The Drug Development Process

When a new drug hits the development stage it can go through a lengthy and complex process before it is seen by the public or distributed to pharmacies. In reality, only two tested innovations out of 10,000 actually become fully licensed treatments. All in all, it can take an average of ten to fifteen years for a new drug to make it from a petri dish in a laboratory onto the shelves of the pharmacy.

The First Stage of Discovering a New Drug

When a new drug is discovered, it relies heavily on in depth knowledge of a specific disease. It is important to understand how biological processes work in the body, as well as the side effects of certain illnesses. This sort of knowledge will reveal potential areas that the drug can target during treatment. At the moment, scientists are now able to design innovative medicines due to immersing information on the shape of biological molecules. This just goes to show how important detailed studies are during the process of discovering a new drug.

Why is the First Stage So Crucial?

These initial steps should be taken very seriously, as studies will reveal more and more about the drug in question. Usually, animals and cells will be used to test the drug first of all. However, this does not mean that the results will be the same in thousands of humans. Often drugs that show positive results in animals won’t have the same effect on humans, so this is why it is important to be cautious with the testing process. This can provide critical data for future trials, but a successful animal trial does not always pave the way for a groundbreaking new treatment.

Qualifying For the First Stage

At this pound thousands of new drugs will have been tested and created so that those with potential can be identified. The dropout rate at this point is very high with less than one in one thousand continuing to the next level. If a new compound shows potential it will then be put through several laboratory tests because a clinical trial on humans can be authorized.

The Three Phases of a Clinical Trial

  1. First of all, the new drug needs to be tested in order to determine its level of safety. At this point it is usually given to a small selection of healthy people. This important phases assists researchers in grasping how the medicine works and what kind of dosage will be suitable.
  2. Studies can now begin, as long as the drug is proven to be safe. The medicine can now be used on people with the condition to see how effective it will be. These in depth trials can take several years to complete, with an average of one or two hundred participants. The study can take several forms, such as controlled, randomised or double blind. In a controlled study the drug is compared to a placebo. In a randomised situation, volunteers are randomly allocated the drug or the placebo. Whereas, in a double blind study neither the participant nor the medical team know which treatment they are going to get.
  3. A larger study can then commence if the medicine shows positive results. The clinical trial will usually expand out to other countries and last another few years. This gives the researchers time to assess the potential of the new compound amongst a broader range of people.

The Process of Licensing

When it comes to drug development, licensing is a crucial stage to get past. In the UK, the MHRA (Medicines and Healthcare products Regulatory Agency) or the EMA (European Medicines Agency) will be the regulating authorities. In the USA the FDA (Food and Drug Administration) are those responsible for protecting public health.

During this process a DMF or Drug Master File might be prepared by the pharma manufacturer and submitted to the appropriate regulator for that area. This document will provide the regulator with information about what was used during the manufacturing process.

Licensing approval can take an average of 12 years and it costs approximately one billion dollars to develop one new successful medine.

Using a New Medicine

Once a drug has been licensed it will be closely surveyed for safety. Within the pharmaceutical packaging there will always be a PIL (Patient Information Leaflet), which outlines how the medicine should be taken and what the potential side effects are.

Clinical trials can also continue well after a compound has been given its licence. This is done so that new treatment uses can be found, the effectiveness can be measured in a broader range of patients and it can be compared to other current treatments.

Although a licence is usually granted for one specific purpose, doctors will be free to prescribe this for other purposes as they see fit. New treatment areas might come into light as a result, but a pharma company will need to show the new data to the authorities in order to extend their licence.

The Process of Patenting

Pharma companies will patent any type of compound that shows potential results during the early stages of testing and development. This stops other companies from copying it for up to twenty years and it also covers the intellectual properties of the drug. Companies will patent their products so that it can recoup the costs of development and so they can invest in future innovative drugs.

Millions of Dollars of Research Can Be Lost Instantly

At any point in the development process a new drug could be rejected at the drop of a hat. Millions of dollars can be lost as a result of these snap decisions, however they are usually due to safety issues, quality or overall effectiveness. A drug won’t be pulled from testing for no reason, however it can still be devastating to see after all the research, development and testing has been carried out. There have been many drugs that have failed at the last hurdle including lonafarnib (a cancer drug) and isradipine for Parkinson’s Disease.

This wealth of information just goes to show the time it takes to develop a new drug, as well as the astounding costs. Many patients have benefitting from new and innovative clinical trials. Even though it is a lengthy process, pharma companies will always continue to develop their research for the greater good.