Q: Nanotechnology is often hyped as either a miracle cure-all or a potential danger. How much of this is grounded in truth
and what is the practical reality of the technology?
The rational design of advanced drug delivery systems and innovative nano-sized therapeutics (nanomedicines) began almost
half a century ago. There are already more than 40 products approved by regulatory agencies for routine use, and many more
technologies are also in clinical development. These first-generation products are making an important contribution and are
seen to be safe and efficacious with an adequate risk–benefit. Follow-on products are also starting to emerge, as well as
novel second-generation nanotechnologies that can be used as therapeutics, imaging agents and combined theranostics.
(VICTOR HABBICK VISIONS/GETTY IMAGES)
Innovative nanoscience in concert with the increased knowledge arising from genomics and proteomics research is creating exciting
opportunities for nanomedicine development using advances in materials science and, in some cases, innovative therapeutics
such as siRNA and aptamers. There is also real potential to develop novel multicomponent systems (e.g., those involving gold
or iron nanoparticles, and polymers and therapeutics as single agents or combination therapies). More in depth discussion
about the opportunities and challenges in these areas can be read in a Duncan and Gaspar paper (1).
Q: What new therapies can nanotechnology enable?
To answer this question, I advise readers to take a look at an interesting historical overview by B. Munos (2). He explains
that during the last 60 years, the FDA has approved approximately 1200 new chemical entities, as well as around 120 biologicals/proteins.
Roughly 40 nanomedicine products have also reached the market, which is interesting given the relatively minor investment
of pharma companies in this area compared with that for low-molecular weight chemical entities and biotech products.
In the coming years, I believe we will see an increasing number of nanomedicine products. Consider for instance that low-molecular
weight synthetic chemotherapy was only born at the beginning of the last century.
In my view, some of the particularly interesting opportunities/advances in nanomedicines include:
- A combination therapy with liposomes containing two drugs is already in Phase I/II development by Celator Pharmaceuticals
- Polymer therapeutics—several polymeric drugs, polymer-proteins/polymer aptamer and block copolymer micelles are now on the
market and there is a strong pipeline for further clinical development
- New manufacturing techniques and template manufacturing (PRINT approach) that are applicable to many areas of advanced drug
delivery. Interesting insight can be read in a Petros and DeSimone paper (3).
- New opportunities for intracellular/cytosolic delivery of macromolecular therapeutics.
- Continuing efforts to improve the delivery of poorly soluble or unstable drugs, improve disease specific targeting and create
new technologies for vaccine delivery.
Q: How fast (or slow) has the pharma industry been to embrace nanotechnology?
The 40 or so first-generation nanomedicines on the market began to arrive in 1990 and now there are many follow-up products
and novel nanotechnology approaches in pipelines. In particular, specific technologies, such as nanocrystals, have been rapidly
embraced over the last decade because they can help solve specific formulation challenges, such as poor water solubility.
When all these technologies emerged as first in class, they were, as with any new, high-risk technology, embraced very slowly
by pharma companies. However, once a technology has arrived in the market, there is always a sudden burst of interest, particularly
as some products gain blockbuster status. With nanotechnology now well established, coupled with the high-drug attrition rate
for low-molecular weight chemical entities, interest in this area has certainly increased.