Editor’s Note: The following is a summary of one of the talks from the 2013 Nano-bio Symposium hosted by Johns Hopkins Institute for NanoBioTechnology held May 17. This summary was written by Christian Pick, a doctoral candidate in the chemical and biomolecular engineering laboratory of Joelle Frechette. Look for other symposium summaries on the INBT blog.
One of the greatest promises of merging nanotechnology with medicine is in the creation of highly selective vehicles for drug delivery based on nanoparticles. However, translating nanoparticles into commercialized medical products comes with many challenges. Anthony Tuesca, a scientist in the Innovative Drug Delivery Group at MedImmune, outlined a number of these challenges and ways to address them.
Research in nanotechnology begins at the lab bench, often without much thought given to future commercialization. But commercialization is a huge undertaking. In between the lab-bench and final product there is a whole litany of challenges that must be tackled. One such challenge lies in scaling up processes for production. As Tuesca stated, for scale-up to be viable, laboratory processes must be compatible with current manufacturing capabilities.
Another challenge is navigating an often confusing regulatory landscape. Although nanoparticle based therapies don’t necessarily invoke harsher requirements than conventional medical treatments (in that both require clinical trials that demonstrate safety and efficacy) more complex technology requires more proof of effectiveness. Interestingly, Tuesca mentions that the U.S. Food and Drug Administration currently lacks an official definition of nanotechnology.
Ultimately, Tuesca’s presentation urges researchers to take a proactive role in translating laboratory discoveries into viable medical technology. Such a role requires researchers to consider future commercialization early in their research and act accordingly.