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.
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World class protein expertise
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.
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High standards in
preclinical testing
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.
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A long history of formulation and manufacturing
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.
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Excellent clinical development and trial execution
Clinical trial execution is a core competency in Novo Nordisk. We conduct value-adding 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.
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Product registration in close collaboration with health
authorities
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.
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Building scientific dialogue in the medical community
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.
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Focus on patients' access to new medicines worldwide
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.
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Device innovation and development
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.?
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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.
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Interested in partnering with Novo Nordisk? We constantly seek to collaborate with academic and healthcare institutions, as well as leading biotech and pharmaceutical companies.
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