Pipelines for Pharmaceuticals & Medical Devices

Clinical research at Yale has led to the development of a number of medications. Some of these, like Zerit, a drug used to fight HIV infection, are already on the market, while others are undergoing testing in clinical trials.

Clinical trials are divided into phases, depending on what is being tested. In the preclinical phase, a drug is tested in the lab. In Phase I, it's tested in a small group of people to determine a safe dosage and learn about side effects. Phase II involves a larger group of people. Phase III is the final step before a drug can be marketed to the public. In this phase, it is tested in large groups of people to confirm its effectiveness, monitor side effects and compare it to other treatments. If the drug is shown to be safe and effective in Phase III clinical trials, a New Drug Application/Biologics License Application (NDA/BLA) is filed with the Food and Drug Administration. The FDA reviews the information gathered at each phase of the clinical trials before the drug is made available to the public.

Medical devices and diagnostic tools also have to be tested in clinical trials before they can be used on patients. Several innovations developed at Yale are widely available, including a technique to detect chromosomal abnormalities and software that provides visual images of heart blood flow and function. Others, such as a blood test to detect early stage ovarian cancer and a surgical technique to stabilize the spine for patients with spinal stenosis are showing promising results in clinical studies.