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The discussion—led by a panel brought together by MDS Pharma Services—focused on biomarker use in both oncology and cardiac evaluations in clinical trials, and how biomarker use can be used moving forward.
Samir Khleif, MD, Chief, Cancer Vaccine Section for the NIH’s National Cancer Institute, described three already identified and used biomarkers within the oncology arena. These include PSA, approved in 1994 as a biomarker for the early detection of prostate cancer; Her-2-neu approved as a biomarker for selection of therapy for breast cancer; and EGFR, approved in tandem with Erbitux for the selection of therapy in NSCLC, pancreatic cancer and other types of cancer.
However, the actual issue of how to develop biomarkers remains “broken,” according to Khleif. Contributing factors include a lack of understanding of scientific pathway to clinical use; lack of understanding of regulatory pathway; lack of a viable business model; and a disconnect between development and delivery.
Drilling down to real-life application, Patrice Hugo, PhD, VP Scientific Affairs, Global Central Lab, MDS Pharma Services, told panel attendees that in its role as a CRO, it has a lot of insight into biomarkers use and application across many indications and studies. However, it legally often
ECG as a Biomarker
Another initiative, the THEW (Telemetric and Holter ECG Warehouse) is similar to the ECG Warehouse and is hosted by the Heart Research Follow-Up Program and the University of Rochester Medical Center.
Hugo later told Applied Clinical Trials that the situation is different outside of cardiac biomarkers. He said, “Unfortunately, although Central Labs are testing hundreds of biomarkers on thousands of patients per year, the lack of access to basic patient medical information makes it almost impossible to perform a macro-analysis across all trials for a given indication to evaluate the clinical utility of a biomarker. In addition, for confidentiality purposes, such analyses might not be possible. The ECG warehouse project, launched by the FDA under the Critical Path Initiative, is a way to circumvent those hurdles. It allows for the macro-analysis of 400,000 ECG profiles to identify Indicators of cardiac toxicity that can be used in drug development and clinical decision-making regarding safety.”
However, Hugo added, “I believe that such projects could also be prioritized to review biomarkers in oncology trials, or other therapeutic areas, to evaluate their clinical use with 100,000s of data points across multiple trials.”
This list from Hugo’s presentation at the panel, indicates current initiatives to address biomarkers:
FDA Predictive Safety Testing Consortium