• Quintiles commits $2.6 million and contributes trial management expertise
  • Seeks dramatic reductions in development time, costs and patient volunteers required
  • FDA, NCI, FNIH and 20 leading cancer centers among I-SPY 2 collaborators

RESEARCH TRIANGLE PARK, N.C. – April 14, 2011 – Quintiles announced today that it will contribute a total of $2.6 million over four years to support I-SPY 2, a unique adaptive clinical trial designed to develop breast cancer therapies twice as quickly and at one-fifth the cost of current methods. Current development costs typically exceed $1 billion and take 12 to 15 years to bring a single drug to market.

The I-SPY 2 clinical trial involves 800 patients with advanced breast cancer at time of primary diagnosis. It employs innovative adaptive trial design and genetic and biological markers from individual patients’ tumors to screen multiple investigational therapies simultaneously. The evaluation of multiple drugs concurrently allows investigators to quickly measure effectiveness.

The design of the I-SPY 2 trial represents a major advance in breast cancer research with promising implications for other cancers and other diseases. Quintiles will make its grant in support of I-SPY 2 through QuantumLeap Healthcare Collaborative, a 501(c)(3) non-profit foundation and a co-project manager of the trial.

“Quintiles’ $2.6 million grant and our joining the I-SPY 2 management consortium reflect the company’s unwavering commitment to patients,” said Dennis Gillings, CBE, Quintiles Chairman and Chief Executive Officer. “Multi-party collaboration, adaptive trial design, biomarker use, and point-of-care data access are major steps in the right direction. Quintiles is proud to be part of this revolutionary effort.”

The Foundation for the National Institutes of Health is the sponsor of I-SPY 2 while the U.S. FDA, National Cancer Institute and 20 leading academic cancer centers are collaborators in the effort. Quintiles joins The Safeway Foundation, QuantumLeap Healthcare Collaborative, several biopharmaceutical companies and individual donors as supporters.

Anna Barker, former Deputy Director of the National Cancer Institute (NCI), an original designer of I-SPY 2 and current Board Member of QuantumLeap, said: “We welcome Quintiles’ financial commitment and its support of our trial. I-SPY 2 represents the best of what we know in science and in the regulatory process. As the leading biopharmaceutical services organization, Quintiles brings the best in clinical trial management practices to this effort to dramatically reduce the time and cost of bringing new therapies to market.”

The study’s co-principal investigator, Laura Esserman, M.D., of the University of California, San Francisco, said: “Because Quintiles works with hundreds of biopharmaceutical companies and healthcare organizations around the world, it can help disseminate I-SPY 2 innovations. We’ve set up a system where everyone can learn more quickly. Our goal is to reduce costs and time-to-market for new drugs that can make a difference in patients’ lives, first for women with breast cancer, then for other cancers as well.”

About I-SPY 2

I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) is a unique clinical trial managed under the auspices of the Biomarkers Consortium--a public/private partnership and collaboration between the Foundation for the National Institutes of Health (FNIH), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and biopharmaceutical companies—and QuantumLeap Healthcare Collaborative. The trial includes the participation of patient advocates, and 20 major cancer research centers and institutional review boards across the United States and Canada.

The trial will cost approximately $27 million over five years. To date, funding has been secured from a variety of sources: non-profit contributors, including the Safeway Foundation; for-profit companies, including Quintiles; and private donors and foundations.

About QuantumLeap Healthcare Collaborative

QuantumLeap Healthcare was established in 2005 as a collaboration between medical researchers at the University of California at San Francisco and Silicon Valley entrepreneurs. Its mission is to accelerate the transfer of high-impact research in clinical processes and technology into widespread adoption so that patients can benefit from the research as soon as practicable. For more information, please visit www.quantumleaphealth.org

About Quintiles

Quintiles is the only fully integrated bio pharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.