RESEARCH TRIANGLE PARK, NC – May 31, 2013 – In advance of the American Society of Clinical Oncology (ASCO) Annual Meeting, Quintiles today announced the release of its perspective on two areas of focus for clinical oncologists – the impact of patient selection in early-phase studies and the use of biomarkers in the treatment of hematologic malignancies.
The first of these reports, Tomorrow’s Path to Improved Early-Phase Oncology Drug Development, explores the importance of key elements to maximize quality and efficiency of go/no-go decisions in early-phase studies. As the understanding of the biology of cancer becomes more sophisticated and generates more opportunities, fundamental challenges caused by the complexities of this group of diseases are becoming more evident. Molecular profiling and leveraging molecular selection of patients has the potential to significantly improve the quality of early decisions in oncology drug development.
“By identifying a well defined group of patients with a particular molecular biological profile, we have the potential to make more efficient decisions on product candidates at the earliest possible stage,” said Philip Breitfeld, M.D., vice president and therapeutic strategy head, Quintiles. “As the cost of oncology drug development rises, the use of targeted therapies represents a path toward more precise treatment approaches that would drive down costs, timelines and failure rates.”
The second report, Biomarkers: Recent Advances in their Application to the Treatment of Hematologic Malignancies, presents a point of view on the value of biomarkers in the early detection and stratification of groups at risk for aggressive disease to improve the overall survival rates associated with late stage diagnosis.
Hematopoietic malignancies, which include a heterogeneous group of diseases such as multiple myeloma, lymphomas and leukemias, are characterized based on the appearance of the cells as well as demonstrating the presence or absence of certain cell surface proteins (Cluster of Differentiation or CD markers), characteristic chromosomal abnormalities, and by the identification of particular genetic mutations.
“While the use of biomarkers is widely supported and the hope of early detection is promising, few biomarkers have been identified or clinically validated for the early detection, progression or risk assessment for such malignancies,” said Harish Dave, M.D., MBA, vice president, global medical strategy head, hematology and oncology, oncology therapeutic area, Quintiles. “Recent advances in understanding of these malignancies and the advent of high-throughput technologies have the potential to facilitate rigorous translational research toward the discovery, development and clinical validation of novel biomarkers.”
Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 27,000 employees conducting business in approximately 100 countries. We have helped develop or commercialize all of the top-50 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes.