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.
"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."