Step change in safe harbors: public-private partnerships.

Step change often occurs when worlds that do not normally interact begin to communicate with each other in ways in which collaboration replaces competition. An example of this, driven by U.S. national interests in maintaining predominance in semiconductor manufacturing, is a company called SEMATECH (SEmiconductor MAnufacturing TECHnology). SEMATECH may also be an example of how the public and private sectors might now begin to work together in the all-important area of biomarkers in cancer drug development. We are in a new era in which targeted therapies make the diagnosis–treatment paradigm central to rational drug development—a paradigm that will ultimately culminate in personalized medicine for people with, or at risk for, cancer. Biomarkers and surrogate endpoints are central to the successful development of medicines to treat and prevent cancer in the 21st century. For this reason, it is an area that merits greater collaboration. SEMATECH [1] was formed in 1987 by 13 firms representing 80% of the U.S. semiconductor manufacturing capacity and the U.S. government, with each side contributing $500 million over 5 years in a public–private partnership that would explore how to solve the critical problems of the day in computer chip manufacture: the density and heat of semiconductors. The research was precompetitive, the risks were shared, and collaboration replaced competition. What evolved were new ways to standardize equipment, supply chain, and manufacture semiconductors in a way from which all companies could derive benefit. As a result, the U.S. re-established its predominance in semiconductor manufacture, competition resumed outside the precompetitive space, and SEMATECH went on to become a successful company with global reach. Could this model be applicable to cancer drug development, where failure of new agents to show substantial benefit, often in late stages of development (phase III), is all too common an event? On February 24, 2004, stakeholders from academia, the National Cancer Institute (NCI), and industry convened in Houston at the invitation of the 41st President of the United States, George H. W. Bush, under the auspices of the CEO Roundtable on Cancer to explore whether the SEMATECH model might be applicable to cancer drug development. As a result of the Houston meeting, the Life Sciences Consortium (LSC) (Table 1) was created as a task force of the CEO Roundtable on Cancer [2], with the intent of having the member companies work together in a precompetitive environment to solve cancer drug development problems in ways that no company might solve on its own: to be “bold and venturesome,” in the words of the former President, the founder of the CEO Roundtable on Cancer. The three areas identified for collaborative improvements were: 1. Improved delivery of cancer drug clinical trials 2. Regulatory streamlining for cancer drug approval 3. Creation of a precompetitive pool of intellectual property for cancer drug development from which all companies, academic centers, and the NCI might improve success in cancer drug discovery and development.