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 The last two decades have included a number of successful partnerships between NCI and industry, leading to the development of highly effective cancer therapeutics like paclitaxel (Taxol) and bortezomib (Velcade). Such collaboration is by no means rare. A number of existing NCI programs, including the RAID program and the NCI-60 Screening Project, already facilitate collaboration between NCI and industry.
But, as the institute becomes more of an enabling platform for the translation of new therapeutics from the lab to the clinic, innovative efforts have been launched that both directly and indirectly allow NCI and the private sector to cooperate.
One area of particular emphasis, explains Dr. James Doroshow, director of DCTD, is NCI's greater role as "a broker" in arranging for the conduct of clinical trials to test new cancer drugs. This is especially true for trials in which researchers at academic medical centers hope to test combinations of agents owned by different companies. Dealing with intellectual property concerns and hashing out the minute details of these arrangements can often lead to long delays, if not entire derailment. But with NCI's enhanced involvement, that's beginning to change.
"We now have 100 trials like this going forward, being performed in academic medical centers," Dr. Doroshow said during a recent seminar for medical reporters. "There are very few examples of a single academic site bringing together [companies with] two investigational agents…Anything we can do to speed up [the negotiation] process will speed up the overall development process."
Another new initiative is a funding mechanism for small businesses developing promising new anti-cancer therapies and cancer imaging technologies. With funding from venture capital companies and so-called "angel investors" becoming more difficult for small businesses to secure, NCI's Small Business Innovation Research (SBIR) Program has developed Phase II Bridge Awards to help small businesses fund the work needed to traverse the so-called "valley of death": the period between the completion of early basic and preclinical research and later stage human studies, including phase I and II clinical trials.
The Bridge Award, explains NCI SBIR Director Michael Weingarten, encourages partnerships between NIH's SBIR Phase II awardees and third-party investors and/or strategic partners that have significant prior experience in the commercialization of emerging technologies. To encourage partnerships with third-party investors, the SBIR Program expects the Bridge Award amount to be matched by non-federal funds. Modeled after a highly successful program developed by the National Science Foundation, the Bridge Awards, Mr. Weingarten says, are an ideal way for NCI to "incentivize early collaboration." Applicants must have previously received a SBIR Phase II award from the NIH.
The institute's leaders also believe NCI's Experimental Therapeutics program will expand NCI's ability to collaborate with industry partners in improving drug development. The program's aim is to use very small phase 0 human trials to shorten the time needed to move the most promising investigational agents into larger phase I human clinical trials. The first such trial, a partnership with Abbot Laboratories, was highly successful, demonstrating that the drug was hitting its molecular target, and identifying a biomarker to measure target inhibition without having to do repeated tumor biopsies.
That single trial, says Dr. Jerry Collins, associate director of NCI's Developmental Therapeutics Program, "has turned around opinions on the outside dramatically. It's one thing to deal with the abstract concept of a phase 0 trial. It's another to have a specific example that demonstrates it."
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Helping Technology Collaborations Flourish
The Advanced Technology Partnerships Initiative (ATPI) will use NCI-Frederick's unique authorities to expand collaborations with industry in developing technologies to translate cutting-edge discoveries into new diagnostic tests and treatments. The first collaborative agreement under this program has just been reached with GE Global Research, using nanoparticles as diagnostic imaging agents.
Another NCI program helping to promote technology collaborations is the Center for Cancer Research's (CCR) Office of Science & Technology Partnerships (OSTP), which began in 2002. The OSTP negotiates agreements with companies that allow many CCR researchers to use new technologies for tasks like assessing protein-protein interactions or conducting gene-expression studies - vital research that represents the earliest phases of drug development.
These are often win-win relationships, stresses Dr. David Goldstein, who directs OSTP. CCR researchers get access to cutting-edge technologies and can leverage economies of scale, and the companies often get valuable input that helps in commercialization of their products.
Similarly, novel models developed through NCI's Division of Cancer Biology Mouse Models of Human Cancers Consortium (NCI-MMHCC) are being used more in NCI-supported academic laboratories for preclinical testing that parallels early clinical trials. NCI is exploring public-private partnerships for these studies, and to leverage the preclinical bioinformatics infrastructure that the NCI-MMHCC developed in collaboration with the NCI Center for Bioinformatics. |
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