Resources at hand

HUNT repository and data

The HUNT resources can successfully help customers shorten the development lead times, increase quality and thus reach regulatory milestones faster, and enter the market at a lower cost. With respect to the diabetes market, this will no doubt have great impact on the development of diagnostic, device and therapeutic products. The health economic impact will of course be high since early diagnosed patients, and earlier in treatment leads to fewer late complications.

Improved glycaemic control in patients taking OADs and accurate methods to measure pancreatic beta-cell massare merely two relevant examples. Likewise is the development of biomarkers for diagnostic purposes, where ongoing research is attempting to identify the best treatment option for each diabetes patient based on collected information about individual patient genetics and metabolism. HUNT may thus make a significant difference in the important area of diabetes diagnostics and perhaps even its prevention.

The HUNT repository and data includes a stable and large cohort group of diabetes donors, very low on immigration and emigration as well as stable on nativity and mortality making the donors even more valuable. A part from the diabetes donors, every single HUNT donor is very well characterised and documented. The industry has been waiting for access to such a large and complete recourse, and now the repository of quality assured samples and material collected across a representative population is available.

Regulatory approval

Regulatory approval and quality assurance demands are stricter than ever and it is well known that solid scientific documentation will no doubt have an important impact on these processes.

With the huge number of donors, HUNT is able to provide top level scientific data and documentation for new indications on existing drugs. As part of this, HUNT can also offer clinical intervention studies on very well characterised donor groups making the biobank a unique resource in the planning of such studies. This will also have great impacton the regulatory approval of new indications.

The HUNT biobank is certified according to the ISO9001:2008 Quality Standard and HUNT Biosciences is the only company or institute that can grant access to the biobank.

HUNT–based research on diabetes

HUNT is associated with the medical faculty at the Norwegian University of Science and Technology and the University Hospital of Saint Olav. More than a 1000 medical professionals are a part of HUNTs internal network.

The Principal Investigators at HUNT are top-level researches in the field of diabetes. Senior researchers include Prof. Kristian Midthjell and Prof. Kristian Hveem.Their publication track includes approximately 200 diabetes publications and other key contributions in the diabetes field. A few key references are located below, and a completelist of publications will be provided upon request.

Kristian Midthjell MD, PhD.
Professor of Public Health at the Norwegian University ofScience and Technology. Professor Midthjell currently holds the following relevantappointments:

• Head of the HUNT Diabetes Project since 1982
• Member of the National Board of Nutrition, Norway
• Medical Advisory Board of the Norwegian Diabetes Association
• Member of the European Diabetes Epidemiology Group.

Kristian Hveem MD, PhD.
Professor of Medicine at the Norwegian University of Scienceand Technology. Professor Hveem currently holds the following relevantappointments:

• Director of the HUNT biobank and the National CONOR(Cohort of Norway) biobank
• Head of the Norwegian biobank infrastructure, BiobankNorway, since 2011
• Director of the Danish National Biobank establishmentin Copenhagen since 2010
• CSO of HUNT Biosciences since 2009.

In addition, HUNT data and biomaterial has been included in many publications on diabetes by external research groups. Among these are groups lead by Professor Michael Boehnke, Department of Biostatistics at the University of Michigan School of Public Health, Professor Pål Rasmus Njølstad, Department of Clinical Medicine at the Universityof Bergen, Professor Valdemar Grill, Department of Cancer Research and Molecular Medicine at the Norwegian University of Science and Technology, and professor Kåre Birkeland, Institute of Clinical Medicine at the University of Oslo.

Access to other registries

The value of gaining access to other registries is tremendous since it is possible to follow a great number of relevant co-morbidities over time. Every patient included inthe HUNT registry is identified by the unique PIN used in every Norwegian registry. It includes every health record, social record, family record, work record, criminal record, etc. Pending approval from the ethics committee, we areable to link every HUNT Diabetes case with the Norwegian registries.

It is possible for HUNT to identify donor groups and match controls using clinical end-points registries in linkage studies. Linkage studies are of great importance as diabetes has several known co-morbidities noted in the linkable registries. This includes cardiovascular diseases, anxiety, depression, musculoskeletal diseases, and various cancer diseases. Each HUNT donor group can be matched on theuse of various medications using the prescription registries as well as links to family members, covering inherited diseases and conditions. Other important registries are the cancer and cause-of-death registries, as well as 40-50 other national quality registries and the Social services registries collected by GPs.

Together with the HUNT information, this constitutes an unprecedented resource in terms of both data and biological material available for clients studying diabetes or developing diabetes-related products. Using this recourse to develop therapeutic and diagnostic products is expected to have great future impact on the development of diabetes. In addition, using supercomputers with complex systembiological modulations, it is expected that the HUNT data will be groundbreaking in the emerging highly computed development of new products.