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EIR: Integration of Resources Fuels Clinical Drug Development

5/23/2012 10:52:03 AM

May 23, 2012 -- Denmark is one of the best places to perform high-quality clinical trials. New legislation speeds up the trial approval process, making it one of the fastest in Europe. Eir, a new Danish health and life science business park, offers fully integrated access to patients, academics, and advanced research laboratories. The integrated access is key to excellence in early drug development, says professor presenting at the 9th annual Anglonordic Biotech Conference.

Boasting the largest clinical trial platform in Scandinavia, Eir – Empowering Industry & Research – attracts clinical trials, offering a fully integrated, one entry, access to laboratories, researchers, clinicians, and a patient population of more than 600,000.

“We might not be big on a global scale, but Eir is the largest fully integrated test region in Scandinavia. Our unique infrastructure and proximity make it easy and fast to initiate large, complex clinical trials on new pharmaceuticals and medical devices”, says Dr. Lars Arendt-Nielsen, Director of Eir and Professor at Aalborg University, Denmark.

New legislation speeds up the trial approval process in Denmark

Clinical testing of a new compound or medical devices is the single largest expense when developing new products. Gaining access to many eligible patients from few institutions and ensure high retention rates can reduce costs substantially. Though Denmark still has the highest number of clinical trials per capita in Europe, there has been a decline in the number of clinical trials conducted over the last years. An increased political focus on this issue has spawned a new law reducing the time for processing clinical trial applications down to 30 days compared with the 60-day period specified in the EU directive.

“It definitely makes a positive difference for us that the Danish Medical Agency has implemented new legislation to support faster approval of clinical trials. My conservative guess is that the approval time has been reduced by at least 30%. This, combined with our long tradition for conducting high quality clinical trials, has fostered our new Eir initiative“, says Lars Arendt-Nielsen. The average approval time of a clinical trial in Denmark is now one of the fastest in Europe.

Unique research supports drug development

Lars Arendt-Nielsen highlights a number of highly advanced research areas in North Denmark. Epidemiological research competences combined with the many patient registries in Denmark provide unique opportunities for post-marketing studies where diseases, drugs, and potential side effects can be linked.

“Another area of excellence is mechanism-based proof-of-concept studies in the early development of new analgesics. We have established the most advanced test platform where we can profile both efficacy and describe which pain mechanisms are affected. This facilitates more qualified go-no-go decisions, as well as it helps to identify the chronic pain patients, who could benefit from the compound. Subsequently, we conduct later phase II and III studies”, Lars Arendt- Nielsen says.

He points to the fact that this success is a result of close collaboration between researchers from Aalborg University, clinicians from the local hospitals, and the CROs in the region. More than 20 international pharmaceutical companies have completed well over 200 clinical trials through Eir and its partners.

With focus on the Danish clinical trial environment Lars Arendt-Nielsen will deliver a keynote speech on: “Excellence in Early Drug Development” at the 9th annual Anglonordic Biotech Conference, held on 24 May 2012 in London.

For further information, please contact:

Jon Black Andersen, Press Coordinator, phone: (+45) 26 72 80 75

Lars Arendt-Nielsen, Director of Eir, Professor and Head of Center for Sensory-Motor

Interaction, Aalborg University, Aalborg, Denmark, phone: (+45) 20 94 07 64

About the Anglonordic Biotech Conference

The conference is by invitation only and has been held for nine consecutive years

The conference is organized by Innovation Norway, Invest in Denmark, and UK Trade & Investment, among others

200-300 are expected to participate this year

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