Despite scientific advances and increased spending for research, the efficiency and productivity of drug development have declined in the last decade.
C-Path projects aim to facilitate positive change in the drug development process by addressing the standards for data submission, for improved methods for testing product safety, and for unmet medical needs.
-Maryellen deMars, PhD
Cancer Biomarkers
C-Path is coordinating an effort to bring pharmaceutical and diagnostic companies together with government agencies in a project that will help guide lung cancer therapy. The Cancer Biomarkers program is one of the major projects for a national collaboration called the Oncology Biomarker Qualification Initiative formed by the FDA, National Cancer Institute, and the Centers for Medicare & Medicaid Services to advance the development of personalized treatment and diagnostic testing for cancer therapy.
C-Path was awarded a pilot grant from the FDA to lead a coalition of twenty pharmaceutical, biotechnology, and diagnostic companies. The goals are to 1) help validate clinical tests for epidermal growth factor receptor (EGFR) as a biomarker for response to a promising class of new drugs, tyrosine kinase inhibitors, and 2) use this as a test case to help standardize the development path and performance requirements of diagnostic tests for cancer. Accomplishments include:
- Collaboration with NCI in the planning of the randomized trial to validate EGFR as a predictive biomarker, one of the first biomarker validation trials in cancer.
- Development of the protocol for comparison and cross qualification of methods/platforms to determine EGFR status in tumor tissue samples.
- Coordination of a program with 14 diagnostic companies to evaluate exploratory methodologies and provide access to clinical samples from the NCI trial.
The Cancer Biomarker Project is important because, despite massive research investment and public demand for treatment, cancer drugs have the highest failure rate in clinical development. Though the scientific community agrees that applying biomarkers that predict the success of therapy is likely to be an effective strategy, pharmaceutical companies have not traditionally developed biomarkers to the point where they have been qualified for use for clinical trials. Also, diagnostic companies typically have not utilized the clinical trial process and cannot justify the investment required to conduct the large studies required to evaluate the ability of these assays to predict the course of disease or response to a therapeutic drug.
By forming this team, C-Path creates a new collaborative relationship that will help bring new accurate cancer diagnostics to market faster and improve outcomes with effective therapies.