[Senate Hearing 108-247]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 108-247

                    ROUNDTABLE ON HEALTH TECHNOLOGY

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                                   ON

EXAMINING HEALTH TECHNOLOGY, FOCUSING ON NANOTECHNOLOGY, INCLUDING THE 
 DANGERS AND SOCIETAL IMPLICATIONS, MARKET BARRIERS AND CHALLENGES OF 
     INTERDISCIPLINARY RESEARCH, AND THE FEDERAL ROLE OF FUNDING, 
                   COORDINATION, AND PRIORITY SETTING

                               __________

                           SEPTEMBER 23, 2003

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions




89-610              U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2003
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512ï¿½091800  
Fax: (202) 512ï¿½092250 Mail: Stop SSOP, Washington, DC 20402ï¿½090001


          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  JUDD GREGG, New Hampshire, Chairman

BILL FRIST, Tennessee                EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming             CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri        BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio                    JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas                  JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama               PATTY MURRAY, Washington
JOHN ENSIGN, Nevada                  JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina    JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia             HILLARY RODHAM CLINTON, New York

                  Sharon R. Soderstrom, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                  (ii)

  




                            C O N T E N T S

                               __________

                               STATEMENTS

                      TUESDAY, SEPTEMBER 23, 2003

                                                                   Page
Gregg, Hon. Judd, a U.S. Senator from the State of New Hampshire.     1
Schloss, Jeffrey A., M.D., National Human Genome Research 
  Institute, Washington, DC; Patricia M. Dehmer, Ph.D., Director, 
  Office of Basic Energy Sciences, Department of Energy, 
  Washington, DC; Samuel I. Stupp, Ph.D., Director, Institute For 
  Bioengineering and Nanoscience in Medicine, Northwestern 
  University, Chicago, IL; and Todd Lizotte, Vice President, 
  Research and Development, Nanovia, LP, Londonderry, NH.........     2

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Mr. Todd Lizotte (graphics)..................................    25
    Ms. Patricia M. Dehmer (graphics)............................    41

                                 (iii)

  

 
                    ROUNDTABLE ON HEALTH TECHNOLOGY

                              ----------                              


                      TUESDAY, SEPTEMBER 23, 2003

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10 a.m., in room 
SD-430, Dirksen Senate Office Building, Senator Gregg, 
(chairman of the committee), presiding.
    Present: Senators Gregg and Murray.

                   Opening Statement of Senator Gregg

    The Chairman. Let me begin the hearing. It is ten o'clock. 
I expect we will have members wandering in and wandering out. 
There is a lot going on, plus I guess the traffic is a disaster 
this morning, which is too bad, but typical, I guess.
    Let me first say on this subject, technology, that this 
committee is extremely interested in this issue because of its 
implications specifically to health care, obviously, which are 
dramatic. The fact that if we look to the future, this appears 
to be the science and the area where we are going to see an 
acceleration of more than geometric proportions, nano 
proportions, that will dramatically affect everything we do, I 
suspect, but especially affect our health care as we deliver it 
in this country and the world.
    As I look at the American experience as we move into this 
century and we see that so much of our manufacturing in a free 
market economy is moving overseas, our capacity as a nation to 
compete is going to be tied to our capacity to lead 
technologies which lead the world, and nanotechnology is 
clearly one of those areas where we, as a Nation, need to lead 
and are leading and the government has an obligation to be a 
sister in this effort.
    And so I wanted to hold this hearing today, first to get a 
thumbnail sketch as to what is happening in the area, but 
second, to hear ideas as to what we should be doing, if 
anything, beyond what the government is already doing, and 
interestingly enough, we appear to be involved in this fairly 
aggressively already, which is hopefully good news. And third, 
issues that we see coming down the road which we need to 
address as a matter of public policy--ethics issues, things 
which we need to address early so that they don't become bumps 
or impediments to the expansion of the technology and the use 
of the technology in a variety of different ways.
    The Chairman. I very much appreciate the fact that the 
witnesses are here today and we have such an expert group. Dr. 
Schloss is the National Human Genome Project researcher in this 
area and, of course, NIH is making a major effort in this area. 
The NSTC, which is the National Science and Technology Council, 
which coordinates the activities in this area, is the 
representative from NIH on that.
    Dr. Dehmer is with the Basic Energy Sciences Office at Oak 
Ridge, and this is an area where we have a huge interest in 
nanotechnology research and appreciate her taking the time to 
be here.
    Dr. Stupp is the Director of the Institute for 
Bioengineering and Nanoscience in Medicine at Northwestern, 
which is on the cutting edge of the use of this area of 
technology in an interdisciplinary way.
    And Todd Lizotte is from New Hampshire and has actually 
commercialized some activities in this area that are exciting, 
especially in the use of very small penetrating micro lasers 
that allow for the introduction of extremely small holes and 
various applications.
    I appreciate your all taking the time to come here. Why 
don't we just begin. I want to do this sort of in a discussion 
format, and so I would suggest that each of you sort of give us 
what your thoughts are in five or 10 minutes and then we will 
move on to discussion, hopefully between you folks and me and 
whoever else comes by, as to where we are going.
    Dr. Schloss?

 STATEMENTS OF JEFFREY A. SCHLOSS, M.D., NATIONAL HUMAN GENOME 
RESEARCH INSTITUTE, WASHINGTON, DC.; PATRICIA M. DEHMER, PH.D., 
   DIRECTOR, OFFICE OF BASIC ENERGY SCIENCES, DEPARTMENT OF 
  ENERGY, WASHINGTON, DC.; SAMUEL I. STUPP, PH.D., DIRECTOR, 
   INSTITUTE FOR BIOENGINEERING AND NANOSCIENCE IN MEDICINE, 
 NORTHWESTERN UNIVERSITY, CHICAGO, ILLINOIS; AND TODD LIZOTTE, 
    VICE PRESIDENT, RESEARCH AND DEVELOPMENT, NANOVIA, LP, 
                   LONDONDERRY, NEW HAMPSHIRE

    Dr. Schloss. Thank you, Senator Gregg, for the opportunity 
to come this morning. I have probably got way too many slides, 
and I understand that. I have a lot of examples at the end. We 
will go through a number of them, and then when we have seen 
enough examples, we will stop.
    We have probably all heard the definition--I have put it in 
here just to make sure that people understood what we are 
talking about. Research and development at the atomic molecular 
or macromolecular levels, so we are being fairly inclusive 
there. The scale is important. It is one-to-100 nanometers, and 
we really focused on this idea of a fundamental understanding 
of phenomena and materials and this idea of creating and using 
structures, devices, and systems with novel properties because 
of the size scale. So all of those things have to come together 
to comprise this new field of nanoscience and nanotechnology.
    So from the biology or health perspective, I am thinking 
of--a number of us are thinking of this in at least two ways 
that are not totally mutually exclusive--they overlap a lot--
one of which is the idea that nanotechnology is operating at 
the same size scale as biological processes. So this offers us 
really a unique vantage point from which to interact with the 
biology of life. One of the key issues there is we can really 
work and study biology at the single molecule level.
    The other aspect of this is that nanotechnology has grown 
up in other fields generally, in the physical sciences, and 
these fields have generated a number of incredibly important 
materials, devices, and tools that we can apply with the 
appropriate research to biological systems. And so we can 
fundamentally understand biological systems and use that 
information to translate out into utility for biology and 
medicine and for other areas of technology, and then we can 
also bring into biology the discoveries from other fields.
    So we coordinate nanotechnology research at NIH through the 
Bioengineering Consortium, or BEACON, and we need to do 
something like that, because with 27 institutes and centers, we 
need a central way to deal with this, and this just represents 
the various components of the NIH that are involved in this 
process.
    You will notice actually that we have three other agencies 
that are represented in the lower right-hand corner who 
participate in BEACON activities, and this is one of the ways 
that we can coordinate across agencies.
    One of the important activities of BEACON has been to hold 
a series of symposia where we reach out to various communities 
that have, in many cases, not been the typical NIH communities 
and use this as an opportunity for people to meet each other, 
to understand the vision of other scientific fields as related 
to biology and medicine and also to understand how we can do 
business at NIH differently in order to promote research in 
those areas. And as you see, one of these was in nanoscience 
and nanotechnology back in June of 2000.
    So the support for nanotechnology at NIH occurs through a 
number of different kinds of programs. A few of them actually 
say nanotechnology in the program announcement, but most of 
them actually don't. Because the mission of the NIH is, of 
course, diagnosis and treatment of diseases, they tend to be 
framed in that context, but there are many opportunities to 
apply nanotechnology ideas in those contexts.
    So this is just a list of program announcements that have 
been generated through BEACON, through this trans-NIH efforts, 
and the first two are specifically for nanoscience and 
nanotechnology. The first is for sort of standard research 
grants that NIH would provide to research institutions, 
colleges, universities, and the second is through the SBIR 
program to help these kinds of ideas and tools get out through 
commercialization. The others are more general programs that 
BEACON has developed, again, through the auspices of all the 
institutes of the NIH, under which people can apply for 
nanotechnology and nanoscience research support.
    And then this is just the list of a few of the many program 
announcements from institutes, usually from consortia of 
institutes, under which nanotechnology can be supported, and I 
have broken them down just for the examples here into sort of 
the different areas of basic research or sensors or tissue 
engineering, disease and syndrome research, and diagnostics and 
therapeutics to give some idea of the breadth of areas where we 
believe nanotechnology is going to be important in the context 
of NIH.
    So our investment in nanotechnology has well more than 
doubled in the time that the NIH budget has doubled. These are 
fairly conservative projections, I think, for the out years. Of 
course, 2003 isn't finished yet, so we will only tally that at 
the end of 2003. And we have actually new programs. The first 
program announcement I showed you is actually a new one where 
we received many applications, and I think our portfolio is 
likely to grow faster than this.
    Through the National Nanotechnology Initiative, several 
grand challenges have been enunciated and the one for health 
care is clearly the one that is most relevant to NIH. And the 
areas where we think that our activities--where nanotechnology 
is going to be important are listed here, detecting disease 
very, very early, before there is any substantial deterioration 
of health, in the tissue regeneration area, and in therapeutics 
delivery.
    So the rest of the slides are really examples. Obviously, 
there is a lot of information covered in each slide, and I 
won't go through it. I will try to point out some key issues.
    So most of these slides represent projects that NIH is 
currently supporting. In a couple of cases, there was no good 
website or place where I could get nice illustrations, so I 
have illustrated it with other research that is not being 
supported by NIH, but in each case, it represents research that 
we are supporting in other grants.
    And the other thing I have done here is not only indicate 
the grantee, but also the Institute of the NIH that is 
supporting it so that you will have some sense of the way that 
this crosses the NIH.
    So this represents a material called quantum dots that 
allow us to do things that we have been able to do in the past 
with organic dyes, but probably a lot better than we were able 
to do it in terms of the different colors which we can use to 
indicate different cellular entities and also the kinds of 
signals we can detect in our imaging.
    And so in this case, it is showing that we can use these 
quantum dots to label various proteins inside of cells and 
learn about them. These can also be used for imaging in whole 
animals, and this is just a study sort of to show you where we 
are. The key thing here is this--in this case, the quantum dots 
are coated with a material that didn't work very well, and I am 
just going to run this movie that runs over 60 minutes. All you 
are supposed to see here is that the signal except in the liver 
disappears very fast. When you coat it with a different 
material, the quantum dots stay in the blood circulation for 
190 minutes.
    So this is where we are. We are trying to learn how to use 
these materials to do in vivo imaging, in this case of a 
mouse--a mouse or a rat, sorry, I can't remember which--in 
order to be able to, in this case, visualize circulation, but 
this will be used potentially for labeling many other things in 
in vivo imaging.
    This is another study also using in vivo imaging using 
quantum dots, again, a collaboration by the company that has 
commercialized these and Cornell University, in which they are 
doing much finer resolution of the circulation, of the 
circulatory system.
    And I wanted to point out this additional item that was 
noted in this publication. No adverse effects on the mice were 
observed and the mice are being maintained to investigate long-
term Q-dot toxicity. This is a very important point, clearly. 
We have to understand how these nano scale materials interact 
with the body. We are now developing the tools, as you can see 
here, to be able to actually do that.
    So there are a number of other sensor examples here in the 
slides. This is an example, instead of coating the outside of 
the nano material with materials that will allow for specific 
biological visualization here, it is the construction of the 
nano material itself that is going to produce fluorescent 
signals that can be visualized in the light microscope and that 
will indicate various interesting and important things about 
the cells' physiology.
    Here is a use of carbon nanotubes that have very unique 
electrical properties. These tubes are one nanometer in 
diameter. They can be centimeters long. The idea here is to put 
something at the tip of the nanotube that will allow us to 
detect some specific biological molecule and then perhaps use 
these in catheters to detect things inside the body.
    Another thing that this slide points out is partnerships 
between agencies. So in this case, it is a collaboration 
between the National Cancer Institute and NASA.
    The next few slides, I won't talk about in detail. They are 
other kinds of sensors technologies that are being supported, 
in this case, under SBIR grants, the work coming from Harvard. 
Here is another one, work actually supported at Massachusetts 
General Hospital, and this is a technology that might be used 
not only to do diagnostics in test tubes, but also potentially 
in vivo imaging once again.
    Quantum dots have many other uses in, for example, in high 
throughput screening. There are many other ways to do high 
throughput screening. There are some very, very novel ways to 
use nanotechnologies. In this case, it is for measuring DNA, 
information from DNA using a pore that is exactly the same size 
in diameter as a DNA molecule. This would be a very new 
approach to DNA sequencing. It uses new physics, new 
fabrication technologies, and there are partnerships all over 
the country that are working on this.
    There are a number of aspects of tissue engineering, most 
of which I won't cover because Dr. Stupp is going to cover 
that, but there are two different approaches here. One is 
modifying existing approaches to tissue engineering and the 
other is create completely new ones.
    There are examples in drug delivery, either for creating 
new ways to deliver existing drugs to make them more effective, 
or creating completely new drugs that didn't exist before, that 
work by different principles using nanotechnologies.
    This is the last slide I will show. This is a 
multifunctional device based on some very elegant chemistry--
beautiful molecules, actually--and the idea here is you will 
create a complex by this very tightly, carefully controlled 
chemistry where you could bring the complex to a very specific 
place in the cell, use this for biopsies or in vivo imaging in 
the whole person to find out where this material is localized 
to target a specific thing that has gone wrong, such as cancer 
cells, and use the same device to deliver therapeutics.
    So I will stop there because I have run just a little bit 
long. I have additional slides that we can use later on to 
illustrate various points if that seems appropriation.
    And so now I will close down my presentation and we will 
move to the next one.
    The Chairman. Thank you, Doctor.
    Dr. Dehmer?
    Ms. Dehmer. Senator Gregg, Senator Murray, it is really a 
pleasure to be able to represent the Department of Energy here 
this morning. I am Pat Dehmer. I head the Office of Basic 
Energy Sciences in the Office of Science in the Department of 
Energy.
    I have given a lot of talks on nanoscience to folks who 
don't have a lot of physical science training and I find that 
starting with a poster that I made several years ago is the 
best way to tell people what some of the challenges are.
    This is the scale of things poster, and I am actually going 
to use--each one of these tics represents an increase of a 
factor of ten, so this might be ten, 100, 1,000, and so forth. 
This is a scale of increasing size.
    The nano world, as Jeff said, is about one-to-100 
nanometers. The micro world, which we are much more familiar 
with, is about one-to-100 micrometers. These two scales differ 
by a factor of 1,000.
    Quite remarkably, until very recently, we were not able to 
see anything in the nano world. We could only see things in the 
micro world. And I think it is not an understatement to say 
that our ability to see atoms has driven both the nanotech and 
the biotech revolutions, and this came about relatively 
recently, in the last 30 or 40 years or so.
    So let us just look at some of the things that nature makes 
in these various size ranges and some of the things that man 
makes in these various size ranges.
    In the micro world, the world that we are familiar with, we 
have red and white blood cells, we have phylage, we have human 
hair, and if you want to get bigger, we have pesky things like 
dust mites and ants and mosquitoes sucking the red out of the 
things natural slogan. So this, we are very familiar with. We 
have been able to see these using visible light microscopes.
    At the nano scale, things are more complicated. Here, we 
see atoms of silicon, solid silicon, spaced by a few tenths of 
a nanometer. Here, we see deoxyribonucleic acid, DNA, this 
wonderful polymer that transmits all the information of life. 
It is actually about 2.5 nanometers wide. If you go to a 
slightly larger biological molecule, a rotor, it is about ten 
nanometers wide. It is at the nanometer scale that Mother 
Nature starts assembling things, and it is at that scale that 
things start having their properties. Metals start having 
metallic properties, biological molecules start having the 
properties of living things. It is an extremely important 
world.
    It took Mother Nature about three billion years to perfect 
these molecules. By contrast, man has been working at control 
over materials for a couple of thousand years if you ignore 
rock hand axes, which are about a million years old.
    So what has man done? On the right hand side of the chart, 
in the micrometer scale region, you see these beautiful MEMS 
devices, micro-electro mechanical devices. A little tooth of 
one of these gears is about the same size as a red blood cell. 
We have been able to drive downward in our industrial 
fabrication to the micron level, and one of our speakers here 
this morning, Mr. Lizotte, is going to tell us about some of 
the things that they have done in this size region.
    However, if you go much lower than this, you can no longer 
do things with fabrication. You have to use a different way, a 
different approach. If you go way down to the level where 
Mother Nature starts putting things together, the atomic level, 
in a tour de force, we have been able--researchers have been 
able to move atoms literally one at a time into quantum 
structures, circles--this is a circle of atoms--or they have 
been able to make slogans. Everyone has seen the IBM slogan 
written with atoms. This is a tour de force and it is not 
likely to go into mass production if you physically have to 
move an atom one at a time.
    The way that we are going to have to solve the problem of 
making nano structures is to do what Mother Nature did, to 
learn how to self-assemble nano structures to get what we want, 
and here is a self-assembled structure that another one of our 
speakers, Dr. Stupp, has made, and he will tell you more about 
that.
    It is only through self-assembly that we are going to be 
able to make nano structures to do what we want to do, and the 
big challenge in the decades to come is to take different kinds 
of nano structures that nature hasn't thought about, put them 
together in various ways so that we can make things that nature 
hasn't done, and in particular, make things that are more 
robust than natural systems. Natural systems are remarkable, 
but they don't withstand high temperatures, high pressures, and 
other kinds of corrosive atmospheres.
    So this, then, is the scale of things and it presents some 
of the challenges. One of the things that Jeff talked about is 
coupling things that man makes with things that nature has 
made, to make nano structures that live inside the body that 
can detect disease, that can act as sensors, and so forth.
    So this, in a nutshell, is the scale of things and where we 
are in man's attempt to control materials at this scale.
    So what is the role of the Department of Energy in all of 
this? The Department has several roles, and I alluded to one a 
moment ago when I said that it has only been recently that we 
have actually been able to see things at this size scale. If 
you look at the little tiny spectrum right in the middle of the 
chart, that is the visible light region, and things that are 
larger than that, you can see with a visible light microscope. 
For example, you can see red blood cells with a visible light 
microscope. Things that are smaller than that, you can't see. 
The laws of physics simply forbid you from looking smaller.
    So in order to see things at the nano scale, we have to 
come up with probes that are themselves the size of atoms, and 
there are three kinds of probes that have emerged, X-rays, 
neutrons, and electrons. The Department of Energy recognized 
quite a few years ago that these would be extremely important 
probes of matter.
    By the way, the discovery of each one of those--electrons, 
neutrons, and X-rays--was made about the turn of the last 
century and they were so important that each one of them 
garnered for its discoverer the Nobel Prize.
    These probes are so important that they have become the 
basis for major user facilities that are shown here. These are 
the user facilities for X-ray scattering and neutron scattering 
that are operated by the Office of Basic Energy Sciences and 
the Department of Energy. We operate four huge light sources 
around the country. We have three operating neutron facilities, 
one at Argonne, one at Oak Ridge, and one at Los Alamos. This 
is the spallation neutron source, a $1.4 billion construction 
project that is underway at Oak Ridge National Laboratory, and 
on the drawing board we have a fourth generation X-ray source.
    Together, these plus the electron beam scattering centers 
that we also run, have really revolutionized our ability to see 
things. And again, it is not an understatement to say that the 
ability to see how Mother Nature puts things together has 
driven both the nanotech and the biotech revolutions, and this 
is one of the main contributions of the Department of Energy's 
Office of Science.
    When the National Nanotechnology Initiative came along, we 
recognized the importance of these major facilities at the nano 
scale and part of the Office of Science's contribution to the 
NNI was to make user facilities for nanoscience that are sited 
alongside of these major facilities for seeing atoms, and these 
are shown here. Under construction right now, we have five user 
facilities for research at the nano scale at Brookhaven 
National Laboratory next to the National Synchrotron Light 
Source at Argonne National Laboratory. This is being funded 
joint by the State of Illinois and DOE, and it is appended to 
the advanced photon source, a major synchrotron.
    We have one at Lawrence Berkeley National Laboratory, 
again, which is adjacent to the advanced light source. We have 
a center going up at Oak Ridge National Laboratory, which is 
attended to the spallation neutron source, and we have a center 
at Los Alamos and Sandia National Lab which is appended to the 
Lujan Neutron Scattering Center, plus also their facility for 
MEMS, which is extremely important.
    So this is part of the contribution of the Department of 
Energy. Another part of the contribution is the support of 
fundamental research, and about 60 percent of the fundamental 
research in nanoscience that has been competed recently has 
gone to the university community.
    This is an example in biomolecular materials, which I am 
not going to go over in the consideration of time.
    This is one that is very interesting and it demonstrates a 
principle that sometimes you don't know what you are going to 
get out of fundamental research. This was a project at Argonne 
National Laboratory--where I spent my formative years, but not 
on this project--on ultrananocrystalline diamond, UNCD. And if 
you don't think of the University of North Carolina when you 
say that acronym, you are better than I am. This is 
ultrananocrystalline diamond, and what it shows is that the 
diamond film forms in grains that are at the nanometer size. 
This is about three to five nanometers across.
    This diamond film has some extraordinary properties. It is 
as hard as natural diamond. It has low coefficient of friction. 
And these two properties mainly can be used as coatings that 
are hard and wear-resistant. It has very high electro-
conductivity that can be varied by many orders of magnitude, 
and that means it is great for MEMS devices because it can be 
little electrical conductors. It has high field emission from 
micropoints--here are some micropoints--and that means it can 
be used as a signaling device because electrons can come off of 
it. It is chemically inert and it is bioinert and it is 
biocompatible, and those things are very important.
    And here is one of the artificial retina projects that is 
ongoing now in the United States, and this film is at the back 
of the retina to help bring the image from the outside into the 
nerve cells in the eye.
    So the folks who thought about making this diamond film 
never had a clue that it might be used some day in an 
artificial retina, and this is some of the magic of 
nanoscience.
    So with that, I am going to thank you for your attention 
and I am going to turn it over to Sam.
    The Chairman. Thank you, Doctor.
    [The prepared information of Ms. Dehmer may be found in 
additional material.]
    The Chairman. Dr. Stupp?
    Mr. Stupp. Good morning. Thank you, Senator Gregg, Senator 
Murray, for the opportunity to brief you this morning on my 
views on nanotechnology and the future of medicine, which is 
what I was asked to do.
    There is no need to define nanoscience, nanotechnology 
anymore. Dr. Schloss and Dr. Dehmer have done a great job of 
that. But I simply want to remind everybody that cells function 
through interactions among nanostructures. In fact, these are 
highly orchestrated----
    The Chairman. Excuse me. I have got to take a call. I will 
be right back.
    Mr. Stupp. Cells function and make life possible by highly 
orchestrated interactions among nanostructures. Most of those 
nanostructures are actually proteins. So with the capabilities 
that we have now to create nanostructures with basically any 
chemistry that is available in the planet, almost, then we are 
in a position to make artificial ones that can talk directly to 
the cells and then control cell behavior or probe cells.
    Now, one of the interesting opportunities in this field is 
regeneration of body parts, regenerative medicine. Targeted 
drug delivery is another one, and, for example, the area of 
more humane chemotherapy or more effective chemotherapy could 
fall under this category. We could also use the nanostructures, 
the artificial ones, to, in fact, detect disease at very early 
stages.
    The related opportunities, of course, that come with all 
this knowledge base have to do with biosecurity, for example, 
and certainly genome mapping, which is also very important in 
regenerative medicine, as well.
    So let me focus on regenerative medicine, which I have used 
as an example, to illustrate how nanotechnology is embedded in 
this problem.
    So, so far, this is what we do, what is illustrated here on 
the right-hand side. We stick metals and ceramics, huge chunks 
of metal, in fact, and ceramic and other materials, composite 
materials, to fix joints and to fix blood vessels with 
artificial polymers, for example. What we should be looking to 
into the future is essentially the left-hand side, that is, 
have a scheme that allows us to regenerate all tissues of the 
body in adulthood. This is the target.
    Now, why is regenerative medicine important? Well, it is 
important certainly because humans are living longer now and 
they will probably continue to live even longer. And the 
current generation, of course, is very interested in high 
quality of life. Humans want to be, at least in developed 
countries, there is a lot of desire to be physically active and 
have a higher quality of life into a more advanced age. This is 
very much characteristic of generations now. So regenerative 
medicine, therefore, will have a great human impact.
    But, of course, there are other issues, you know. For 
example, the societal implication here is to basically think 
about the fact that we then need to keep populations in a 
highly productive and ideal State into a more advanced stage, 
and that brings, of course, all kinds of problems.
    The needs for regenerative medicine are many, but I wanted 
to focus on a few here which I think are important. Real 
progress in this field, which is highly interdisciplinary, will 
require combining the frontiers of technology, in this case 
nanotechnology, with biology and clinical medicine. This is all 
about interdisciplinary science and technology, and countries 
that do not know how to tackle with interdisciplinary science 
and technology will not win in this field, both from a human 
point of view, of course, and an economic point of view, 
because this is also an economic opportunity.
    We have in this country many entrepreneurial bright 
students which are going to be attracted to this objective 
because this is one of the great biomedical challenges of the 
century, to be able to regenerate the human body. But they need 
to be backed up by an interdisciplinary culture which is not 
there yet. So this is an issue that we need to ask questions 
about all the time because no one has the right formula yet for 
interdisciplinary education and research. The universities need 
to deal with this constantly. The agencies, of course, have to 
deal with it, as well, and they have a very critical role to 
play.
    The issue is that teams of scientists and engineers of 
different fields is not enough. What you really need is 
multilingual scientists and engineers that can effectively do 
interdisciplinary work.
    Now, here are some of the great targets, in my view, of 
regenerative medicine. We certainly should have as a developed 
society, we should have a way to reverse paralysis, and we 
don't have a way to reverse paralysis now, reverse blindness. 
So what needs to be done here is spinal cord regeneration and 
retinal regeneration, for example. Heart regeneration is 
extremely important, as well, and this is something that 
afflicts a large section of the population. If we could do that 
after heart attacks, then quality of life would be much higher. 
The same thing with stroke, which is a problem for almost a 
million people every year just in the U.S. There is need for 
cell therapies, basically to substitute for the pancreas that 
doesn't produce insulin, and here, regenerative approaches are 
also important, as well.
    Everybody would like to have access to cartilage and 
adulthood, because that causes the damaged cartilage, which no 
one in this room can grow cartilage right now because I suspect 
there is no one here that is under 18. So it is all gone. If we 
have an injury in cartilage, it will cause a lot of pain, 
decrease quality of life, and this attempts to fix this 
problem. It is also a multibillion dollar business. So if we 
had solutions, it would be a very attractive problem.
    No one knows how to repair bone universally, and, of 
course, bone repair is something that afflicts an extremely 
large portion of the population every year. And, of course, 
nobody dies with their original permanent teeth, which is 
another reality here. It would be great if we could regenerate 
enamel, for example, and not have to use dentures and all the 
porcelain and metal that gets placed in our mouths throughout 
life.
    So how is nanotechnology embedded in this problem of 
regenerative medicine? Well, the key is that we need to have 
scaffolds. To regenerate tissues in adulthood is like building 
a building. You need a scaffold. So the scaffold is needed, 
which is made up of nanostructures that can talk directly to 
cells and instruct them on what to do next. Of course, a lot of 
the information to design the scaffolds, to design the 
nanostructures of the scaffold, need to come from genomic and 
proteinomic information so that we know which signals we are to 
provide to cells in order to regenerate different tissues.
    We also need to be concerned with stem cell biology. We are 
going to have to know how we want to deal with that problem. 
And, of course, regulatory work, such as the FDA, will need to 
be important, as well.
    So I want to illustrate the problem with this nanostructure 
which was developed in my laboratory. We basically, using the 
spirit of nanoscience and nanotechnology, went out to create an 
artificial nanostructure that would mimic collagen fibrils, 
because collagen fibrils are everywhere in your body. They are 
the most common component of the natural scaffold where cells 
live in the various tissues of the body. So having a way to 
create an artificial one where we can change, let us say, the 
chemistry here to customize it to neurons or to retina or to 
heart or to bone, is extremely important.
    We were able to do that in the slide which you already saw 
in Dr. Schloss's and Dr. Dehmer's talks. It shows a molecular 
rendition of this nanostructure. Just to show you how 
interdisciplinary this activity is, this structure, which 
should be of great interest to the NIH community because it is 
for regenerative medicine, the fundamental science that was 
needed to develop it actually came from support from the 
Department of Energy. And so this shows you how difficult it is 
to predict where things are going to come from and why is it so 
important to constantly be interested in interdisciplinary 
science and research.
    These nanostructures combine proteins, for example. So if 
we know from genomics and proteinomics what proteins make what 
tissues grow, we can stick them there by design using specific 
techniques. We can load the middle of the structure in that 
cargo compartment with drugs, like hydrophobic drugs, for 
example, that are important in creating strategies for 
regenerative medicine, to actually make them work in the 
clinic.
    This slide shows you how those fibers really look like when 
they are in three dimensions, and that is a picture of the 
scaffold where the cells can be. And so they form networks and 
the networks have some strands which are single nanofibers, 
other strands which are groups of twos or threes.
    We have been able to customize them for the spinal cord 
injury recently, a problem, and so we have already in the 
laboratory nanofibers which cause neuroprogenitor cells to 
differentiate specifically into neurons and very rapidly. So 
this slide is an illustration of that differentiation. The 
green says that they are neurons, and you see very, very 
extensive neurites coming out of a cluster of progenitor cells.
    The most interesting aspect of this problem is that other 
cells like glial cells have not appeared in the presence of our 
scaffold. Glial cells are implicated in the spinal cord injury 
problem because glial cells, when there is a spinal cord 
injury, they create a scar which prevents neurons from 
reconnecting and then healing.
    So these synthetic nanostructures were able to direct 
progenitor cells to go only into the direction of being neurons 
and nothing else, and normally, in materials that had been 
explored for this purpose, you get mixtures of cells. You get 
glial and neurons. And so this will be important for spinal 
cord injury repair.
    Bone, which is very important for the entire population 
because we will always depend on a healthy skeleton. We can't 
move around with a fractured skeleton. We have problems, 
osteoporosis, for example, and all of these things that connect 
very much to high quality of life.
    The same nanofiber, the same synthetic structure, we were 
able to customize it so that it would grow bone crystals very 
rapidly that mimic exactly those found in natural bone. We were 
able to reconstruct the crystallography and the nanostructure 
details of bone mineral present in natural bone using a 
different molecular structure in the nanofiber. So it is 
possible to customize this to different tissues.
    In the case of cartilage, which is this yellow region shown 
here, and if you have a cartilage injury, you will be miserable 
for a long time and maybe the rest of your life because it is 
very difficult to regenerate it, we have found nanostructures 
in which chrondocytes, which are the cells of cartilage, can 
actually produce--remain in the phenotype that is 
characteristic of chrondocytes and produce the proteoglycons 
which are so critical to formation of cartilage.
    This area right here indicated as PA gel is chrondocytes 
sitting on nanostructures. Over here, these are chrondocytes 
sitting on tissue culture plastic or some other material that 
is not designed, and so there, the cells lose the 
characteristic phenotype which allows them to produce 
cartilage. So it is a very exciting possibility that we 
actually can go in, design a nanostructure, and talk directly 
to cells and get them--send them in pathways that will lead to 
regenerated tissues.
    Another great target is the heart, and I think here the 
same thing will apply. We will need to find out what are the 
right signals, the right epitopes, as biologists call them, and 
growth factors that are necessary for this to happen.
    Now, to conclude, I just want to give you a few thoughts 
about how I think we should proceed. It is clear that these 
artificial systems in regenerative medicine, which is the 
example I chose to use, they will be developed by highly 
creative teams of physical scientists, engineers, biologists, 
and clinicians, everybody working together. But all the members 
of the team will have to speak several languages. Otherwise, 
this will never happen.
    So the interdisciplinary culture is not necessarily going 
to emerge spontaneously. There are people that are naturally 
interdisciplinary. Others are not naturally interdisciplinary, 
and Federal agencies, for example, can do a lot to promote that 
culture through the programs they create. I think NIH and DOE 
both are doing an excellent job so far, but I don't want to say 
that it is a perfect job yet because there is a lot of work to 
be done, and frankly, the formula is not there yet.
    I think universities are willing to do technology transfer. 
That is another issue that is important here. We must be very 
much aware of the fact that large companies are really not 
doing the R&D work that is going to be necessary for this 
field. And the venture capitalists, which are terribly scared 
right now for whatever happened in the 1990s, are pulling back 
and they are not ready to invest in high-risk quantum leap 
projects. And so again, the Federal agencies need to intervene 
and help move these processes along.
    I would say that we need to ask the question of whether or 
not our country is offering the best possible resources we can 
offer to make science an attractive career for young people. I 
question that. I am not really sure. We can discuss that later 
if you would like. But I think having those resources is 
critical for a segment of the population.
    There is a segment of the population that goes into science 
that will be scientists no matter what you do, okay, so you 
don't need to do anything for those. But there is another 
segment that are undecided and they make selections about 
business careers, legal careers, medical careers, different 
careers, and going that pathway for accidental reasons 
sometimes or just because the right opportunities are not 
presented to them at the right time. So that is where we have 
to look, because I don't think we have just the large--we do 
not have the right number of people, of bright young people in 
this country going into science and engineering careers right 
now.
    Business as usual will not do. I mean, to go after this 
particular objective that I have described to you. Thank you.
    The Chairman. Thank you, Doctor.
    Mr. Lizotte?
    Mr. Lizotte. Good morning, Senator Gregg and Senator 
Murray. I appreciate this opportunity to come here. I am 
definitely very intrigued by a lot of the work that is 
happening.
    I dealt in the area of practical, bring-it-to-the-market 
kind of areas and my discussion will be from a small business 
perspective, some of the areas that we do in micro as we are 
transitioning and looking toward a future for nanotechnology.
    One of the things, I will just introduce our company in 
general, what we see as transitioning from micro to nano, some 
of our products in homeland security and defense, and some of 
our traditional markets over the years, and I will end it with 
some closing statements.
    NanoVia, I am the Vice President of R&D at NanoVia, and 
typically where we operate is we operate from the point of 
looking out into the universities and in the national labs and 
looking for opportunities, and that is when materials are 
created, when processes are created, even if in the basic 
scheme of things. A lot of the technology we deal with here is 
for micromachining or microengineering, microfabrication is 
technology that came out of the microelectronics industry. What 
we are doing is adapting it to applications which can be 
commercially viable.
    Now, those commercial applications can be things as simple 
as computers. One of the areas that we focus on is the 
efficient attachment of chips, computer chips and processors to 
chip carrier devices. Also, in the area of microfluidic 
delivery, including catheter delivery, schemes for delivering 
drugs or therapeutic drugs, and also our latest technology 
stuff in pulmonary drug delivery.
    Our services, once again, are geared toward the research, 
process, and equipment development within our marketplace, 
which is micro systems, or microelectromechanical systems and 
passive mechanical micro devices.
    Some of the images you can see which we always throw up for 
scale purposes, the upper image there is a human hair with 
small sections cut out of it using our particular laser 
technology, and where you can see that, we can create very high 
finesse cuts through different materials without damaging the 
surrounding structure.
    One of the things I like to do with talking to people about 
scale, especially when you are talking microtechnology and 
nanotechnology, is to say that in the micro scale, one micron 
is equivalent--if you look at a human hair is about 100 to 150 
microns, whereas a nanometer is one-80,000th of the diameter of 
a human hair. So it is a very broad scale.
    Now, as far as commercial development in nanotechnology 
from a small business perspective or getting it out into the 
commercial area, it is going to be a long coming. There is not 
going to be anything super-substantial in the new few years, 
other than maybe in the bio areas. But we do see some things, 
especially in materials, that we are interested in. We are 
looking at materials that can withstand, as was said earlier, 
different environments and utilizing that material in our 
processes.
    One of the things that we kind of look at microtechnology 
is we say micro is the new macro for the United States. The 
traditional manufacturing of welded assemblings and stuff of 
that nature is really getting shipped offshore. Even from 1999, 
when we started out, we were developing a process to triple the 
throughput of chip packages for laptop computers and we really 
thought we had something. We pushed it forward and built a tool 
and what we found was all of the market between 1997 and about 
2000 shipped to Taiwan and China. So with that much 
manufacturing overseas, we saw, well, there is probably not too 
much opportunity for us to build equipment in that area, so 
what we end up doing is licensing that technology, and we ended 
up licensing that technology to a Japanese concern.
    But we doubled back and we focused on things that we felt 
were key areas where we could see a potential for manufacturing 
in the United States, and the areas we see, of course, are 
medical device and diagnostics, some of the microwave 
components or communications components and high-value-added 
products. We still see these being competitively built in the 
U.S. and we see a market there for us in the future.
    One of the things that Dr. Stupp had talked about, which we 
are also very--we say is very important, is--we call it a 
multidiscipline education. One of the things that is 
interesting about engineers is that when engineers enter into a 
workforce, typically, they go into a company and they might 
have one discipline, myself as a mechanical engineer. But I 
entered into an organization which demanded that I know optics 
and I know lasers.
    So what ends up happening is in that kind of an environment 
where profitability and you get delivering to the customers 
there, you learn those disciplines and you learn them rapidly. 
And over a short career of 10 years, you might also dabble in 
electronics or electricity for some applications or even 
semiconductor processes. So what happens is that in the 
manufacturing environment, we are creating engineers and 
manufacturing engineers who have multiple disciplines, and also 
in chemistry and such of that nature.
    So we see ourselves as a small business and as a growing 
business in this market as being the facilitators of taking the 
technology that is developed in the laboratories and the 
universities and actually applying them to potentially 
commercial products.
    Now, a lot of the things that we have been working on in 
regards to products, like I will just say from 15 years ago, 
you know, we started drilling holes in small devices for ink 
jet and now we are drilling--and those holes are anywhere from 
100 microns to 75 microns, around the diameter of a human hair, 
and now we are drilling one-micron holes to facilitate the 
atomization of pharmaceuticals that can be delivered down into 
the deep lung.
    What we see with the micro to nano is an opportunity for us 
to really stake a claim in this new market that is coming out, 
and what we see is one of the things that is a big barrier to 
some of the foreign competitors, specifically in the Far East. 
We tend to say that they operate in a herd mentality, which is 
typically an engineer or staff engineer within a facility, 
there will be ten people applied in the manufacturing floor to 
solve one problem.
    I personally have consulted in Taiwan and I have seen this 
happen, where it takes them a long time to--and that is because 
they do not operate the same way we do and they also don't have 
a multidiscipline ethic in regards to when they get into the 
workforce. They only want to do their one job, and I see that 
as a benefit in regards to our competitiveness.
    As far as this market, we see opportunities in new capital 
equipment requirements. As has been discussed, we only recently 
have been able to see down to an atomic level. That gives us 
the potential of actually developing the new tools that are 
coming out and I think we might have a strategic advantage 
there. Those tools can be built by companies like ourselves. 
Once the basic science has been done, we can apply it and 
productize it and bring it into the market.
    One of the other things that is key in all these markets is 
U.S. companies hold a significant market share in most of the 
diagnostic aspects, in microelectronic ICs and communications 
devices. So I see that we have a strong position.
    Here are some applications that we are doing in regards to 
the homeland security and defense. Off to the side, you can see 
this one micron diameter hole. To drill a one-micron hole is 
pretty easy if you do one. We do a thousand every second and 
multiple--we have a system which does even more than that every 
quarter of a second and we do it to a six sigma level, which 
basically is about one defect per million. That is a 
requirement, especially for drug delivery, because you can't 
have a situation in which someone tries it and it fails, 
especially if you are delivering maybe something therapeutic 
that they need immediately, say for diabetes or something like 
that.
    We are working on some other applications in regards to 
making microstructures and even nanostructures. In our world, 
we look at nanostructures from our perspective at below a 
micron. So one micron is 1,000 nanometers, you know, a tenth of 
a micron, in that range, 100 nanometer range is really what we 
are calling our nano at this level at this point. And one of 
the things we are doing is structures for different types of 
ID, holographic ID for anti-counterfeit technology, and also 
some military applications for tagging military vehicles to 
identify them as friend or foe from aircraft and such, some 
interesting optical technology.
    This is an example which I talk about in regards to 
pulmonary drug delivery and where I see that there is a 
potential here to kind of revive some of our traditional 
manufacturers. One of the things is we have an opportunity in 
some select areas to work on machine technology and get a 
foothold in there, process technology in regard to how the 
things are processed, the assembly technology, and in this 
case, we are talking about some traditional lamination and 
application which is done by people like make paper and such. 
But if some of these traditional corporations could transfer 
over into these newer areas, they could find newer markets and 
maybe higher value added markets, which could help them out and 
transition from old technology.
    And then, of course, product technology. That is where the 
key is. You can have one element of it, but if you are selling 
the product, then you are talking about true manufacturing, and 
then, of course, down to the end user.
    Some of our traditional markets, I already talked about, 
microelectronics packaging, single-dose commercial pulmonary 
drug delivery devices, which we look at potentially third-world 
medical applications for giving a lot of these countries the 
ability to do immunizations and stuff of that nature without 
very complex delivery systems, holographic and defractive 
optics, and fluid metering, which includes ink jet, because 
that is always a good market out there for us financially, but 
bio analysis. We do a lot in regard to micro channel plates and 
some advanced stuff that we call ``lab on a chip,'' and maybe 
even create devices which these people could use in regards to 
their work, basically, create devices which allow them to do 
their work easier or faster and such.
    In closing, one of the things that we have been thinking 
about is what is the role of government in regards to small 
business. The Small Business Innovative Research grants are 
very interesting vehicles. Our experience with them, though, is 
that even if you get through the first phase, you are not going 
to get through the second phase. There is a potential you won't 
get to that second phase. And the thing is, is that a lot of 
the times, you will see a lot of these programs don't go past 
the first phase.
    In a small business environment where we are looking at--
where we have technology, we believe in our technology, and if 
we show a track record of success with our company, one of the 
things is we don't see the SBIR program as being very 
attractive, because what it does is it maybe gives you one 
piece, but it doesn't guarantee you to bring it to the next 
level of marketing it.
    We are trying to see if there is a potential of talking 
about things where it is a small business entrepreneurial 
grant, where we are talking about something where we do have a 
product, or we have something which is maybe out of the 
laboratory which is fundamentally there but needs to be 
productized and is maybe a higher level of potential success.
    The SBIR first phase grants are about the same level of 
risk. Our feeling is if there is a potential link, commercial 
entity, to one of these programs where it is just at the cusp 
of being productized, that would probably allow us to bring it 
into the mainstream and apply it. It is one thing that we are 
thinking of looking at.
    And we look at these grants, looking at funding different 
levels of where these products come out.
    Another area is a multiindustry alliance grant, and this 
would be something we have been contemplated and which we 
currently do without Federal funding, and that is we look for 
traditional manufacturers who maybe are, say, a molding 
company, and they are very good at what they do and they have 
very highly skilled or a highly-skilled workforce, but we need 
micro molding. And what we do is we introduce to them the micro 
molding concept, which gives them an entry into this market 
they have never even been exposed to. If there was a way in 
which we could look at some type of funding to bring certain 
products out this way, where we maybe link these different 
traditional manufacturers, maybe in different regions of the 
country and different disciplines and try to bring it together 
to maybe bring them into this new type of technology.
    One of the things that, I think just as a final note, is 
that unless you have a workforce that can handle this type of 
technology, even if you develop it, you just can't bring it to 
market from a product level. One of the things that we have now 
is even with some of the students and stuff that are coming 
into the workforce is they just don't have the background in 
microtechnology, and now we are talking about nanotechnology. 
There is definitely a shortfall, as Dr. Stupp was talking 
about, in regards to their education and their ability to adapt 
into a micro world when they were educated at a macro level. 
That is definitely something.
    We typically see about a three-year--we bring in an 
engineer, it will take them about 3 years to bring them up to 
speed on the process and the technologies that actually exist, 
and they are always changing. And that is if we keep them, we 
can retain them, because there are always opportunities being 
put forward.
    That is all I have to say.
    The Chairman. Thank you. It is especially interesting 
because of the basic technologies, which I think is a key issue 
for us as a Nation, so I appreciate that.
    [The prepared information of Mr. Lizotte may be found in 
additional material.]
    The Chairman. I was just wondering, these were excellent 
presentations and gave me some strong background here, I am 
sure Senator Murray, too, and these records will be available 
to others. But I am wondering, Dr. Stupp, you mentioned the 
regeneration. If you are a person out there today who has a 
spinal cord injury, that is exciting news, but is it realistic 
news? I mean, what is the time frame here when we move from the 
dream to some form of actual reality, if there is such a time 
frame that is predictable?
    Mr. Stupp. I think--well, it is probably reasonable to say 
that this might happen in, say, 10 years, maybe five to 10 
years. Five would be very optimistic, but I think it is 
reasonable within 10 years.
    However, the discovery by definition is not predictable and 
there could be breakthroughs that will accelerate the process. 
I think that it would probably come in stages, and so even 
earlier than 10 years, we may see very small steps that can be 
taken to at least return some motion to paralyzed individuals. 
Maybe they won't have a normal life, but it will be slightly 
better than it is today.
    The Chairman. And, Dr. Schloss and Dr. Dehmer, what should 
we do in the area of funding? Is it more funding or is there 
more focus? Should we reorient programmatic activity to 
accelerate Dr. Stupp's dream here, which appears to be just 
over the horizon?
    Dr. Schloss. One thing I would like to see us do is to be 
careful not to too narrowly focus the funding. The things that 
Dr. Stupp is describing, I think he has pointed out, rely on 
discoveries from many different areas, and we don't know 
exactly which of those areas the solutions are going to come 
from.
    I think what we want to do is encourage, as several people 
have said, teams of investigators who bring expertise from a 
lot of different areas to be working together, to be 
communicating effectively--not just working in the same 
physical space, but communicating, so they can bring all of 
these ideas together.
    That is why a number of us have developed funding 
mechanisms and new programs that may not specifically focus on 
nanotechnology, but focus on solving important problems in 
biomedicine. That said, sometimes those targeted on a medical 
problem funding approaches can tend to--what you end up funding 
might be the most obvious next step toward solving a problem. 
We have to be really, really vigilant about keeping an open 
mind to leaps forward.
    So that is, I think, one of the big challenges for the 
agencies, is how to balance these various needs, where we have 
people who--your question implied, I have the spinal injury 
now, or my daughter has a spinal injury now. I want to see a 
solution to that. We have to balance the very obvious near-term 
research with the things that may not come out for 10 years.
    So it is challenging. I mean, obviously, more money is 
always great.
    The Chairman. Well, do you think there is a structure in 
place at various NSF, NIH energy that is allowing for that sort 
of more global view, or is there something that needs more 
attention?
    Dr. Schloss. I think there are things in place, and we are 
also very aware that it needs more work.
    Ms. Dehmer. I am going to agree with everybody. More 
seriously, I think what we are seeing is an evolution in the 
way science is done. When I was in school and when my 
colleagues were in school, we very rigidly fell into a 
chemistry department or a physics department or a material 
science or a biology department. The entire science structure 
of the Nation, and that includes the universities, the Federal 
laboratories, and the funding agencies, have to recognize that 
the problems are no longer defined by these tidy departmental 
names.
    We have seen an evolution, no question about it. Sam is 
tenured in how many departments?
    Mr. Stupp. Three.
    Ms. Dehmer. Three. And what are they?
    Mr. Stupp. Chemistry, medicine, and material science.
    Ms. Dehmer. And we are going to be seeing more of those 
kinds of things. We are going to be seeing more students cross-
train, speaking a language that they didn't speak in individual 
departments.
    This is happening. Science is a pull that drags 
universities and Federal laboratories and funding agencies 
along. But in addition, the institutions and the funding 
agencies have to recognize what is happening and be a push, as 
well. It is happening. It will happen naturally, but everybody 
has to recognize that it needs nurturing.
    The Chairman. I think Mr. Lizotte's point also is--and 
certainly Dr. Stupp's point--is that you can't do it without 
human capital coming up.
    Mr. Stupp. Right.
    The Chairman. Is this technology so advanced in its need 
for academic background that it makes it impossible, for 
example, for us to educate average workers, people who are 
coming through the system through a technical college system, 
to be contributors to the manufacturing side, or does it 
gradate out like other sciences?
    Mr. Stupp. Well, I think that certainly we will have to 
educate workers on the manufacturing side, because once 
nanotechnology is implemented in many products, there will be 
certain procedures that have to be used. Clearly, that kind 
of--that group of individuals is not going to be the one making 
discoveries.
    The Chairman. Right.
    Mr. Stupp. So yes, there will be need for education at many 
different levels as the new technologies get implemented. But I 
think the most important one right now, in 2003, if we think 
about how we move forward, is to ask ourselves if we are doing 
everything we can to encourage--to make science an exciting 
career for young people. I mean, we need to ask that question 
very seriously.
    I think the NSF, for example, does a lot of great things, 
but they don't have very much money. I mean, they spread 
themselves very thin and sometimes they are not effective 
because the resources aren't there.
    The Chairman. Of course, a big element of that is economic 
return----
    Mr. Stupp. Sure.
    The Chairman. --which drives a capitalist society and draws 
people in. How far are we from Mr. Lizotte being able to 
execute on your ideas and initiatives in the nano area?
    Mr. Stupp. Well, I think the nano area very much needs the 
start-up company model to move forward, and I think you are 
beginning to see this culture develop. It is very difficult 
right now, with some exceptions, to think about the right R&D 
programs in the traditional large companies of this country. I 
think these technologies need to move out of the laboratory 
into very small start-up companies that then slowly receive 
more and more investment and then eventually are acquired, 
perhaps, by the larger ones, and then products will be 
developed that way.
    I think the start-up company culture is very important in 
nanotechnology and we should do everything we can to promote 
it. It also creates employment. It is very exciting employment 
for our Ph.D. students, for example, because they are not 
excited about going to the large--I don't want to use specific 
names of companies, but we all know which ones those are--they 
are not excited about those jobs because they know they are 
going to be there solving problems about existing products and 
they find that boring and not challenging. Twenty, 30 years 
ago, they went to those companies to do research and to 
introduce innovation and produce new products. That opportunity 
really isn't there for them anymore.
    So the start-up company takes a bright Ph.D., 
entrepreneurial students and keeps them on that mold, and that 
has a very, very positive impact. So it is a source of 
employment and a source of wealth, because eventually real 
development takes place in those start-up companies.
    The Chairman. And Mr. Lizotte made some good suggestions 
there. Did you have a comment?
    Mr. Lizotte. Yes, I have a comment in regards to--as just a 
perspective. In the micro world, it was easy for me to transfer 
into, back in the mid-1980s, in from a macro education into the 
micro world very easily because there was the equipment was 
already in place. All we were adapting was the existing 
infrastructure in the semiconductor and microelectronics 
industry, and that had 60 years worth of development in the 
equipment end and the device end.
    I think we are at the--my belief, we are at this same 
situation as these discoveries that are happening, and sorry 
for this terminology, and maybe at a test tube level or 
chemistry level, where the thing is, is that the problem is 
those tools don't exist. You don't have the equipment in place. 
So what is happening is you are making discoveries, but then 
you are saying, okay, well, how do I scale this up and make it 
profitable? How do I make it into a product and such? And that 
is the problem.
    Back when I came into this marketplace, there was a full 
established discipline, so I could read and I could train and I 
could work on that equipment and come up to speed very rapidly 
and make my own discoveries over the years. In this case, there 
is no equipment. It is you have got a discovery and you are 
struggling now with how am I going to scale this up, and I see 
that as a big issue because the new people coming in that might 
have some micro background don't have any equipment to jump on 
and focus on the manufacturing end of it. So I think it is 
going to be difficult, the translation of this stuff back into 
industry. Maybe in the bio area, which there is a lot of 
equipment out there in the bio area, but nanotechnology as 
applied to maybe all the other markets, like materials and 
stuff of that nature, I think it is going to be a hard time to 
ramp up and bring into the marketplace.
    Mr. Stupp. And that is exactly where I think the--why the 
start-up companies are so important.
    The Chairman. Doctor, you were going to make a point, Dr. 
Schloss?
    Dr. Schloss. No, it is past.
    The Chairman. OK. Unfortunately, we are going to have a 
vote here in a minute, but let me ask one more question. To 
what extent are we going to get down the road here 3 years and 
you are going to have that capability of actually saying to 
somebody, well, we can cure something very significant, whether 
it is spinal or cartilage or whatever, and we run into an 
ethics problem? To what extent is that a potential, and if it 
is a potential, how should we try to anticipate it and avoid 
it?
    Mr. Stupp. Your question is about, are we going to run into 
an ethical problem.
    The Chairman. Right.
    Mr. Stupp. It is not clear to me that there would be an 
ethical problem. I think the only problem that I can see would 
be related to the cost of the procedures and whether the 
population at large would be able to afford them. I mean, they 
will initially be relatively expensive procedures, and so I 
think affordability might be the issue.
    The Chairman. Well, that is the issue throughout medicine 
today already.
    Mr. Stupp. Exactly. But at the same time, if you have, let 
us say, joint disease, or if you have a spinal cord injury, the 
cost to the government of an individual being afflicted with 
joint or spinal cord disease is enormous. The cost of the new 
procedures that nanotechnology will bring will be minute 
compared to what we currently spend. So there will be a need to 
balance those two, but----
    The Chairman. You don't see stem cell----
    Mr. Stupp. Right. OK. The stem cell----
    The Chairman. --a policy question here?
    Mr. Stupp. OK. I would like to answer this way. 
Regenerative medicine procedures, advanced ones which are based 
on nanotechnology, will be possible with or without stem cells. 
Now, so there will be advances that will not require stem 
cells. They will be based entirely on nanotechnology.
    There will be others that will require stem cells, and, in 
fact, many of them will require combinations of the two. So I 
think the best solutions in the long run will be those that 
utilize nanotechnology and also look to stem cell biology. The 
combination of the two, I think will be the most effective.
    The Chairman. You were going to say something, Dr. Schloss?
    Dr. Schloss. No, I really agree, a very good answer.
    The Chairman. Are there any other points folks want to make 
on any of this?
    Mr. Lizotte. Just one thing. I know there is a lot of 
debate and there was a lot of stuff in regards to this 
nanotechnology and a lot of books have been written and a lot 
of science fiction not involved in biotechnology. I have never 
feared technology. I always say that there are a lot of things 
that potentially can kill us out there.
    I have been dealing with nano particles and stuff, debris 
from processes I have worked on for the last 15 years and there 
are safeguards and infrastructure in there in which to 
alleviate any of those concerns of small particles being 
ingested by humans and this, that, and the other thing.
    You are always going to have situations where somebody does 
something wrong, but I think a lot of this technology is so 
beyond the groups that might use things like this for things 
that are maybe not so useful in society, but my feeling is a 
lot of this stuff is science fiction.
    The Chairman. I agree with that. I don't see that as--I 
think that threat, although it is represented, there are so 
many other things that are very simple to do----
    Mr. Lizotte. Right.
    The Chairman. --that it would be unusual for somebody to 
pursue this.
    Mr. Stupp. Senator Gregg, if I could just say one more 
thing, I think there is enormous hype about the dangers of 
nanotechnology. In fact, my community is trying very hard to 
eliminate that because the hype and the problem is really 
people that have, for some reason, and it is very difficult to 
understand where this exactly came from, where did it come 
from, but there is an enormous amount of hype about the dangers 
of nanotechnology. They are definitely not based on fact.
    The Chairman. I think that is a problem the technology 
world has that we continue to see, whether it is genetically 
modified foods, which significantly improve production and 
reduce poverty and reduce hunger being stopped by people who 
think they are doing good, to science like this. We have to--I 
think as long as we are transparent about it----
    Mr. Lizotte. Right.
    The Chairman. --and aggressive in being transparent on 
science, that the average person is going to appreciate the 
benefits over any threat.
    Mr. Stupp. That is correct.
    The Chairman. The key is for us that are in the public 
policy arena and for you who are in the science arena to be 
constantly pushing transparency so that people can't make up 
conspiracy theories----
    Mr. Lizotte. That is right.
    The Chairman. --based on some information that they think 
is being hidden from them. And so that is why this hearing is, 
I think, useful and will be covered.
    I congratulate you on the science you are doing. I honestly 
feel, and I think Mr. Lizotte made the point excellently, that 
we are not as a nation going to be compete with China in basic 
manufacturing. We are going to compete clearly in our 
capability of adding value, and where we are really going to be 
adding value is in breakthrough science activity, and this is 
clearly one of them and you folks are on the cutting edge, so 
you hold our future, not only from a science standpoint, but 
potentially from an economic standpoint, in your hands.
    So please keep up the good work, and our committee is here 
to try to be supportive and helpful, and if you think there are 
things you need from the Congress, tell us. We want to react.
    [The prepared statements of Senators Enzi and Murray 
follow:]

                   Prepared Statement of Senator Enzi

    Mr. Chairman, the application of technological advances in 
today's healthcare is one of the key contributors to the longer 
and healthier lives that most of us enjoy. Today's surgical 
techniques, for instance, make those of a generation ago look 
positively primitive. The current trend toward less invasive 
surgery allows people to recover from surgeries more quickly, 
which gets them back to productive pursuits more quickly, which 
is good for them, our economy and our society.
    The application of nanotechnology in medicine has the same 
potential to move today's healthcare forward by leaps and 
bounds. Nanotechnology, however, is not the process of making 
current technologies smaller--it is the science of building 
completely new technologies at the molecular level.
    Molecular devices will give us the ability to attack 
diseases and conditions cell by cell. Imagine if we were able 
to fight cancer, for instance, by targeting specific cells, 
instead of attacking broad areas of tissue. The possibilities 
are limitless.
    In May, I visited Ireland with the U.S.-Ireland Alliance. 
During the trip, Congressman Xavier Becerra and I visited the 
Nanotechnology Center at Trinity College in Dublin and learned 
about some interesting areas of research.
    One of these areas is nanofluidics--the engineering of 
fluid-carrying systems at ultra-small dimensions. Trinity 
College's physics and clinical medicine departments are 
collaborating in research on advanced nanofluidics 
instrumentation for applications in medical diagnostics and 
pharmaceutical industry.
    From its research, the group at Trinity College has started 
a spin-off company that will be located for the time being in 
the ``Innovation Centre'' of the college. The company, known as 
Allegro Technologies, is specializing in the development of 
advanced instrumentation for high-throughput screening for 
applications that pharmaceutical company could use in the 
development of new drugs.
    Interestingly, Trinity College screens its proposal for 
internal funding in two ways. The first is through traditional 
``peer review'' to determine the most promising possibilities 
for advancing our collective knowledge base. The second is 
through attempting to determine the potential business 
applicability of the research. By putting each proposal through 
both of these rounds of scrutiny, Trinity College demonstrates 
that it values basic research, but especially the type of basic 
research that can lead to product breakthroughs.
    As we look at nanotechnology in medicine, we ought to 
ensure that both basic and applied research receive adequate 
attention. Traditionally, the National Institutes of Health and 
other federal agencies have funded business-oriented applied 
research through their Small Business Innovation Research 
(SBIR) programs. I understand that we are already funding 
applied nanotechnology research through SBIR grants to small 
businesses, and I support this, because our nation's risk-
taking small businesses will probably develop many, if not 
most, of the major breakthroughs in medical nanotechnology.
    I commend Chairman Gregg for convening this roundtable 
discussion, and I look forwarding to working with him and my 
fellow Committee members to make sure that the federal 
government plays an appropriate role in supporting the 
development of nanotechnology and its application in medicine 
and healthcare.

                  Prepared Statement of Senator Murray

    Mr. Chairman: I appreciate your efforts in putting together 
this HELP Committee roundtable to discuss the emerging 
opportunities presented through nanotechnology. The health care 
and job creation potentials for this field are truly exciting.
    This innovative new technology provides new hope and 
possibilities for how we treat heart disease.
    As all of my colleagues know, cardiovascular disease is the 
number one killer of men and women in this country. And in many 
cases, it is a silent killer.
    Devices that offer the possibility of destroying cancer 
cells without surgery could both improve--and save--lives.
    Federal support for developing this new technology must be 
comprehensive, coordinated and innovative.
    We need to enhance and grow existing biomedical technology 
and infrastructure.
    We need to ensure that federal agencies are ``partners with 
the research community''--rather than competing for 
bureaucratic and regulatory turf.
    To achieve new technology breakthroughs we must increase 
our support--particularly through appropriations to the 
research community.
    This is a huge public undertaking, but it will have huge 
rewards for health care and for high wage family jobs.
    I appreciate the involvement of all of today's participants 
in this roundtable and thank them for their leadership in this 
area.
    The Chairman. Thank you. We appreciate your coming by.
    [Additional material follows.]

                          ADDITIONAL MATERIAL























































































[GRAPHIC] [TIFF OMITTED] T9610.044

[GRAPHIC] [TIFF OMITTED] T9610.045

[GRAPHIC] [TIFF OMITTED] T9610.046

[GRAPHIC] [TIFF OMITTED] T9610.047

[GRAPHIC] [TIFF OMITTED] T9610.047

[GRAPHIC] [TIFF OMITTED] T9610.048

[GRAPHIC] [TIFF OMITTED] T9610.049

[GRAPHIC] [TIFF OMITTED] T9610.050

[GRAPHIC] [TIFF OMITTED] T9610.051

[GRAPHIC] [TIFF OMITTED] T9610.052

[GRAPHIC] [TIFF OMITTED] T9610.053

[GRAPHIC] [TIFF OMITTED] T9610.054

[GRAPHIC] [TIFF OMITTED] T9610.055

[GRAPHIC] [TIFF OMITTED] T9610.056

[GRAPHIC] [TIFF OMITTED] T9610.057

[GRAPHIC] [TIFF OMITTED] T9610.058

[GRAPHIC] [TIFF OMITTED] T9610.059

[GRAPHIC] [TIFF OMITTED] T9610.060

[GRAPHIC] [TIFF OMITTED] T9610.061

[GRAPHIC] [TIFF OMITTED] T9610.062

    [Whereupon, at 11:27 a.m., the committee was adjourned.]

