Regulatory Affairs Manager
14 February, 2017
Nordic Bioscience has for more than two decades developed and manufactured novel in vitro diagnostic devices, i.e. enzyme-linked immunosorbent assays (ELISAs). We have obtained regulatory approval of these products in both Europe and the US and we continue to file applications for newly developed tests. Reorganizing our small regulatory group, we are seeking a Regulatory Affairs Manager to take responsibility for this important area within Nordic Bioscience.
Read more about the opportunity here:
An Intelligent Approach to Clinical Trial Monitoring
Many pharmaceutical companies are excited by Risk-Based Monitoring but are uncertain about how to implement such an initiative.
Nordic Bioscience has pioneered Risk-Based Monitoring since 2011 and our mission is to provide the industry with credible data that supports a change in the monitoring approach.
Recently, we published a review in the European Journal of Clinical Pharmacology that supports risk-based monitoring and concludes that reduced source data verification combined with a centralized, risk-based approach may be the solution to reduce monitoring costs while improving data quality.
Novel Biomarker Research
Nordic Bioscience to participate in EU funded ALD research project GALAXY
16 December, 2015
For the next 6 years, Nordic Bioscience will be part of the EU funded Alcoholic Liver Disease (ALD) research project GALAXY, which has a total budget of DKR 47 million. The aim is to find an easy and effective way to identify the people who do not know that they have the disease. Nordic Bioscience’s contribution is evaluation of our Protein Fingerprint biomarkers for early diagnosis, treatment monitoring, selection of patients for treatment and predictive for drug treatment response in patients with alcoholic liver disease.
Nordic Bioscience’s central and specialized laboratory services continue to grow
EU funded OA research project APPROACH
23 September, 2015
For the next 6 years Nordic Bioscience will play a significant role in the EU funded osteoarthritis (OA) research project APPROACH, which has a total budget of EUR 15 million. The aim is to identify the patients most likely to respond to a given treatment using a validated biomarker drug development tool box for OA. Nordic Bioscience’s contribution is application of our validated proprietary Protein Fingerprint biomarkers, our FDA certified laboratory to ensure high quality and reproducibility of measurements, and regulatory approval process expertise.
Successful completion of phase I study
19 August, 2015
Together with our subsidiary KeyBioscience AG, we are proud to announce the successful completion of our phase I study with our novel Dual Amylin and Calcitonin Receptor Agonist (DACRA) that we currently are developing for type 2 diabetes, obesity and NASH. The DACRA KBP-042 is an insulin sensitizer which causes a significant weight reduction. The study confirmed tolerability of the molecule and more importantly indicated a substantial potential for treatment efficacy in the target population.