OVERVIEW OF DRUG INNOVATION TO COMMERCIALIZATION

Abstract

The research, development, and approval of a drug product is a continuous but lengthy process involving drug discovery, laboratory development, animal studies, clinical trials, and regulatory registration. This lengthy process is necessary to assure the effectiveness and safety of the drug product. It takes about 10-15 years to develop one new medicine from the time it is discovered to when it is available for treating patients. The average cost to research and develop each successful drug is estimated to be $800 million to $1 billion. This number includes the cost of the thousands of failures: For every 5,000- 10,000 compounds that enter the research and development (R&D) pipeline, ultimately only one receives approval. These numbers defy imagination, but a deeper understanding of the R&D process can explain why so many compounds don’t make it and why it takes such a large, lengthy effort to get one medicine to patients. Ultimately, though, the process of drug discovery brings hope and relief to millions of patients.