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It takes a lot to develop a single new drug in the United States: an estimated $1 billion and 12 to 15 years. Biomarkers Consortium, a unique partnership between government, cancer centers and pharmaceutical companies, believes we can do better. The group is poised to revolutionize the way new drugs are studied and made available to patients.
In 2009, the consortium completed its first project, identifying a predictive biomarker for Type 2 diabetes. The group’s new five-year breast cancer study, called Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis (I-SPY2) will simultaneously study 12 different drugs in patients who are newly-diagnosed with early-stage invasive cancer at 20 cancer centers.
The innovative trial will focus on neoadjuvant treatment to determine whether new types of chemotherapy can reduce tumors before surgery. Using a patient’s biomarkers—DNA that defines the biology of the tumor—researchers will tailor individual treatment, matching the best investigational drug to each patient. The researchers will then study how cells react and hope to quickly identify which treatments are most effective in specific types of patients. If approved, investigational drugs that are found to work successfully in trial participants can then be prescribed for women who have similar biomarkers.
The I-SPY2 effort differs from traditional research in several important ways. Conducted with unprecedented cooperation, it will study multiple drugs simultaneously, and participating companies will share information involving how genes can predict patient response. Results will be made available to the entire cancer research and development community. I-SPY2 may not only bring more effective breast cancer drugs to patients who need them, it may represent the future of cooperative research.
Read more about the I-SPY2 trial.
April 20, 2010