Cancer agency works to get nanomedicine from lab to clinic

The National Cancer Institute is taking several steps to smooth the path by which nanomedical discoveries in the lab are translated into preventives, diagnostics and treatments that will be used to help patients.

"We want to get these new agents into regulatory review and into the clinic," said Anna D. Barker, PhD, NCI's deputy director for advanced technology and strategic partnerships. "We want to move forward in a proactive way." Her comments were part of a presentation made during last month's meeting in San Diego of investigators involved in the NCI Alliance for Nanotechnology in Cancer.

This effort includes the Food and Drug Administration and the National Institute of Standards and Technology, both of which are contributing to the development of criteria for nanoscale materials as well as preclinical toxicology and efficacy testing protocols. In addition, the NCI requires researchers who receive funding related to the project to have partners that can commercialize any developments that result.

"It's really important to get industrial players involved early on, because that's how we will get new developments fastest to the patient's bedside," said Sanjiv Gambhir, MD, PhD, professor of radiology and nuclear medicine at Stanford University.

Nanomedicine has been a buzzword for the past few years, particularly with regard to cancer. Many experts see it as a potential mechanism for the application of personalized medicine -- making it more likely that a patient is treated with the optimal therapy early.

"We don't want to wait months to see if the tumor will shrink," Dr. Gambhir said. "We want to know quickly whether the drug works and if we should change the therapy or continue it."

Scientists also hope that this line of research will lead to better ways to track how cancer moves through the body, streamline clinical trials, combine therapeutics with diagnostics and create drugs that are able to treat diseased cells without harming healthy tissue.

"Traditional cancer drugs are very systemic and toxic, and nanotechnology offers a way around that," Dr. Barker said.

In a related development, the National Institutes of Health announced in October that the funding of four additional institutions completes its national network of nanomedicine centers. Eight institutions are now investigating the physical properties of structures inside cells and training students in this discipline.

"Future progress in medicine will depend on our understanding ... the complexity of biological systems," said Paul A. Sieving, MD, PhD, head of the NIH's Nanomedicine Initiative and director of the National Eye Institute.

But researchers say the enterprise will not be able to help patients unless regulatory uncertainty is resolved. In an attempt to do just that, the FDA held its first major public meeting Oct. 10 on nanotechnology materials in products regulated by the agency.

This work is regarded as particularly crucial because, although nanotechnology is in its very early stages, significant fears have arisen about its possible environmental impact, and several organizations have issued reports criticizing the FDA for not taking a more active role to ensure that emerging products are safe.