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Nano has become a fashionable four-letter word in everyday conversation — from nanosecond to the new “iPod Nano” (even though nanoparticles and nanomaterials have nothing to do with the products or expressions). The term has come to signify quick, fast or tiny — and at the cutting edge. Just as equally, nano has pushed ideas once considered science fiction into the realm of reality. Today, nanotechnology represents science at the cutting edge, in particular, as it converges with biology, medicine and information technology. Driven by advances in genomics, cell biology, chemistry and computational science, one area of research expected to generate revolutionary contributions is cancer nanotechnology. The application of convergent technologies to cancer is creating more effective methods of detection, treatment and prevention. “What if doctors could search out and destroy the very first cancer cells of a developing tumor? What if a broken part of a cell could be removed and replaced with a functioning miniature biological machine? What if a pump the size of a molecule could be implanted in the sick to deliver life-saving medicine precisely when and where needed?” It may sound futuristic, but these are questions the National Institutes of Health seek to answer. Two years ago, the NIH launched a three-pronged “Roadmap for Medical Research” initiative to accelerate the pace of life science discovery from research to practice. This included the challenge of better understanding the emerging complexity of biology, molecular libraries and imaging, nanomedicine, bioinformatics, and computational biology, and translating that knowledge into effective prevention strategies and new treatments yielding medical benefits within 10 years. The establishment of Nanomedicine Development Centers serving as the centerpiece of the NIH Nanomedicine Roadmap Initiative would allow for the creation of a multidisciplinary scientific staff capable of conducting research about how biological molecular machines are constructed. By gathering this knowledge, scientists could better understand how to develop new nanoscale tools to build synthetic biological devices, such as tiny sensors to detect and scan for the presence of infectious agents or metabolic imbalances, as well as miniature devices positioned to destroy infectious agents or fix damaged cell parts. It is at the nanometer scale, or one-billionth of a meter, that biological molecules and structures operate inside living cells — a scale not even visible through a conventional laboratory microscope. Unresolved questions such as those raised by the NIH may come true. If so, the ultimate goal of nanomedicine would be achieved by using nanoscale tools to improve human health, based on highly specific medical intervention from discoveries in physics and chemistry. To this end, the NIH initiative has committed approximately $80 million to advance the Nanomedicine Initiative. According to the National Nanotechnology Initiative Strategic Plan (December 2004), one American dies from cancer every minute, while one out of every two men and one out of every three women will be diagnosed with cancer during his or her lifetime. The Centers for Disease Control and Prevention report that cancer will kill approximately 570,000 people in the United States this year. Early in 2003, the director of the National Cancer Institute, Andrew C. von Eschenbach, announced his goal to eliminate the suffering and death due to cancer by 2015. The NCI, a component of the NIH, hopes to develop a new Clinical Proteomics and Biomarker Discovery Program. Proteomics, considered one of the most promising areas for drug and device discovery and development, are enabling scientists to identify patterns of protein markers associated with the onset of cancer and its progression. Biomarkers hold the promise for personalized medicine and creating designer therapies. The NCI also supports research on novel nano-devices that can detect and pinpoint early-stage cancer, deliver anti-cancer drugs to precise malignant cells, and immediately assess the real-time effectiveness of those drugs. It has committed $144.3 million in funding over five years for cancer-directed nanotechnology. With increased resources for cancer imaging expected in 2006, the NCI hopes to: (1) use nanotechnology to design “smart” injectable, targeted contrast agents that improve the resolution of cancer to the single-cell level; and (2) engineer nanoscale devices capable of addressing the biological and evolutionary diversity of the multiple cancer cells that make up a tumor within an individual. In vivo cancer imaging using nanoscale quantum dots, or tiny crystals that glow when stimulated by ultraviolet light, is now being investigated by another NCI-supported team. Currently, some of the materials and techniques being applied to cancer nanotechnology problems include: (1) early imaging agents and diagnostics to simultaneously detect cancer at its pre-symptomatic stage and deliver anti-cancer agents to the tumor; (2) surveillance systems to detect mutations triggering the cancer process; (3) genetic markers that indicate a predisposition for cancer; and (4) tools that predict drug resistance as well as signal when a therapy is effective in real-time. NANOTECHNOLOGY IN CANCER The NCI Alliance for Nanotechnology in Cancer is an all-encompassing national initiative created with the purpose of accelerating the application of the best capabilities of nanotechnology to cancer, while supporting and coordinating the cancer nanotechnology programs. To guide its development, the NCI Alliance drafted a plan to detail the impact of nanotechnology on clinical oncology. Within this plan, the NCI will establish four programs: (1) hubs to develop and apply nano-solutions to the diagnosis and treatment of cancer; (2) multidisciplinary research teams; (3) nanotechnology platforms for cancer research, including molecular imaging and in vivo nanotechnology imaging systems; and (4) the Nanotechnology Characterization Laboratory in collaboration with the National Institute of Standards and Technology to develop data that will facilitate standards for nanoscale devices and streamline regulatory review of products by the Food and Drug Administration prior to commercialization. The medical field and pharmaceutical industry will be the most potentially valuable recipients of research currently being conducted at the nanoscale. However, because of the multidisciplinary nature of nanotechnology, the swift advance of cancer research faces several challenges. Converting research in nanomedicine to commercially viable products requires FDA approval. This can be an arduous process even though the FDA claims that it has regulated many products with particulate materials at the nanoscale and expects many nanotechnology products to be classified as “combination products.” However, the NCI now submits investigational new drug applications electronically to the FDA. This multi-purpose process assures a speedier review of applications while promoting timely cost-efficient patient access. In addition, it ensures the safety and efficacy of nanoproducts, while concurrently fostering innovation. Last year, the NCI and FDA formed a task force resulting in the creation of the Office on Oncology Drug Products to better focus on the regulatory drug and therapeutic biologics review process. Still, a question of concern is whether conversion of an existing drug into a nanoparticulate form creates a new chemical entity subject to a new regulatory approval process. The FDA regulates nanomedical products within the framework provided by current statutes. It classifies medical products as drugs, biologics or devices. The Center for Drug Evaluation and Research is responsible for regulating drugs. Medical devices are regulated by the Center for Devices and Radiological Health, while biologics fall under the Center for Biologics Evaluation and Research. However, classification and jurisdictional designation, together with the application of appropriate regulations to all components of a product once the center has been designated are issues of concern. Nanoscale components blur distinctions between mechanical, chemical and biological modes of action thereby increasing the difficulty of the FDA in determining if a product is a drug, device, biologic or combination product. Because of the nature of nanotechnology, this may ultimately result in the possibility of creating an entirely new class of products requiring the creation of a new classification. The FDA will require scientific experts who can think across those disciplines. INTELLECTUAL PROPERTY The U.S. Patent and Trademark Office lacks a formal classification scheme for nanomedicine patents, as well as effective automation tools specific to conducting a nanomedicine “prior art” search. While the office is providing multidisciplinary training to their examiners, reviewer expertise in nanotechnology is still lacking. Critical to proteomics investigations is the dependence of high quality blood and tissue samples, or biospecimens. NCI has supported bio-banks available for use by researchers. At issue, however, is the lack of standardization in the collection and storage of human biospecimens, compliance with genetic privacy protection, as well as access and data availability. Creating alliances among the medical community, materials scientists, chemists, physicists, bioengineers and computer scientists challenges communication styles and priorities. Lack of cooperation and understanding between and among the scientific disciplines is one of the difficult challenges facing nanotechnology researchers today. Generalizations about nanomaterials and their toxicity, as well as a lack of clarification of differences among various nanoparticles create confusion and often derail best efforts to move therapeutics into a clinical setting. Cancer and nanotechnology each raise complex issues with many unknowns. Taking measures to lessen potential product liability in tort issues after a product, drug, device or biologic containing nano-particles has transferred from laboratory to market is often not considered or understood by scientists while working at the research and development stage. Because of the nature of nanotechnology and the uncertainty of many of its effects, researchers in the laboratory need to incorporate risk analysis alongside their research. Engaging attorneys early on to join the multidisciplinary alliances forged to advance novel technologies might prove beneficial to pre-empt the potential for adverse legal ramifications later. Sonia E. Miller, an attorney in private practice in New York and Washington, D.C., is founder and president of the Converging Technologies Bar Association.

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