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Pressure
BioSciences’ Richard Schumacher Describes Pressure
Cycling Technology and its Many Applications
Pressure
BioSciences is a fledgling company with a mature
technology. Pressure cycling technology (PCT) uses
pressure to control molecules with applications
ranging from sample preparation to the inactivation of
pathogens. The Company is currently focusing its
technology development program in the area of sample
extraction, as they feel that this addresses a huge
and important market—researchers studying RNA, DNA,
proteins, or small molecules. CEO and Founder Richard
T. Schumacher talked to Pharma DD about his latest
venture and his plans for broadening PCT’s scope,
both within and outside of sample preparation.
Pharma DD: How did
you become involved with Pressure BioSciences?
Schumacher:
Pressure BioSciences is what remains of Boston
Biomedica, a company that I founded in 1986 to develop
and supply quality control products for infectious
diseases testing. In 2004, Boston Biomedica found
itself struggling to adequately fund all of its varied
enterprises, one of which was pressure cycling
technology (PCT). So we split the company up and sold
off the divisions to companies that could better
capitalize and support the specific programs. In what
has now become Pressure BioSciences, we are
exclusively focused on developing and expanding the
use of PCT.
Pharma DD:
Why are you so committed to PCT?
Schumacher:
I firmly believe that PCT’s potential surpasses that
of any technology I have ever worked on. We clearly
feel there is a market need for PCT. Its predominant
application right now is in sample preparation,
particularly extraction. We feel that this market is
potentially huge, as it includes anybody who needs to
study RNA, DNA, proteins, or small molecules, whether
from plant, animal, human, or microbe sources, and
whether from cell or tissue. We believe that PCT
offers clear advantages when compared to all other
current extraction methods, including the opportunity
to get material out of cells and tissues faster, more
safely, and more reproducibly.
With
PCT it is possible to take tissue sections from a
laboratory animal, put them into our disposable PULSE
Tubes, and quickly and easily extract the bio-molecule
of interest. The samples can even be shipped in the
PULSE Tubes, or stored pre- and post-processing for
extraction or study at a later date. The alternative
is to take the same tissues out, grind them by mortar
and pestle, sonicate or homogenize them, or beat them
up with beads, all of which pose multiple safety and
quality issues to the investigator.
But
tissue extraction is just one application--PCT is an
enabling, platform technology. Its potential
applications both within and outside of extraction are
mind-boggling. We never thought much about forensics,
for example, until someone approached us with a
problem—that to extract nucleic acid from bones
meant that they had to pulverize the bone, which meant
that it could not be returned intact—and the process
took nearly 24 hours to complete. Within a couple of
months, we were able to show that we could extract
sufficient nucleic acid from bone faster and better
than other methods currently being used—and we did
not have to pulverize the bone, which meant that the
bone fragment could be returned to the family or the
burial ground intact.
We
are becoming more and more convinced that all
biomaterials each have their own distinct pressure
profile, and that by determining these profiles, we
will be able to better harness and utilize the power
of PCT. To this end, we are currently studying the
pressure profiles of a number of materials. This will
allow us to look at the potential of PCT in areas such
as differential lysis, where it might offer the
ability to lyse certain cellular components and not
others, all by subjecting the material to different
levels of pressure, or a different number of pressure
cycles. In addition, we are also looking at the
ability of PCT to differentially inactivate. For
example, we know that we can inactivate some pathogens
and not others in the same sample because some (if not
all) pathogens (e.g., viral, bacterial) have different pressure profiles. We can
also use pressure to control the kinetics of how
antigens and antibodies associate and dissociate. And
pressure can be used to purify proteins and elute them
off columns. These are but a few examples of how PCT
can be applied outside of sample preparation.
We
have patents issued in all these areas. But they’re
sitting on the back burner because we feel that
extraction represents such a huge, potential market
need, and there are minimal regulatory hurdles to get
over in this area. Once we’ve captured a good piece
of the extraction market, we can then look at
broadening PCT’s applications to other areas.
Pharma DD:
How do you plan to accomplish that?
Schumacher:
We are well poised to do so, because the groundwork
was laid over the course of six years and $12 million
spent developing the PCT technology at Boston
Biomedica. While we may look it, we are not a
development-stage company. We are much further along
the road to scientific acceptance and commercial
success than most companies that are less than two
years old. We have approximately 24 months of cash at
our current burn rate assuming no sales. And we have
already developed and had sales of our first product.
So I think our timeline is much shorter than for other
young companies. We will also be able to circumvent
many of the hurdles common to start ups, since we have
adequate cash, a very experienced scientific and
management team, a growing and receptive market need,
and a technology that has already had a great deal of
initial development and third-party validation.
Pharma DD:
What are your biggest challenges?
Schumacher:
Our biggest challenge is convincing people to break
the mold of how they do sample extraction. Pressure
BioSciences has a novel, interesting, and in many ways
better way of extracting materials from cells or
tissues. But we’re competing against methods that
have been around for decades and that are inexpensive
at first blush.
So
our difficulty is in getting scientists to understand
that they may not be extracting everything from their
sample that they need or want using conventional
methods. Or second, that other methods cannot
guarantee the same level of reproducibility and
ease-of-use that PCT can.
But
perhaps most importantly is the safety issue:
Everything with PCT is done inside a sealed processing
container (the PULSE Tube) within a sealed chamber. In
this world of bioterror agents and infectious
diseases, it’s important to emphasize that PCT
offers a nearly unprecedented level of safety in
sample extraction.
So
our biggest hurdle is getting the scientific
corroboration so that people will say “you need this
technology because it offers you more distinct
advantages than existing methods.”
Pharma DD:
How are you addressing that?
Schumacher:
We’ve been working to get our instrument into the
labs of thought leaders in the hopes that they will
evaluate it, use it to generate data, and then present
their findings at scientific meetings and symposia and
in peer-reviewed publications. Our first instrument
was released for evaluation last June. We placed 11
more in 2005 and early 2006. Several sites (University
of New Hampshire, the FBI, and the FDA) purchased the
PCT Sample Preparation System pretty quickly. Other
sites have presented and published data that were
generated using PCT. The word is starting to get out,
and as it continues, we hope that scientists will
begin to realize how powerful this technology
is—once this happens, we believe that PCT will find
its way into laboratories all over the world.
Pharma DD:
What is the next step?
Schumacher:
To continue getting our instrument into the labs of
thought leaders, and getting them to use it with the
expectation that they will present and publish their
data. We’ve ordered 25 additional instruments, which
we expect to receive by the end of the year.
We
have been pretty quiet on the investor relations front
since the Company was re-invented. I have been fond of
saying that I did not want to talk too much about this
exciting technology until we had all of our “ducks
lined up in a row”—well, with the progress that we
have made recently, I feel that the ducks are not only
finally lined up, but I believe that I can actually
hear them quacking!
To
that end, we’ll be attending an investor conference
for the first time in a year (our second ever), the
RedChip Investor Conference, which will be held next
month in New York. We intend to continue presenting at
additional investor meetings thereafter.
For
more information about Pressure BioSciences and
pressure cycling technology (PCT), please visit www.pressurebiosciences.com
URL:
http://www.pharmadd.com/exclusivecontent/Pressure Biosciences.asp
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