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Research Triangle Park, North Carolina, United States:
Quintiles today announced plans to improve the development of biomarker-targeted therapies through a novel approach that promotes the genomic “pre-profiling” of cancer patients. As a first step, Quintiles is undertaking a study with the participation of US Oncology Research, supported by McKesson Specialty Health and The US Oncology Network, to explore the operational feasibility and clinical benefits of an upfront approach to the genomic profiling of tumors from metastatic colorectal cancer (mCRC) patients. The study will investigate how pre-profiling and genomic sequencing data may support physician treatment decisions, including the identification of appropriate clinical trials for patients.
“Today, the industry’s approach to stratifying patients through genomic screening is sequential – testing for oncology biomarkers one at a time, and often only as part of screening for participation in a single clinical trial,” explained Jeffrey Spaeder, M.D., chief medical and scientific officer for Quintiles. “Early indications from this study suggest that we can provide physicians and patients with early visibility on potentially clinically actionable biomarkers within a rapid two-week timeframe. This level and speed of analysis has promise to save valuable time in administering potentially life-saving therapies to patients, and reduce the development times of precision medicines.”
As cancer research and care enter the era of precision medicine, Quintiles is actively transforming the model for testing new therapies. Pre-profiling may accelerate early testing of new biomarker-targeted therapies by enabling biopharmaceutical companies to focus on molecules with high potential for safety and effectiveness. For cancer patients and physicians, pre-profiling enables the efficient matching of the right patients to the right clinical studies, and increases patient access to innovative therapies.
“Our work is taking a critical step toward making precision medicine a reality,” continued Spaeder. “Quintiles’ end-to-end design and delivery model for connecting genomic testing with clinical trials supports the needs of patients, physicians and drug developers. Our goal is to provide oncology investigators and their patients with access to effective, cutting-edge therapies through a model built upon experience and high-quality cancer care.”
About the “Pre-profiling” Feasibility Study
The primary objective of the study, titled “Feasibility study of Biomarker Analysis for Patients with Metastatic Colorectal Cancer,” is to determine the number of genetic changes that occur within mCRC patients that are targeted by U.S. Food and Drug Administration approved therapies, as well as those targeted by therapies in development. The study will perform a broad-based biomarker analysis on mCRC patients, and the results will be reported to the treating physicians in a clinically meaningful format to help identify higher-risk patients and aid in selecting better treatment options.
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. To learn more about Quintiles, please visit www.quintiles.com.
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect, among other things, Quintiles’ current expectations and anticipated results of operations, all of which are subject to known and unknown risks, uncertainties and other factors that may cause Quintiles’ actual results, performance or achievements, market trends, or industry results to differ materially from those expressed or implied by such forward-looking statements. Therefore, any statements contained herein that are not statements of historical fact may be forward-looking statements and should be evaluated as such. Without limiting the foregoing, the words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “should,” “targets,” “will” and the negative thereof and similar words and expressions are intended to identify forward-looking statements. These statements are subject to risks, uncertainties and assumptions described under the section entitled "Risk Factors" in Quintiles’ prospectus dated May 8, 2013, filed with the Securities and Exchange Commission (“SEC”) on May 9, 2013, as such factors may be updated from time to time in Quintiles’ periodic filings with the SEC, which are accessible on the SEC's website at www.sec.gov. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and in Quintiles’ filings with the SEC. Unless legally required, Quintiles assumes no obligation to update any such forward-looking information to reflect actual results or changes in the factors affecting such forward-looking information.
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