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Transcript: "How Medicines are Developed"

Announcer: Whether they investigate how medicines work, study the lifecycle of bacteria or crunch numbers in a computer, scientists across the globe are united by a compelling desire to better understand how life works.

Jeremy Berg, Ph.D.: By understanding how life works, new medicines can be developed and by doing biomedical research scientists can help make people feel better, live healthier lives or recover better from diseases.

Announcer: Developing effective new medicines and treatments takes a lot of work. Where do scientists start?

Jeremy Berg: To come up with new drugs, in many cases, the first step is understanding the basic processes of life. From there, when one understands what goes wrong in disease, particular targets for new medicines can be identified.

Announcer: To understand the basic process of how life works, scientists conduct what is called basic research where they seek answers to important biological questions.

Jeremy Berg: Basic research gets out the fundamentals of how life works without concern about which disease might be involved. Once you understand basic research, basically how life works, they understand -- then it's much easier to understand what happens when something goes wrong and that's what disease is all about.

Announcer: Today's pioneering research in simple organisms like mice, fruit flies and round worms is pointing scientists to new treatments for many diseases.

Jeremy Berg: The one aspect of basic research is often times it's easier to do experiments in simple organisms rather than in people, so some of the most important cancer treatments have come from studies in baker's yeast. There have been other important drugs that have been developed by studying fruit flies or round worms, these model organisms, as we call them, can allow experiments that would be impossible to do in people and provide tremendous insights that drive the drug development process. This basic research really underpins the whole process.

Announcer: To find out if a drug is both safe and effective in people, scientists conduct research studies called clinical trials.

Jeremy Berg: In clinical trials, the first goal is to make sure that a medicine is safe. Once it's established that it's safe, then it's tested to see whether it's effective in treating a particular disease or condition. In the course of the testing to see whether it's effective, things like the dose and the way it's taken are adjusted to try to maximize its effectiveness. Once that's done, then the drug may be approved for use by the Food and Drug Administration. But even once a drug is approved, that's not the end of it. As people continue to take the medicine, doctors follow up and collect information to see if it's effective in different groups or if there are other side effects and so on, so the drug can be used effectively in the widest population.

Announcer: Heart disease, cancer, arthritis, kidney disease and some forms of diabetes were once thought to be the natural consequences of aging. We now know that these disorders are neither natural nor inevitable. Coming up with treatments for diseases of aging is a major focus of biomedical research.

Jeremy Berg: There are thousands of different medicines in the pipeline at the basic research level. There are new ideas for developing medicine for treating Alzheimer's Disease, for treating Parkinson's Disease, for treating many different types of cancer, for treating heart disease, for treating high blood pressure and they're all along the various stages, from the basic research being done to being in clinical trials to being submitted to the FDA and awaiting final approval for use in humans.

Announcer: The National Institutes of Health make these breakthroughs possible by supporting research to understand the basic biology of health and disease.

Jeremy Berg: NIH plays a key role as a partner, so the development of new medicines involves a partnership between NIH and researchers and hospitals and universities around the country and other government agencies -- the Food and Drug Administration, the pharmaceutical industry, all working together to provide the basic knowledge and then the more applied information necessary to develop a drug, test it and allow patients to have access to it.

Announcer: Scientists studying diseases and the effects of medications on the body discover new facts every day. This information fuels the search for even better ways to preserve the health of everyone and that is a prescription for healthy living.

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