The Process of Drug Development

Drug development is a long, grueling process that requires an extensive amount of research, time, and money. Believe it or not, there are many potential new medicines that have been discovered, but only a small amount of those medicines get approved by the FDA. Dr. Michael Decker discusses the steps necessary regarding the drug development process. Potential new drugs are constantly being discovered through basic research. Only a few of the many drugs discovered are used for clinical trials. Eventually, only one is approved by the FDA. However, it does not stop there. After being approved, the drug requires post-approval research and monitoring. This process involves several years, failures, and uncertainty. During Dr. Decker’s presentation, he mentions that the drug development process is not only long and expensive, but it is also risky. In the article “Drug discovery and development: Role of basic biological research,” Mohs and Greig shared a diagram created by Cummings et al., who showed the duration and cost of developing an AD drug. Out of the 244 drugs that were reviewed in clinical trials, only 4% were approved. It took 13.5 years from the time of discovery to launch and $1,778MM, which was the overall cost of the drug over the years of its development (Cummings et al., 2014).

Recently, there were two new drugs discovered for a rare disease, sickle cell anemia. In the article, “Two New Drugs Help Relieve Sickle Cell Disease. But Who Will Pay?” it talks about how two new treatments were discovered for people with sickle cell disease. The two drugs, Adakveo and Oxbryta, were recently approved by the FDA  This is the first known treatment that has been approved in over 20 years. For two decades, people have been doing research, clinical trials, and experiencing failures, before finally getting the drug approved. This is an example of the long, demanding process of drug discovery. Not only is the discovery of this drug costly, but these two drugs are too expensive for the people who need them the most—they cost about $100,000 a year.

            Drug development will continue to be a long and extensive process because of the many factors that must be considered, such as understanding the disease that the drug is meant for, identifying the biological targets for a drug, lead identification, etc. It is necessary in order to produce the best type of drug for the specific disease. In addition to being time consuming, the process of discovering a new drug is quite expensive. Not only is it expensive for the companies who developed these new drugs, but it is also costly for people who need to take them. This is necessary in order to fund other research projects that are geared towards discovering other new drugs.

Works Cited:

Kolata, Gina. “Two New Drugs Help Relieve Sickle Cell Disease. But Who Will Pay?” The New York Times. 1 Dec. 2019. https://www.nytimes.com/2019/12/07/health/sickle-cell-adakveo-oxbryta.html?searchResultPosition=4.

Mohs RC, Greig NH. Drug discovery and development: Role of basic biological research. Alzheimer's & Dementia: Translational Research & Clinical Interventions. Volume 3, Issue 4, Pages 651-657 (November 2017). DOI: 10.1016/j.trci.2017.10.005.