5 Stages of The Drug Discovery Process: An Introduction

Drug discovery is a very long and taxing process. Across the spheres of biotechnology, medicine, and pharmacology, drug discovery is mostly classified as an expensive process.

Did you know that in the US alone, a new drug can take approximately 12-15 years to get available in the market?

Not only this. An average new drug can take nearly $1 billion to be accessible at retail pharmacies. However, research is of paramount importance.

Through the various stages of drug discovery, doctors can get fresh insights into disease processes. Such insights can help them in highlighting novel pathways through which drugs can get developed.

Here are the five steps of drug discovery which every new drug has to go through:

Stage One: Target identification and Validation

The first and foremost step of drug discovery is target identification and validation. In therapeutics, the cellular or the modular structures that occur naturally on their own play a crucial role in disease progression. Hence, this makes them suitable targets for therapeutics. 

A target usually gets considered to be reliable when it is safe, effective, and when it can satisfy the clinical needs of the patient.

Once target identification gets over with, the next part is validation. This generally gets implemented through a systematic validation approach.

Stage Two: Hit identification and Validation

After the target identification and validation gets completed, the second stage is to find out whether the small molecule has given the anticipated effect against the identified targets or not.

Today, there are several techniques through which these hits can get identified. A few of them include- knowledge-based approaches, virtual screening, and high-throughput screening.

Once the hits get finally identified, the next part is again validation.    

Stage Three: Moving from Hit to Lead

Following the identification of hits, the next primary objective of the group of researchers is to distil each set of the Hits series.

This step is crucial to fabricate those compounds that are more efficacious and productive. Most of the experts recommend that multiple series must get sorted through in tandem.

This is because there are high chances that several of the hit series would end up failing, essentially because of the very facets of the series. When focus gets channeled to diverse sets of hit series, the chances of failures get significantly reduced.

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Stage Four: Lead Optimization

This stage is vital for the drug to become a preclinical drug candidate. At this stage, the key vision is to preserve the suitable properties of the lead compound while working on it, to repair its structural deficiencies.

It is at this stage in which it gets determined whether the drug is giving the desired effects in the targeted body area or not and whether it is inducing any side effects or not.  

Specialists in this field recommend that step four must get conducted under an integrated approach- when experts from medicinal chemistry and drug metabolism come together and give useful insights.

Stage Five: Late Lead Optimization

In case this stage gets ignored, severe issues can occur in the future related to the drug’s safety and effectiveness. Hence, before proceeding to the preclinical and clinical trials, the late lead optimization is necessary for ensuring the safety of the lead compound.

The late lead optimization is also crucial for enabling vitro tests. The motive of this stage is to eliminate the safety risks and to move forward with only those leads that present amongst the best safety profiles.

These five stages make sure that whichever drug enters into preclinical and clinical trials are more or less free from any toxic leads that can cause the drug to fail in the final stages.

Most of the revolutionary drugs that have brought a change in the world were first made to go through these stages.

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