The dawning of the age of nanomedicine

Science has pushed the boundary of the miniscule in medicine to the nano-scale level, and now with the European Science Foundation’s report on nanomedicine not only defining the field but also making recommendations for its future, it would seem that a new age is dawning 

Commercial applications of nanotechnology are beginning to make an impact on various aspects of healthcare - from point-of-care diagnostics based on engineered gold nanoparticles and polymer-based drug delivery techniques for targeted release of active components, to imaging agents that enable cellular processes to be monitored in real time.

Such applications give but a hint of the potential of systematically applying nanotechnology in medicine, both to improve diagnosis and treatment, and for the prevention of disease. The technology provides the means to monitor people on the basis of known genetic predispositions, diagnose disease before there are any symptoms, administer drugs that are precisely targeted, and use non invasive imaging tools to ensure treatment is effective.

But to achieve this vision, there needs to be a coherent European approach to develop and promote medical applications of nanotechnology – or nanomedicine – which pulls together many elements from across physics, chemistry and biology.

This is the conclusion of a thirty-strong expert group set up early in 2003 by the European Science Foundation to consider what elements are needed to develop nanomedicine as a distinct discipline, survey Europe’s current strengths and weaknesses, and set out a road map for developing the field over the next ten years.

What is Nanomedicine?

The first task for the 30 academics and industrialists who wrote the report was to define nanomedicine. “It took a large number of experts many hours to review the field and come up with a definition that is useful for regulators and policy makers,” Ruth Duncan of the Centre for Polymer Therapeutics at Cardiff University and chair of the committee, said at a meeting in Brussels to launch the report, ‘Forward Look on Nanomedicine’.

The conclusion is that nanomedicine is the science and technology of diagnosing, treating and preventing disease and traumatic injury, of relieving pain and of preserving and improving human health, using molecular tools and molecular knowledge of the human body.

The field embraces five subdisciplines of analytical tools; nanoimaging; nanomaterials and nanodevices; novel therapeutics and drug delivery systems; and clinical, regulatory and toxicological issues.

Challenges in creating a pan-European approach to nanomedicine

“Bringing together all these interdisciplinary components, and get them working truly in collaboration is a challenge,” said Duncan. She noted that there are a number of funding sources in Europe that are tagged ‘nano’. In addition, there is a base of skills, a number of research institutes involved in the field, companies that are emerging to commercialise research findings, signs of early clinical involvement, and emerging expertise in the toxicology of ultrafine particles.

“But as ever, there is a failure to translate these elements into a coherent approach,” believes Duncan. A long-term strategy is needed for device development and drug development because these processes cannot be markedly accelerated. In education there is not sufficient integration of clinical research with basic research, while too many regulatory agencies across Europe have a say in the development and use of nanomedicines.

“While there maybe nano resources, there is a fragmentation of effort, with a national approach [to the field] when what we need is a pan-European initiative,” said Duncan.

Currently the EU research programme Framework 7, due to begin at the start of 2006, proposes funding health and nanotechnology research separately. Duncan called for the “explicit removal of this divide.” She also wants to see more interdisciplinary education and training, and help with commercial exploitation to make nanomedicine “an attractive arena for companies that develop these high risk technologies.”

Duncan added, “Communication is really important. We need better articulation of what the field is, to explain it to those with the purse strings, and to the public.”

Over and above the coordination required to generate a coherent approach to nanomedicine, new research is required to generate an understanding of the toxicology within the patient, and the environmental impact of the release of free nanoparticles.

The report says that designing a clinical trial for a nanopharmaceutical presents new challenges because nanoparticles with dimensions smaller that 100 nm exhibit fundamentally different physical, chemical and biological properties from larger particles.

“The special properties of nano-objects that are only exhibited at the nanoscale suggest that nanopharmaceuticals may also require a new array of toxicological and safety tests,” says the report.

Another contributor to the report, Rogerio Gaspar, of Coimbra University in Portugal, told the meeting regulators that they will also need to take account of the fact that nanomedicines offer advantages over their conventional counterparts. “We are moving to a new scenario of improved targeting [of drug molecules] leading to increased efficacy and reducing toxicity.” This implies that changes could be made in the regulatory system that would speed nanomedicines to market.

Recommendations for Action

The report sets out several series of recommendations across different aspects of nanomedicine. General research objectives over the next five years include developing engineering technology for immobilising cells or molecules on surfaces, developing non-invasive in vivo diagnostic systems and producing implantable or injectable parenteral nanodevices for diagnosis and therapy.

The report also looks further into the future by providing recommendations for the next ten years research. They include understanding the cell as a three dimensional complex system; nanosensing of multiple, complicated analytics for in vitro measurement of biochemical, genomic and proteomic networks, their dynamics and their regulation; and rapid fingerprinting of all components in blood samples.

It is hoped that these research plans will be matched with five and ten year plans to enable manufacturing to move into the production of in vitro multi-analyte nanodiagnostics and in vivo nanosensors and devices.

The report also laid out more strategic, political recommendations. These included a focus on major disease areas such as cancer, neurodegenerative and cardiovascular disorders; Interdisciplinary education and training in nanomedicine ensuring that Europe has sufficient specialists in the field and to prevent a brain drain; Support for academic-industrial collaborations in nanomedicine, including access to manufacturing facilities. It was also stated that acknowledgement was needed of nanomedicine as a new class of pharmaceuticals that need a new approach to regulation. Safety and environmental concerns including the potential toxic effects of free nanoparticles was also raised as a point to be confronted. Importantly, the report also recommends that the general public, politicians and the media understand nanomedicines, including the advantages and potential drawbacks.

Duncan said she hopes the report will be a catalyst for action. “I truly believe we are at the dawn of a new beginning and that implementation of these recommendations should enable Europe to play a continued role in the controlled development of nanomedicine.”

By Nuala Moran