Medical Device Daily Contributing Writers

The European Medicines Agency (EMEA; Brussels, Belgium) added to the season of goodwill as 2008 drew to a close with promises of new facilities for advanced therapies and new resources for scientific advice for companies developing innovative products.

The agency's work program for 2009, released in late December, highlights the upcoming inauguration, on Jan. 15, of the new committee for advanced therapies. This is the tangible outcome of the European Union's new regulation designed to ease the introduction of gene- and cell-based therapies and tissue engineering products by harmonizing regulatory approval procedures across the market of the 27 member countries of the EU.

Provision has been made in the agency's 2009 budget for activities in this area to be supported by adequate resources – including, particularly, the necessary expertise to ensure that the regulatory process keeps pace with innovation.

Another of the priority areas for the agency this year will be increased provision of scientific advice in the area of innovative development methods. Scientific advice, frequently with related assistance in designing testing protocols for orphan medicines, has been an increasingly important function of the agency in a bid to speed up the development of high-quality therapeutics.

Companies can seek advice either during the initial development of a medicinal product, before submitting a marketing authorization application, or later, during the post-authorization phase. Again, budgetary provision is being made for greater availability of experts and staff for engagement with companies working with new therapies and new approaches to therapy.

Overall, the agency's draft budget for 2009 totals €188.6 million ($200 million), up nearly 4% over 2008. Core activity areas expected to grow also include work with medicines for pediatric use, and cooperation with the agency's international partners.

The level of initial marketing authorization applications for human medicines is expected to remain stable, at around 112 applications during the year.

The new year will not be without challenges for the biopharmaceutical industry. EMEA's plans include moves toward strengthening pharmacovigilance activities through its new network of centers for pharmacoepidemiology and pharmacovigilance, more robust risk management plans and signal detection, and greater transparency and provision of information to the public.

It envisions opening up EudraVigilance, the EU database on adverse drug reactions, to the public in 2009, and greater public access is expected to information about paediatric clinical trials held in EudraCT, the EU database on clinical trials.

In the wider EU context, debates are expected to intensify over pricing and reimbursement of new medicines, over the use of animals in drug development, and over how far companies may go in using patent law to protect their discoveries without being accused by EU antitrust authorities of non-competitive behavior.

iCAD links up with Planmed, Agfa

iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) solutions, reported that its SecondLook Digital CAD technology customized for use with Planmed's (Helsinki, Finland) Nuance FFDM system is now available outside of the U.S.

iCAD has received CE-mark approval to market and sell its customized solution with Planmed Nuance mammography systems. It said units have been placed at Terveystalo Breast Cancer Screening Center in Helsinki.

"When analyzing iCAD's SecondLook Digital CAD with Planmed Nuance Full Field Digital Mammography unit using selenium flat-panel detector ... the true positive findings detected at double readings of screening mammograms were also marked accurately by CAD," said Martti Pamilo, MD, of Terveystalo, the leading private healthcare provider in Finland.

Vesa Mattila, VP of Planmed, hailed the results of the iCAD integration to the Nuance FFDM system, saying, "As CAD is becoming widely accepted in Europe, iCAD's technology is an important addition to Planmed's digital mammography systems and solutions."

"Our partnership with Planmed marks an important step in iCAD's mammography strategy," said Ken Ferry, president/CEO of iCAD. "Coupling our SecondLook CAD technology with Planmed's ... system is a key element in our overall goal to increase the use of iCAD's systems in markets around the globe to better enable clinicians to identify breast cancer earlier."

Currently available in more than 2,200 healthcare centers worldwide, iCAD's solutions aid in the early detection of the most prevalent cancers, including breast, colon, prostate and in the future, lung cancer.

Planmed is focused on developing imaging equipment and accessories allowing early detection of breast cancer.

Separately, iCAD reported that its SecondLook Digital CAD technology customized for use with Agfa HealthCare's (Mortsel, Belgium) computed radiography (CR) systems is now available throughout Europe.

iCAD has received CE-mark approval to market and sell its customized solution with Agfa HealthCare's CR systems, and units have been placed at Bundes-Knappschaftkrankenhaus P ttlingen in Germany.

"The availability of our CAD technology with Agfa Healthcare's solutions in Europe marks another milestone in our business strategy to increase the use of iCAD systems outside of the U.S.," said Ferry. "Our new partnership underscores Agfa's leadership in diagnostic image management solutions and our shared commitment to improving early detection of breast cancer in Europe."

Agfa HealthCare, a member of the Agfa-Gevaert Group, is a provider of IT-enabled clinical workflow and diagnostic image management solutions, and systems for capturing and processing images in hospitals and other healthcare facilities.