Although most people rarely stop to consider it, the drugs we receive over the pharmaceutical counter to treat common ailments have been on a long and arduous journey to get where they are.
The development of most drugs takes around 12 years in total and will have incurred research and production costs of around $1.5 billion on average. Along the way, countless other similar treatments will have failed or been refused – while even the drug in question will have likely passed through multiple iterations. For obvious reasons, there are incredibly tight safety controls surrounding the production of drugs and medicines.
The research stage
Most drugs begin their journey to production in a university lab, normally as the result of pharmaceutical company funding to understand a disease or condition better. Research is typically conducted at a cellular or molecular level to build up a more comprehensive understanding of how the disease works. This then allows scientists to devise a new treatment that can interfere with the disease’s normal operation – for example, by blocking a receptor.
Molecules were previously sourced from natural compounds like plants or fungi, but genetics is now playing an increasingly important role in creating new medicines, designed specifically for purpose and produced using computers. Often, many thousands of these potential compounds can be produced but are gradually cut back to just 10 or 20 possible contenders.
Computer and animal testing
Once potential treatments have been identified, the next step is to ensure they are safe and also test that they can be effective against the target disease. Scientists will perform extensive computer modeling and tests on cells and animals to evaluate the efficacy and, perhaps more importantly, safety. In a typical development cycle, only 50% of the candidates will make it past this crucial stage.
When trials are complete, the developers will make a clinical trial application. This application is reviewed by teams of medical and scientific experts to ascertain whether adequate testing has been performed to merit the drug being moved to the human testing stage.
Companies like TeamTech have extensive testing and development facilities, built specifically for this process to ensure a drug product is ready before proceeding tothe review stage.
If the review board decides the drug passes all the required safety and efficacy criteria, they will allow the drug to be moved to human trials. Human trials consist of three (sometimes four) distinct phases, each with a specific purpose.
Phase one is small-scale testing mainly to test safety; phase two is concerned mostly with secondary safety tests and ascertaining appropriate dosage on groups of hundreds of patients; phase three involves tests on thousands of individuals (often based internationally) with the final aim of proving safety and efficacy.
Presuming the drug passes these phases it will be approved for general release.
If a compound shows considerable promise, pharma companies will look to patent it early in the development timeline. This protects their significant investment and intellectual copyright and stops other companies from copying it for 20 years. Of course, due to the length of time it typically takes to develop a drug (as noted, up to 12 years), the majority of this patent will have often expired by the time drug is ready for full release.
It is estimated that for every 25,000 laboratory compounds that are developed, just 25 will make it to the human testing phase, and only five will be released to the public. Of those remaining five, studies suggest just one will end up turning a profit.