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As with any emerging technology, advances are paced by the amount of funding available. Much of today's nanotechnology-based devices and diagnostics are still in the hands of academia, research institutes and the government. Venture capitalists remain cautious. But many of the larger device firms either have some projects in the works or are funding efforts at small start-ups.

The growth of nanotechnology is similar to the biotech world: A researcher spins out a company to develop his or her unique device or diagnostic. Once proof of concept is achieved, venture capital and larger companies step in to fund the big guns.

The U.S. government has been a major supporter of nanotechnology development, the largest in the world. In 2001, the Clinton administration established the National Nanotechnology Initiative to coordinate federal nanotechnology research and development. Federal funding for research projects in this area has grown from $464 million in 2001 to a proposed $1.5 billion for 2009 to be shared among 13 agencies.

The U.S. Department of Health and Human Services, which funds human health nanotech projects through the National Institutes of Health gets about $226 million of that pie, fourth in line after the Department of Defense, Department of Energy and the National Science Foundation. Of that amount $125.7 is directly targeted to the nanoscale device and system research projects.

Federal program for nanotechnology R&D was given greater recognition in 2003 witf the enactment of the 21st Century Nanotechnology Research and Development Act, intended to remove red tape and improve interagency coordination of federally supported research efforts. Thus, new researchers today can say that they have not received some level of funding from the U.S. government.

Federal efforts are yielding a slew of products, queuing up for regulatory review. The NCI and FDA also are working closely to bring scientists and reviewers together and develop a more sophisticated knowledge base. The NCI offers customized education to FDA reviewers and managers, to ensure that they keep pace with new nanomaterials as the science evolves. The NCI also is sharing nanoparticle characterization results from the NCL with the FDA.

Despite the funding, re-sources and encouragement, regulatory hurdles loom, in-cluding potentially greater scrutiny.

For example, one of the first nanotechnology drugs ap-proved three years ago, Abraxane for breast cancer, slipped under the radar, likely producing closer monitoring of what is, what isn't "nano." It also faces the problem of its uniqueness as a technology. The watchdog agency Project on Emerging Nanotechnologies (Washington) said that U.S. regulatory authorities, mainly the FDA, are ill-equipped — primarily because under-resourced — to identify or act on the safety issues concerning the oncoming wave of nano-products.

The National Cancer Institute plays a major role in coordinating the nanotech research efforts of the National Institutes of Health.

Among the programs it has established:

• Centers of Cancer Nanotechnology Excellence — comprised of seven hubs with funding to develop and apply nano-technology and nanoscience solutions to the diagnosis and treatment of cancer.

• Cancer Nanotechnology Platform Partnership — tightly focused programs designed to develop the technologies to underpin new products in six key programmatic areas: molecular imaging and early detection, in vivo imaging, reporters of efficacy (e.g., real-time assessment of treatment), multifunctional therapeutics, prevention and control, and research enablers (opening new pathways for research).

• The Nanotechnology Characterization Laboratory (Frederick, Maryland) — performing analytical tests to guide the research community; support regulatory decisions; and help identify and monitor environmental, health, and safety ramifications of nanotechnology applications. It also works closely with the FDA.

• Multidisciplinary research training, team development and career development initiatives — to establish integrated teams of cancer researchers.