Exploring the five phases of drug development

Drug development is undeniably complex.

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From molecule discovery to FDA review and safety monitoring to commercialization, there are many opportunities for things to go right and for things to go wrong. In , the FDA approved 37 new drugs, or &#;novel&#; drugs .1 But that doesn&#;t account for the many others that didn&#;t make the cut. In fact, the overall probability of success for new molecular entities is only 12%.2

To be deemed a &#;success,&#; a new drug must make it through five specific phases: 1) discovery and development, 2) preclinical research, 3) clinical research, 4) FDA review, and 5) safety monitoring.

Below, we explore each step in more detail.

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In the discovery stage &#; the first step in bringing a new drug to market &#; researchers evaluate compounds to determine which could be candidates for development as medical treatments.

The process begins with the identification of a new target molecule, a protein or other molecule involved in the disease process. Once a target molecule is identified, scientists must design and synthesize a new compound that will interact with the target molecule and influence or inhibit its function.

Researchers use several methods in the discovery process to identify and evaluate potential treatments. They include:

• Testing many molecular compounds to find if they offer possible benefits against diseases
• Re-testing existing treatments to see if they offer benefits against other diseases
• Using new information about diseases to design products that could stop or reverse the effects of the disease
• Adopting new technologies to treat diseases, such as those that provide the ability to target specific sites within the body or manipulate genetic material

During the discovery stage, researchers may look at thousands of compounds to identify candidates for development as therapeutic treatments. Typically, only a few compounds look promising and call for further study. The Pharmaceutical Journal, a research publication based in the United Kingdom, estimates that for every 10,000 compounds tested in the discovery stage, only 10-20 compounds move on to the development phase. And only about half of those entering the development phase ultimately proceed into preclinical trials.