Thursday, January 13, 2005

Living on nano time

Dr. James Baker, biologic nanotechnology professor at the University of Michigan, wrote yesterday:

    Nanotechnology is a very young science and most of the breakthrough advances are in early stage development. Because it takes up to eight to ten years to get approval for new therapeutics, there will be a significant delay with many of the more remarkable applications for nanotechnology. Thus, the five-year window is less likely to bring unique change, whereas the ten to twenty year window is probably when the more remarkable applications will be seen.

My only question -- and it's probably a naive one, but it takes a simple man to ask a simple question -- is "why?" Yes, I understand how necessary it is for any new drug or therapy to go through a rigorous approval process, but if these are truly better, more-precise technologies than the old sloppy method of chugging a gallon of medicine at a problem the size of thimble, then aren't they deserving of "fast-track" status?

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

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