BioCentury This Week opens an important dialog on "Regulatory Innovation" in its Sunday, Nov. 28 broadcast, devoting the entire program to a conversation with Dr. Mark McClellan, Director of the Engelberg Center for Health Care Reform at the Brookings Institution, and the only person to head both FDA and Medicare. Dr. McClellan discusses obstacles in the current clinical trials process, and the resulting obstacles for drugs reaching patients in a timely and cost-effective manner.

Dr. McClellan specifically highlights the I-SPY2 Clinical Trial as a leading example of the type of regulatory reform necessary to move the industry forward.

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.

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.

The December 21, 2011 issue of the Journal of the American Medical Association includes a Commentary entitled “Accelerating Identification and Regulatory Approval of Investigational Cancer Drugs” authored by Dr. Laura Esserman, MD (and Principal Investigator of the I-SPY 2 Trial) and Janet Woodcock, Director of the Center for Drug Evaluation and Research of the FDA. The Commentary starts by stating the problem with getting new drugs to market today – “The development of new drugs is becoming increasingly expensive”and oncology drugs, in particular, have a high clinical failure rate. The current return on capital investment in drug development by US public companies was recently reported as less than 0.3%. The low probability of success, coupled with rapidly accelerating expenses, means that drug development is increasingly the purview of only 2 organization types: a few large companies and myriad small, venture capital “funded start-up firms. At an estimated cost of $1.0 billion to $1.8 billion for developing a successful new drug, funding for such risky ventures, particularly for oncology drugs, may diminish.”

The methodology behind the I-SPY 2 Trial is cited in this Commentary as one important example of how to dramatically speed up the process.

To read the full Commentary, click here:JAMA article (Dec 2011).full

The I-SPY2 Trial was featured in an NBC Nightly News segment on Monday, December 19th. The introduction by Brian Williams states “Right now, as you may know, it typically takes a decade or more to prove that a new drug works, and then to get it approved for women who desperately need it and get it to market. Our chief medical correspondent, Robert Bazell, tells us about an attempt to accelerate that process.”


Nov. 8, 2011 - Safeway Inc. today announced its stores raised $14.5 million in October for breast cancer research. The company thanked its customers and employees for their commitment to finding a cure for the most common form of cancer for women.

UCSF’s Carol Franc Buck Breast Care Center is one of the recipients of the Safeway Breast Cancer Awareness campaign funds. “We are so grateful to Safeway for its leadership and vision, and to the company’s customers for every dollar they donate,” said Laura Esserman, M.D., Professor of Surgery and Radiology, and Director of the Carol Franc Buck Breast Care Center at the University of California, San Francisco. “Safeway is providing the critical resources to build systems to revolutionize breast cancer care.”