The development of new drugs is a complicated and expensive process. On average, it costs an estimated $2.5 billion for a new drug to proceed through the discovery and creation process necessary for FDA approval. FDA approval is critical because it ensures that, by the time a drug becomes available to patients, it is safe, effective, and well understood.
There are several steps that go into the process of creating a new drug and ensuring it meets the strict standards for FDA approval. One of the earliest stages is known as drug discovery. In this stage, researchers must determine what they are trying to accomplish with the new drug and perform multiple studies to determine which parts of the body may be receptive to compounds to help meet those goals.
As an initial stage in drug discovery, target identification is the process of identifying which molecules within the human body may affect the course of a disease. Researchers must ensure the target is druggable or can be altered by other compounds. Unfortunately, not all molecules are receptive to drugs, making them poor candidates for such a process.
Once researchers have identified a drug target and determined which behavior they are looking for, they can move ahead to the next step.
The process of high throughput screening can identify families of similar compounds that show an effect on a particular biological molecule. High throughput screening is a process in which scientists and researchers can test thousands of different chemical compounds at once.
Another example of a tool that can speed the drug screening process is microscale thermophoresis. This technique analyzes interactions between drug targets and compounds by detecting minute changes in the temperature and fluorescence (light energy) during the reaction. Microscale thermophoresis offers high sensitivity, efficiency, and diversity of choices.
Development into a Drug
Once researchers have identified a promising compound that has a desirable effect on the drug target, the compound must then undergo optimization. A common obstacle during this stage is that compounds that are successful in controlled experiments under laboratory conditions may be less effective when introduced to the human body. Researchers must then go back a step in the hopes of finding a different compound or target, or a way to alter the current compound to be more effective. In fact, only 1 in 20 drugs is successful enough in clinical trials to continue to the next step.
Potential Cost Reductions
With this in mind, it’s clear why drug discovery is such a complicated, expensive process. As tools like high throughput screening and microscale thermophoresis are more highly utilized, researchers can save time and money. Ineffective targets and compounds can be eliminated much earlier in the process. As workflows become more efficient and the rate of FDA approval for new drugs increases, future discoveries are on the horizon.