Even though the field of medical technology has already discovered the nanoworld a long time ago, it is still not as fully researched as it should be. Physicians dream about curing diseases such as cancer with an injection containing nanoparticles. But this is still a long way off in the future since research is continuously facing obstacles. An action plan now addresses the existing problems and proposes solutions.
In this interview with COMPAMED-tradefair.com, Dr. Klaus-Michael Weltring talks about the regulatory and financial obstacles affecting nanotechnology development and why nanomedicine actually benefits the healthcare system.
Dr. Weltring, the German NanoBioMedicine Platform has recently presented an action plan involving nanotechnology in medicine. What is the objective of this plan?
Dr. Klaus-Michael Weltring: We are basing this on the preceding position paper on the subject. The focus of both papers is how research and development need to be promoted in the area of nanomedicine. However, our action plan also illustrates the clinical demand in the areas of diagnostics, therapy or regenerative medicine for example and how research can meet it. We also attempted to create an integrated picture by presenting what the translation from research to practice looks likein its respective context. We answer questions such as, "What are the prerequisites for studies and funding?" or "How can nanotechnology be successfully applied in medicine?"
What obstacles do you see in nanomedicine development?
Weltring: Generally, there is the approval process of course. Nanotechnology is still not as well researched as other technologies. For instance, we still donot really know much about the toxicology of nanomaterials. Existing tests and test systems are often not suitableto answer questions on nanotechnology and need to be adapted.
The interdependency between medical products and medical devices are even more specific. If you take a look at a nanoparticle for example that is an imaging marker on the one hand whileit can also specifically transport an active substance on the other, you have two very different applications. Medical technology on the one hand and pharmacology on the other. There is still no clarity on regulatory processes for these so-called "borderline products".
What specific steps do you suggest for research findings to be translated into practice faster?
Weltring: We suggest setting up a service to characterizethese types of materials for instance. This is the goal of the "European Nano-Characterization Laboratory" EU project, in which we are also involved. Researchers and small and medium-sized enterprises (SMEs) should be able to check here whether their materials are safe enough for the clinical phase.
Another request is to close funding gaps after the “proof of concept” stages are completed. Even though their safety in the lab or clinic was established at the end of these stages or a prototype is available, the funding from public sources that is usually set up for three to five yearsis completed. From the industry’s perspective, this is still too early to invest and researchers are not able to continue their work. We recommend continued funding from varied sources to create a gradual transition from public to joint public and industrial all the way to full industrial funding.
How do German nanomedical research and its framework fare in an international comparison?
Weltring: Other European countries essentially have the same problems in terms of regulation, funding and continuous lack of cooperation between the industry sector and research. The position of SMEs is going to become more problematic. Thanks to the new regulation for medical devices (Medical Device Regulation, MDR), requirements for the approval process will become increasingly challenging to the point where many SMEswill not be able to handle them.Compared to the U.S., these conditionsare presently starting to reverse: while the EU raised the bar for the approval processes in medical technology and in vitro diagnostics, the FDA is currently lowering its requirements.
Needless to say, these topics always play a role at the European and German level, especially when it comes to small and medium-sized enterprises in the medical technology sector. We have now articulated this from a nanomedicine perspective.
How is nanomedicine or nanotechnology actually able to help the healthcare system? Does all of this effort pay off?
Weltring: Of course it does. Ultimately, all diseases originate at the nanoscale because proteins and genes are activated and deactivated at this level. We are able to understand diseases better thanks to nanotechnology. It is one of the key technologies in medicine that is going to fuel many new trends: ranging from personalized medicine, genome analysis through next-generation sequencing, drug delivery, functional imaging, regenerative medicine all the way to functionalized implant coatings.
Having said all that, I need to put this into perspective:needless to say, nanotechnology is not the only answer.In many cases, it needs to work together with other key technologies for us to implement complex medical solutions. And sometimes it is just a small cog in a large wheel that makes up the big picture.