How Are New Medicines Developed?

A core part of life science marketing is about signposting new products, medical technology and pharmaceuticals to ensure that people who need or would benefit from new medicines have access to them as soon as possible.

The process of developing a new medicine can take years, from an initial theory or discovery to manufacturing, clinical trials and final approval and sale.

On average, the journey of a medicine that makes it to market can take 12 years and while entire books have been written on a drug’s journey from discovery to pharmacy shelves, here are the main steps that all medicines will go through.

Discovery

The first step, and the stage of development that has gone through the most change over the past century, is how we discover new medications that may have the potential to treat diseases.

In the past, this happened purely by luck, which formed the basis for traditional medicines that worked but without people at the time knowing exactly why they worked.

Eventually, the active ingredients found in these traditional remedies were found and isolated, and this formed the basis of classical pharmacology: the screening of compounds and the use of chemical libraries to look for therapeutic effects.

After the human genome was sequenced, a new process known as reverse pharmacology became widely used, a method of drug discovery focused on a target molecule that is believed to cause a disease or disorder and then look for candidate molecules that help create the desired effect.

Once a candidate is found, the active compound that provides the therapeutic effect is synthesised and modified to increase its potency as much as possible and then the medicine can start to be developed.

Pre-Clinical Research

Preclinical trials are about testing the drug with the aid of computer models and lab-grown cells to determine the following about a new medicine:

• How it is absorbed, distributed, metabolised and excreted (ADME) by the body,
• How it works and the benefits of taking it.
• The best dosage and way to administer it (tablets, injections, liquid, creams, inhalers).
• Any side effects or other harmful results.
• Whether the effect of the drug is different depending on age, gender, race or ethnicity.
• Whether it interacts with other medication.
• Whether it is better or worse than similar drugs used for the same treatment.

This turns a potential compound into a medicine that can be used, but most compounds fail at this step by either being too dangerous or not working well enough.

Clinical Development

The next step is the development of clinical trials, which are undertaken in a safe, effective manner to ensure that they are safe to use and work the way the preclinical trials suggested they should.

Typically there are three phases to a clinical trial:

• Phase I – also known as a pilot study, this involves a very small number (usually less than 100) of healthy volunteers who will take the drug to essentially confirm how it works and whether it is safe.
• Phase II – The second phase involves less than 500 patients who receive either the new drug, the current standard drug or a placebo, depending on the nature of the trial.
• Phase III – A wider trial of up to 5,000 patients, undertaken under very strict ethical guidelines and in preparation for approval and full-scale production.

MHRA Approval

In order to sell a medical product in the UK, it must be approved by the Medicines & Healthcare products Regulatory Agency (MHRA). This is an involved application process, that may be expedited depending on the applications and necessity of the drug in question.

Once it is approved for use, it can be sold subject to the conditions of that approval.