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Drug development

What does it take to develop a new medicine? To start with, you need a dedicated team of top scientists and other professionals. The journey might take up to fifteen years.

Illness or its symptoms treated in a new way

Drug development is done in global collaboration with external experts, healthcare professionals, and health and marketing authorities.

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    Target identification and validation

    Identification of  a drug target in the human body – most commonly a protein or gene – and conducting validation experiments to show therapeutic effect on development of an illness or on symptoms.  

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    Drug molecule identification

    Selection of suitable drug molecules for further research from up to thousands of potential molecules.

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    Lead molecule optimisation

    Lead molecules modified,tested and improved. Aim is to identify a few molecules with best possible efficacy and safety as drug candidates.

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    Preclinical research

    Confirmation that molecules are sufficiently safe for testing in humans: In vitro in test tubes and cell culture, and in vivo in laboratory animal tests. 



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    Clinical trial authorization application

    Clinical trial of a drug requires authorisation from authorities. Early research has taken 3-5 years.

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    Phase I: about 1 year

     

    • First tests on humans: 20–100 healthy volunteer Participants in clinical trial 
    • Oncology drug clinical trials start directly with patients 
    • Tests the safety and behaviour of a drug in the body 
    • Only about one in ten molecules that enter clinical trials becomes a finished drug

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    Phase II: 1-3 years

    • Drug tested the first time on actual Patients in clinical trial. Trial size 100–500 patients. 
    • Consistency of effects and the original idea confirmed 
    • Safety and behaviour of a drug in the body studied

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    Phase III: 2-4 years

    • Aim is to confirm efficacy and safety of a drug with clinically and statistically significant number of patients 
    • Hundreds of trial clinics around the world. Trial size 1,000–5,000 patients. 

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    Marketing authorization application: about 1 year

    Approval of drug by authorities can be sought based on pre-clinical and clinical results. 

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    New drug available for use in patients

    Total costs of developing a new drug up to EUR 2* billion. 
    *Includes costs of unsuccessful projects. 
    Developing an idea into a finished drug takes 10-15 years. 

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    Phase IV: Drug safety follow-up

    Data collected on use and possible adverse effects of a drug throughout its entire lifespan.