BioWorld International Correspondent

BRUSSELS, Belgium - The European biotech industry is starting to take biosecurity issues seriously. EuropaBio, one of the industry's principal European associations, has just set up a task force aiming to counter the threat of deliberate theft or diversion of deadly pathogens and toxins for criminal purposes.

The task force also will have a role in biodefense - the broader range of measures to prevent and respond to possible biological attacks. It will oversee the assessment of medical countermeasures such as vaccines, antiviral and other drug treatments, and non-medical countermeasures in areas such as detection, protection, decontamination, modeling and simulation.

The EuropaBio move comes in response to an invitation from the European Union to explore ways of coordinating industry and national initiatives.

The task force is made up of companies and national associations with an interest in biotech applications related to biosecurity and biodefense. Its role is to increase general awareness, communicate industry's needs and interests to European and international authorities, and to promote R&D investment in biosecurity and biodefense. Distinct working groups will cover detection and diagnostics, vaccines, antibodies, genomics and proteomics, and decontamination and bioremediation.

European Agency Reflects On Nanotechnology

The potential for nanotechnology-based medicines is under review by the European Medicines Agency, which has just released a paper that reflects the current thinking and initiatives it has taken "in view of recent developments in relation to nanotechnology-based medicinal products."

Nanotechnology "will contribute in developing a more proactive paradigm for the diagnosis and therapy of diseases," the paper predicted. Medicines containing nanoparticles already have been authorized both in the European Union and the U.S. under the existing regulatory frameworks, it pointed out, and "although nanosizing does not necessarily imply novelty, it is expected that nanotechnology will yield innovative products."

The likelihood, predicted the agency, is that these products could span the regulatory boundaries between medicines and medical devices, challenging the current criteria for classification and evaluation.

They might exhibit a complex mechanism of action combining mechanical, chemical, pharmacological and immunological properties and combining diagnostic and therapeutic functions. In addition, appropriate expertise will have to be mobilized for evaluating the quality, safety, efficacy and risk management of nanomedicinal products.

The majority of current commercial applications of nanotechnology to medicine are geared toward drug delivery to enable new modes of action, as well as better targeting and bioavailability of existing medicinal substances. Pending the emergence of more understanding of the potential and of appropriate guidance, the agency has created an innovation task force to coordinate scientific and regulatory competence in the field of the emerging therapies and technologies, and to provide a forum for early dialogue with applicants on regulatory, scientific or other issues that might arise from the development.