Originally Published MPMN April 2009

EDITOR'S PAGE

Nanotechnology Needs You

Fanfare surrounding nanotechnology trumpets the field as a medical panacea. But, a few products aside, the technology has yet to make the transition from the lab to the clinic. With so much progress being made seemingly daily in the field, what’s the hold up? Not surprisingly, it’s regulatory red tape. With nanotechnology, however, FDA is on a mission to pinpoint regulatory obstacles and develop solutions.

As part of its public health mission and aligned with its 2004 Critical Path Initiative, FDA has formed a public-private partnership with the Alliance for NanoHealth (ANH; Houston), an eight-member multidisciplinary consortium dedicated to supporting the development of nanotechnology-based medical solutions. Through the Nanotechnology Initiative, the two organizations will collaborate with the intent of establishing clear-cut guidelines, processes, equipment, and protocols to facilitate regulatory approval of nanotechnology-enabled medical products.
“Currently, FDA does not have any specific guidances on nanotechnology-based medical products, so they do it on a case-by-case basis,” notes Jason Sakamoto, COO, ANH.
The partnership is looking to change that. It began last year when FDA and ANH teamed up to host a workshop aimed at assembling members of industry and various agencies to identify regulatory challenges hindering commercialization of nanoengineered medical products. Attendees concluded that biodistribution of nanoparticulates in the body and associated imaging modalities were among the greatest concerns. Additional needs identified included understanding mass transport across compartmental boundaries in vivo, creating mathematical and computer models to develop a periodic table for nanoparticles, establishing standards for benchmarking new materials, and actualizing an analytical toolkit for making nanopharmaceuticals.
Identifying the main regulatory obstacles is the first step in solving them. Overcoming them, though, will require a team effort on a much grander scale. Research conducted under the partnership will be available to the public, which is a start. However, researchers and members of industry will need to pool their thoughts, resources, and capabilities in order to commercialize nanotechnology-enabled medical breakthroughs.
“[The initiative] provides companies and other stakeholders a mechanism to develop scientific answers or solutions at the economy of scale that if they could combine their efforts, it could be a whole lot more efficient than if each poured a ton of their own money to develop these answers and standards that would just be specific to them,” Sakamoto adds.
Most important is expediting approval of these innovative and potentially lifesaving technologies. Hopefully, the FDA/ANH collaboration will help to facilitate this goal. At the very least, it’s a nanostep in the right direction.
Shana Leonard
Editor
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