Medical Device Daily Contributing Writer
and Staff Reports

The European Science Foundation (Brussels, Belgium) has set out a plan to develop and promote medical applications of nanotechnology, and called on European Union governments to make the investment needed to translate disparate elements from proteomics, genomics, drug delivery, diagnostics and imaging into a coherent framework for nanomedicine.

To date the impact of nanotechnology on healthcare is patchy, with largely unrelated advances in diagnostics, imaging agents and drug delivery techniques. But the foundation's two-year investigation of the field concluded that medical applications of nanotechnology — or nanomedicine — has the power to deliver a paradigm shift in healthcare and make it possible to monitor people on the basis of known genetic predispositions, diagnose disease before symptoms, administer precisely targeted drugs and use non-invasive imaging tools to demonstrate that effective treatment.

But to achieve that, many unrelated elements from physics, chemistry and biology need to be brought together and integrated.

“Bringing together the interdisciplinary components and getting them working truly in collaboration is a key challenge,“ said Ruth Duncan of the Center for Polymer Therapeutics at Cardiff University (Cardiff, Wales), who chaired the investigation.

Beyond this, it is necessary to provide government agencies and policy makers with a route map that will enable them to take a strategic approach to investing in nanomedicine, and ensure the regulatory agencies and related industrial and commercial interests are quickly able to transfer advances in nanomedicine into general use.

“Then of course, the public is very important. We need to explain the opportunities vs. the risks, and generate an understanding of what nanomedicine means,“ said Duncan, speaking at a meeting held earlier this month to launch the report.

The first task for the 30 academics and industrialists who compiled the report was to define the field — it covers the application of nanoscale tools and knowledge across five subdisciplines of therapeutics and drug delivery: clinical, regulatory and toxicology issues, materials and devices, imaging and analytical tools.

According to the report, “Forward Look Study on Nanomedicine,“ Europe has many of the building blocks needed to create a coherent structure for nanomedicine. There are multiple funding sources, many of which are tagged “nano,“ there is a talent base, a number of research institutes with an interest in the field, a burgeoning industrial sector, and a growing body of clinical expertise with nano-sized drug-delivery systems, including liposomes, antibodies and polymers, in routine clinical use.

“But as ever, there is a failure to translate this across, because Europe is lacking a long-term strategy for healthcare covering drug development and device development that is funded over the long time scales involved in getting new drugs to market,“ Duncan said.

In addition, there is a fragmentation of effort, with most work being carried out on a national level when the need is for an alignment of regional, national and pan-European research. There is not sufficient integration between clinical and basic research to enable advances to be translated from the laboratory to the clinic.

Also, new research is required to improve understanding of their toxicology, both within the patient and the environmental impact of the release of nanoparticles.

Since nanomedicines are expected to be designed around a clear understanding of the molecular interactions involved in particular disease areas, the regulators will need to establish a case-by-case approach to approvals.

510(k) filing for CollaGuard product

Innocoll (Ashburn, Virginia) said that its wholly owned subsidiary, Innocoll Pharmaceuticals (Athlone, Ireland), has filed a 510(k) application with the FDA for CollaGuard, an advanced wound care product based on Innocoll's CollaRx membrane technology, indicated for the management of superficial and deep wounds.

CollaGuard will be manufactured by Innocoll's wholly owned subsidiary, Syntacoll GmbH (Saal, Germany), and having already received CE-mark approval, will be distributed in Europe by Innocoll Pharmaceuticals.

CollaGuard is comprised almost entirely of purified type-I native collagen protein, which stimulates the natural wound-healing process. CollaGuard provides the barrier protection of film dressings while also taking up excess wound exudates to provide an ideal moist environment.

FDA approves MedImmune's UK facility

MedImmune (Gaithersburg, Maryland) said that its newly constructed influenza vaccine manufacturing facility in Speke, UK, has been approved by the FDA. The facility allows MedImmune to produce up to 15 million bulk doses per month, or about 90 million bulk doses per influenza manufacturing season, of its trivalent, intranasal influenza vaccine, FluMist.

The square footage of the new facility is 10 times larger than MedImmune's existing bulk manufacturing facility in Speke, and features larger testing and storage facilities, as well as automated inoculation capabilities. The facility uses a new filtration process, which is expected to provide greater sterility assurance during bulk production.

MedImmune plans to begin manufacturing FluMist at the new site next year.

bioMerieux exercises RNA option

Gen-Probe (San Diego) said bioMerieux SA (Marcy L'Etoile, France) has exercised a second option to develop diagnostic products for certain undisclosed disease targets using Gen-Probe's ribosomal RNA technologies, pursuant to a year-old agreement. In exchange, bioMerieux will pay Gen-Probe a $2.1 million license fee.

bioMerieux also retains an option to develop products for other disease targets by paying Gen-Probe up to an additional $900,000 by the end of 2006. Gen-Probe also would receive royalties.

Cerus seeks CE mark for Intercept

Cerus (Concord, California) reported submitting its application for CE marking of its Intercept Blood System for plasma in Europe.

The system, being jointly developed by Cerus and Baxter Healthcare, is designed to reduce the risk of transfusion-transmitted diseases. It inactivates pathogens such as HIV, hepatitis B and C viruses, bacteria, and parasites that may be present in donated plasma intended for transfusion.

Claes Glassell, president and CEO of Cerus, called the filing “one more step in our plan to commercialize the Intercept Blood System for all three components: platelets, plasma and red blood cells.“

While donated plasma is generally tested for a limited number of specific pathogens, testing does not eliminate the risk of viral or bacterial contamination. The Intercept for targets the nucleic acids of a broad spectrum of viruses, bacteria and other pathogens.

Based on Cerus' Helinx technology, the company says that Intercept “offers the potential to inactivate untested-for and emerging pathogens before they become a major transfusion risk to patients.“