Spotlight on Research

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Drug Discovery and Development - A Life Saving Investment

Discovering and developing new treatments for cancer is a lengthy and expensive process. But therapeutics that use the latest knowledge and the best technology are absolutely essential for us to move forward in our fight against cancer. The process begins in laboratories at university, research institute, government, or industrial facilities where individual or groups of scientists identify possible drug agents to target cancer. Once identified as potential agents, compounds must be screened, tested, and used successfully without serious adverse effects in clinical trials.

Preclinical testing validates the safety and biological activity of a compound in the laboratory and in animal models. Clinical trials determine safe and most effective dosages, how a treatment should be administered, its efficacy, and patient outcomes. At any point in this drug development process, researchers may discover that the compound does not work in quite the way they were hoping. Animals have such intricate molecular biology that a drug that effectively disrupts cancer development in isolated cells may behave differently in a mouse, and differently still in a human. When a drug does not work, researchers must decide whether to abandon that compound or take it back to the laboratory and try to modify it. Once these steps are completed, new drugs must then be approved by the Food and Drug Administration through a rigorous process before they can be used to treat cancer.

Only one in 5,000 compounds or fewer make it to FDA approval. The total length of time from initial discovery to FDA approval averages around 15 years and the total cost can be as high as $500 million to develop a single new drug. As we attempt to design or discover more targeted therapeutics, the costs may be even higher. However, only through this painstakingly thorough process of drug discovery and development do the many lifesaving cancer drugs coming out every year reach the patients whose lives are touched by them.

chart of timeline for drug discovery and development

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