DRUG DISCOVERY

To find and develop active pharmaceutical compounds that are safe, effective, and suitable for manufacture, requires a surprising breadth of research and investigation. According to the current state of chemical and biological sciences utilized for pharmaceutical development, some 5,000–10,000 chemical compounds have passed through laboratory screening for each new medicine licensed for human use.

Around 250 of the 5,000–10,000 compounds examined will go into preclinical research, and 5 will go into clinical testing. The entire process of developing a medicine, from discovery to marketing, can take 10 to 15 years. This section introduces the typical flow of the discovery process for New Molecular Entities (NMEs) within the pharmaceutical industry.

The Discovery of NMEs results from the efforts of a diverse group of public and commercial entities involved in the development and manufacturing of active pharmaceutical ingredients (APIs) and drug products. Many publicly financed institutions do basic research in fields including chemistry, biochemistry, physiology, microbiology, and pharmacology as part of this process.

Rather than focusing on the production of a product or technology, basic research typically aims to gain a better knowledge of natural chemicals or physiological processes. This allows researchers at both public and private institutions to apply this fundamental knowledge to the discovery of new NMEs matched to specific metabolic pathways or protein targets.

Scientists and medics working in a range of research institutions and universities perform the first steps in this procedure. Their findings are published in peer-reviewed scientific and medical journals. These findings aid in the identification of potential new targets for NME development related to specific disease states. A drug receptor, an enzyme, a biological transport route, or any other mechanism engaged in body metabolism could be suitable targets.

Almost all of the complex biochemical operations in the human body and within all of our cells are controlled by enzymes. Characterization of the three-dimensional enzyme structure and key active sites on the enzyme are major NME discovery and structure-based drug design components. High-throughput protein structure determination enables the screening of large numbers of candidate NMEs and significantly reduces discover timelines.

Once suitable targets and NMEs have been identified, Pharmaceutical corporations carry out or direct the majority of the remaining work involved in drug research and development.