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Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary
don’t want drugs to be developed in a void, we must ensure that the interdisciplinary work needed becomes standard practice or we’re just wasting time.”
Dr. Hayes noted that the chances of codevelopment of a tumor marker and a therapeutic occurring at the start of clinical testing are about 10 percent, because often what was originally thought to be a good marker for the therapeutic turns out to be ineffective, and a new tumor marker shows more promise. He suggested that the FDA should stipulate that no registry trial be accepted without a prospective codevelopment plan, or at least a prospective plan for a specimen bank, and a transparent system to access specimens that provides adequate protection for intellectual property rights. “The sin is that the large pharmaceutical companies have not collected and bagged and stored specimens so that we could ask questions from the trials that they’ve run,” he said.
“A lot of therapies are generic, like chemotherapy, that we apply right now based on prognostic factors,” Dr. Hayes noted, “but we could really come up with better predictive factors for these therapies.” He suggested that in addition to codevelopment of specific markers, testing of generic markers for existing chemotherapies should also be done. Dr. Leonard concurred, noting that “there is a tremendous amount of research on markers for the proper use of existing drugs. But if you’re going to fix the marker development, validation, and implementation system for the new drugs, please do it for existing ones too.” Dr. Bruce Quinn of Foley Hoag, LLP, added that biomarkers for generic drugs are just as important to develop as those for new branded drugs.