FDA-NCI Partnerships to Accelerate Cancer Drug Development
The two federal appointees with the most impact on cancer drug development are the Commissioner of the FDA and the Director of the NCI. Mark McClellan M.D., PhD., was the most recent Commissioner of the FDA. He is a medical internist/principal investigator and a Stanford professor of medical economics. Andrew von Eschenbach M.D., Director of the NCI, is a urological surgeon/principal investigator from M.D. Anderson Cancer Center, and himself a two-time cancer survivor. Both of these physician leaders are devoted to streamlining new cancer drug development. They have recently created a new FDA-NCI partnership to assist in the developmental aspects unique to cancer drugs.
To further accelerate the NDA process, Dr. McClellan has lead the FDA to adopt a paperless system requiring all NDAs to be submitted electronically as of 2004. Furthermore, the NDA process will become a Continuous Marketing Application (CMA) that will review portions of the NDA in advance to help streamline the final approval. Dr. McClellan is currently consolidating the entire FDA into one campus, instead of the 40 different locations that it currently resides. In 2005, Dr. McClellan was recruited to lead the Center for Medicare Services. Currently in 2006, Dr. Von Eschenbach is serving as both the director of the NCI and acting commissioner of the FDA.
Due to the FDA-NCI partnership, new precedents have been set to accommodate future cancer trials. Examples include: combining two experimental drugs in a phase II trial to test synergy prior to market approval of either single agent alone. Theoretically, some investigational monoclonal antibodies and vaccines may not have efficacy if used individually, but may work in combination.
Recently, the FDA has allowed research trial uses of the combination of standard chemotherapy and experimental Phase I agents in the front line treatment for metastatic cancer. Previously, metastatic cancer patients had to exhaust all standard chemo options prior to gaining access to experimental Phase I drugs. Now, access to Phase I experimental agents may be incorporated into the front line treatment setting combined with standard chemo.
The FDA has become extremely proactive in drug development through partnerships with pharmaceutical industry and start-up biotech companies to provide regulatory guidelines and outsourcing regulatory consultants. In addition to regulatory control, the FDA is a valuable part of the process for quality drug development. The NCI-FDA partnership has a challenging goal: as per Dr. von Eschenbach’s statement to “target and control cancer” and “eliminate the suffering and death due to cancer by 2015.”
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