are both being developed when neither one is really even that close to an FDA approval,” he said.

Dr. Canetta noted additional clinical collaborations between two pharmaceutical companies, each contributing their own investigational drug. These collaborations included Bristol-Myers Squibb and Roche in the clinical testing of a combination for melanoma, and Bristol-Myers Squibb and Genentech in the clinical testing of a combination for colorectal cancer, done under the auspices of CTEP. These trials show that it is possible to do combination trials with experimental agents and address concerns about intellectual property and regulatory issues. “All that it takes is recognition of the unmet medical need and willingness to cooperate,” he said.

Even more complex, multi-industry collaborations have been forged, as exemplified by the I-SPY 2 TRIAL and BATTLE 1 and 2 trials (see Appendix A). Mr. David Wholley, director of the Biomarkers Consortium, said that having the Foundation for the National Institutes of Health (FNIH) act as a trusted third party was key to forging the 19 agreements involved with the I-SPY 2 TRIAL. FNIH acts as the holder of the IND and as the manager of the IP rights that stem from the trials. Mr. Wholley said an outside legal counsel who has worked with the I-SPY 2 TRIAL and is skilled in the area of IP licensing said she was amazed that FNIH was able to garner these agreements, and noted it would not have been possible if FNIH was not a trusted third party and a nonprofit organization.

Dr. Herbst noted that the four companies sponsoring the BATTLE 2 trial have been flexible in the choice of agents the investigators have used, even as this choice evolved when more knowledge on targeted therapies emerged. “The company allowed us to work with drugs from other companies and bring other collaborators in. We have a good example where academia and industry really worked well together,” Dr. Herbst said.

The PI3K team funded by Stand Up To Cancer has invested $500,000 to purchase 50–100 gram quantities of 10 investigational drugs that recently entered Phase II clinical trials and that were of interest to them for combination therapies. The team’s strategy is to test these drugs as single agents and in combinations, and to immediately inform the companies that make these drugs if they observe efficacy in any of our mouse models as indicated by tumor shrinkage. They then work with the companies that make the drugs to facilitate their biomarker-driven combination trials (sometimes involving two companies).

Agents used for testing are obtained from both industry and CTEP, and accrual is facilitated by interactions with the Translational Breast Cancer Research Consortium, the Gynecologic Oncology Group, and other individual centers, Dr. Cantley noted. The PI3K team also lever-

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