We have different service models based on the research question and aim of the collaboration. Feel free to reach out to the Business Development team with any questions you may have to our business services.

The team can be reached at this email address: businessdevelopment(at)nordicbio.com.

Pre-Clinical

Discovery

Compound screening & selection

We perform compound screening in translational models such as in vitro or in vivo models to select molecules with a measurable effect on tissue remodeling using Protein Fingerprint biomarkers. Based on the most favorable biomarker profile our collaborators select the best compounds.

Compound validation

Compound validation projects aim to utilize translational models and Protein Fingerprint biomarkers to characterize the mode of action of lead compounds in the tissue.

 

Pre-clinical

The main purpose is to provide biological validation of a given treatment and its effect in the tissue using our in-house biomarkers. Many of our biomarkers are translational, which can be used in pre-clinical studies to select the markers which are modulated. This selection can then be applied in further drug development across development phases.

Compound screening & selection

We perform compound screening in translational models such as in vitro or in vivo models to select molecules with a measurable effect on tissue remodeling using Protein Fingerprint biomarkers. Based on the most favorable biomarker profile our collaborators select the best compounds.

Compound validation

Compound validation projects aim to utilize translational models and Protein Fingerprint biomarkers to characterize the mode of action of lead compounds in the tissue.

Stakeholder Material (IND-enabling)

Biomarkers can be measured in observational and research cohorts to obtain early proof of a concept of a suitable biomarker panel in humans.

The purpose of IND-enabling studies is to secure approval to conduct the first-in-human clinical trials with a new drug.

Nordic Bioscience’s biomarkers can aid in creating stakeholder material based on data generated in pre-clinical models as well as observational and research cohorts. The biomarkers may also help to elucidate the mode of action of the drug.

Clinical

Phase 1b

Pharmacodynamic modulation

Nordic Bioscience’s biomarkers may be utilized to observe pharmacodynamic evaluation as well as to obtain insights on the effect of compounds on ECM remodeling.

Tolerability

Nordic Bioscience’s biomarkers aid in determining the optimal dose by evaluating how each dose affects the biomarkers. This could be compared with data generated

Safety

Nordic Bioscience’s CAP-accredited laboratory conducts safety studies to provide insights on the effect of the drug on the body.

Mode-of-action

Biomarkers may be used to elucidate the mechanism of action of a compound by evaluating how the compound affects tissue turnover in patients.

Potential efficacy

Nordic Bioscience's biomarkers support drug development by signaling potential treatment efficacy in the target population.

Phase 2

Phase 2a

Nordic Bioscience’s biomarkers may be utilized to observe pharmacodynamic evaluation and treatment efficacy as well as to obtain insights on the effect of compounds on ECM remodeling.

Measurement of ECM remodeling biomarkers in phase 2 studies can be utilized for patient stratification by identifying those patients that progress faster in the disease or that have a higher risk of adverse outcome.

Phase 2b
Dose finding

Nordic Bioscience’s biomarkers aid in determining the optimal dose by evaluating how each dose affects the biomarkers.

Safety

Nordic Bioscience’s CAP-accredited laboratory conducts safety studies to provide insights on the effect of the drug on the body.

Phase 3

Screening

Measurement of ECM remodeling biomarkers in phase 3 studies can be utilized for patient inclusion and exclusion.

Differentiation

Measurement of ECM remodeling biomarkers in phase 3 studies can be utilized for patient stratification by identifying those patients that are more likely to respond to treatment.

Mode-of-action

Biomarkers may be used to elucidate the mechanism of action of a compound by evaluating how the compound effect tissue turnover in patients.

Repurposing/label extension

Nordic Bioscience has generated biomarker data in various chronic diseases involving the extracellular matrix. If you decide to repurpose a drug in a different area, we can compare the generated biomarker data with in-house biomarker data to better understand if tissue remodeling is affected in the new disease area.

FDA

Regulatory approval

Nordic Bioscience's biomarkers aid in obtaining regulatory approval from the FDA.

From the FDA's website, "FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework."

Personalized healthcare

Personalized healthcare, or precision medicine, differs from most medical treatments which are designed for general use as a one-size-fits-all approach. Nordic Bioscience's biomarkers help develop precision medicine tailored to treat patients in need with improved efficacy. Target the right patient, with the right treatment, at the right time.

 

Services

 

Sample measurements

 

We are able to provide biomarkers measurements from our biomarker portfolio throughout all phases of drug development in our CAP-certified laboratory. In case the biomarkers are not listed in our portfolio, please use the ‘Get in touch’ button to reach out to see if we can validate the biomarker of interest.

 

Assay development

 

We provide customized assay development for your target of interest in our R&D facilities. We have extensive experience in antibody generation and assay development of over 30 years.

 

Pilot project

 

The pilot project serves as an introduction to the Nordic Bioscience biomarker technology. The aim of a pilot project is to evaluate a fixed number of preclinical and/or clinical samples in a panel of biochemical assays and includes close interaction with a dedicated Nordic Bioscience science team. Using this service model we are able to dedicate some of our own resources to increase the chance for success. The flexibility allows multiple preclinical/clinical projects to be integrated with this pilot project.

 

Biomarker measurement in models

 

The various Nordic research teams have extensive experience in the measurement of biomarkers in many in vitro and in vivo models, such as cell systems, cartilage, mice, rat, pig, cynomolgus, precision-cut organ slices as well as many other models. In most cases, the targeted sequences of our biomarkers are conserved between species, but we also develop species-specific biomarkers. This ensures a full translational approach from cell to model to human.

 

Data interpretation, biomarker and strategy, …

 

As part of advisory science, our world’s leading extracellular matrix experts are able to provide assistance in data interpretation, biomarker selections as well as biomarkers strategies for your projects. 

 

Nordic’s Translational models

 

Nordic Bioscience is able to set up and run translational models such as the fibroblast system (the ‘Scar-in-a-Jar’ model) with different fibroblasts such as lung fibroblasts, renal fibroblasts, cardiac fibroblasts, hepatic stellate cells, dermal fibroblasts, and cancer-associated fibroblasts. These models have been optimized to enable the measurement of ECM remodeling biomarkers. Moreover, Nordic has optimized translational models such as precision-cut organ slices with partners which also allows us to run compounds for customers and measure ECM remodeling biomarkers in the supernatant.

 

Statistical
support

 

We are pleased to offer our data analysis services to help ensure that you make the most of the information output from our extracellular matrix biomarkers. Our statistical and bioinformatics team will provide you with customized data analysis.

Please don't hesitate to contact us if you have any questions or other inquiries.

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