At Nordic Preclinical Sciences, we have the expertise in identification and validation of pharmacodynamic (PD) biomarkers which are vital for the drug discovery process from early preclinical studies to the clinic. There could be different types of PD biomarkers and examples of such includes various Protein biomarkers including Phosphoproteins and Cytokines.
Drug effect on the target can be quantitatively measured by monitoring/analyzing PD biomarkers. These are vital to understand the link between drug dosage, biological response and therapeutic benefits as observed in the clinical studies. A PD biomarker will elucidate whether a drug is modulating the intended target, the biological impact of modulating the target and the optimal drug dosing and scheduling strategy.
The PD biomarkers discovery steps are dependent on the drug-target interaction. Our experienced scientists at Nordic Preclinical Sciences can help you to identify and develop the right biomarkers to support your therapeutic indication. With us you will have the access to the cutting edge molecular techniques to explore potential biomarkers, from Proof of Mechanism (POM) to support PK/PD studies, as well as protein expression profiling for patient segmentation and clinical efficacy support via Proof of Concept (POC) biomarkers development. Our flexible and collaborative approach will ensure that your team obtain an efficient and robust PD biomarker fit for your purposes.
Proteomics is a broader term comprised of several techniques and methods for global analysis of proteins in biological samples such as plasma, cells and tissues. Proteins are vital for all biological functions of
any living organism,
from enzymatic reactions to cellular signaling, and serves as hormonal signaling molecules, providing recognition sites for the immune system, and serving as building blocks responsible for maintaining the cell's form and structure. Proteomic analysis (proteomics) refers to the systematic identification and quantification of the proteins of a biological system (cell, tissue, organ, biological fluid, or organism), the proteome, at a specific point in time. Mass spectrometry based methods are most often used for proteomic analysis, which is also an unbiased high-throughput method. Please check our Proteomics Services for more details.
Protein kinases represent an important class of drug targets. A classical method to measure the modulation of a protein kinase is to measure the phosphorylation of their (patho)physiological substrate. At Nordic Preclinical Sciences, we will customize the assay and select the best platform to measure substrate phosphorylation to meet your needs from immunoblotting to ELISA/AlphaLISA to flow cytometry. For projects that would benefit from simultaneously monitoring the phosphorylation status of multiple signaling intermediates, we can explore the development of assays using the Meso Scale Discovery (MSD) which allows up to 111 analytes to be measured in a single sample.
Cytokines are an important group of PD biomarkers for therapies aimed at modulating the immune response. Cytokines are released into circulation by leukocytes and thus, can be easily measured in a broad variety of biological samples including whole blood. There is a broad spectrum of cytokines with varying actions from pro-inflammatory to anti-inflammatory. The nature of the cytokines regulated by new therapies is highly dependent on the leukocyte population involved in the disease and expression of the drug target. At Nordic Preclinical Sciences, we will work with you to define the most appropriate cytokine(s) panel to be measured and then tailor the assay to meet the needs of your project. We have several technological platforms that can be used depending on requirements. For projects in which measuring one or two cytokines is sufficient, ELISA and/or AlphaLISA would be a cost-effective approach. However, we can also measure a large panel of cytokines using the MSD or Luminex multiplex assay platform which allows up to (50 or more) analytes to be measured simultaneously in a low volume (50 ml) of a single sample. This latter approach provides a cost-effective method to obtain a more complete picture of the effects of a drug on limited sample material.