• Question: How long does it take to develop a drug?

    Asked by Cubey123 to Eleni, Hannah, Jenny, Oli, Steven on 11 Nov 2016.
    • Photo: Oliver Charity

      Oliver Charity answered on 11 Nov 2016:


      Hi Cubey,

      Drug development can take varying amount of time, from 5 years to over 20 years, and there are many stages involved to make sure that it is safe for use. An issue with the type of treatments that my work is related to is that viruses are living, and therefore require different testing to normal drugs, and as of yet these methods have not been developed. People do use bacteriophage (the viruses I work with) for food products and in farm animals to reduce the harmful bacteria.

      Oli

    • Photo: Hannah Bolt

      Hannah Bolt answered on 11 Nov 2016:


      Hi Cubey123,

      As Oli said, drug discovery can take an incredibly long time. Firstly, scientists have to find some promising molecule to be a potential new drug. Then the drug must be tested in what we call ‘clinical trials’. There are several stages to these and we make sure that the drug is safe for human use, what dose we should give, if there are any side effects and how well the drug actually works.

      For every drug that is successful at the clinical trial level, there are usually thousands of other drugs that fail. This means it is very expensive and a time consuming process. It is estimated that getting one new drug through clinical trials for doctors to use costs $2.6 billion!

      Some facts:
      – On average it takes 12 years for a drug to travel from a research lab to being used on patients.
      – If 5,000 drugs are tested in the first stage of clinical trials, only 1 will ever be approved for use in humans!

      Hannah

    • Photo: Steven Street

      Steven Street answered on 12 Nov 2016:


      Hi Cubey123,

      That’s a good question! It’s kind of like how long is a piece of string though, as there is no hard and fast rule.

      Typically as the others have said so nicely, it takes well over 5 years, usually 10-20 years, and involves millions if not billions of pounds to succeed in clinical trials!

      I can give you a rough idea though by describing the discovery of my favourite drug, Glivec. This was the first targeted cancer therapy, and was discovered by rational drug design as opposed to ‘by accident’ or involving a natural lead compound.

      The BCL-ABL mutant tyrosine kinase enzyme was discovered in 1990. It took chemists at Novartis 2 years to discover the lead compound that would later become the successful drug, and in 1992 the first patent was filed. In 1998 it entered clinical trials. In between these times they were likely trying to work out the optimum formulation and other optimisations, as well as patenting it in several different countries. In 2001, it was approved by the US FDA after only 2.5 years in clinical trials! This is extremely quick, and things can typically take much longer than that. So it went from initial target discovery to approved drug in the space of 11 years, which isn’t too bad!

      Steve

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