At Novo Nordisk, our scientists are working on the frontiers of new discovery in our therapy areas. We have expertise across the pharmaceutical value chain and we collaborate with academia and biotech companies around the world to foster new innovations.
Early in the value chain, our scientists are evolving and testing ideas based on unmet medical needs.
At Novo Nordisk, we offer world-class protein and peptide technology expertise including expression, engineering and formulation. We have close to 100 years of experience in designing and engineering proteins that mimic mother nature for the treatment of diabetes and since then also other serious chronic diseases.
When a lead medicine candidate is chosen, the pharmacological properties, safety and toxicity are tested in animal models. The pharmacological properties include pharmacokinetics and pharmacodynamics. At Novo Nordisk, we always maintain high bioethical standards focusing on animal care and welfare, and we integrate pre-clinical assessments of new medicine candidates early in the development process.
At Novo Nordisk we have a long history and strong expertise in formulation and upscaling of lead medicine candidates for human testing.
During formulation, the active molecule is mixed with excipients into a safe and conveniently administered product, which is stable and suitable for manufacturing. Upscaling of the medicine candidate requires robust processes and method development to ensure the high quality and sufficient amounts required for clinical testing. Finally, the medicine candidate is packed and labelled before distribution for clinical testing around the world.
Clinical trial execution is a core competency in Novo Nordisk. We conduct clinical trials in-house via our global clinical, medical and regulatory network and in close collaboration with external experts and health care professionals. We focus on fast and efficient trials execution benefitting the patients and on diversifying our clinical trials to serve local needs. Novo Nordisk ranked #1 in 2017 and 2015 in CenterWatch’s bi-annual global survey on clinical trial site relationships.
Following successful completion of a clinical trial programme for a new medicine, 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 file contains all efficacy and safety data from the clinical trials as well as from the pre-clinical testing and upscaling. At Novo Nordisk, our employees in Denmark and Bangalore work in close collaboration with global health authorities to ensure strong product labels, which guide the patients’ use and outcomes of the treatment.
At Novo Nordisk, we prepare the market for new medicines by partnering with stakeholders to generate, interpret and communicate relevant scientific data and clinical information. Our R&D centres in Denmark and Bangalore collaborate closely with external experts and international professional associations as well as our global affiliate network to engage and educate relevant healthcare providers about the science, our medicines and the patients’ needs.
Once approved, the commercial organisation assumes responsibility for making the new medicine accessible to the patients, and building awareness and uptake in the market. At Novo Nordisk, 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 the patients using our medicines.
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. Novo Nordisk R&D has a long-standing heritage in device innovation, and it is our goal to develop next generation devices to further enhance administration convenience, including alternative delivery systems such as oral delivery.
To contribute to the scientific community in our areas of expertise, we take pride in publishing our scientists’ new findings. Visit the library to explore some of their recent work.