In a special meeting
held last fall, leaders in nanotechnology discussed
major challenges facing the field. The unprecedented
level of collaboration that is involved emerged as one
of the discipline’s key attributes. "For
nanotechnology to really work, it has to be an
interaction between the biologist, the chemist, the
physicist, and the engineer," says Trevor Castor,
president & CEO of Aphios Corporation. "We’re
trying to address molecular issues at a nano level
through a systems approach. So collaboration is
required for all those disciplines to be successful in
the utilization of nanotechnology for health
disparities and health problems."
Says Martin C. Woodle,
chief science officer of Intradigm, nanotechnology
represents a multidisciplinary cutting edge, and
companies, small or large, cannot tackle all of those
aspects themselves. "It really requires the
entire community of many academic groups, of different
small companies that are developing specific
technologies, for example, imaging capabilities that
have never been developed before." He adds that
the tremendous interaction is required not just
between what are traditionally considered allies, but
"Groups that might have been considered
competitors. It’s really got to be a team effort in
the broadest sense."
Anil R. Diwan,
president of NanoViricides, believes that
nanotechnology’s prospects for improving quality of
life fro cancer patients are pretty clearly defined as
they do exist, noting that what will be critical
beyond this point are the regulatory aspects.
"This is a completely different kind of animal
— these are not simple materials, and that is a
challenge for researchers as well as for
manufacturers."
Says Wendy R. Sanhai,
senior scientific advisor for the FDA’s Office of
the Commissioner, "Under the agency’s Critical
Path Initiative, we are trying to create models for
collaboration in the regulatory context — how do you
get multiple stakeholders to share information, while
respecting proprietary knowledge and commercially
confidential information, and do it toward a goal of
developing pre-competitive tools that could benefit
everyone?" Such tools could be used by multiple
stakeholders toward development of final products.
"We see the FDA’s
role as stimulating innovation by helping to
coordinate or facilitate the development of those
types of collaborative efforts," Sanhai says,
acknowledging the importance of intellectual property
with respect to a growing field such as nanotechnology.
"But even taking that into consideration, as much
as we can share information, best practices, or know
how, I think it would benefit all of us in the long
run."
Nano Challenges
According to Woodle,
analytics and manufacturing are daunting challenges
facing the field. "It’s tough enough to bring
cutting-edge science to public usage, let alone
systems that require multiple areas of cutting-edge
science and technology." "We’re making
systems in this nano-scale domain that haven’t been
made before," he says, citing analytics as a
major need that will be an important aspect of moving
things forward. Similarly, Woodle identifies
manufacturing as a crucial hurdle in terms of making a
reproducible manufacturing system and taking it to
much larger scales.
Says James R. Baker,
Jr., director of the Michigan Nanotechnology Institute
for Medicine & Biological Sciences, "We
really have to be concerned about public
acceptance," adding that in many ways, science
fiction has defined nanotechnology for the general
public.
"But there’s
another aspect as well about public acceptance,"
adds Woodle. "That is the value of the commercial
products we produce. We need to make sure we’re cost
effective — that the costs of what we are producing
are reasonable and contribute to society’s
needs."
Obtaining funding, as
might be expected, is another challenge. Baker says
the key there is proving value. While nanotechnology
products are expensive, he contends they are very high
value. "They help the health system with
controlling cost by replacing traditional imaging or
biopsy or other types of approaches that are actually
more costly," he says. "If we can show that
it not only improves the outcome but saves money, then
I think we meet the dream that we have for nanotech."
Funding frequently
follows the image for an area, says Woodle, citing
nanotechnology as a fairly hot area. "There’s a
fair bit of excitement and enthusiasm, and therefore
support for the area, which is very appropriate."
He cautions that one of the problems that can come
from excitement is over-expectations followed by
regressions in excitement and funding when
expectations aren’t met. "Every technology has
to be developed with great hopes for lots of
capabilities," he says, noting that while some of
those capabilities prove to be real and realizable,
"Other capabilities don’t turn out to be as
real as we learn about what the technology really is.
So it’s important to make sure we keep the funding
level of excitement good but not too good."
Sanhai points out the
importance of not forgetting about the next phase —
manufacturing — amidst an intense R&D focus.
While developing tools for R&D, "It is also
important that we look at things like cGMPs and try to
make that process as efficient as possible." She
points out that manufacturing costs have been found to
be more than R&D, so when looking at the set of
activities associated with medical product
development, "Look at the entire spectrum and try
to see how you can shorten that and make it more
efficient."
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