Our scientific approach

The pharmaceutical value chain

Our scientific approach

When it comes to innovative treatments and medical devices that improve lives, our scientists and engineers work at the frontiers of discovery. The Pharmaceutical Value Chain helps us to get innovative treatments and devices into the hands of patients who need them.

Understanding the journey

Step 1 - Ideation

Ideation involves extensive collaboration with academia and biotech companies from around the world. Our scientists and engineers evolve, test and validate ideas together with patients and the medical community to ensure that our focus is 100% aligned with their unmet medical needs. To make it out of ideation, we need to have identified the potential for lasting and valuable change.

Step 2 - Pre-clinical testing

When a lead medicine candidate is chosen, we must begin to understand the behaviour of the substance once administered to living tissue, as well as the biochemical and physiological effects of it. Following pre-clinical assessments, safety and toxicity are tested with animal models, maintaining the highest bioethical standards of care and animal welfare.

Step 3 - Upscaling

Upscaling is where we prepare the formulation of lead medicine candidates for human testing. The active molecule is mixed with excipients into a safe and conveniently administered product that is stable and suitable for manufacturing. The processes and method development ensure high quality in sufficient amounts for clinical testing. The medicine candidate is then packed and labelled for distribution to clinical testing centres around the world.

Step 4 - Clinical testing

In close collaboration with external experts and healthcare professionals, we design and conduct value-adding clinical trials in-house via our clinical, medical and regulatory network. We focus on maximising value and quality while minimising disruption via fast and efficient clinical trial execution, and by diversifying our clinical trials to serve local needs.

Step 5 - Product registration

Following successful completion of a clinical trial programme, a registration application must be submitted to local health authorities to obtain marketing authorisations in all countries where the product will be marketed. The application contains all efficacy and safety data from the clinical trials, the pre-clinical testing and the upscaling process. Our employees work in close collaboration with global health authorities to ensure strong product labels, which guide the patients’ use and outcomes of the treatment.

Step 6 - Engage medical community

To ensure the medical community is aware of new innovative treatments, we partner with stakeholders to generate, interpret and communicate relevant scientific data and clinical information. Working closely with external experts and international professional associations, our R&D centres engage and educate relevant healthcare providers about our medicines, the science behind them and the unmet needs they address.

Step 7 - Access to medicine

Once approved, the commercial organisation assumes responsibility for making the new medicine accessible to the patients by building awareness and uptake in the market. The R&D organisation continues to do relevant clinical trials of the marketed medicine, engage in scientific dialogue, maintain regulatory files and, most importantly, monitor the safety for patients using our medicines.

Step 8 - Safe and correct dosing

Device development ensures convenient and safe administration of our medicines. During the R&D process, delivery systems for the new medicine candidates are developed in parallel to ensure safe and correct dosing in a convenient way. Our long-standing heritage in device innovation drives us to develop next generation devices that further enhance administration convenience. 

Kristal Troy, Novo Nordisk US.

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Marie Darting and Pernille Thomasen, Novo Nordisk Denmark

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Diseases areas Sustainable business