This article is part of our special report Frontier Research – A good return on investment?.
New interdisciplinary research on nanotechnology and cancer biology is taking us one step closer to developing personalised care plans for cancer, but this tiny technology poses a huge challenge for EU regulation due to its small size and fast-paced evolution.
As part of an ongoing research project funded by the European Research Council (ERC), researchers are working on engineering novel nanotechnologies that can autonomously manoeuvre, target and diagnose the various cells that make up cancerous tumours.
The ultimate aim of the project is to create personalised diagnostic nanotechnologies which will be able to predict, ahead of time, which treatment will be best for each cancer patient.
According to the World Health Organisation, cancer is the second most important cause of death in Europe after cardiovascular diseases.
In 2015 alone, 1.3 million people died from cancer in the EU, accounting for more than a quarter of the total number of deaths.
Despite advances in medical research, many of the most common treatments are ineffective for large numbers of patients. In fact, 30% of cancer patients are prescribed a medication their tumour does not respond to or, alternatively, drugs that induce adverse side effects patients cannot tolerate.
Moreover, healthcare costs across the EU are rising as the population ages and chronic diseases become more prevalent.
There is, therefore, a need to develop technological advances which are able to predict which treatment will be best for each cancer patient. This is an emerging field of research known as ‘personalised medicine’.
By offering tailor-made prevention and treatment strategies for individuals or groups of individuals, patients are able to receive specific therapies that work best for them, meaning less money and time is wasted on trial and error treatments.
In 2018, Belgian politician Lieve Wierinck told EURACTIV that the patient of the 21st century wants an individual treatment accustomed to their specific needs, but that this will require significant additional efforts of all stakeholders involved.
Nanotechnologies are set to be a major technological force for change in shaping all industrial sectors in the foreseeable future but are increasingly becoming impactful therapeutic tools, granting tissue-targeting and cellular precision that cannot be attained using systems of larger scale.
Professor Avi Schroeder, PhD Associate Professor of Chemical Engineering at Technion Institute of Technology and lead researcher on the project, told EURACTIV that “nanotechnology holds great promise for personalised care and holds great potential for the future of cancer treatment”.
He added that he foresees “in the near future, nanoparticles that will be loaded with the specific drug combination that is best for each patient, accounting for his or her own genetic and epigenetic disease profile”.
However, at the same time, scientists have raised concerns that the basic building blocks of nanotechnologies—particles smaller than one billionth of a metre—pose a potential new class of risk to health and the environment, and the technology presents new challenges for the current regulatory framework.
EURACTIV spoke with Dr Falk Ehmann, head of the Innovation Task Force at the European Medicines Agency (EMA), who said that nanotechnology has been an established area of research for over 20 years and that, although nanotechnology comes with “uncertainties”, the benefits of using the technology for cancer treatments vastly outweigh the risk.
He said nanotechnology holds huge potential for lowering the toxicity risk of cancer drugs whilst optimising the dose, ensuring a more efficient treatment that carries fewer side effects.
He also highlighted the “enormous potential” of this fast-growing sector for job creation and growth in the EU, adding there should be a focus on facilitating research in this area.
However, he specified that this was much more straight forward for cancer treatment than for other sectors, such as food, and that regulation must reflect these differences accordingly.
Innovation outpacing regulation
The EMA has recognised the importance of the establishment of recommendations for nanomedicines to guide their development and approval, which includes the creation of harmonised definitions in all Europe to the development of protocols for the characterisation, evaluation and process control of nanomedicines.
Furthermore, ongoing research is rapidly leading to the emergence of more sophisticated nanostructured designs, which poses additional regulatory challenges.
Ehmann stressed that as the technology gets more sophisticated, it must be put under more scrutiny and that each medical innovation must be individually considered for each specific “patient population”.
Similarly, Schroeder acknowledged that there are difficulties to overcome to expand the clinical implementation of these systems, citing a need for “a collaborative effort of academia, industry and the regulatory agencies in order to assure safety and efficacy measures are taken”.
He highlighted in particular that EU efforts to translate nanotechnologies to the clinic more efficiently are hampered by the lack of dedicated regulatory experts and characterisation laboratories for preparing nanotechnologies for clinical trials.
He explained that it is especially important to address this now, as many of these new discoveries are ready to be taken the next step towards clinical realisation.
[Edited by Zoran Radosavljevic]