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Groundbreaking Public-Private Collaboration Combines Personalized Medicine and Novel Trial Design to Develop Potentially Life Saving New Breast Cancer Drugs Print E-mail

Today, March 17, 2010, leaders from the academic research community, members of congress, including Senator Arlen Specter (D-PA), and leaders from government agencies, including Dr. Janet Woodcock from The Food and Drug Administration (FDA) and Anna Barker from The National Cancer Institute (NCI), joined the Biomarker Consortium* at the National Press Club to announce the launch of "The I-SPY 2 trial", a highly anticipated clinical trial to help screen promising new drugs being developed for women with high risk, fast-growing breast cancers.
"This is an excellent example of a new and innovative model to truly help patients," said Dr. Ellen Sigal, Chair & Founder of Friends of Cancer Research, and Chair of the Public-Private Partnerships committee for the Foundation for the NIH (FNIH). "This type of public-private partnership, with collaboration between government agencies, patient groups, industry and multiple academic institutions, is vital to the process, and is the direction science needs to be heading."
This announcement comes after an announcement, on February 23rd, of a joint FDA-NIH Leadership Council to spearhead collaborative work on important public health issues. More information on the announcement last month can be found [HERE].
  • The I-SPY 2 trial will employ a groundbreaking clinical trial model that uses biomarkers from individual patients' tumors to screen promising new treatments and identify which treatments are most effective in specific types of patients.
  • The innovative adaptive trial design will enable researchers to use early data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly.
"I-SPY 2 promises to leverage convergence of progress on a number of research fronts to speed the evaluation of promising new breast cancer drugs using molecular cancer biomarkers to identify those agents that are effective in specific subpopulations of breast cancer patients," said Dr. Anna D. Barker, Deputy Director, NCI, and Co-Chair of The Biomarkers Consortium Cancer Steering Committee. "This will allow us to finally design advanced, smaller and less expensive Phase III trials that test the right drugs in the right patients."
  • The large-scale trial involves a unique collaboration by scientists from NCI, FDA, and nearly 20 major cancer research centers across the country. 
  • Study results will be made broadly available to the entire cancer research and development community.

    • “The I-SPY 2 trial explores a whole new way to rapidly screen new cancer treatments and match the therapy to specific markers,” said Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research at the FDA. “Developing individualized medicines needs a solution bigger than any one group can generate. The Biomarkers Consortium is a public-private collaboration of scores of organizations working together to achieve this critical mission. It is a model for the future and FDA is proud to be a founding member.”

    • Currently, it takes over $1 billion, 12 to 15 years, and thousands of patient volunteers to get a single drug to market.  I-SPY 2 was developed to allow the activity of drugs to be assessed much earlier in the research process, potentially enabling drugs to be developed and approved using fewer patients, less time and far fewer resources.
    • The goal is to shave several years and hundreds of millions of dollars off the current process. 

    FNIH will manage the trial as part of The Biomarkers Consortium, a public-private biomedical research partnership that endeavors to develop and qualify biomarkers to speed the development of medicines and therapies for detection, prevention, diagnosis, and treatment of disease and improve patient care.  Members of the Consortium include over fifty partners including the NIH, FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Centers for Medicare & Medicaid Services, the Biotechnology Industry Organization (BIO), major pharmaceutical companies, and numerous non-profit medical research organizations.

    For more information visit: www.ispy2.org