On September 27 and 28, about thirty experts in pharmaceutical, biomedical and engineering sciences, biology, regulatory toxicology and nanotoxicology and in property law gathered in Bern, Switzerland to discuss the "Current Challenges Facing Inorganic Nanoparticles in Medicine and Industry". This conference and working session addressed several compelling issues involved with inorganic nanoparticle biomedical and translational research in academic, industrial, commercial, governmental, and regulatory contexts. The initiators of this conference, Dr. Margarethe Hofmann-Amtenbrink, scientifically coordinating the European Project NanoDiaRA, Drs. Peter Wick and Heinrich Hofmann, both representing the Competence Center of Materials Science and Technology (CCMX) of the ETH Board in Switzerland, and the latter also involved as partners in the NanoDiaRA project, found a compelling need for better assessment of nanoparticle toxicity, for coherence between scientific developments and corresponding regulation, and for defining the pre-requisites for implementing such regulation. This motivated the conference.
Having this challenge in mind the workshop addressed three key issues:
(i) „Nanoparticles Properties and Characterisation Methods“: Nanoparticle size and shape and nanoparticle physico-chemical properties are critical to verify and to follow to understand their interactions with living systems throughout the whole entire product life cycle. This is the basis for the second key issue.
(ii) „Toxicity Assessment“: Today we know that despite the proliferation of nanoparticle research and production, both in Switzerland and worldwide, high-throughput, reliable and standardised methods are still needed for rapid assessment of their toxicity under various exposure, dosing and biological conditions. It is still in discussion if results from in vitro investigations are sufficiently meaningful, reliable and predictive to evaluate the risk-benefit balance of nanoparticles and secondly, what animal experiments are necessary to best mimic the situation in humans – if possible at all. Key issues (i) and (ii) are again prerequisites of (iii) the regulatory aspects.
(iii) „Regulation“ is a very important part of the whole product life cycle of nano-enabled products. Effective and facile communication methods must be established among researchers, developers, and regulatory bodies to facilitate responsible transfer of research results that reliably assess toxicity (if any) and ensure product safety for industrial and medical users. As research and development in nanotechnologies/nanoparticles for diagnostics, pharmaceutics and nano-therapies are continuously evolving and new details about nanoparticle properties and toxicity and, by this, also about its benefits and risks, are disseminated in professional and lay journals, radio and television, associated legal issues must be considered, and appropriate measures taken to provide both security for future markets and safety to the consumer.
Alessandra Hool, MatSearch organized the two-days seminar and workshop accompanied by societal evening session at the Adult Education Center Bern (Program). Beside the German-speaking experts also Dr. Sergio Bellucci, CEO of TA Swiss, and Lada Leyens, swissmedic, were invited at the animated Panel Discussion with the title “Nanomedizin – Chancen und Risiken“ chaired by Ms Hool. About 20 interested people discussed with the experts.
The program is based on the fact that nanoparticle development and especially that of inorganic particles is still challenging due to the insufficient understanding in methodology of particle characterization and toxicology testing. Although industrial produced nanoparticles are used in all kinds of applications and nanoparticles for medical applications are in development and some of them even available on the market, the understanding in detail about the interrelation between physical, chemical and biological properties and the impact of such particles on humans and the environment is still not fully understood. These uncertainties influence legal issues which are going along with the marketability of such products and the acceptance by the companies and the end-users as well.
The speakers and chairs of the discussions were chosen to present and reflect the various fields involved in the value chain of inorganic nanoparticles for industrial and medicinal use.
The talks can be downloaded here:
- Karin Aschberger, Joint Research Centre Ispra:
Research Prioritisation to deliver an Intelligent Testing Strategy for Engineered Nanomaterials - ITS Nano
- Gerrit Borchard, Université de Genève:
Developing a European Pharmacopoeia monograph for non-biological complex drugs: What do we need to know?
- Thomas Broschard, Merck Serono:
Safety Aspects of Nanoparticles – In vivo an in vitro Investigations with SPIONs
- Lindsey Crowe, Hopitaux Universitaires de Genève:
Advanced SPION enhanced MRI in experimental research
- David W. Grainger, The University of Utah:
Comparing nanoparticle biodistributions to classical microparticles in human circulation
- Heinricht Hofmann, EPF Lausanne:
Overview of Nanoparticle Technology and Characterisation
- Silke Krol, Fondazione I.R.C.C.S. Istituto Neurologico “Carlo Besta”:
Designed nanoparticle solution for medical problems
- Adriele Prina-Mello, Trinity College Dublin:
Nanomedicine in Europe and contribution towards H2020
- Elen Stokes, Cardiff Law School:
Legal regulation of nanotechnologies
- Christoph Studer, Federal Office of Public Health, Switzerland:
Regulations of Nanomaterials
- Jörg Uhlig, NanoSight Ltd., UK:
Characterisation of Nanoparticles using Nanoparticle Tracking Analysis
- Peter Wick, EMPA, St. Gallen:
Central Test Laboratory: Requirements