Drug development is a long, expensive, and failure-prone process. It requires cutting-edge scientific skills, and collaboration across multiple disciplines within the pharmaceutical industry and among educational institutions, research laboratories, government regulators and healthcare professionals.
It takes 8-12 years on an average for a new drug to be developed for human use, and only 10 of around 10,000 substances identified as potential drugs will make it to the human testing stage. What’s more, only about one in 10,000 substances identified as potential drugs on preliminary screening will eventually be marketable.
Potential new medicines are patented as soon as they are discovered, and the discoverer usually has less than 10 years of exclusive marketing rights remaining by the time regulators approve a medicine for marketing.
Drug development goes through three basic stages: discovery, full development and clinical trials.
- Drug discovery: The process begins with a new idea directed at chemically modifying a disease process. It involves developing a drug that will react with a new molecular target within the human body. The idea is usually generated from a thorough knowledge and understanding of disease processes and a continuing involvement with research in the specific therapeutic area of interest.
- Full development: Drugs that are shown to work the best in Phase 2 studies have the least side effects, are expected to be the most economically viable, and are mass tested on thousands of patients. This phase of drug development is called Phase 3 or full development. New medicines are very expensive in the early years of sales to pay for the cost of drug development, publicize the benefits of the new therapeutic option, and provide returns to shareholders of the company.
- Clinical research: Human trials are carried out when pre-clinical data demonstrates that it may be useful in treating a disease, and reasonably safe for initial testing in humans, among other things. A clinical trial has to be properly designed and planned to provide reliable efficacy and safety data. It also has to be approved regulatory authorities and by an Ethics Committee that permits the trial to be conducted at a particular institute.