I-SPY 2 TRIAL Is Collaborative in Partnership and Support

I-SPY 2 is a unique public/private partnership and collaboration between the Foundation for the National Institutes of Health (FNIH), the Food and Drug Administration (FDA), the National Cancer Institute (NCI), 20+ leading academic cancer centers (researchers and physicians), the Safeway Foundation, QuantumLeap Healthcare Collaborative and patient advocates.

With the goal of dramatically improving time-to-market of new cancer treatments, I-SPY 2 TRIAL depends on philanthropy to fund this innovative research.  The trial will cost approximately $27 million over five years.  To date, funding has been secured from a variety of sources, including non-profit foundations (notably the Safeway Foundation); pharmaceutical companies, including Johnson & Johnson, Amgen, Lilly, Pfizer, Eisai and Genentech; Quintiles TransNational Corp as well as individuals.

At the present time, the I-SPY 2 TRIAL is constrained by our ability to fund new Trial sites.  The more sites we can fund, the more patients can be enlisted, and the faster the drugs can be approved. More significantly, once I-SPY ’s adaptive-trial design process is validated by I-SPY 2 results, this new, accelerated clinical trials process can be established as the new standard for faster all drug development in the US.

The Foundation for the National Institutes of Health (FNIH), Biomarker Consortium and QuantumLeap Healthcare Collaborative are actively involved in raising the remaining funds from pharmaceutical companies, corporations, non-profit cancer organizations, philanthropic foundations and individuals.

Looking Ahead

I-SPY 2 is a great beginning, and with additional funding, the approach can be further expanded. In addition to breast cancer, The I-SPY 2 model holds tremendous promise for many other cancers and diseases.  It also poses the possibility of moving the adaptive trial concept even further to the point of adapting within patients once we have identified successful new agent/biomarker pairs.

How Can You Help?

The I-SPY 2 TRIAL is looking for individual and corporate supporters to help us advance this very important research. This project will yield benefits to patients by allowing new cancer treatments to be approved much faster and at much lower cost. Additionally, the lower investment threshold for drug approval means that new treatments for smaller patient populations will be able to reach the market.

For pharmaceutical companies, the benefits of I-SPY 2 TRIAL is immense.  By reducing many years and many hundreds of subjects from the standard clinical trial today, I-SPY 2 can save hundreds of millions in drug development costs.

If you are an individual supporter, you can donate via the Donate button on this website, or please contact us at: info@ispy2.org. We will be happy to answer any questions you may have about your support for the trial.

If you are representing a corporate entity (for-profit or non-profit), we welcome your interest in support for the I-SPY 2 TRIAL. Please contact us at: info@ispy2.org