Increasing understanding of drug targets and new therapies through biomarkers and innovative clinical studies, to progress better treatment options for the patients we serve
In Global Translation, our aspiration is to change how we conduct research and development in Novo Nordisk. We identify and apply biomarkers in innovative clinical trials to measure how our drugs work in patients, and we generate human data to enable patient segmentation and precision medicine for future treatments.
In Global Translation, we span across the entire Novo Nordisk value chain. We follow the projects from early research to late-stage clinical development and all the way to the market. This demands broad expertise and interdisciplinary collaboration, and we take pride in teamwork and seamless knowledge sharing.
Our key deliverables are biomarker identification and assay establishment, design and conduct of first-human-dose trials, use of biomarker readouts to conclude on the efficacy of new drugs as early as possible, and development of precision medicine and diagnostic solutions.
In addition, we are building the clinical innovation centre CLINiC, which will open in 2023 on the historic Novo Nordisk Steno Memorial Hospital site in Gentofte, Denmark. The CLINiC site will include a laboratory, pharmacy and beds for 40-50 patients at a time. Here, we conduct advanced and innovative clinical trials with high flexibility and short turnaround times.
With laboratories and offices in Måløv, Greater Copenhagen Region, a clinical phase 1 unit in Gentofte, and many of our important collaborators situated at Novo Nordisk sites across the world, we have established a dynamic and flexible working environment catering to the needs of each individual employee.
As Novo Nordisk’s research pipeline is expanding we are also growing, and offer many opportunities for scientific learning and career progression. We are looking for new talented colleagues with a variety of diverse professional backgrounds – including hands-on experience in designing and conducting clinical trials; biomarker expertise, such as building assays and applying biomarkers in drug development; or basic research scientists with a deep understanding of human disease mechanisms.
In Translational Research, we are committed to identifying biomarkers and generating high-quality biomarker data to guide decision-making in research & development. Translational Research at Novo Nordisk consists of two departments, Biomarker Identification & Biomarker Assay Development, that work closely together to identify, qualify and quantify pharmacodynamic or response biomarkers to de-risk projects in research & early clinical development phases. We apply different technologies & know-how to identify, qualify and quantify prognostic and predictive biomarkers to enable precision medicine.
The technologies we use include but are not limited to ELISA, MSD, Simoa, AlphaLisa, flow cytometry, cell-based assays, imaging, transcriptomics, proteomics/peptidomics, metabolomics. Our scientists also leverage clinical data and data from cohorts to back translate clinical results into biomarkers that can enhance the development of new assets.
In Translational Development, we lead the individual project’s translational strategy. This includes tracking pharmacodynamic biomarkers that can be used to indicate efficacy in our early trials by demonstrating that our candidate drugs engage with the target and have some mechanistic or disease-modulatory effect. We pre-define success criteria to support the decision to proceed or stop a project based on trial biomarker data.
We also focus on precision medicine to build a better understanding of which patients may have a greater need or benefit from a new therapeutic treatment. This starts with building biological understanding and scientific hypotheses in human disease cohorts. These hypotheses are then tested and validated in our clinical development programmes and ultimately may be used to select a specific sub-population to be included in the drug label.
Diagnostic development runs in parallel and is integral to our precision medicine strategy. Diagnostics may be needed to better diagnose the disease, identify patients who progress faster in their disease or respond better to a particular treatment and come with differing regulatory demands.
The translational, precision medicine and diagnostic strategies are developed by cross functional teams bringing together and building end-to-end scientific, medical, regulatory and commercial thinking across the project’s life cycle.
In Early Clinical Pharmacology, we are scientifically and operationally responsible for designing, planning and executing first human dose and early clinical pharmacology trials. We are investigating the safety, pharmacokinetics and biomarkers of our early development projects and are working across various therapeutic areas and technology platforms.
Our area consists of Trial Managers, Clinical Trial Administrators and Clinical Pharmacology Specialists working closely together to ensure the success of our clinical trial activities.
CLINiC (the Clinical Innovation Centre) is a newly established area in Global Translation. At CLINiC we will be responsible for the conduct of a number of phase 0 and phase 1 clinical trials for Novo Nordisk, complementing the existing setup, where trials are outsourced to Contract Research Organisations (CROs). The main focus of trials to be conducted at CLINiC will be first in human, formulation optimisation and exploratory studies including investigation of biomarkers and target engagement.
We are a team of research nurses, lab technicians, doctors, trial managers, pharmacy staff, volunteer recruiters and other operational team members working out of a newly renovated, state of the art facility in Gentofte, Copenhagen