Susan Slovin develops vaccines at the Memorial Sloan-Kettering Cancer Center in New York City using tumor- associated antigens for prostrate cancer. She has completed multiple Phase I and Phase II clinical trials, which test safety and dosing. She has designed a Phase III trial for efficacy--the last stage required for approval by the Food and Drug Administration (FDA). Nevertheless, she can't proceed.
Scientists are required to use the FDA's Good Manufacturing Practices (GMPs), which makes the cost of preparing the vaccine prohibitive for Slovin. Through each of her early cancer vaccine trials, which typically enrolled only 15 to 30 patients, Memorial Sloan-Kettering's own bioorganic chemistry laboratory, a nonGMP facility, synthesized the precursor of the vaccine and then a small GMP facility conjugated it. But for a larger Phase III trial with more than 200 patients, the FDA requires scientists to test the same compound that would be marketed if approved....
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