How long do you think it takes from the time the drug is discovered to the time it comes in the market?

In 2002, survey found that the average time for the development of a drug is about 12 years and 10 months, and only 1 in 10 drugs are able to make it to the market. In this article, we take a look at  why it takes for the discovery of the drug.

Once a drug has been discovered that effectively treats the disease or condition, the drug has to undergo a target validation. This is to show that the drug indeed affects as disease process and the modulation of the target will have a therapeutic effect on the host. Following this, an important step in drug discovery is the assay development. The assay should answer critical questions such as the ones shown below.

• Relevance: Does the drug directly relate to the target?
• Reliability/Robustness: Are results reproducible and statistically significant?
• Practicality: Do time, reagents, and effort correlate with quality and quantity of results?
• Feasibility: Can assay be run with resources at hand?
• Automation: In order to screen large numbers of compounds, can assay be automated and run in highly parallel format?
• Cost: Does cost of the assay permit scale-up for high-throughput screening

Assay development is very important as any compromise would have substantial downstream consequences.

Screening and hits to lead is the next step to collect and screen the collection of the compound library. This is to synthesize, collect and characterize compounds required in the manufacturing of the drug. The success of the screening depends on the availability of compounds, their quality and diversity. Thus, causes it to become the most costly part of drug discovery.

The goal of the subsequent step, known as lead optimization, is to produce a pre-clinical drug candidate. It is a complex, non-linear process of refining the chemical structure of the drug to improve its characteristics. This stage is often a bottleneck of the drug discovery program.

Next, the drug enters the development stage, which requires attention to Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and 21 CFR (describing the code of regulations for food and drugs). Finally the drug has to undergo clinical trials before it is able to enter the market and reach the patients.

The journey from bench top to bedside is indeed a long one with many obstacles along  its development. Many pharmaceutical companies are trying hard to shorten the process so as to provide safe, effective medication to the patients as quickly as possible.

More information can be found here.

Photo: Flickr/All Too Familiar