How Are New Drugs Developed?

The process of developing a new drug from the initial idea to a marketed product involves many different stages and can take more than 12 years to complete. These stages include:

 

1. Discovery

During the discovery phase, researchers study a disease to gain an understanding of how it affects the biological processes in the body. This involves looking into what may be causing the disease, usually with the aim of identifying proteins involved in the disease process. It is through better understanding of disease processes and pathways that targets for new treatments are identified.

Proteins are commonly targeted by drugs as they play critical roles in the body and diseases. However, drug targets can also be RNA, DNA and other genes.

Researchers then form a hypothesis on whether inhibiting or activating a specific protein or gene may help treat a specific disease.

 

2. Molecule development

Once researchers have found a molecule that can target their specific disease, they can start testing the molecule in different combinations to find out which formulation makes the molecule work most effectively.

Thousands of molecule combinations are screened in the hope of finding one or more promising candidates that show signs of potentially stopping or reversing a disease.

 

3. Preclinical research

Before testing a drug on people, researchers must find out whether it has the potential to cause serious harm. This is known as the ‘drug toxicity’. Safety and efficacy tests are therefore conducted using computerised models, cells and animals.

At this stage of the drug development process, scientists need to work out the most effective delivery mechanism for the molecule, i.e. will the medication be a tablet, inhaler, gel or cream? What will the optimal dose be?

In the UK, approval by the Medicines and Healthcare products Regulatory Agency (MHRA) is required before any testing in humans can occur.

 

4. Clinical research

Preclinical research answers basic questions about a drug’s safety; however, is not a substitute for studies on how the drug will interact with humans.

Drug testing on humans involves several phases:

• Phase 1: A small group of healthy volunteers are given a single dose of the drug to determine its safety.
  
  
• Phase 2: The drug is tested on people with the condition it’s intended to treat to determine its effectiveness. At this stage, researchers will also aim to determine the most effective dose and method of delivery (for example, oral or intravenous) and the appropriate dosing interval.
  
  
• Phase 3: A larger study is conducted on anywhere from a hundred to several thousand patients. This phase aims to reconfirm the phase 2 findings in a larger population.

 

5. Regulation

The results from the clinical trials can then be submitted to a regulatory agency to obtain a license. Licensing is needed to confirm the quality, efficacy and safety of a medicine. A license also demonstrates that all the proper checks have been carried out and that the potential benefits of the medicine are believed to outweigh the risks.

In the UK, licences are granted by The Medicines and Healthcare Products Regulatory Agency (MHRA).

 

6. Manufacturing

Once a medicine is licensed and has UK market access approval, it can now be manufactured at scale in preparation for supply to the NHS!

 

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