This, of course, is happening already. First, nanoscale drug delivery devices promise to take years (not to mention dollars) off of drug development simply because drug companies no longer need to use the “throw spaghetti on the wall and see what sticks” technique. And, in some cases, “fast-track” status is granted to some of these techniques.
As Carl Wherrett and John Yelovich wrote in The Motley Fool last year:
- American Pharmaceutical Partners (Nasdaq: APPX) has received fast-track
status for its novel nanoparticle-based drug, Abraxane, on the back of
favorable phase 3 results for use in treating metastatic breast cancer
when compared to the current treatment of Taxol, produced by
Bristol-Myers Squibb (NYSE: BMY). Taxol sales in 2003 were $9 billion
for a variety of treatments. (Blogger’s note: FDA approval came last week)
Skyepharma (Nasdaq: SKYE) estimates that 40% of drug candidates are
abandoned at an early stage due to the body’s inability to absorb the
drug. The company’s nanoparticulate drug-delivery technology promises
to remove a lot of these barriers, open up new opportunities, and widen
the market for some current drugs on the market. More here
Outside the FDA approval process, Scott Rickert, president of Nanofilm, has the right idea. He’s proposed a nanotech multiple award schedule that would give nanotech companies special preference in federal contracts and subcontracts for three years. Rickert has talked to the U.S. treasury secretary about this issue.
But that doesn’t break the FDA bottleneck. The biggest hope in cutting down that wasted time lies with the U.S. National Cancer Institute’s Alliance for Nanotechnology in Cancer, which promises to help cut through the red tape that clutters the path toward approval of potentially life-saving drugs.
But this program might find itself on a collision path with those who argue for a slowdown of the entire nanoworks. Clouding the issue are questions raised over nanoparticle toxicity — questions that U.S. nanotech guru Clayton Teague says will take about five years to even begin to answer. As Canadian NanoBusiness Alliance chief Neil Gordon writes: “At stake is delaying nanotechnology scientists from finding possible cures and solutions for cancer, clean water, and cost-effective alternative energy, among many others.”
Another piece of the solution is to bridge the gap between the basic materials companies and labs working on vital nanotech processes and the doctors who could really use them. I expand on that a bit over here, and am working on some more solutions along those lines.
Maybe it’s just me, but isn’t this more worthy of our efforts than these “nanotechnology” products?
NanoBot Backgrounder
NanoChat transcript
Nanoparticles clobber cancer with sneak attack
Serious side effects may result from ignoring nano
‘All we have is speculation on toxicity’
Educating the Regulators
…. in fish (buckballs are a specific type of nanoparticle). I support thorough testing of nanoparticles. Considering the recent problems with Vioxx and Celebrex, even the testing of non-nano drugs is currently inadequate.