.org.uk)
National Institutes of Health - National Cancer Institute (2004) Cancer Nanotechnology Plan: A strategic
initiative to transform clinical oncology and basic research through the directed application of nanotechnology,
NCI, NIH, USA (http://nano.cancer.gov/alliance_cancer_nanotechnology_plan.pdf)
2. ESF Scientific Forward Look on Nanomedicine: Policy Briefing 23 February 2005 (www.esf.org)
7
Executive summary
Background Procedure
Recent years have witnessed an unprecedented The ESF Forward Look on Nanomedicine was
growth in research in the area of nanoscience. There conducted through a Steering Committee which
is increasing optimism that nanotechnology applied initially organised a series of five specialised work-
to medicine will bring significant advances in the shops held from 1 to 5 March 2004. These work-
diagnosis treatment and prevention of disease. shops involved small groups of experts from
However, many challenges must be overcome if the academia and industry representing the different sub-
application of Nanomedicine is to realise the disciplines of the Nanomedicine field. Each group
improved understanding of the pathophysiological was invited to review the issues listed above, and to
basis of disease, bring more sophisticated diagnostic prepare draft recommendations in their area of
opportunities, and yield more effective therapies and specific expertise (participants are listed in Appen-
preventive measures. dix I).
Both the optimism and the challenges have A final Consensus Conference was held at Le
prompted governmental, science and funding organ- Bischenberg, France from 8 to 10 November 2004.
isations to undertake strategic reviews of the current The meeting was attended by more than 70 repre-
status of the field, their primary objectives being to sentatives coming from academia, industry, private
assess potential opportunities for better healthcare foundations, and governmental agencies supporting
as well as to assess the risk-benefit of these new scientific research. Collectively they were able to
technologies, and determine priorities for future review and revise the outputs from the earlier disci-
funding. The outcome of the European Science pline-specific workshops, paying special attention
Foundation’s Forward Look on Nanomedicine is to the boundaries within this multidisciplinary
presented here. scientific field. Moreover the Consensus Conference
was able to review the underpinning topics of
Objectives Science Funding and Policy Making, Commercial
Exploitation, Education, and Communication.
In 2003 the Medical Standing Committee of ESF Participants are listed in Appendix II.
(EMRC) initiated the European Science Founda-
tion’s Forward Look on Nanomedicine. The aims of Definitions
this study were to gather European experts from
academia and industry to: The field of ‘Nanomedicine’ is the science and
• Define the field technology of diagnosing, treating and preventing
• Discuss the future impact of Nanomedicine on disease and traumatic injury, of relieving pain, and
healthcare practice and society of preserving and improving human health, using
• Review the current state-of-the-art of Nanomedi- molecular tools and molecular knowledge of the
cines research human body. It was perceived as embracing five
• Identify Europe’s strengths and weaknesses main sub-disciplines that in many ways are over-
• Deliver recommendations on: lapping and underpinned by the following common
– future research trends and priorities for funding technical issues
– organisational and research infrastructures needed
at the national and European levels to support coor- • Analytical Tools
dinated scientific activities • Nanoimaging
– the mechanisms needed to facilitate effective • Nanomaterials and Nanodevices
dissemination of information to the general public • Novel Therapeutics and Drug Delivery Systems
and policy makers. • Clinical, Regulatory and Toxicological Issues
8 EXECUTIVE SUMMARY
The aim of ‘Nanomedicine’ may be broadly Recommendations

defined as the comprehensive monitoring, control,
construction, repair, defence and improvement of The sub-fields indicated above significantly over-
all human biological systems, working from the lapped in terms of the underpinning science (mate-
molecular level using engineered devices and rials science, analytical techniques, and safety
nanostructures, ultimately to achieve medical bene- issues), and the perception of the core European
fit. In this context, nanoscale should be taken to strengths and weaknesses in each sub-field were
include active components or objects in the size very similar.
range from one nanometre to hundreds of nanome-
tres. They may be included in a micro-device (that • Nanomaterials and Nanodevices
might have a macro-interface) or a biological envi- Advances should begin with the optimisation of
ronment. The focus, however, is always on nanoin- existing technologies towards specific Nanomedi-
teractions within a framework of a larger device or cine challenges. The development of new multi-
biologically, within a sub-cellular (or cellular) functional, spatially ordered, architecturally varied
system. systems for targeted drug delivery was seen as a
priority. There is a pressing need to enhance expert-
Forward Look on Nanomedicine ise in scale-up manufacture and material character-
isation, and to ensure material reproducibility,
Miniaturisation of devices, chip-based technologies effective quality control and cost-effectiveness.
and, on the other hand, ever more sophisticated novel These issues should be addressed urgently to enable
nanosized materials and chemical assemblies are rapid realisation of clinical benefit (within five
already providing novel tools that are contributing years).
to improved healthcare in the 21st century. Opportu- For realisation to application within the next
nities include superior diagnostics and biosensors, decade new materials are needed for sensing multi-
improved imaging techniques – from molecules to ple, complicated analytes in vitro, for applications
man – and not least, innovative therapeutics and in tissue engineering, regenerative medicine and 3D
technologies to enable tissue regeneration and repair. display of multiple biomolecular signals. Telemet-
However, to realise Nanomedicine’s full poten- rically controlled, functional, mobile in vivo sensors
tial, important challenges must be addressed. New and devices are required, including construction of
regulatory authority guidelines must be developed multifunctional, spatially ordered, architecturally
quickly to ensure safe and reliable transfer of new varied systems for diagnosis and combined drug
advances in Nanomedicine from laboratory to delivery (theranostics). The advancement of bioan-
bedside. alytical methods for single-molecule analysis was
seen as a priority.
• Analytical Tools and Nanoimaging

These aspects were viewed as complementary even
though many of the technologies required are very
different in being designed for ex vivo, cellular or
in vivo/patient use.
Once again the opportunity was identified to
refine existing nanotechniques allowing analysis of
normal and pathological tissues to quickly bring a
better understanding of initiation and progression
of disease. Identification of new biological targets
for imaging, analytical tools and therapy is viewed
as a research priority. There is a need to develop
novel nanotechniques for monitoring in real time
cellular and molecular processes in vivo, bringing
improved sensitivity and resolution. Mechanisms to
allow early translation of research based on molec-
ular imaging using nanoscale tools from animal
models to clinical applications should be estab-
EXECUTIVE SUMMARY 9
lished. This would close the gap between molecu- Toxicology

lar and cellular technologies understudy, and allow
rapidly commercialisation of clinical diagnostic There is an urgent need to improve the understand-
nanotechnologies. ing of toxicological implications of Nanomedicines
In the longer term, research should develop a in relation to the specific nanoscale properties
multimodal approach for nanoimaging technolo- currently being studied, in particular in relation to
gies, and assist the design of non-invasive, in vivo their proposed clinical use by susceptible patients.
analytical nanotools with high reproducibility, sensi- In addition, due consideration should be given to the
tivity and reliability. Such tools would allow a para- potential environmental impact and there should be a
digm shift in pre-symptom disease monitoring, and safety assessment of of all manufacturing processes.
enable the use of preventative medicines at an early Risk-benefit assessment is needed in respect of
stage. The simultaneous detection of several mole- both acute and chronic effects of nanomedicines in
cules, analysis of all sub-cellular components at the potentially pre-disposed patients – especially in rela-
molecular level, and replacement of antibodies as tion to target disease. A shift from risk-assessment to
detection reagents are seen as particularly important proactive risk-management is considered essential at
challenges for basic research. the earliest stage of the discovery, and then the devel-
opment of new nanomedicines.
Novel Therapeutics and Drug
Delivery Systems Clinical Applications and Regulatory
Issues
Nanosized drug delivery systems have already
entered routine clinical use and Europe has been As the technologies are designed based on a clear
pioneering in this field. The most pressing challenge understanding of a particular disease, disease-
is application of nanotechnology to design of multi- specific oriented focus is required for the develop-
functional, structured materials able to target ment of novel pharmaceuticals. In addition, it will
specific diseases or containing functionalities to be important to establish a case-by-case approach
allow transport across biological barriers. In addi- to clinical and regulatory evaluation of each
tion, nanostructured scaffolds are urgently needed nanopharmaceutical. High priority should be given
for tissue engineering, stimuli-sensitive devices for to enhancing communication and exchange of infor-
drug delivery and tissue engineering, and physically mation among academia, industry and regulatory
targeted treatments for local administration of ther- agencies encompassing all facets of this multidisci-
apeutics (e.g. via the lung, eye or skin). plinary approach.
To realise the desired clinical benefits rapidly,
the importance of focusing the design of technolo- Research Strategy, Policy
gies on specific target diseases was stressed: cancer, Organisation, Funding and
neurodegenerative and cardiovascular diseases were Communication
identified as the first priority areas.
Longer term priorities include the design of In terms of education, a need for more formal inter-
synthetic, bioresponsive systems for intracellular disciplinary training courses in the area of Nanomed-
delivery of macromolecular therapeutics (synthetic icine was foreseen. At the undergraduate level these
vectors for gene therapy), and bioresponsive or self- would cover the basic scientific disciplines includ-
regulated delivery systems including smart nanos- ing molecular biology, colloidal chemistry, cell phys-
tructures such as biosensors that are coupled to the iology, surface chemistry, and membrane biophysics.
therapeutic delivery systems. 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 essen-
tial to ensure a trained workforce to oversee clinical
development of new nanomedicines.
10 EXECUTIVE SUMMARY
Timely exploitation of newly emerging Nano- Conclusions

medicine technologies was seen as a key issue. This
is an area of general weakness. There is a need to This Forward Look on Nanomedicine has defined
establish specific Nanomedicine-related schemes to the remit of this emerging and important field.
promote academic-commercial partnerships. The Nanomedicine is clearly multidisciplinary and
growth of clusters or highly selected teams, chosen builds on the existing expertise in a large number of
for personal excellence or track record would ensure different scientific fields.
most rapid progress. To facilitate industrial develop- European strengths have been identified, as have
ment the establishment of more manufacturing sites the short- and long-term opportunities, and priori-
with a Good Manufacturing Practice designation ties for the development of Nanomedicine-related
able to support small and medium enterprises would technologies have been recognised.
help in transferring projects more rapidly into clini- When applying nanotechnology to medical uses,
cal development. it is particularly important to ensure thorough safety
Establishment of good communication is a evaluation of any new technologies and also to
universal challenge for research and development review the likely environmental impact. In each
at the interface of scientific disciplines and at the specific case, careful risk-benefit evaluation is
leading edge. There is a continuing need to promote required.
more truly trans-disciplinary conferences. Encour- Most importantly, an open and continuing
agement of goal-oriented research partnerships dialogue is required to ensure all interested parties,
between large medical centres and university including the general public, are well informed as
research groups is essential to progress the field. to the ongoing technology developments in the field
It was noted that scientifically qualified politi- of Nanomedicine. As much has been written in the
cians are not common, and the regional, national popular press, quality information is required to
and European programmes seldom show alignment, assist policy makers and scientists to distinguish
suggesting less than optimal communication. Seri- “science fact” from “science fiction’’.
ous effort needs to be made by scientific opinion
leaders in Nanomedicine to ensure that politicians
Governmental
are well briefed. Not only will better diagnostics, Agencies
and Funding
treatments and prevention for life-threatening and Policy Makers
debilitating disease bring healthcare benefits to an Regulatory
Academic Scientists incl.:
Agencies
ageing population, research and development in Chemistry
Physics
Nanomedicine also offers the potential of employ- Biology Pharmaceutical
Medicine and
ment and economic benefits with a reduction of Engineering Nanomedicine
Mathematics Related
healthcare budgets. Information Technology Industries
General Public
There is an urgent need to more clearly articulate

and better communicate the potential benefits of
Nanomedicine to the general public as a whole.
Engagement of the scientific community in early
dialogue with the general public is crucial in order
to discover any public concerns regarding Nanomed-
icine. Continuing regular dialogue is essential to
address and alleviate any public concerns.
11
1. Nanomedicine: A New Opportunity

for Improved Diagnosis, Prevention
and Treatment for Disease
1.1. Definition of Nanomedicine 1.2. Position of Nanomedicines

within the Healthcare Portfolio
The field of Nanomedicine is the science and tech-
nology of diagnosing, treating and preventing The highest causes of mortality in Europe are
disease and traumatic injury, of relieving pain, and cardiovascular disease and cancer. In addition demo-
of preserving and improving human health, using graphic changes are producing an ageing population.
molecular tools and molecular knowledge of the This in itself is leading to new healthcare challenges.
human body. It embraces five main sub-disciplines There is rising prevalence in diseases of the central
which are in many ways overlapping and are under- nervous system, such as senile dementia,
pinned by common technical issues. Alzheimer’s disease, Parkinson’s disease, and
diseases associated with ageing, for example arthri-
tis and ocular diseases. Whilst much progress was
made in the 20th century in respect of the therapies
for infectious diseases, emergence of resistance,
HIV/AIDS and other new infectious diseases, for
example SARS, present new challenges.
Nevertheless, as the 21st century begins, we are
witnessing a paradigm shift in medical practice.
Nanomedicine is expected to contribute signifi-
cantly to the overall healthcare portfolio.
Genomics and proteomics research is already
rapidly elucidating the molecular basis of many
The aim of Nanomedicine may be broadly diseases. This has brought new opportunities to
defined as the comprehensive monitoring, control, develop powerful diagnostic tools able to identify
construction, repair, defence and improvement of genetic predisposition to diseases. In the future,
all human biological systems, working from the point-of-care diagnostics will be routinely used to
molecular level using engineered devices and identify those patients requiring preventative
nanostructures, ultimately to achieve medical bene- medication, to select the most appropriate medica-
fit. In this context, nanoscale should be taken to tion for individual patients, and to monitor response
include active components or objects in the size to treatment. Nanotechnology has a vital role to play
range from one nanometre to hundreds of nanome- in realising cost-effective diagnostic tools.
tres. They may be included in a micro-device (that There are increasing challenges within the phar-
might have a macro-interface) or a biological envi- maceutical industry to locate drugs more efficiently
ronment. The focus, however, is always on nanoin- to their disease targets. As the search for improved
teractions within a framework of a larger device or medicines for life-threatening and debilitating
biologically a sub-cellular (or cellular) system. diseases continues, two distinct approaches are
It was noted that Nanomedicine is built on the being taken to achieve this aim. The first is within
science and technology of complex systems of drug discovery and builds on identification of new
nanometre-scale size, consisting of at least two molecular targets which are being used to design
components, one of which is an active principle, and ‘perfect fit’ drug molecules with more specific ther-
the whole system leading to a special function apeutic activity. These efforts continue via:
related to the diagnosis, treatment or prevention of screening of natural product molecules to identify
disease. candidates with pharmacological activity;
12 1. NANOMEDICINE: A NEW OPPORTUNITY FOR IMPROVED DIAGNOSIS, PREVENTION AND TREATMENT FOR DISEASE
© WHO world health report 2003

Adult mortality: probabilities of death between 15 and 60 years of age by cause,
selected epidemiological subregions, 2002
World
Africa
very high adult mortality
Americas
low adult mortality
South-East Asia
low adult mortality
Europe
p HIV / AIDS
high adult mortality Other communicable diseases
Europe
p Noncommunicable diseases
very low adult mortality
Western Pacific
low adult mortality
0 100 200 300 400 500 600

Probability of death between 15 and 60 years of age per 1000 population
preparation of carefully tailored synthetic low effective delivery gene therapy and other macro-
molecular weight drugs via traditional medicinal or molecular therapeutics will be realised only with the
combinatorial chemistry; aid of multicomponent, nanosized delivery vectors.
• nanofluidics for targeted synthesis; Non-invasive patient imaging using techniques
• nanodetection for target identification; and such as gamma camera imaging, magnetic reso-
• discovery of natural macromolecules, including nance imaging, X rays and ultrasound are important
antibodies, proteins and genes that have inherent established tools used to assist diagnosis and moni-
biological activity. tor response to treatment. Molecular level imaging
The second, and a complementary approach, is using techniques such as positron emission tomog-
the creation of drug delivery systems that can act as raphy (PET) can also provide information on drug
a vehicle to carry and guide more precisely the targeting, drug metabolism and disease response to
abovementioned agents to their desired site of therapy. Several nanoparticle-based magnetic reso-
action. In 2002 and 2003, more biotechnology prod- nance imaging (MRI) agents have already been
ucts (proteins and antibodies) and drug delivery approved for routine clinical use, and it is recog-
systems were approved by the US Food and Drug nised that future application of nanotechnology has
Administration as marketed products than new low an enormous potential in this field. Complex
molecular weight drugs. supramolecular assemblies are already being
Nanosized hybrid therapeutics (e.g. polymer- explored in research and development to yield
protein conjugates) and drug delivery systems (lipo- agents for molecular imaging in the context of MRI,
somes and nanoparticles) have already been approved ultrasound, optical imaging, and X-ray imaging.
for routine use as medicines. The drug delivery Moreover, in the longer term, the combination of
systems entering the market have been designed to imaging technologies and drug delivery systems has
achieve disease-specific targeting, to control the the potential to yield theranostics devices.
release of the drug so that a therapeutic concentration
© Schering AG
is maintained over a prolonged period of time, or to

provide more convenient routes of administration
(e.g. oral, transdermal and pulmonary) and reach
locations in the body that are traditionally difficult to
access, such as the brain. Via the use of coatings,
ever more sophisticated devices are emerging that
allow localised controlled release of biologically
active agents.
Complex supramolecular assemblies, nanoparti-
cles and polymeric materials in many different
forms are already playing an important role in the
construction of nanopharmaceuticals. It is clear that
the contribution of nanotechnology will continue to
grow in the future, and it is widely believed that
13
2. Current Status of Nanomedicine Research

and Forward Look
Output of workshops held in Amsterdam March 2004 and the Consensus Conference Le Bischenberg
November 2004
2.1. Science and Technology ular targets for therapy. It is perceived that many
nanotechnology-derived tools will, in the future, be
2.1.1. Workshop on Analytical Techniques routinely used in diagnosis of many diseases long
and Diagnostic Tools before they will be approved as treatments.
Workshop participants:
In the case of these devices, nanoscale objects
Dr Patrick Boisseau (chair) were defined as molecules or devices within a size-
Dr François Berger, Prof. A.W. McCaskie, range ofone to hundreds of nanometres that are the
Dr Françoise Charbit, Dr Rosita Cottone, active component or object, even within the frame-
Prof. H. Allen O. Hill, Prof. Lars Montelius, work of a larger micro-size device or at a macro-
Dr Kristina Riehemann, Dr Ottila Saxl, interface.
Dr Jürgen Schnekenburger, Prof. Yosi Shacham,
Prof. Clemens Sorg, Dr Dimitrios Stamou, Scope of this discipline
Prof. Csaba Szántay In the area of nanoanalytical techniques and diag-
nostic tools that will find application in the sectors
Introduction of diagnostics, medical devices and pharmaceutical
There is considerable anticipation that miniaturisa- drug discovery, a wide range of technologies are
tion via the application of nanotechnology and new being developed for both in vitro (diagnostics and
nanotools will lead to novel surgical and analytical sensors) and in vivo use (in line sensors, implanta-
tools and diagnostics for use ex vivo. It is envisaged bles and surgical tools) with a range of biological
that such techniques will increase our ability to iden- targets including cells, DNA and proteins. Research
tify predisposition to disease, monitor disease and development in this field is extremely multidis-
progression and identify the most relevant patient ciplinary and there is considerable synergy with the
treatments. Moreover, a new generation of surgical ‘nanoimaging and manipulation’ and the ‘nanoma-
tools is predicted that will be able to assist diagno- terials and nanodevices’.
sis and deliver therapy at a cellular level. In the Analytical and point-of-care diagnostic product
context of larger ex vivo diagnostic devices, the design is already supported by the use of nanoparti-
focus of this research lies on nanointeractions. cles and nanodevices. For example, biosensor tech-
Europe has a relatively strong position in basic nology based on nanotechnology represents a huge
research in this field but failure to exploit its inven- opportunity to revolutionise diagnostics in the
tions is a continuing problem. DNA and protein healthcare environment. Healthcare professionals
chips are already widely used as research tools and in primary care and hospital clinics are shortly
are helping to provide a better understanding of the expecting to be able to use low-cost tests able to aid
molecular basis of diseases and identify new molec- the diagnosis by simultaneous measurement of
Bioarrays and Biosensors Nanofabrication Nano-objects Detection

DNA chips lab on chip nanotubes electrochemical detection
protein-chips pill on chip nanowires optical detection
glyco-chips nanofluidics nanoparticles mechanical detection
cell-chips nanostructured surfaces electrical detection
- by scanning probes
- by mass spectrometry
- by electronmicroscopy
biosensors for single nanodevices
and multiple analytes and nanoelectronics
14 2. CURRENT STATUS OF NANOMEDICINE RESEARCH AND FORWARD LOOK
© Jürgen Schnekenburger
multiple parameters using a simple test strip with- Cells as complex 3D systems: the organisation
out having to measure each parameter individually. and function of cells can not be described by
Such test strips must be disposable and cost effec- the simple analysis of their contents
tive. So far only single analyte strips have been
available but multisensor dry enzyme, hand-held
systems being developed in Europe are leading the
way towards fast and accurate multiparameter
analysis.
Genome
There is an opportunity to focus on technically
more mature developments that are more likely to be
successful, and also to address niche markets that
have better prospects for exploitation. Moreover,
techniques and tools developed for analysis and diag-
nostics in the medical field have the potential for
wider application, for example, in the context of envi- Proteome
ronmental monitoring, control of food hygiene etc.
An ideal near-patient diagnostic system

• Fast Minimise consultation time (<1 minute) Workshops held under the auspices of the Euro-
• Simple Lay person (nurse’s aid) can use pean Federation of Pharmaceutical Industries and
• Portable Take the test to the patient Associations (EFPIA) have identified a number of
• Storage Room temperature for consumables bottlenecks delaying development of new pharma-
• Painless Minimally invasive blood sampling
ceuticals. To improve clinical performance and early
• Single step One sample, one strip, many analytes
access to innovative medicine there is a recognised
• Platform One instrument, many diseases
need for improved biomarkers and surrogate mark-
ers to allow prediction of efficacy. Improved in
While there is no lack of innovation in Europe, silico tools are needed for toxicogenomics, toxico-
there was agreement that in many areas Europe is proteomics, and metabonomics that can be used to
lagging behind. The DNA array market, for example, improve the predictability of toxicological profile
is dominated by Affimetrix, an American company. of innovative medicines.
While DNA chips are being widely used in research,
their difficulties in securing quality assurance and
regulatory approval, their production flexibility and 2.1.2. Workshop on Nanoimaging
speed to result are well known. Although other more and Manipulation
technically complex chips are available, so far they Imaging at the molecular level,
are substantially more expensive. measurement of molecular forces
Underlying research was seen as a further Euro- Workshop Participants:
pean strength, particularly in relation to the identi- Prof. Jean-Louis Coatrieux, Dr Mauro Giacca
fication of medical targets. Current genomics and (chairs)
proteomics techniques give a limited insight into Dr Andreas Briel, Prof. Salvatore Cannistraro,
cellular function. In the future, the combination of Prof. Martyn Davies, Dr Sjaak Deckers,
these techniques with imaging methods such as Dr Nicole Déglon, Dr Franz Dettenwanger,
TOF-SIMS analysis, and raster electron microscopy Prof. Paul Dietl, Rainer Erdmann,
by atomic force microscopy of living cells will give Prof. Robert Henderson, Dr Arne Hengerer,
more information on individual protein function and Dr Peter Hinterdorfer, Dr Corinne Mestais,
cell signalling. Prof. Hans Oberleithner, Prof. T.H. Oosterkamp,
Dr Andrea Ravasio, Dr Hui Wang
Introduction
Imaging is becoming an ever more important tool in
the diagnosis of human diseases. Both the develop-
ment of imaging agents based on micro- or nanopar-
ticles, organic dyes etc., and the development of
2. CURRENT STATUS OF NANOMEDICINE RESEARCH AND FORWARD LOOK 15
highly sophisticated instruments supported by Techniques Examples
powerful computation (2D, 3D reconstruction) have Optical imaging SNOM, STED, Raman SERS,
already given rise to a significant move from inva- and Spectroscopy FRET, FRAP
sive to less invasive clinical imaging. This is allow- Surface plasma TIRF, NIRF, Multiphoton LSM
resonance
ing an ever more sophisticated imaging-based
Magnetic Resonance X-CT
diagnosis, particularly in cancer, neurological and Imaging
heart diseases. Nuclear Imaging micro-PET, SPECT
Nanotechnology has an important role to play in Scanning probe AFM
further developing this field. Earlier diagnosis with a microscopy and force
non-invasive tool can allow earlier treatment and this microscopy
Ultrasound
treatment approach can be much less expensive and
Optical tweezers
often more effective. In addition, economists Multimodal fluorescence probe and SPM,
consider living healthier, longer lives to be econom- nanoimaging fluorescence and laser
ically beneficial. There are potential risks and side- is the future and tweezers
effects from new imaging agents based on will link structure to opto-acoustic imaging
nanomaterials, but risk-benefit analyses will be/are function and vice versa
being conducted at an early stage. One of the great-
est problems in the transfer of these approaches into Europe has a number of leading academic
routine clinical use lies in the slow approval process groups and several leading companies who are
of new materials for human use by regulatory agen- pioneers in the development of imaging techniques
cies. and innovative contrast agent production (e.g.
Imaging at cellular, and even sub-cellular and Bracco SpA, GE formerly Amersham, Philips
molecular level, is still largely a domain of basic Medical Systems, Siemens Medical Solutions and
research. However, it is anticipated that these tech- Schering AG).
niques will find their way into routine clinical use. Basic research has already developed the first
Atomic force microscopy (AFM) and AFM-related methods to monitor in vitro the assembly of multi-
techniques have become sophisticated tools, not only component biological complexes, protein traffick-
to image surfaces of molecules or sub-cellular ing and the interactions between single molecules.
compartments, but also to measure molecular forces There is a recognised opportunity to use nanotech-
between molecules. This is substantially increasing nology to improve these molecular imaging tech-
our knowledge of molecular interactions. niques, and to construct real-time intracellular
tomography. Objective methods for assessment of
Scope of this discipline image quality are also needed in vitro and in vivo.
Because of its interdisciplinary nature, the field of Tools are currently under development that allow in
Nanoimaging and Manipulation is also identified as vitro evaluation of basic mechanisms, but it was felt
having a considerable overlap with the other disci- that these could quickly be developed towards real
plines, particularly in relation to nanomaterials ex vivo and clinical applications.
(nanoparticles will play an ever more important role In the context of in vivo and clinical imaging, the
as imaging agents), and clinical, regulatory and development of novel techniques for macromolec-
toxicological issues. ular imaging was seen as a particular priority.
The field termed here ‘Nanoimaging’ overlaps Europe has been at the forefront of the development
with the field already called ‘Molecular Imaging’. of polymeric gamma camera imaging agents and
In this case the target to be imaged will have a dendrimer-based MRI imaging agents. Improved
spatial resolution in the order of 1-100 nanometres, image analysis is a particular goal. There is a need
and preferably a time resolution for imaging in the to improve 3D reconstruction and quantitative data
order of milliseconds. The opportunities for analysis. Improved visualisation techniques are
improvements and breakthroughs with the assis- needed also for stereo-imaging, virtual and
tance of nanotechnology were seen in terms of both augmented reality imaging, and image-guided
existing and emerging technologies. The imaging manipulation.
techniques discussed are listed: Opportunities exist for both invasive and non-
invasive clinical imaging, e.g. endoscopy for
targeted imaging, use of optical catheters and devel-
opment of nanosized systems allowing manipula-
tion, target selection, local stimulation and poten- materials and drug delivery system development.
tially local modification. Historically, radiolabelled antibodies have already
Development of more sophisticated imaging been transferred to market as diagnostic tools in
equipment requires an integrated approach. Under- cancer, and in the form of radiolabelled antibodies
pinning research must involve all aspects of the and antibody conjugates as a therapeutic agent. It can
process. be argued that the radiolabelled therapeutic antibody
Parallel to the development of the analytical is the first nanosized theranostic.
equipment, research and clinical development is Development of molecular imaging diagnostics
ongoing to provide a new generation of nanoimag- is expected to have a major impact on healthcare in
ing agents. These include both synthetic nanoparti- the future and the opportunities are summarised
cles (including dendrimers and polymeric below.
nanoparticles) and biological nanoparticles (nanoor-
ganisms). In the future it is likely that these imaging
tools will become ever more complex, multicompo- 2.1.3. Workshop on Nanomaterials
nent systems combining contrast agents and track- and Nanodevices
ing probes (e.g. quantum dots, magnetic and Workshop participants:
superparamagnetic beads, nanoshells and nanocol- Prof. Jeffrey Alan Hubbell, Prof. Ruth Duncan
loids) with new targeting ligands. For targeted (chairs), Prof. Wim Hennink,
systems, carriers can be used which may require Prof. Helmut Ringsdorf (co-chairs),
additional surface modification, and linkers that Prof. Hans Börner, Prof. João Pedro Conde,
bring additional challenges for physicochemical Dr John W Davies, Prof. Harm-Anton Klok,
characterisation and safety evaluation. In some cases Prof. Helmuth Möhwald, Dr Mihail Pascu,
combination of a range of signal modalities (e.g. Prof. José Rivas, Dr Christoph Steinbach,
organic dyes) is also used. Imaging and contrast Prof. Manuel Vázquez, Dr Peter Venturini,
agent design has a considerable overlap with nano- Dr Petra Wolff, Prof. Andrew McCaskie
Molecular Imaging Diagnostics (MDx): Impact on healthcare in the future
© Philips
Genetic DNA Developing First Progressing
disposition mutations molecular symptoms disease
signature
Today Screening Diagnosis Treatment &

Follow-
& Staging Monitoring
up
Earlier diagnosis,
optimized workflow
• Unspecific • Diagnostic • Surgery • Diagnostic
markers imaging • Cath-lab imaging
• POC • Biopsies • Radiation • Unspecific
imaging therapy markers
• Mammo-
graphy
Future
Screening Diagnosis Treatment &

Follow-
& Staging Monitoring
up
• Specific • Molecular • Mini-invasive • MI, MDx

markers imaging: surgery • Non-invasive,
(MDx) quantitative, • Local/target- Quantitative
whole-body ed drug imaging
• CA Diagnosis delivery &
tracing
• Tissue analy-
sis (MDx)
Introduction tro-mechanical systems (MEMS), nanoparticles,

All aspects of Nanomedicine rely on progress in and polymer therapeutics. There are also consider-
nanomaterials research, and the nanoengineering able strengths in engineering materials (surfaces and
needed to create devices to realise their goals. Mate- nanosized and nanostructured polymers and
rials science is being employed to generate probes colloids) to control and direct cellular function for
and techniques that are helping to understand basic biomedical applications, and the materials science
biological mechanisms. On the other hand, emer- relating to tissue engineering and regenerative
gence of more sophisticated nanomaterials and medicine, bioactive materials and the related stem
nanodevices is required to develop diagnostic and cells as sources.
surgical tools, drug delivery systems and in vivo The overall Nanomedicine-related goals for the
diagnostics into routine clinical practice. Moreover, research and development in nanomaterials and
nanoscale assemblies for ligand display are already nanodevices were identified as the development of
emerging as multicomponent 3D architectures able technologies to satisfy the following applications:
to assist tissue engineering and promote tissue
repair. Biological Applications:
Nanopharmaceuticals (drugs and drug delivery • Definition of target and pathway and network
systems) are nanoscale assemblies, which can be identification
relatively simple; for example, nanoemulsions, nano- – Via multiple, co-assembled biomolecules
particles or polymer conjugates (of proteins or drugs), • Definition of mechanisms of signalling and signal
or complex mutlicomponent systems containing transduction
drugs, proteins or genes, and an array of targeting – Via artificial assemblies in vitro
ligands and signal systems to enable in vitro or in
vivo detection. The nanomaterials and nanodevices Medical Applications:
that are being developed have scales from molecule- • Drug targeting
to assembly-to functional device in the nanometre- – Whole body, cellular, sub-cellular localisation
size range. of drugs, proteins and genes
This field is rapidly moving from the develop- • Drug discovery
ment of individual building blocks to multifunc- – High Throughput Screening technology with
tional, often biomimetic and bioresponsive systems. biomolecular or cellular read-outs
– Novel bioactives, obtained through nanotechnology
The combined knowledge and expertise of synthetic
– Novel drug delivery systems
and physical chemistry as well as biological chem-
istry are required for the development of effective • Diagnostics and sensing
– In vitro (multiple analyte detection) and in vivo
nanomaterials and nanodevices that are efficient and
safe in the biological environment. • Regenerative medicine
Most importantly, it was noted that the research – Materials to regulate cell signalling and
differentiation, and also controlling morphogenesis
in nanomaterials and nanodevices must strive for
thus helping to bring functional integration
biological and medical relevance with this in mind.
The potential timescale for development of practi-
cal-to-use systems could be relatively short. As Enabling technologies currently being developed
nanodiagnostics, e.g. a dendrimer-MRI agent, are include new systems for physical assembly, new
already in clinical development, it can be predicted routes to macromolecular synthesis via chemical
that those nanodiagnostics under in vitro develop- and biosynthesis. In the latter case, minimisation of
ment today should be available for clinical evalua- nanoparticle or polymer polydispersity and hetero-
tion within the next few years. Over the next few geneity is essential for use in the construction of
decades, considerable growth in the routine clinical nanopharmaceuticals.
use of in vivo nanodiagnostics as well as nanother- Further development of combinatorial chemistry
apy was predicted. and biology is a certainty bringing multiple-func-
tionality into library design to provide high-level
Scope of this discipline functional screening technology. The planar 10-100
Europe is particularly strong in physical and multi- nm scale systems for screening and detection that
functional chemical assembly of nanostructures will emerge will have multiple, integrated detection
(supramolecular chemistry), and colloid and poly- systems. Hierarchical, oriented, multicomponent
mer science including development of micro-elec- displays of biological molecules with passivation of
Liposomes Antibodies Viruses as
© Prof. Ruth Duncan

background effects were seen as a particular chal-
and their viral vectors
lenge. Control and feedback technologies are conjugates
needed to enable biomolecular recognition to be
transferred into practical-to-use detector develop- Polymer
micelles
ment. For analytical systems, increased sensitivity
is needed, and analysis of functional systems. Nanopharmaceuticals
Development of new materials with complex
functionality is already ongoing. This is particularly
important in the context of tissue engineering scaf-
folds and arrays for detection. Spatial control of
functionalisation is needed with ordered display of Nanoparticles Polymer-protein Unimolecular polymer
orthogonal functionality, and the ability to design conjugates and dendrimer conjugates
into a system-triggered control of response; that is,
new bioresponsive materials. Improved methods for
surface functionalisation of colloids and surfaces are They include liposomal anticancer agents, antibody-
needed as well as new and validated analytical tech- drug conjugates, polymer-protein conjugates,
niques to ensure safety and reproducibility. Integra- nanoparticle-based imaging agents and an anti-
tion of multiple-functionality (fluidics, with cancer delivery system (see Appendix VI). There are
manipulation and detection) will enable translation also a large number of constructs (including the first
to implantable configurations with telemetric detec- polymer-based gene delivery system) in clinical
tion and control. development. These can be viewed as the first-
generation Nanomedicines and future developments
2.1.4. Workshop on Drug Delivery will build on these successes.
and Pharmaceutical Development
Scope of this discipline
Dr María José Alonso, Prof. Ruth Duncan (chairs),
The nanosized drug delivery systems currently
Prof. Thomas Kissel (co-chair) under development are either self-assembling, or
Dr Oliver Bujok, Prof. Patrick Couvreur, involve covalent conjugation of multicomponent
Prof. Daan Crommelin, Dr Julie Deacon, systems, e.g. drug, protein and polymer. The mate-
Dr Luc Delattre, Prof. Mike Eaton, rials used to create such drug delivery systems typi-
Prof. Claus-Michael Lehr, Dr Laurant Levy, cally include synthetic or semi-synthetic polymers,
Prof. Egbert Meijer, Dr Milada Sirova, and/or natural materials such as lipids, polymers and
Prof. Karel Ulbrich, Prof. Arto Urtti, proteins. If classified by function, many materials
Prof. Ernst Wagner, Dr Jaap Wilting used for drug delivery are bioresponsive and/or
biomimetic. An increasing number of nanosystems
Introduction are being proposed as drug carriers. They include
Nanopharmaceuticals can be developed either as micelles, nanoemulsions, nanoparticles, nanocap-
drug delivery systems or biologically active drug sules, nanogels, liposomes, nanotubes, nanofibres,
products. This sub-discipline was defined as the polymer therapeutics and nanodevices. Magnetic
science and technology of nanometre size scale nanoparticles are being developed for diagnostic
complex systems, consisting of at least two compo- imaging and disease targeting, for example, liver
nents, one of which is the active ingredient. In this and lymph node targeting following intravenous
field the concept of nanoscale was seen to range administration.
from 1 to 1 000 nm. For the past thirty years, Europe has pioneered
Over the last three decades Europe has been at the development of many of these technologies and
the forefront of the research and development of research in the area of nanodrug delivery is still
nanosized drug carriers including liposomes, forging ahead. Pharmaceutical science is especially
nanoparticles, antibodies and their conjugates, poly- strong, but research is increasingly interdisciplinary
mers conjugates, molecular medicine (including both across Europe and indeed globally. There is
proteins) and aspects of nanobiotechnology includ- already a number of major programmes and strate-
ing tissue engineering and repair. gic initiatives in Europe promoting interdisciplinary
There are a growing number of marketed nano- research and training in drug delivery, although
sized drug delivery systems and imaging agents. there has not been any clear emphasis within the
EU Framework 6 Programme (FP6) to promote With good interaction between academia and
networks of excellence and specific projects able to industry, increased European funding to strengthen
enhance activities in the area of Nanomedicine. the translational research and development, and
There are three principal goals of drug delivery building on past successes, these goals can be
research today: more specific drug delivery and realised quickly. However, tremendous challenges
targeting; greater safety and biocompatibility; and also lie ahead. There is still a lack of communica-
faster development of new, safe medicines. To tion in a field where the multidisciplinarity of the
achieve these goals the current nanotechnologies research continues to grow. At the research stage,
being applied to drug delivery and pharmaceutical chemistry-physics-pharmaceutical science-biology-
research include the following: medicine must work in concert. There is a concern
that regulatory hurdles may become so high that the
Nanotechnologies industry will be reluctant to accept the risk of devel-
• Supramolecular chemistry-Self assembling drug oping innovative technology. In addition, because
carriers and gene delivery systems of the variable quality of the scientific representa-
• Nanoparticles and nanocapsules tion within public debate and concerns raised about
• Antibody technologies nanotechnology as a whole, there is an apprehen-
• Polymer-drug conjugates sion that the general public may be reluctant to
• Polymer-protein and antibody conjugates
accept new concepts and technologies.
• Nano-precipitation, nanocrystals
• Emulsification technologies
• Liposome technology 2.1.5. Workshop on Clinical Use, Regulatory
• In situ polymerisation and Toxicology Issues
• Tissue engineering and repair Workshop participants:
• Dendrimer technologies
Dr Wolfgang Kreyling, Prof. Rogério Gaspar (chairs),
• Molecular imprinting
Dr Paul J. A. Borm (co-chair)
Prof. Luc Balant, Dr Janna de Boer,
In parallel to the technology development there Dr Thomas Bruhn, Prof. Kenneth Donaldson,
is a need to develop pharmaceutical formulations Dr Benoit Dubertret, Prof. Ruth Duncan,
that can be conveniently administered to patients Prof. Mike Eaton, Prof. Mauro Ferrari,
and that display acceptable shelf-life stability. Prof. Alberto Gabizon, Prof. Varban Ganev,
Validated analytical techniques are also needed Dr Andreas Jordan, Prof. Harm-Anton Klok,
to confirm the identity, strength and stability of Prof. Jørgen Kjems, Dr Mihail Pascu,
complex nanomedicines. New chemical and physi- Prof. Helmut Ringsdorf, Dr Valérie Lefèvre-Seguin,
cal techniques must be developed during scaling-up. Dr Ottila Saxl, Dr Milada Sirova, Prof. Karel Ulbrich
During research and development molecular
imaging techniques (e.g. AFM) are increasingly Introduction
being used, and in vitro (e.g. caco-2 cells, blood brain As for any other conventional medicine, the entire life
barrier models, and skin models) and in vivo models cycle of nanopharmaceuticals includes production,
are being developed to understand better cellular and distribution, clinical administration, consumer safety
whole-body pharmacokinetics. There is also a need (human body effects and side-effects), and waste
to examine carefully pharmacokinetic and pharma- disposal. While the clinical applications usually
codynamic correlations to allow carefully design of concern only the selected stages of the life cycle, toxi-
drug targeting and controlled release systems. cological effects may exist in all the stages. Both clin-
ical applications and toxicology of nanopharmaceuti-
In the near future, nanodrug delivery systems and cals must be studied and examined comprehensively.
pharmaceutical research have the potential to When designing a clinical protocol for a nano-
contribute significantly to the furtherance of Nano- pharmaceutical there are new challenges. Clinical
medicine. The key topics of investigation are: trials and epidemiology studies may be significantly
• vectors that will overcome the biological barriers different from those for conventional diagnostic and
for effective gene delivery therapeutic agents. Early dialogue and collaboration
• cancer targeting between scientists, clinicians, toxicologists and regu-
• brain delivery latory authorities are increasingly recognised as one
• combination of the potential of antibody targeting of the important issues to ensure rapid clinical uses
with nanoparticle and liposome technology. of safe nanopharmaceuticals.
Scope of this discipline uses e.g. veterinary)

Nanoscale objects, typically but not exclusively with • consumer and staff safety
dimensions smaller than 100 nm, smaller than • waste management/fate in environment.
200 nm for ultrafiltrable range and smaller than
1 000 nm for dendrimers, exhibit fundamentally Although the nanopharmaceuticals that have
different physical, chemical and biological proper- already entered routine clinical use have been rigor-
ties from those of the corresponding mass materials. ously tested with regard to safety, there have been
These distinctive properties, together with the comparatively few toxicological studies published
nanoscale size which is in the same scale of the natu- on nanopharmaceuticals. However, this issue needs
rally occurring biomolecules, promise revolutionary to be explored, based on the large literature in the
potential applications in clinical practice. Nanomed- toxicology field describing the effects of nanopar-
icines or nanopharmaceuticals may therefore be ticles, either present in the environment as pollu-
defined as nanoscale material to be used for clinical tants or made as a result of the industrial production
diagnosis, treatment, and prevention of human disor- of non-medical and non-biological materials.
ders. Nanomedicine application depends on the
structures and mechanisms which are functional Cancer Chemotherapy and Drug Targeting
only on nanoscale-mediated macro-molecular and
supra-molecular assemblies. Increased Therapeutic Index
In particular, the following areas were considered:
Technology Application
Toxicity Activity
Nanopharmaceuticals Cancer
– in current use or Antiviral agents
entering routine use Arteriosclerosis
in the short-term future Chronic lung diseases
(within 5 years) Diabetes
Nanopharmaceuticals Gene therapy
– with potential clinical Tissue engineering
applications in the longer Tissue/cell repair
term future (10 years)
Europe has considerable experience in the clini-
Nanodevices Delivery of diagnostic cal development of nanopharmaceuticals (particu-
and therapeutic agents
larly in cancer). Pre-clinical toxicology to ‘good
laboratory practice’ (GLP) has assessed antibody-
There are very strict regulations and approval drug conjugates, polymer-drug conjugates and
processes for any medicine (via regulatory agencies nanoparticle-based chemotherapy. During the devel-
such as FDA, EMEA etc.) or any material proposed opment of novel anticancer treatments there is
for human use. It must undergo rigorous toxicology always a careful evaluation of risk-benefit.
studies as part of the regulatory approval process. Since Europe has particular strengths in the
However, the special properties of nano-objects that research areas of toxicology of inhaled ambient or
are only exhibited at the nanoscale suggest that occupational fine and ultrafine particles there is an
nanopharmaceuticals may also require a new array excellent opportunity to redress the current mismatch
of toxicological and safety tests. It was agreed that between studies on toxicology of nanomaterials and
new strategies in toxicology for Nanomedicine must those involved in research and development of
go hand-in-hand with the development of nanophar- Nanomedicine-related technologies.
maceuticals in order to ensure the safe yet swift As there seems to be enormous prospects for the
introduction of nanomedicines to clinical use. application of nanotechnology in medicine, the Euro-
The toxicology of nanopharmaceuticals, nano- pean Nanomedicine research community should act
imaging agents and nanomaterials used in device proactively to seize the opportunity to clearly define
manufacture should be considered during their entire the ground rules for the related toxicological
life cycle: research, and the related clinical and industrial devel-
• stages of production/manufacture opment of these important technologies.
• preclinical and clinical development (or for other As yet there are no regulatory authority guide-
lines specific to Nanomedicine. As the number of 2.2. Research Strategy and Policy
nanopharmaceuticals increases there is a need to
review and define appropriate regulatory authority 2.2.1. Organisation and Funding
guidelines directed towards each new class of Workshop participants:
Nanomedicine. It would be timely to produce ‘Good Prof. Claus-Michael Lehr (chair),
Clinical Practice’ (GCP) guidelines that may be Prof. A.W. McCaskie (co-chair)
applied to the clinical development of specific fami- Dr María José Alonso, Prof. Luc Balant,
lies of drug delivery systems or therapeutics. Some Dr Janna de Boer, Prof. Salvatore Cannistraro,
examples of well-established categories of pharma- Dr Rosita Cottone, Dr Nicole Déglon,
ceuticals involving nano-objects are polymer- Dr Franz Dettenwanger, Prof. Thomas Kissel,
protein, polymer-drug conjugates and nanoparticle- Prof. Helmuth Möhwald, Dr Mihail Pascu,
associated chemotherapy. There may be specific Prof. Clemens Sorg, Dr Christoph Steinbach,
clinical endpoints that are unique to these nanomed- Prof. Manuel Vázquez, Dr Petra Wolff
icines, and there may also be specific issues relating
to good manufacturing practice (GMP) compliance. It was suggested that current funding mechanisms
Second generation nanopharmaceuticals are do not adequately address the needs of Nanomedi-
already being, or will be, developed based on first cine. The structure of programmes and the diversity
generation systems. An integrated strategy will be of sources (e.g. European, national, regional and
the key for toxicological evaluation of new nano- charities) can obscure routes to funding. This is
materials that are emerging. There is a need for pre- further limited by traditional borders between scien-
clinical and clinical test standardisation and an tific disciplines; e.g. chemistry, physics, biology,
evaluation of the environmental impact of these medicine and engineering, which can effectively
systems in the context of academic research and exclude transdiscipline and interface research. In
industrial development. On a case by case basis many cases the funding opportunities are often
there is a need to define toxicokinetics, toxicoge- restricted by the requirement of an industrial part-
nomics, and toxicoproteomics. This field might be ner. Moreover, selection criteria can often be politi-
defined as ‘Toxiconanomics’. This research effort cal, rather than based on scientific excellence. The
should be conducted by virtual networks of basic fact that EU FP6 applications were channelled into
and applied scientists using existing expertise as a main themes of ‘Health’ or ‘Nanotechnology’ was
starting point. Industrial collaboration should be a contributory factor, leading to the ineffectiveness
used to establish standard reference materials. of FP6 to successfully support the stated Nanomed-
icine objectives of this scheme. The possibility of
an EU Technology Platform in Nanomedicine was
noted and welcomed.
It was noted that there is an opportunity to
improve communication/coordination between the
different funding agencies across Europe. There is
a specific need to reflect the multidisciplinary
nature of Nanomedicine in funding opportunities
presented.
The funding opportunities available for basic
technological research must initially be available for
pure academic groups without an underlying
requirement of an industry partner. All calls for
proposals and applications should encourage the
appointment of multiple partners from different
disciplines with internationally leading expertise.
The evaluation of such multidisciplinary proposals
must be undertaken by a multidisciplinary expert
panel using the same format used by the US
National Institutes of Health (NIH) study groups.
Whilst the European networking instruments (e.g.
COST, Network of Excellence etc.) are considered
helpful, in the future there must also be enough ment involving both specialised small and medium
funding to undertake basic and applied Nanomedi- enterprises (SMEs) as well as larger companies. To
cine research (that is, for salaries, instruments, and encourage rapid technology transfer there is a need
consumables). to generate clusters or highly selected teams chosen
Means to improve funding and organisation at for personal excellence, and not to fragment resources.
the level of political bodies, policy makers and Nanomedicine is particularly multidisciplinary
national organisations were identified. The funda- so there are many opportunities to cross-licence
mental requirements to progress Nanomedicine technologies; for example diagnostics and pharma-
quickly are more investment for Nanomedicine R ceuticals. Joint ventures involving confidential R&D
& D, greater understanding of the complexities of relationships could be very successful, but with a
this multidisciplinary area, and a higher priority for complex supply chain, the intellectual property port-
specific technologies that will improve healthcare folio needs careful management. Good communi-
for society in Europe. cation and project management skills are needed.
To be competitive and effective in commerciali-
Specific opportunities include: sation, speedy globalisation is imperative. European
• Those aspects of Nanomedicine that have been funding schemes often dictate the choice of part-
realised and transferred into practice today have ners. To be effective in Nanomedicine development
arisen from previous basic research programmes. a global perspective is needed involving growing
Universities should be able to pursue a more entre- partnership with the USA and other funding agen-
preneurial freedom and spirit to increase inven- cies. To encourage the establishment of more effec-
tiveness that will feed the future technology tive SMEs working in the Nanomedicine field, more
pipeline. focused funding and a fast response to grant appli-
• Nanomedicine should be discussed in terms of cations are needed.
pharmacoeconomic value at an early stage with As Nanomedicine becomes fashionable, a good
regulatory authorities, policy makers and health- understanding of the end user-supplier interface is
care stakeholders. vital. Companies that appreciate the medical needs
• The potential of Nanomedicine to create not only and the practicalities of their technology will be best
new products, but also new jobs (socioeconomic placed to commercialise. There is a need to promote
value) needs to be appreciated. meetings and a technology directory to assist indus-
• Public awareness about the opportunities and real- try to network. However, Nanomedicine presents a
istic risks of Nanomedicine is necessary and can complex array of end-users. The medical doctors’
be brought about by educational programmes. wish list of technologies is not yet commercially
National support for Nanomedicine would be validated. Large companies have a time horizon for
enhanced when action groups and patient-support market entry that is too short for many new tech-
groups are more aware of the benefits that these nologies, while the activities of SMEs is often too
technologies can already bring. confidential to allow wide discussion. This can make
dialogue difficult. There is a real need to increase
confidence in Nanomedicine technologies by losing
2.2.2. Commercial Exploitation the hype and focusing resources to pick winners.
Dr Julie Deacon (chair), Dr Oliver Bujok,
Dr Françoise Charbit, Dr John Davies, 2.2.3. Interdisciplinary Education
Dr Sjaak Deckers, Dr Benoit Dubertret, and Training
Prof. Mike Eaton, Rainer Erdmann, Workshop participants:
Dr Arne Hengerer, Dr Corinne Mestais, Prof. Hans Oberleithner (chair),
Dr Pierre Puget, Dr Jürgen Schnekenburger, Prof. Robert Henderson (co-chair)
Prof. Csaba Szántay Dr Patrick Boisseau, Dr Paul J. A. Borm,
Dr Luc Delattre, Prof. Varban Ganev,
Transferring the technologies arising from Nanomed- Dr Peter Hinterdorfer, Prof. Jørgen Kjems,
icine research into clinical reality and generating Dr T.H. Oosterkamp, Dr Andrea Ravasio,
commercial value from research will rely on the Dr Kristina Riehemann, Prof. Arto Urtti,
generation of intellectual property, licensing, tech- Dr Peter Venturini, Prof. Ernst Wagner,
nology transfer, and collaborative product develop- Dr Jaap Wilting
The standard of university education in Europe, in 2.2.4. Communication

physics, chemistry, biology, pharmacy and medi-
cine, to master’s level, is very high. It was noted that Dr Ottila Saxl (chair), Prof. Ruth Duncan,
specific Nanomedicine training should be developed Prof. Harm-Anton Klok, Dr Valérie Lefèvre-Seguin,
rapidly to provide an educated workforce and Dr Mihail Pascu, Prof. Helmut Ringsdorf.
researchers to support this rapidly growing field.
New programmes providing education and training Communication issues were discussed in relation
in Nanomedicine should encourage interdiscipli- to: (i) difficulties in communication within the
narity. master’s courses, or early postgraduate multidisciplinary scientific environment; (ii)
medical or scientific training should be developed communication between the scientists and the
with a focus on Nanomedicine. policy makers; and importantly (iii) the perception
In recent years there has been a reduction in the of the general public.
basic science component of undergraduate medical In general, government departments, research
degrees. Although this may be appropriate for many ministries and university faculties continue to oper-
clinicians, there is a danger that there will be a ate in separate compartments. A paradigm shift in
shortfall in the number of clinician-scientists. These the way of operation is needed. Otherwise there is
are the very people needed to support the transfer no doubt that Europe will lose out in developing a
of Nanomedicine into routine clinical practice. leading position in Nanomedicine, an area that
Widespread adoption of MD/PhD degree demands a multidisciplinary approach. This will be
programmes, with some provision for nanoscience exacerbated by the emphasis on converging tech-
training, should be encouraged to provide core nologies in FP7 as the basis of future products.
scientific training for clinicians. In addition, new A major barrier to collaboration is the lack of
funding is needed to support the introduction of understanding between scientists of different disci-
such courses, and also for postgraduate clinical plines. This needs to be addressed by the establish-
training in nanoscience. ment of more truly transdisciplinary research groups
In Europe, training in different scientific disci- and more truly transdisciplinary conferences and
plines is currently highly focused, which is a great workshops. The creation of transdisciplinary goal-
strength. However, this presents the danger of indi- driven ‘clusters’, virtual centres and ‘poles’ should
viduals lacking knowledge outside their own field, also be actively encouraged. Partnerships should be
possibly preventing productive communication encouraged between large medical centres and
across disciplines. It was proposed that formal inter- university research groups, leading to goal-oriented
disciplinary training programmes should be insti- research. Transdisciplinary meetings should be held
tuted, focusing on basic scientific topics; for within medical centres and sponsored by a medical
example molecular biology, colloidal chemistry, cell leader. This could be facilitated through available
physiology, surface chemistry, and membrane instruments at the European level. Additionally, the
biophysics. numbers of transdisciplinary PhDs should be
Several European Centres of Excellence should increased, as well as transdisciplinary exchanges at
be established (possibly relating to the sub-disci- every level – from secondary to tertiary.
plines of Nanomedicine) to provide an interdisci- The benefits and the threats of Nanomedicine
plinary environment in which participants can need to be clearly articulated to the politicians and
‘speak the same language’, thus helping to bridge policy makers. Benefits include employment poten-
the gap between chemical, physical and biomedical tial and the ability to meet the needs of the ageing
scientists. This would provide the infrastructure for population. Threats include losing out on important
direct interactions between scientists, clinicians and economic opportunities and not meeting the aims of
entrepreneurs; e.g. ‘Nanomedicine Centres’. Such the Lisbon agenda. Serious consideration needs to
centres could also be used to provide structures for be also given to lobbying politicians by opinion
undergraduate courses that encourage an interdisci- leaders in the Nanomedicine world. There is also a
plinary frame of mind and allow establishment of lack of scientifically qualified politicians, and
Erasmus-type programmes for Nanomedicine. communication problems have already resulted in
Importantly, both academic scientists and clini- a lack of alignment of the regional programmes, the
cians should have the opportunity and training to national programmes and the EU programmes.
help them identify methods for commercial In the recent past, many top quality transdisci-
exploitation of their work. plinary projects and/or papers have not been recog-
nised as such, as the reviewers lack the necessary

knowledge. Failure to recognise the significance of
our success in multidisciplinary activities has been a
great loss to European scientific growth. One way
forward is that the national and European funding
agencies that provide funds and who audit research
output take a lead in pushing for equal weighting
for transdisciplinary research.
Nanotechnology has to counter two preconcep-
tions in the mind of the general public. Nanotech-
nology was initially (and continues to be) popu-
larised through science fiction, and many of the
well-established nanoimages are figments of the
imagination of Hollywood-inspired artists. Secondly,
it suits sensation-seeking journalists to compare
nanotechnology with the already discredited geneti-
cally modified organisms (GMO) technology. The
fact that nanotechnology is such a broad area –
covering most if not all areas of technological devel-
opment, and particularly in the context of the pres-
ent argument – can make the term Nanomedicine
almost incomprehensible to the general public.
To avoid backlash, Nanomedicine-related devel-
opments must be presented in a realistic way, with-
out overhyping. It is important to focus on the real
benefits that people understand: better diagnostics,
smaller doses, fewer side-effects, disease targeted
therapy, better efficacy, etc.
The media must be handled intelligently and
with caution. And there could be a benefit in provid-
ing them with carefully constructed ‘copy’ in
advance of any new development. Individuals who
have to interact with the press should receive special
training. It was also considered important to
improve the breadth of communication; through
possibly organising thematic meetings aimed at
informing focus groups. Nanomedicine awareness-
raising activities need public funding (at all levels)
in order to ensure a continued dialogue with all
stakeholders.
25
3. European Situation and Forward Look –

SWOT Analysis
All the technology based workshops held in Amsterdam from 1 to 5 March 2004 were independently invited to
conduct a SWOT analysis regarding the current status of European activities in the field. There was considerable
consensus across these groups and the results were summarised and presented at the Consensus Conference
held at Le Bischenberg. Below is a summary of the most significant points agreed.
Strengths
Funding and Academic Research Environment Commercial Technology

Strategic Issues and Education for Research Exploitation
and Development
• The diversity • The strong • There are already • There are a number • Molecular and
of funding sources educational base in several major European of world leading clinical imaging
provides a wide Europe and training clusters and Centres of European companies in techniques, and
range of funding style Excellence in the Field imaging/contrast agent contrast agent research
opportunities of Nanomedicine and nano- and development are
pharmaceuticals areas particular strengths
• European • Potential exists • There are a number • Existing expertise

programmes such as to rapidly expand of SMEs working in drug delivery
the EU Marie-Curie Nanomedicine R & D in the technology research and the
scheme and the ESF and pharmaceutical clinical development of
training courses areas relating to nanopharmaceuticals
provide good training Nanomedicine
opportunities although
more focus should be
put on Nanotechnology
in Medicine
• There are many • Visionary institutions • Ongoing • Strong basic sciences,

leading academic such as the New Drug standardisation efforts particularly in
groups in the sub- Development Office at the European - antibody
disciplines of and Cancer Research Medicines Agency technologies
Nanomedicine UK have facilitated for the Evaluation - nanoparticle
early phase cancer of Medical Products technologies
clinical trials and (EMEA) - polymer therapeutics
supported translational - gene delivery systems
activities, especially - biological models for
for innovative nano- cell and tissue-based
pharmaceuticals in vitro screening
• Leading research
groups in ultrafine
particle toxicology
26 3. EUROPEAN SITUATION AND FORWARD LOOK – SWOT ANALYSIS
Weaknesses

and Development
• EU programmes • Insufficient integration • The size of many • Inefficient translation • Interfacing clinical
lack long-term of clinical research nanotechnology of concept to product medicine and basic
strategy as it changes regional clusters and because of inadequate research
every 5 years. medical research venture capital,
Nanomedicine centres is too small excessive bureaucracy
research needs both a and lack of medical
short-and a long-term input
strategy.
• Low funding rates • Too much replication • Small clusters often • Interaction with the • Interfacing basic
and complex of R&D efforts in lack adequate funding numerous regulatory biological sciences
administrative universities and in authorities, and materials sciences
procedures have been companies across (fragmentation) and
problems associated Europe differences in
with FP6 regulations can deter
those considering
product development
• FP6 has not been • Specific guidelines, • Lack of ability to • Lack of competitive
effective for regulations and test interact with regulating edge in chip-based
supporting research protocols for agencies at the technologies
and development of Nanomedicine are still investigational new
Nanomedicine awaiting to be drug (IND) stage when
developed developing new
technologies, compared
with USA
• Too little funding • Compared to the • Inadequate industrial

for application- USA and Asia: investment in long-term
oriented and requirement of ethical (or basic) research and
translational research approval for many relatively few
aspects of Nano- companies to cooperate
medicine research with or assist with
are more demanding commercialisation
• Lack of a • Recent change in • Ineffective

coordinated European clinical trial regulations organisation of
Research Council able (new EU directive) will the health system and
to allocate funding delay clinical trials for inadequate provision
based only on nanopharmaceuticals, of accredited labs can
excellence without a particularly in cancer limit options for clinical
political agenda research and
development in the field
of Nanomedicine
3. EUROPEAN SITUATION AND FORWARD LOOK – SWOT ANALYSIS 27
Opportunities

and Development
• Identification of • European courses • Better use of human • Better exploitation • Development of

Nanomedicine as a integrating the resources e.g. well- of innovation at the a new generation of
key area for funding biological and physical educated people European level through nanosized materials
in FP7. Explicitly sciences toward coming from Eastern easier access to venture and devices that can
removing the divide nanoscience, Europe capital, better dialogue be used as a tool kit
between Health and nanobiology, and most with regulatory agencies
Nanotechnology importantly • Increased and government • Design of innovative
nanotechnology collaborations between support for R & D diagnostics and
applied to medicine European companies in Nanomedicine. biosensors
(e.g. imaging and Accelerate Nano-
pharmaceutical) and medicine research
academic institutions from lab to clinic and
then the market
• Improved healthcare • Via new education • Establish enhanced • Move towards cost • Design of
for European citizens programmes establish a job opportunities and a effective patient- nanopharmaceuticals
technically skilled competitive individualised and implantable
workforce able to international position in treatments, and point of devices for improved
address the challenges Nanomedicine care diagnostics drug delivery
of Nanomedicine
research and
development
• Establish Networks • Proactive risk • Use experience with • Design of vectors

of Excellence in the management with an first generation able to
sub-disciplines of immediate feed back to anticancer - assist drugs to better
Nanomedicine via Nanomedicine nanopharmaceuticals to reach their target
coordination of development at the rapidly develop second (transferring
recognised leading earliest time point generation medicines across biological
edge researchers and with increased barriers)
companies specificity with less - ensure biotech drugs
toxic side effects for a reach their intracellular
wider range of target targets
diseases
• At the European • Reduced health costs • Development

and National level by earlier detection of of nanomaterials able
establish well defined predisposition allowing to control biological
goal oriented use of preventative signalling and provide
Nanomedicine intervention, and more a biomolecular display
focused projects effective monitoring of for tissue engineering
building on specific chronic illness leading and to promote tissue
technical expertise to improved therapy repair
28 3. EUROPEAN SITUATION AND FORWARD LOOK – SWOT ANALYSIS
Threats

and Development
• EU and/or national • Failure to respond • Continued erosion of • Difficulties in • Lack of scientific

bureaucracy limiting quickly to the need for the European managing intellectual dissemination and
the best use of more multidisciplinary pharmaceutical property with many truly interdisciplinary
funding for research training targeted at industry different national patent exchange in the field
and innovation Nanomedicine, leading organisations. Poorly of Nanomedicine
to Inadequately trained capitalised companies
workforce can lose their
intellectual property
base
• Continued • Increasing lack • Pharmaceutical • Inability to secure • Mismatch between

fragmentation of science companies sufficient funding (and studies on toxicology
of efforts in the (under)graduates concentrating their time) to commercialise of nanomaterials
Nanomedicine field, research outside innovative products and Nanomedicine
particularly economic, • Too many young Europe researchers in certain
political, and researchers leaving sub-disciplines
regulatory aspects Europe, particularly to
USA via brain-drain
• Discrepancies • Researchers • Overregulation • Failure to consider

between promises becoming unwilling and inadequate the environmental
and facts in funding to take on high risk funding for small impact of new materials
projects because of the companies
need to generate data • Failure to consider
(success) for subsequent the safety of new
project evaluation materials in respect of
proposed applications
• Negative public and • Lack of a balanced

political perception. understanding of
A different perception the risk-benefit of
by the public on risks Nanomedicine-related
of the use of products in their many
nanopharmaceuticals forms and applications
was noted, compared
to the uses of
nanotechnology in
hi-tech products;
e.g. computers and
mobile telephones
29
4. Recommendations and Suggested Actions
bility, and own journal

4.1 General Recommendations • Support to clusters for internal cooperation and
European coordination
4.1.1. Priority areas in Nanomedicine for
the next 5 years 4.1.4. Interdisciplinary Education
• Engineering technology for immobilising cells or and Training
molecules on surfaces • Trained people for technology management and
• Programmes to generate reproducible and reliable transfer (PhD + MBA)
platforms integrating micro- and nanotechnologies • Tailored education on management for scientists
• Methods to deposit such platforms and such • Fellowships to support academics gaining experi-
components ence in industry
• Proactive risk management with an immediate • Multidisciplinary training
feedback to Nanomedicine development • Fellowships for complementary education for
• Clinical applications scientists
• Development of satisfactory sensitivity of in vivo
methods
• Developing of non-invasive in vivo diagnostic 4.2. Scientific Trends
systems
• Implantable or injectable parenteral nanodevices 4.2.1. Nanomaterials and Nanodevices
for diagnosis and therapy General directions should be:
• optimisation of existing technologies to specific
4.1.2. Priority areas in Nanomedicine Nanomedicine challenges
for the next 10 years • development of new multifunctional, spatially
• Understanding of the cell as a 3D complex system ordered, architecturally varied systems for targeted
• Bioanalytical methods for single-molecule analy- drug delivery
sis • enhancement of expertise in scale-up manufacture,
• Nanosensing of multiple, complicated analytics characterisation, reproducibility, quality control,
for in vitro measurement of biochemical, genomic and cost-effectiveness
and proteomic networks, their dynamics and their Specific directions should be:
regulation • new materials for sensing of multiple, complicated
• Nanosensing in vivo with telemetrically controlled, analytes for in vitro measurement
functional, mobile sensors • new materials for clinical applications such as
• Rapid fingerprinting of all components in blood tissue engineering, regenerative medicine and 3D
samples display of multiple biomolecular signals
• telemetrically controlled, functional, mobile in
4.1.3. Commercial Exploitation vivo sensors and devices
• European seed funds for nanotechnology applied • construction of multifunctional, spatially ordered,
to medicine architecturally varied systems for diagnosis and
• Intellectual Property management combined drug delivery (theranostics)
• Improved interactions with the EU regulatory • advancement of bioanalytical methods for single-
system to promote rapid commercialisation of molecule analysis
innovation
• Establishing incubators for innovative companies 4.2.2. Nanoimaging and Analytical Tools
in nanomedical applications Specific developments should include:
• New reference organisation (such as EMBO) in short term
nanobiotechnolgy/nanomedicine possibly with • use and refinement of existing nanotechniques in
prestigious positions, scientific excellence, visi- normal and pathological tissues for the under-
30 4. RECOMMENDATIONS AND SUGGESTED ACTIONS
standing of initiation and progression of disease • case-by-case approach for clinical and regulatory
• development of novel nanotechniques for moni- evaluation of Nanomedicines
toring in real time cellular and molecular processes • highly prioritised communication and exchange of
in vivo and for molecular imaging to study patho- information among academia, industry and regu-
logical processes in vivo, with improved sensitiv- latory agencies with a multidisciplinary approach
ity and resolution
• identification of new biological targets for imag- 4.2.5. Toxicology
ing, analytical tools and therapy General directions should be:
• translation of research based on molecular imag- • improved understanding of toxicological implica-
ing using nanoscale tools from animal models to tions of nanomedicines in relation to material prop-
clinical applications erties and proposed use by the potentially predis-
• closing of the gap between the molecular and posed, susceptible patient
cellular technologies and the clinical diagnostic • thorough consideration of the potential environ-
nanotechnologies mental impact, manufacturing processes and ulti-
Specific developments should include: mate clinical applications in toxicological investi-
longer term gations for nanomedicines
• development of a multimodal approach for nano- • risk-benefit assessment for both acute and long-
imaging technologies term effects of nanomedicines with special consid-
• design of non-invasive in vivo analytical nanotools eration on the nature of the target disease
with high reproducibility, sensitivity and reliability • a shift from risk assessment to proactive risk
for use in pre-symptom disease warning signal, management at the earliest stage of new nanomed-
simultaneous detection of several molecules, icines discovery and development
analysis of all sub-cellular components at the
molecular level, and replacement of antibodies as
detection reagents by other analytical techniques 4.3. Research Strategy and Policy
4.2.3. Novel Therapeutics and Drug Delivery 4.3.1. Organisation and Funding
Systems Recommendations
Specific developments should include: • improved coordination and networking of research
short term activities and diverse range of funding sources at
• application of nanotechnology to develop multi- the European, national and regional levels
functional structured materials with targeting capa- • creation of new Nanomedicine-targeted funding
bilities or functionalities allowing transport across schemes to better facilitate both transdisciplinary
biological barriers and interface research that is critical for success in
• nanostructured scaffolds (tissue engineering), Nanomedicine
stimuli-sensitive devices and physically targeted • establishment of European Centres of Excellence
treatments in the field of Nanomedicine
• a focus on cancer, neurodegenerative and cardio- • modification of funding mechanisms for basic
vascular diseases and on local-regional delivery technological research to permit academic-group-
(pulmonary/ocular/skin) only applications
Specific developments should include: • development of funding procedures with sufficient
longer term scale and scope; for example with longer term
• a synthetic, bioresponsive systems for intracellu- funding rather than continuous short-term funding
lar delivery of macromolecular therapeutics and cycles, to enable research for seriously tackling
bioresponsive/self-regulated delivery systems goal-oriented problems
(smart nanostructures such as biosensors coupled • establishment of economic and social benefits of
to delivery systems) Nanomedicine and communication of them to
stakeholders and the public
4.2.4. Clinical Applications and Regulatory Suggested Action
Issues • coordinated funding of basic research in Nano-
General directions should be: medicine through ESF EUROCORES and Euro-
• disease-oriented focus for Nanomedicine devel- pean Commission FP7 instruments (e.g. ERA-Net)
opment in specific clinical applications
4. RECOMMENDATIONS AND SUGGESTED ACTIONS 31
4.3.2. Commercial Exploitation threats from inaction: the benefits consisting of

Recommendations employment potential and meeting the medical
• establishment of a scheme supporting academic/ needs of the ageing population; and the threats
commercial ventures, such as a European version including missed economic opportunities
of the Small Business Innovative Research program • engagement of the scientific community in regu-
of the US National Institutes of Health lar dialogue with the general public in order to
• involvement of clusters or highly selected teams, discover likely public concerns early, and contin-
chosen for personal excellence or track record uation of dialogue to address and alleviate public
• establishment of more manufacturing sites with concerns by the presentation of clear facts
‘Good Manufacturing Practice’ designation to • supply of non-specialist information on potential
support small and medium enterprises for trans- benefits of Nanomedicine to the general public in
ferring projects more rapidly into clinical devel- a timely fashion, with the emphasis on the fact that
opment Nanomedicine is based on mimicking the elegance
Suggested Actions of nature
• liaise with regulatory authority for Good Manu- Suggested Actions
facture Practice designation • organise truly transdisciplinary conferences using
• conduct policy study on the feasibility for a the ESF Research Conference scheme or related
European Small Business Innovative Research schemes at the European Commission
programme • set up a communication entity, possibly in the
form of a small enterprise, to report scientific find-
4.3.3. Interdisciplinary Education and Training ings and innovation to the public.
Recommendations
• establishment of formal interdisciplinary training
courses, mainly at the undergraduate level, cover-
ing basic scientific disciplines such as molecular
biology, colloidal chemistry, cell physiology,
surface chemistry, and membrane biophysics
• institution of new programmes, at master’s or early
postgraduate level (with combined medical and
scientific training), to support the rapidly devel-
oping field of Nanomedicine
• encouragement of more interdisciplinary MD/PhD
degree programmes, with some provision for
nanoscience, to provide core scientific training for
both scientists and clinicians in the longer term
Suggested Action
• facilitate the establishment of interdisciplinary train-
ing courses, masters and MD/PhD programmes via
ESF networking instrument (a la carte Programme),
COST and European Commission instruments (e.g.
Network of Excellence)
Recommendations
• promotion of more truly transdisciplinary confer-
ences focusing on the specific themes of Nano-
medicine to facilitate better communication
between research disciplines
• encouragement of goal-oriented research partner-
ships between large medical centres and univer-
sity research groups
• clearer articulation and better communication of
the benefits of embracing Nanomedicine and the
32
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USA
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www.nrc.ca/nanotech/home_e.html
Journals • National Institute for Nanotechnology - University

Alberta;
It should be also noted that many journals http://www.nint.ca/
contain relevant information but they are not
• Pacific Northwest National Laboratory’s effort
necessarily designated “Nano”.
in nanoscience
www.pnl.gov/nano/index.html
• IEE Proceedings Nanobiotechnology
www.iee.org/proceedings/nbt • Center for Nanotechnology, University of Washington
http://www.nano.washington.edu/
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nanotechnology, visit the AIP/APS Virtual Journal of • Center for Biological and Environmental
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http://www.ruf.rice.edu/%7Ecben/
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Nanotechnology
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approach to nanoscale science
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http://www.sciam.com/nanotech/www.sciam.com/
nanotech
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http://www.dovepress.com/IJN.htm
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http://www.jnanobiotechnology.com/home/
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http://www.tandf.co.uk/journals/titles/17435390.asp
37
6. Appendices
Appendix I Campus de Beaulieu

35042 Rennes Cedex • France
ESF Forward Look Workshop Participants jean-louis.coatrieux@univ-rennes1.fr
Amsterdam, Netherlands, 1-5 March 2004 Dr Andreas Briel
Schering AG
Workshop on Analytical Techniques and Drug Delivery Systems
Diagnostic Tools, Amsterdam, 1 March 2004 13342 Berlin • Germany
Andreas.Briel@schering.de
Dr Patrick Boisseau (Chair)
CEA-Nano2Life Prof. Salvatore Cannistraro
17 rue des Martyrs Dipartimento di Scienze Ambientali
38054 Grenoble Cedex 9 • France Istituto Nazionale per la Fisica della Materia
patrick.boisseau@cea.fr Università della Tuscia
01100 Viterbo • Italy
Dr François Berger
cannistr@unitus.it
Centre Hospitalier Universitaire
Rue des Carabins-Ancienne Prof. Martyn Davies
38043 Grenoble • France Laboratory of Biophysics and Surface Analysis
Francois.Berger@ujf-grenoble.fr School of Pharmacy, University of Nottingham
University Park
Prof. H. Allen O. Hill
Nottingham NG7 2RD • United Kingdom
Inorganic chemistry laboratory
martyn.davies@nottingham.ac.uk
University of Oxford
South Parks Road Dr Sjaak Deckers
Oxford OX1 3QR • United Kingdom Molecular Imaging and Diagnostics
allen.hill@chem.ox.ac.uk Philips Medical Systems Nederland BV
P.O. Box 10.000
Dr Jürgen Schnekenburger
5680 DA Best • Netherlands
Gastroenterologische Molekulare Zellbiologie, UKM
sjaak.deckers@philips.com
University of Münster
Domagkstr. 3A Prof. Paul Dietl
48149 Münster • Germany Institute of Physiology
schnekenburger@uni-muenster.de University of Innsbruck
Fritz-Pregl-Str. 3
Prof. Yosi Shacham
6020 Innsbruck • Austria
University Research Institute for NanoScience and
paul.dietl@uibk.ac.at
NanoTechnology
Tel Aviv University Rainer Erdmann
Ramat Aviv, 69978 Tel Aviv • Israel PicoQuant GmbH
yosish@eng.tau.ac.il Rudower Chaussee 29 (IGZ)
12489 Berlin • Germany
Dr Dimitrios Stamou
photonics@pq.fta-berlin.de
Laboratory of physical chemistry of polymers and
membranes (LCPPM) Dr Mauro Giacca
EPFL International Centre for Genetic Engineering and
1051 ausanne • Switzerland Biotechnology (ICGEB)
dimitrios.stamou@epfl.ch Padriciano 99
34012 Trieste • Italy
giacca@icgeb.org
Workshop on Nanoimaging and Manipulation,
Dr Corinne Mestais
Amsterdam, 2 March 2004
CEA Grenoble
Prof. Jean-Louis Coatrieux (Chair) Département Système pour l’Information et la Santé
Lab. Traitement du Signal et de l’Image 17, Rue des Martyrs
Université de Rennes 1 38054 Grenoble Cedex 09 • France
corinne.mestais@cea.fr
38 APPENDIX I
Prof. Hans Oberleithner Prof. Ruth Duncan (Co-chair)

Institute of Physiology Centre for Polymer Therapeutics
University of Münster Welsh School of Pharmacy
Robert-Koch-Str. 27a Cardiff University
48149 Münster • Germany Redwood Building
oberlei@uni-muenster.de King Edward VII Avenue
Cardiff CF10 3XF • United Kingdom
DuncanR@cf.ac.uk
Workshop on Nanomaterials and Nanodevices,
Prof. Daan Crommelin
Amsterdam, 3 March 2004
Department of Pharmaceutics
Prof. Jeffrey Alan Hubbell (Chair) Utrecht Institute for Pharmaceutical Sciences
Laboratoire de médecine régénérative et PO Box 80082
de pharmacobiologie 3508 TB Utrecht • Netherlands
EPFL d.j.a.crommelin@pharm.uu.nl
1015 Lausanne • Switzerland
Prof. Patrick Couvreur
jeffrey.hubbell@epfl.ch
Faculté de Pharmacie
Prof. Wim Hennink (Co-chair) Universite de Paris-Sud
Department of Pharmaceutics 5 rue J-B Clement
Utrecht Institute for Pharmaceutical Sciences 92296 Chatenay-Malabry • France
Utrecht University patrick.couvreur@cep.u-psud.fr
3508 TB Utrecht • Netherlands
Prof. Mike Eaton
w.e.hennink@pharm.uu.nl
UCB-Celltech
Prof. João Pedro Conde 216 Bath Road
Department of Materials Engineering Slough, Berks SL1 4EN • United Kingdom
Instituto Superior Tecnico mike.eaton@ucb-group.com
Av. Rovisco Pais 1
Prof. Thomas Kissel
1096 Lisboa • Portugal
Institut für Pharmazeutische Technologie und
joao.conde@ist.utl.pt
Biopharmazie
Dr John W Davies Philipps-Universität Marburg
Polymer Laboratories Ltd Ketzerbach 63
Essex Road 35032 Marburg • Germany
Shropshire kissel@staff.uni-marburg.de
Church Stretton SY6 6AX • United Kingdom
Prof. Claus-Michael Lehr
john.davies@polymerlabs.com
Department of Biopharmaceutics and Pharmaceutical
Prof. Helmuth Möhwald Technology
Max-Planck-Institute of Colloids and Interfaces Saarland University
Wissenschaftspark Golm Im Stadtwald, Bldg. 8.1
14476 Potsdam • Germany 66123 Saarbrucken • Germany
moehwald@mpikg-golm.mpg.de lehr@rz.uni-sb.de
Prof. José Rivas Prof. Egbert Meijer

Dpto. Física Aplicada, Campus Universitario Sur Laboratory of Macromolecular and Organic Chemistry
Universidad de Santiago de Compostela Eindhoven University of Technology
15782 Santiago de Compostela • Spain Den Dolech 2 , STO 4.36
farivas@usc.es 5600 MB Eindhoven • Netherlands
e.w.meijer@tue.nl
Workshop on Drug Delivery and Pharmaceutical

Development, Amsterdam, 4 March 2004 Workshop on Clinical Applications
and Toxicology, Amsterdam, 5 March 2004
Prof. María José Alonso (Chair)
Department of Pharmaceutical Technology Dr Wolfgang Kreyling (Chair)
Faculty of Pharmacy GSF National Research
University of Santiago de Compostela Centre for Environment and Health
15782 Santiago de Compostela • Spain Institut für Inhalationsbiologie
ffmjalon@usc.es Ingolstädter Landstrasse 1
85764 Neuherberg • Germany
kreyling@gsf.de
APPENDIX II 39
Dr Paul J. A. Borm Dr Patrick Boisseau

Centre of Expertise in Life CEA – Nano2Life
Sciences (CEL) 17 rue des Martyrs
Hogeschool Zuyd 38054 Grenoble Cedex 9 • France
Nieuw Eyckholt 300 patrick.boisseau@cea.fr
6419 DJ Heerlen • Netherlands
Prof. Salvatore Cannistraro
p.borm@hszuyd.nl
Dipartimento di Scienze Ambientali
Prof. Kenneth Donaldson Instituto Nationale per la Fiscica della Materia
ELEGI Colt Laboratory Università della Tuscia
School of Clinical Sciences and Community Health, 01100 Viterbo • Italy
Medical School cannistr@unitus.it
University of Edinburgh
Prof. Jean-Louis Coatrieux
Wilkie Building, Teviot Place
Lab. Traitement du Signal et de l’Image
Edinburgh EH 8 9AG • United Kingdom
Université de Rennes 1
ken.donaldson@ed.ac.uk
Campus de Beaulieu
Prof. Alberto Gabizon 35042 Rennes Cedex • France
Shaare Zedek Med. Ctr. jean-louis.coatrieux@univ-rennes1.fr
Oncology Institute
Prof. Hans Oberleithner
POB 3235
Institute of Physiology
Jerusalem 91031 • Israel
alberto@md.huji.ac.il
Robert-Koch-Str. 27a
Dr Rogério Gaspar 48149 Münster • Germany
Laboratory of Pharmaceutical Technology oberlei@uni-muenster.de
Faculty of Pharmacy
University of Coimbra
3000 Coimbra • Portugal ESF Member Organisations and
rgaspar@ff.uc.pt Representatives/Political Bodies
Dr Andreas Jordan Dr Janna de Boer
MagForce Applications The Netherlands Organisation for Health Research
Center of Biomedical Nanotechnology and Development (NWO)
Campus Charite, CBN, Haus 30 P.O. Box 93245
Spandauer Damm 130 2509 AE The Hague • Netherlands
14050 Berlin • Germany boer@zonmw.nl
andreas.jordan@charite.de
Dr Oliver Bujok
VDI Technologiezentrum GmbH
Physikalische Technologien
Graf-Recke-STr. 84
Appendix II 40239 Düsseldorf • Germany
bujok@vdi.de
ESF Consensus Conference Participants
Dr Jean Chabbal
Le Bischenberg, France, 8-10 November 2004 Dept. Microtech. Biol.&Health
CEA-L2t
Steering Committee 17, Rue des Martyrs
Prof. Ruth Duncan (Chair) 38054 Grenoble Cedex 09 • France
Centre for Polymer Therapeutics jean.chabbal@cea.fr
Welsh School of Pharmacy Dr Françoise Charbit
Cardiff University CEA Grenoble
Redwood Building LETI-DTBS
King Edward VII Avenue 17, Rue des Martyrs
Cardiff CF10 3XF • United Kingdom 38054 Grenoble Cedex 09 • France
DuncanR@cf.ac.uk francoise.charbit@cea.fr
Dr Wolgang Kreyling (Deputy-chair) Dr Rosita Cottone
GSF National Research Centre for Environment Mission Affaires Européennes on sabbatical of BMBF
and Health (Ministry of Research, Germany) Direction de
Institut für Inhalationsbiologie la Technologie Ministère délégué à la Recherche
Ingolstädter Landstrasse 1 1, rue Descartes
85764 Neuherberg • Germany 75005 Paris • France
kreyling@gsf.de rosita.cottone@technologie.gouv.fr
40 APPENDIX II
Dr Julie Deacon Prof. Manuel Vázquez

UK Micro and Tanotechnology Network Instituto de Ciencia de Materiales de Madrid, CSIC
Farlan Cottage Campus de Cantoblanco
Lower Road 28049 Madrid • Spain
Cookham, Berks SL6 9HJ • United Kingdom mvazquez@icmm.csic.es
julie.deacon@pera.com
Dr Peter Venturini
Dr Nicole Déglon National Institute of Chemistry
CEA/Service Hospitalier Frédéric Joliot Hajdrihova 19
4, place du Général Leclerc 1000 Ljubljana • Slovenia
91401 Orsay Cedex France • France peter.venturini@ki.si
Nicole.deglon@cea.fr
Dr Petra Wolff
Dr Luc Delattre Bundesministerium für Bildung und Forschung (BMBF)
Département de Pharmacie Referat 511 Nanomaterialien
Pharmacie Galénique et Magistrale Heinemannstr. 2
Université de Liège 53175 Bonn • Germany
Avenue de l’Hôpital, 1 – Bât. B36 petra.wolff@bmbf.bund.de
4000 Liege 1 • Belgium
l.delattre@ulg.ac.be
Academic Experts
Dr Franz Dettenwanger
VolkswagenStiftung Prof. María José Alonso
Kastanienallee 35 Department of Pharmaceutical Technology
30519 Hannover • Germany Faculty of Pharmacy
dettenwanger@volkswagenstiftung.de University of Santiago de Compostela
15782 Santiago de Compostela • Spain
Dr Mauro Ferrari
ffmjalon@usc.es
The National Cancer Institute
110U Davis Heart and Lung Research Institute Dr Paul J.A. Borm
31 Center Drive MSC 2580 Centre of Expertise in Life Sciences (CEL)
The Ohio State University Hogeschool Zuyd
Room 10A52 Nieuw Eyckholt 300
473 West 12th Avenue 6419 DJ Heerlen • Netherlands
Columbus OH 43210-1002 • USA p.borm@hszuyd.nl
ferrari@lvd1.bme.ohio-state.edu
Prof. Hans Börner
Dr Valérie Lefèvre-Seguin Max Planck Institute of Colloids and Interfaces
Direction de la Recherche, Ministère délégué Department of Coloid Chemistry
à la Recherche Research Campus Golm
1, rue Descartes • 75005 Paris • France Am Mühlenberg 1
valerie.lefevre@recherche.gouv.fr 14424 Potsdam • Germany
boerner@mpikg-golm.mpg.de
Dr Corinne Mestais
CEA Grenoble Dr Benoit Dubertret
Département Système pour l’Information et la Santé ESPCI, Laboratoire d’Optique Physique
17, Rue des Martyrs CNRS UPRA0005
38054 Grenoble Cedex 09 • France 10, rue Vauquelin
corinne.mestais@cea.fr 75231 Paris Cedex 10 • France
benoit.dubertret@espci.fr
Prof. Julio San Roman
CSIC Prof. Alberto Gabizon
Institute of Polymers Shaare Zedek Med. Ctr.
Juan de la Cierva 3 Oncology Institute
28006 Madrid • Spain POB 3235
jsroman@ictp.csic.es Jerusalem 91031 • Israel
alberto@md.huji.ac.il
Dr Christof Steinbach
Dechema e.V. Prof. Varban Ganev
Theodor-Heuss-Allee 25 Medical University of Sofia
60486 Frankfurt a.M. • Germany 2 Zdrave Street
steinbach@dechema.de 1431 Sofia • Bulgaria
ganev@medfac.acad.bg
APPENDIX II 41
Dr Mauro Giacca Prof. A.W. McCaskie

International Center for Genetic Engineering Surgical&Reproductive Sciences
and Biotechnology (ICGEB) Medical School, University of Newcastle upon Tyne
Padriciano 99 Newcastle upon Tyne NE2 4HH • United Kingdom
34012 Trieste • Italy A.W.McCaskie@newcastle.ac.uk
giacca@icgeb.trieste.it
Prof. Helmuth Möhwald
Dr Robert M. Henderson Max-Planck-Institute of Colloids and Interfaces
Department of Pharmacology, University of Cambridge Wissenschaftspark Golm
Tennis Court Road 14476 Potsdam • Germany
Cambridge CB2 1PD • United Kingdom moehwald@mpikg-golm.mpg.de
rmh1003@cam.ac.uk
Prof. Lars Montelius
Dr Peter Hinterdorfer Division of Solid State Physics
Institute for Biophysics Department of Physics
Johannes Kepler Universität Linz Lund University
Altenbergerstr. 69 Box 117
A-4040 Linz • Austria SE-221 00 Lund • Sweden
peter.hinterdorfer@jk.uni-linz.ac.at Lars.Montelius@ftf.lth.se
Prof. Thomas Kissel Prof. Roeland J.M. Nolte

Institut für Pharmazeutische Technologie Department of Organic Chemistry
und Biopharmazie University of Nijmegen
Philipps-Universität Marburg Toernooiveld 1 - U 052
Ketzerbach 63 6525 ED Nijmegen • Netherlands
35032 Marburg • Germany nolte@sci.kun.nl
kissel@staff.uni-marburg.de
Dr T.H. Oosterkamp
Prof. Jørgen Kjems Leiden Institute of Physics
Department of Molecular Biology Leiden University
University of Arhus Niels Bohrweg 2
C.F.Mollers Alle, Build. 130 2333 CA Leiden • Netherlands
DK-8000 Aarhus C • Denmark tjerk@phys.leidenuniv.nl
kjems@biobase.dk
Dr Pierre Puget
Prof. Harm-Anton Klok Département Systèmes pour l’information et la santé
Ecole polytechnique fédérale de Lausanne (EPFL) (DSIS)
Institute de matériaux, Laboratoire de polymères LETI - CEA Grenoble
Ecublens 17, rue des Martyrs
CH-1015 Lausanne • Switzerland 38054 Grenoble cedex 9 • France
harm-anton.klok@epfl.ch pierre.puget@cea.fr
Prof. Jean-Marie Lehn Dr Andrea Ravasio

Institut de Science et d’Ingénierie Supramoléculaires Department of Physiology
Laboratoire de Chimie Supramoléculaire University of Innsbruck
ISIS/ULP Fritz-Pregl-Str. 3
8, allée Gaspard Monge 6020 Innsbruck • Austria
BP 70028 • F-67083 Strasbourg Cedex andrea.ravasio@uibk.ac.at
lehn@isis.u-strasbg.fr
Prof. Helmut Ringsdorf
Prof. Claus-Michael Lehr University of Mainz
Department of Biopharmaceutics and Pharmaceutical Raum 00.125
Technology Düsenbergweg 10-14
Saarland University 55128 Mainz • Germany
Im Stadtwald, Bldg. 8.1 ringsdor@mail.uni-mainz.de
66123 Saarbrucken • Germany
Dr Jürgen Schnekenburger
lehr@rz.uni-sb.de
Gastroenterologische Molekulare Zellbiologie, UKM
Prof. C.R. Lowe University of Münster
Institute of Biotechnology Domagkstr. 3A
University of Cambridge 48149 Münster • Germany
Tennis Court Road schnekenburger@uni-muenster.de
Cambridge CB2 1QT • United Kingdom
c.lowe@biotech.cam.ac.uk
42 APPENDIX II
Dr Milada Sirova Rainer Erdman

Institute of Microbiology ASCR PicoQuant GmbH
Videnska 1083 Rudower Chaussee 29 (IGZ)
142 20 Prague 4 • Czech Republic 12489 Berlin • Germany
sirova@biomed.cas.cz photonics@pq.fta-berlin.de
Prof. K. Ulbrich Dr Rogério Gaspar

Czech Republic Academy of Science Laboratory of Pharmaceutical Technology
Faculty of Pharmacy
Institute of Macromolecular Chemistry
University of Coimbra
Heyrovského námestí 2
3000 Coimbra • Portugal
CZ-162 06 Prague 6 • Czech Republic
rgaspar@ff.uc.pt
ulbrich@imc.cas.cz
Dr Arne Hengerer
Prof. Arto Urtti Siemens Medical Solutions
University of Kuopio MR MI
Department of Pharmaceutics Karl-Schall-STr. 4
P.O.Box 1627 91054 Erlangen • Germany
FIN-70211 Kuopio • Finland arne.hengerer@siemens.com
Arto.Urtti@uku.fi
Dr Laurent Levy
Prof. Ernst Wagner Nanobiotix
Pharmaceutical Biotechnology Rue Pierre et Marie Curie - BP27/01
Department of Pharmacy 31319 Labege Cedex • France
Ludwig-Maximilians Universität München (LMU) Laurent.levy@nanobiotix.com
Butenandtstr. 5-13 Dr Kristina Riehemann
81377 Munich • Germany Integrated Functional Genomics (IFG)
erwph@cup.uni-muenchen.de University of Münster
von-Esmarch-Str. 56
Dr Jaap Wilting
48149 Münster • Germany
Utrecht Institute Pharmaceutical Sciences
k.riehemann@uni-muenster.de
University of Utrecht
Sorbonnelaan 16 Prof. Csaba Szántay Jr.
3585 CA Utrecht • Netherlands Spectroscopic Research Division
J.Wilting@pharm.uu.nl Chemical Works of Gedeon Richter Ltd.
H-1475 Budapest
P.O.B. 27 • Hungary
cs.szantay@richter.hu
Industrial & Regulatory Experts
Dr Andreas Briel
Schering AG Nanotechnology Information Suppliers
Drug Delivery Systems
13342 Berlin • Germany Dr Ottila Saxl
Andreas.Briel@schering.de The Institute of Nanotechnology
6 The Alpha Centre
Dr John W Davies
University of Stirling Innovation Park
Polymer Laboratories Ltd
Stirling, FK9 4NF • United Kingdom
Essex Road
ottilia@nano.org.uk
Church Stretton
Shropshire, SY6 6AX • United Kingdom
john.davies@polymerlabs.com
ESF/EMRC/COST
Dr Sjaak Deckers
Molecular Imaging and Diagnostics Prof. Luc P. Balant
Philips Medical Systems Nederland BV COST TC Medicine & Health
P.O. Box 10.000 • 5680 DA Best • Netherlands Department of Psychiatry
sjaak.deckers@philips.com University of Geneva
2, Chemin du Petit-Bel-Air
Prof. Mike Eaton
UCB-Celltech 1225 Chene-Bourg • Switzerland
216 Bath Road luc.balant@medecine.unige.ch
Slough Dr Thomas Bruhn
Berks SL1 4EN • United Kingdom Institute of Experimental Dermatology
mike.eaton@ucb-group.com University of Münster
von-Esmarch-Str. 58
48149 Münster • Germany
tbruhn@uni-muenster.de
APPENDIX III 43
Nathalie Geyer Ambisome® (liposomal amphotericin B) are > $100

European Science Foundation million (€ 83.77 million) sales per annum
1, quai Lezay Marnésia
BP 90015 • 67080 Strasbourg Cedex • France * Vision paper and basis for a strategic research agenda for
ngeyer@esf.org NanoMedicine, European Technology
Platform on NanoMedicine - Nanotechnology for Health –
Dr John Marks EU publication September 2005
1, quai Lezay Marnésia
BP 90015 • 67080 Strasbourg Cedex • France
jmarks@esf.org
Prof. Mihail Pascu

Appendix IV
ESF-COST Office
Medicine and Health; Biomaterials European Projects and Networks Undertaking
149, Avenue Louise Nanomedicine Research
P.O. BOX 12
1050 Brussels • Belgium European Networks
mpascu@cost.esf.org
EU funding opportunities in the Nanotechnology
Prof. Clemens Sorg
Research Area
Institute of Experimental Dermatology
www.cordis.lu/nanotechnology/
von-Esmarch-Str. 58 Communication on nanotechnology from the European
48149 Münster • Germany Commission, ‘Towards a European strategy on
sorg@uni-muenster.de nanotechnology’
www.cordis.lu/nanotechnology/src/communication.htm
Dr Hui Wang
European Science Foundation Illustrated brochure entitled ‘Nanotechnology, Innovation
1, quai Lezay Marnésia for tomorrow’s world’ ftp://ftp.cordis.lu/pub/
BP 90015 • 67080 Strasbourg Cedex • France nanotechnology/docs/nano_brochure_en.pdf
hwang@esf.org
The PHANTOMS Nanoelectronics Network scheme
www.phantomsnet.net
A general European site on European nanoscience and

technology.
Appendix III www.nanoforum.org/
Projected Market for Nanomedicines European National Nanocentres

The Swiss ‘National Centre for Nano Scale Science’ at
The market of nanomedicines is rapidly rising as new prod-
Universität Basel
ucts are being approved. It is expected that this market will
www.nanoscience.unibas.ch/
reach a significant economic potential within 5 to 10 years.
Currently, little data is available on the market of nanomed- Nanoscience @ Cambridge University
icines in Europe. http://www.nanoscience.cam.ac.uk/
London Centre for Nanotechnology

Market size worldwide 2003 for medical devices
http://www.london-nano.ucl.ac.uk/
and pharmaceuticals*
Medical devices € 145 billion Nanolink at University of Twente
Pharmaceuticals € 390 billion Nanolink
www.mesaplus.utwente.nl/nanolink/
Expected market growth: 7-9% annually
Centre of Competence Nano-Scale Analysis in Hamburg
Within the market of pharmaceuticals, advanced drug deliv-
www.nanoscience.de/
ery systems account for approximately 11% market share
http://www.nanoanalytik-hamburg.de/shtml/index.
(€42.9 billion). This market is expected to expand rapidly as
shtmlhttp://www.nanoanalytik-hamburg.de/shtml/
only a few products are currently in clinical application and
index.shtml
many more in clinical trials or in the process of being
approved. As an example, the current estimates for Centre for NanoScience based at Ludwig-Maximillians-
Doxil®/Caelyx® (PEGylated liposomal doxorubicin) Universität, München
are $300 million (€ 251.32 million) sales per annum www.cens.de/
44 APPENDIX IV
Centre of Competence NanoBioTechnology, Saarland, Contact: Sergey Piletsky

Germany Email: s.piletsky@cranfield.ac.uk
www.nanobionet.de/
HEPROTEX
Centre of Competence NANOCHEM, Saarbrücken, Objectives: To develop a joint research infrastructure for
Germany development of protective textiles. With new innovations
www.cc-nanochem.de in textiles, forms will become more widely used in
surgical procedures than for just traditional uses such as
The German Ministry of Education and Research
wound care.
supports six national Competence Centres
Contact: Hilmar Fuchs
www.nanonet.de/nanowork/indexe.php3
Email: stfi@stfi.de
Nano-World, The Computer-Supported Cooperative
INCOMED
Learning Environment on Nanophysics, a Swiss Virtual
Objectives: The aim is to reduce 90% of implant
Campus
complications, by way of an innovative method of
www.nanoworld.unibas.ch/zope/nano/en
coating objects with a thin layer of hydroxylapatite,
Center for NanoMaterials at Technische Universiteit bioactive glass or mixtures of both in order to give
Eindhoven, Holland biocompatible surfaces.
www.cnm.tue.nl Contact: Christoph Schultheiss
Email: christoph.schultheiss@ihm.fzk.de
Center for Ultrastructure Research, Austria
www.boku.ac.at/zuf/ INTELLISCAF
Objectives: The aim is to produce intelligent scaffolds
Institute of Nanotechnology at the Forschungszentrum
using nanostructured particles and surfaces to give
Karlsruhe
materials which will help regenerate tissues such as bone
http://hikwww1.fzk.de/int/english/welcome.html
or skin on their implantation.
DFG-Centrum für Funktionelle Nanostrukturen Contact: Soeren Stjernqvist
http://www.cfn.uni-karlsruhe.de/index.html Email: info@teknologisk.dk
Nanostructures Laboratory at MFA Research Institute for MENISCUS-REGENERATIO

Technical Physics and materials science Objectives: The aim is to use tissue engineering to
http://www.mfa.kfki.hu/int/nano/ produce an artificial meniscus with a structure similar to
the natural tissue.
Paul Scherrer Institut - Laboratory for Micro- and
Contact: Claudio de Luca
Nanotechnology
Email: cdeluca@fidiapharma.it
http://lmn.web.psi.ch/index.html
Nano-Science Center at Københavns Universitet

http://www.nano.ku.dk/ EU 6th Framework Programme
MIC National Micro- and Nanotechnology Research Search: http://eoi.cordis.lu/search_form.cfm

Center at DTU
Microrobotnic surgical instruments
http://www.mic.dtu.dk/
Project Acronym: (none).
NanoBIC - NanoBioCentrum at University of southern Objectives: To develop microrobotic surgical instruments
Denmark for new types of surgery.
http://www.sdu.dk/Nat/nanobic/index.php Contact: Georges Bogaerts
Email: geboconsult@lps-business.com
MOBIAS
European Projects
Objectives: To develop a way to manufacture implants
BIOMIN and scaffolds with several materials and to vary the
Objectives: The aim of the project is to form composition throughout the structure, to give multiple
nanostructure composites of biomaterials and inorganic functions.
compounds for applications in, e.g. implants. Contact: Gregory Gibbons
Contact: Ralph Thomann Email: g.j.gibbons@warwick.ac.uk
Email: r_thomann@igv-gmbh.de
NA.BIO.MAT
BIOSMART Objectives: The design and development of self-
Objectives: To establish an infrastructure for coordinating assembling biocompatible polymers, for applications in,
research into the design and application of biomimetic e.g., tissue engineering.
materials and smart materials with biorecognition Contact: Gaio Paradossi
functions, including new porous biorecognition materials Email: paradossi@stc.uniroma2.it
for tissue engineering.
APPENDIX V 45
Nanoarchitecture NMMA
Objectives: Nanostructuring modification of biomaterials Objectives: To carry out interdisciplinary research (for
for tissue engineering and other biomimetic applications. medical applications) into the possibilities
Contact: Vasif Hasirci nanotechnology offers for shaping surface and internal
Email: chasirci@metu.edu.tr structure, and using molecular biology to control
interactions between materials and cells.
NanoBone
Contact: Krzysztof Kurzydlowski
Objectives: To apply nanotechnology, in terms of
Email: KJK@inmat.pw.edu.pl
structuring, to bone repair and regeneration.
Contact: Fernando Monteiro NONMETALLICIMPLANTS
Email: fjmont@ineb.up.pt Objectives: To create new/improved polymer materials
for implants and scaffolds, with the necessary structure to
Nanostres
optimise their function.
Objectives: To use nanotechnology techniques to create
Contact: Jan Chlopek
implants and implant technologies for skeletal tissues.
Email: chlopek@uci.agh.edu.pl
Contact: Josep Anton Planell
Email: plannell@cmem.upc.es SAM-MED-NET
Objectives: To gain a better understanding of self
NB-TISS-INTER-MED
assembly mechanisms for applications in biomimetic
Objectives: To redress the issue of the decreasing
materials (e.g. tissue engineering).
European market share in medical devices.
Contact: Frederic Cuisinier
Contact: Ian McKay
Email: fred.cuisinier@odonto-ulp.u-strabg.fr
Email: ian.mckay@pera.com
Appendix V
Nanomedicines in Routine Clinical Use or Clinical Development
Liposomal formulations in clinical use and clinical development

Product Status Payload Indication
Daunoxome® Market daunorubicin cancer
Doxil®/Caelyx® Market doxorubicin cancer
Myocet® Market doxorubicin cancer
Ambisome® Market amphotericin B fungal infections
Amphotech® Market amphotericin B fungal infections
Monoclonal antibody-based products in the market

Antibody Target Payload Use
Therapeutic antibodies
Rituxan® CD20 inherent activity CD20+ve Non-Hodgkin’s
Lymphoma
Herceptin® HER2 inherent activity HER2 +ve breast cancer
Antibody-drug conjugates
Mylotarg® CD33 calicheamicin Acute Myeloid Leukaemia
Radioimmunotherapeutics
Tositumomab® CD20 [131I]iodide Non-Hodgkin’s Lymphoma-
targeted radiotherapy
Zevalin® CD20 90
Yttrium Non-Hodgkin’s Lymphoma-
targeted radiotherapy
Immunotoxins
Anti-B4-blocked ricin CD19 blocked ricin Non-Hodgkin’s lymphoma
targeted immunotoxin
Anti-Tac(Fv)-PE38 (LMB2) CD25 Pseudomonas Haematological malignancies
exotoxin fusion protein
PEG-antiTNF Fab CDP870 TNFα Phase III Rheumatoid arthritis and
Crohn’s disease
46 APPENDIX V
Nanoparticles as imaging agents and drug carriers

Product Compound Status Use
Imaging Agents
Endorem® superparamagnetic Market MRI agent
iron oxide nanoparticle
Gadomer® Dendrimer-based Phase III MRI agent-cardiovascular
MRI agent
Drug delivery
Abraxane® Albumin nanoparticle Market Breast cancer
containing paclitaxel
Polymer Therapeutics in the market or transferred into clinical development

Compound Name Status Indication
Polymeric drugs
Poly(alanine, lysine, Copaxone® Market Multiple sclerosis
glutamic acid, tyrosine)
Poly(allylamine) Renagel® Market End stage renal failure
Dextrin-2-sulphate Emmelle® gel Market Phase III HIV/AIDS - a vaginal
virucide formulated as a gel
Dextrin-2-sulphate Phase III HIV/AIDS - polymer
administered intraperitoneally
Poly(I):Poly(C) Ampligen® Phase III Chronic fatigue immune
dysfunction (myalgic
encephalomyelitis; ME)
Polyvalent, polylysine VivaGel™ Phase I/II Viral sexually transmitted
dendrimer containing SPL7013 diseases, formulated
as a vaginal gel
Polymer-oligonucleotide conjugates
PEG-aptamer Macugen™ NDA filed Age-related macular degeneration
Polymer-protein conjugates
PEG-adenosine deaminase Adagen® Market Severe combined immuno-
deficiency syndrome
SMANCS Zinostatin Stimalmer® Market Cancer - hepatocellular
carcinoma
PEG-L-asparaginase Oncaspar® Market Acute lymphoblastic leukamia
PEG-a-interferon 2b PEG-intron™ Market Hepatitis C, also in clinical
development in cancer, multiple
sclerosis, HIV/AIDS
PEG-a-interferon 2a PEG-Asys® Market Hepatitis C
PEG-human growth hormone Pegvisomant® Market Acromegaly
PEG-GCSF Neulasta™ Market Prevention of neutropenia
associated with cancer
chemotherapy
PEG-antiTNF Fab CDP870 Phase III Rheumatoid arthritis and
Crohn’s disease
Polymer-drug conjugates
Polyglutamate-paclitaxel CT-2103, XYOTAX™ Phase II/III Cancer -particularly lung cancer,
ovarian and oesophageal
HPMA copolymer-doxorubicin PK1; FCE28068 Phase II Cancer -particularly lung and
breast cancer
HPMA copolymer-doxorubicin- PK2; FCE28069 Phase I/II Cancer -particularly
galactosamine hepatocellular carcinoma
HPMA copolymer-paclitaxel PNU166945 Phase I Cancer
HPMA copolymer camptothecin MAG-CPT / PNU166148 Phase I Cancer
HPMA copolymer platinate AP5280 Phase II Cancer
HPMA copolymer platinate AP5346 Phase I/II Cancer
Polyglutamate-camptothecin CT-2106 Phase I/II Cancer
PEG-camptothecin PROTHECAN™ Phase II Cancer
Polymeric micelles
PEG-aspartic acid-doxorubicin NK911 Phase I Cancer
micelle
APPENDIX VI 47
Appendix VI ImaRx Therapeutics

uses SonoLysis technology which employs tiny micro
European Companies Active and nanobubbles injected into the bloodstream to enter
into regions of thrombosis. When external ultrasound is
in Nanomedicines’ Development
applied, the microbubbles cavitate and dissolve blood
clots into smaller particles.
A list of some companies active in nanomedicines’
Website: www.imarx.com
development. This list is not meant to be
comprehensive. iMEDD
is a biomedical company developing advanced drug
iNano
delivery systems based on MEMS technology. iMEDD’s
website containing links to several companies and
lead drug delivery platform, NanoGATE, is an implant
institutions that could be helpful in the start-up phase of
that uses membranes containing pores with nanometre
new companies
dimensions that control the diffusion of drugs at a
Website: http://www.inano.dk/sw179.asp molecular level.
Pronano Website: www.imeddinc.com
Swedish site for the promotion of nanotechnology in LiPlasome Pharma
industry has developed a prodrug and drug delivery platform that
Website: http://www.pronano.se/ can be used for targeted transport of anticancer drugs.
Advanced Photonic Systems APhS GmbH Their prodrug and drug delivery technology is based on
Advanced Photonic Systems manufactures lasers, laser smart lipid based nanocarriers (LiPlasomes) that can be
systems and components, with a focus on fast and ultra applied for targeted transport of anticancer drugs.
fast-pulsed lasers. Website: liplasome.com
Website: http://www.advanced-photonic-systems.com/ MagForce Applications
Bio-Gate Bioinnovative Materials GmbH is a group of companies that have developed the magnetic
Bio-Gate develops and tests anti-infective materials using fluid hyperthermia method (MFH). This is a minimally
invasive cancer therapy that attacks cancer at the cellular
nanosilver, for medicine and other industries.
level whilst leaving healthy tissue largely unharmed. The
Website: http://www.bio-gate.de
method consists of two components; nanosized iron oxide
DILAS, Diodenlaser GmbH particles (MagForce) and an external magnetic field
DILAS designs and engineers various products (standard applicator (MFH).
or custom designed) in the field of High Power Diode Website: www.magforce.de
Lasers
MagnaMedics
Website: http://www.dilas.de
uses its SensithermA therapy to help combat AIDS. The
JenLab GmbH principle of the therapy is the selective overheating of the
JenLab uses femtosecond laser technology to develop virus and the infected cells by means of magnetic
instruments for biotechnology and biomedical nanoparticles. SensiTherm therapy is also used in the
applications. treatment of liver tumours.
Website: http://www.jenlab.de Website: www.nanovip.com
Kleindiek Nanotechnik Micromet AG

Kleindiek Nanotechnik produces micro and nano is using antibodies to create novel drugs that precisely
positioning systems, with high precision and resolution, and effectively combat human diseases such as cancer or
combined with a large working range. rheumatoid arthritis.
Website: http://www.nanotechnik.com Website: www.micromet.de
NEWCO Surgical Nanobiotix

NEWCO Surgical is a supplier of innovative surgical has developed their NanoBiodrugs™ which are nano-
instruments and accessories throughout the UK. particles with a diameter smaller than 100nm. The core of
Website: www.newco.co.uk the nanoparticle is a NanoProdrug in an inactive form that
can then be activated by external physical activation. This
Capsulution Nanoscience AG generates a local therapeutic effect destroying the
uses LBL-Technology® for making unique pathological cells. Activation is achieved by a magnetic
capsules, allowing the manufacture of extremely precise field similar to that of an MRI machine, or by laser.
nano- and micron-sized capsules. Website: www.nanobiotix.com
Website: www.capsulution.com
Nanogate Technologies
Flamel Technologies concentrates on inorganic-organic nanocomposites as
has developed Medusa which is nanoencapsulation well as self-organising nanostructures based on chemical
technology to deliver native protein drugs. nanotechnology
Website: www.flamel.com Website: www.nanogate.de
48 APPENDIX VI
Nanomix Inc Companies Active in Tissue Engineering

Website: nano.com
Alchimer SA
NanoPharm AG Alchimer develops and produces coatings for biomedical
has developed nanoparticles as a drug delivery implants and microelectronics.
formulation using NANODEL technology. Drugs are Website: http://www.alchimer.com/
bound to nanoparticles and then transported to their
BioTissue Technologies AG
specific target. It is even possible to transport drugs
BioTissue produces autologous skin grafts, bone and
across the blood-brain barrier.
cartilage implants.
Website: nanopharm.de
Website: www.biotissue-tec.com
NOSE
GfE Medizintechnik GmbH
Nanomechanical olfactory sensors.
GfE develops and produces titanium-coated (‘titanized’)
Website: http://monet.unibas.ch/nose/
implants.
Novosom AG Website: http://www.gfe-online.de/opencms/opencms/
specialises in the development and production of gfe/en/mt/index.html
liposomes, liposomal nanocapsules and liposomal
IIP-Technologies GmbH
vectors.
IIP has developed an artificial retina that can help restore
Website: www.novosom.de
some sense of vision.
Pharmasol GmbH Website: http://www.iip-tec.com/english/index.php4
has developed lipid nanoparticles as an alternative
Micromuscle AB
delivery system to polymeric nanoparticles.
Micromuscle develops and produces electroactive
Website: www.pharmasol-berlin.de
components for medical devices.
Psividia Ltd Website: http://www.micromuscle.com
is a biomedical technology company which has produced
pSiMedica
a material designed to enable drug molecules to be held
pSiMedica has developed a form of silicon that is
in nanoscale pockets which release tiny pulses of a drug
biocompatible and biodegradable. BioSilicon can be used
as the material dissolves. The rate of dissolution can be
in various medical applications.
controlled so that delivery can be achieved over days or
Website: http://www.psimedica.co.uk
months.
Website: www.psividia.com TransTissue Technologies GmbH
TransTissue creates replacement tissues such as bone and
SkyePharma
cartilage using tissue engineering.
is a leading developer, manufacturer and provider of drug
Website: http://www.transtissue.com
delivery technologies. One of its technologies uses
nanoparticles which allow targeted drug delivery in the NAMOS GmbH
lung. NAMOS produces ‘intelligent’ surface coatings for
Website: www.skyepharma.com materials using nanotechnology.
Website: http://www.namos.de/
c3
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EUROPEAN

ESF Forward Look on Nanomedicine

Participants at the European Science Foundation’s Forward Look on Nanomedicine

Steering and Organising Committee

Recent years have witnessed an unprecedented growth in research in the area

Here the discussions and recommendations are presented in full. Implementation

1. Commission of the European Communities Communication: (2004) Towards a European Strategy

The aim of ‘Nanomedicine’ may be broadly Recommendations

• Analytical Tools and Nanoimaging

lished. This would close the gap between molecu- Toxicology

Timely exploitation of newly emerging Nano- Conclusions

There is an urgent need to more clearly articulate

1. Nanomedicine: A New Opportunity

1.1. Definition of Nanomedicine 1.2. Position of Nanomedicines

© WHO world health report 2003

0 100 200 300 400 500 600

is maintained over a prolonged period of time, or to

2. Current Status of Nanomedicine Research

Bioarrays and Biosensors Nanofabrication Nano-objects Detection

An ideal near-patient diagnostic system

highly sophisticated instruments supported by Techniques Examples

Molecular Imaging Diagnostics (MDx): Impact on healthcare in the future

Today Screening Diagnosis Treatment &

Screening Diagnosis Treatment &

• Specific • Molecular • Mini-invasive • MI, MDx

Introduction tro-mechanical systems (MEMS), nanoparticles,

Liposomes Antibodies Viruses as

© Prof. Ruth Duncan

Scope of this discipline uses e.g. veterinary)

In particular, the following areas were considered:

The standard of university education in Europe, in 2.2.4. Communication

nised as such, as the reviewers lack the necessary

3. European Situation and Forward Look –

Funding and Academic Research Environment Commercial Technology

• European • Potential exists • There are a number • Existing expertise

• There are many • Visionary institutions • Ongoing • Strong basic sciences,

Funding and Academic Research Environment Commercial Technology

• Too little funding • Compared to the • Inadequate industrial

• Lack of a • Recent change in • Ineffective

Funding and Academic Research Environment Commercial Technology

• Identification of • European courses • Better use of human • Better exploitation • Development of

• Establish Networks • Proactive risk • Use experience with • Design of vectors

• At the European • Reduced health costs • Development

Funding and Academic Research Environment Commercial Technology

• EU and/or national • Failure to respond • Continued erosion of • Difficulties in • Lack of scientific

• Continued • Increasing lack • Pharmaceutical • Inability to secure • Mismatch between

• Discrepancies • Researchers • Overregulation • Failure to consider

• Negative public and • Lack of a balanced

4. Recommendations and Suggested Actions

bility, and own journal

4.3.2. Commercial Exploitation threats from inaction: the benefits consisting of

5.1. Key Reports on • Nanotechnologies: A preliminary risk analysis

• K. Bogunia-Kubik, M. Sugisaka (2002) From molecular

• A.C. Richards Grayson, I.S. Choi, B.M. Tyler,

• Nanotechnology database, at Loyola College, Maryland, North American Nanoinitiatives

Journals • National Institute for Nanotechnology - University

• Nano Letters; pubs.acs.org/journals/nalefd/index.html

• Nanotechnology focuses on the interdisciplinary

• Scientific American : Nanotechnology