|
COVER SHEET
HEADLINE (Center):
SCOPE OF SERVICE
Body:
P3 Scientific (formerly
Part Three Corporation), based in St. Paul, Minn., is a preeminent
testing facility that provides
excellence-driven
and
innovation-focused
solutions to regulated
industries. Registered with the FDA since 1997, P3 Scientific has
an outstanding reputation for offering comprehensive and
quality-proven scientific testing solutions. The experienced
professionals of P3 Scientific offer cGMP-compliant analytical
support from discovery through critical development phases to market
release.
P3 chemistry labs offer
analytical testing solutions with unmatched expertise in inhalation
and transdermal dosage forms. P3 Scientific microbiology labs solve
challenging development problems for complex formulations and
devices, including testing in accordance with compendial methods.
P3’s physical testing labs perform physical and structural analysis
of products and materials. P3 also offers stability storage and
testing, precisely designed and implemented protocols, customized
method development and validation, regulatory guidance and
compliance consulting.
P3 continues to
anticipate market change and regulatory developments by investing in
people, innovative technology, and processes to meet the extensive
testing needs of pharmaceutical, medical device, and combination
product customers. For example, when the FDA released compliance
guidelines for aseptic processing, P3 invested in RiboPrinter®
Microbial
characterization systems for genotypic bacterial identification.
SECTION - CORPORATE FACTS (left justified):
Address:
1281 Helmo Avenue North
Oakdale,
Minnesota 55128
Phone:
651/738-2728 / 877/952-1500
Web site:
www.p3scientific.com
Number of
employees: 80
Total
square footage of facility: 36,000
HEADLINE 2 (Centered):
Chronological History:
SECTION - DATE FACTS (tab-delimited):
July,
2005 ISO/IEC 17025 Certification
January,
2005 Name changed to P3 Scientific, Inc.
March,
1999 Microbiology laboratory added
April,
1997 FDA Registration
October,
1995 Analytical Chemistry laboratory added
December,
1984 Part Three Corporation founded
# # #
BIO SHEET 1
HEADLINE (Center):
James A. Meyer
President and CEO
P3
Scientific, Inc.
Body:
James A. Meyer serves
as the president and CEO of P3 Scientific, Inc. As president, Meyer
is responsible for the overall financial and business operations of
the company. Meyer is also a member of the P3 Scientific board of
directors.
Before joining P3
Scientific, Meyer held several top management positions with Midwest
corporations. He was president of Tru-Corporation, a contract
manufacturing company in Wichita, Kan. In this position Meyer led
the operational and financial restructure of the corporation. In
addition to serving as president, Meyer served as a member of the
Tru-Corporation board of directors.
Prior to that, Meyer
was the general manager of Newport Corporation in Plymouth, Minn.,
where he devised a long-term strategic plan, improved processes,
quality, satisfaction and asset utilization.
Before joining Newport
Corporation, Meyer was vice president of operations for Jacobson
Machine Works, Golden Valley, Minn.
Prior to joining
Jacobson Machine Works, Meyer was vice president of operations for
Schott Corporation, Wayzata, Minn. Before that, he was manager of
manufacturing/quality engineering, where he was responsible for
developing and implementing lean/cellular manufacturing techniques,
reducing cycle time, and improving quality and productivity.
Before joining Schott
Corporation, Meyer was manager of technical services at ETA Systems,
St. Paul, Minn. Here Meyer directed a core team that developed
procedures and documentation to decentralize the leading-edge
Control Data subsidiary. He was a member of a MRP startup team and
became a primary TQM and new-hire technical trainer.
Meyer also worked as a
senior industrial engineer and was an officer in the U.S. Air Force.
Meyer holds a Bachelor
of Science degree in behavioral science from the U.S. Air Force
Academy. He also earned a masters degree in Industrial Engineering
from North Dakota State University. In addition, Meyer is a
certified quality engineer and a certified quality auditor.
# # #
BIO SHEET 2
HEADLINE (Center):
Grace A.
Thornhill, Ph.D.
Technical Director
P3 Scientific
Body:
Grace A. Thornhill has
more than 20 years experience as a microbiologist in both industry
and academia. Her areas of expertise include general microbiology,
molecular biology, and microbial identification.
In her position as
technical director for P3 Scientific (formerly Part Three
Corporation), Thornhill is responsible for directing research and
development activities. She also leads the identification and
implementation of innovative technology, such as ribotyping. She
routinely speaks nationally and internationally on rapid
microbiology technologies, including their applications and
advantages.
Before being named
technical director, Thornhill served as a laboratory manager, where
she oversaw the daily operations of the microbiology division. Under
her direction, the P3 Scientific Microbiology lab became known for
method development and validation of microbiology methods for
complex drug formulations and drug delivery systems
Prior to joining Part
Three Corporation, she held an assistant professor position at the
University of Wisconsin - River Falls, where she taught
undergraduate and graduate courses in microbiology, molecular
biology, cell biology, general biology, virology, vertebrate
physiology, emerging infectious diseases, and vaccine design.
Thornhill’s industry
experience also includes Protein Design Labs where she set up a
microbial identification lab and assisted with method development.
Thornhill earned a
Bachelor of Science degree in microbiology from the University of
Minnesota and a doctorate of microbiology from the University of
Minnesota.
Thornhill is an active
member in good standing of ASM, PDA, Medical Alley/MNBIO, AAPS, and
Henrici Society.
# # #
OVERVIEW SECTION
HEADLINE (Center):
What Should You
Expect from Your Outsourcing Supplier?
Body:
Shelly Paipal-Umland
P3 Scientific, Inc.
In just over two
decades outsourcing in the pharmaceutical industry has grown into a
necessary tool for success. But, if you’re like most end-users of
contract research organizations (CROs) you may occasionally wonder,
is that all I get? Should you expect more from your CRO? You and
many others have the same questions. With outsourcing slated to grow
exponentially over the next five years, your CRO should be able to
provide answers to these questions, and many more.
According to Thomas
Kupiec , author of “Analytical Outsourcing” (Contract Pharma, March
2003), outsourcing is virtually unlimited. Analytical outsourcing
alone was expected to grow 20% per year from $10 billion in 20031.
The consulting firm of Arthur D. Little estimated 15 % annual growth
in pharmaceutical outsourcing, thus making it a $48 billion industry
by 20082. Clearly, outsourcing is here to stay.
SUB-HEAD (Left-justified):
You Get What
You Pay For
Body:
When choosing your CRO,
beware of basing your decision on price. The old motto “you get what
you pay for” certainly applies. Generally the low price leader will
cost you more time and money in the long run. With low-cost,
high-volume providers you run the risk of longer turnaround times on
commonly outsourced projects. Instead of price, take a good hard
look at their quality system and their value add-ons. However, it is
fair to ask, are you getting what you pay for from your CRO? If
you’re not confident in the results they produce and feel that there
is a lack of timely and effective communication, then the answer
should be a resounding no.
Along with reducing
development time and costs, your outsourcing supplier should free up
resources to focus on innovation. They should also communicate
proactively and offer tracking and trending to ease the burden of
results analysis. A CRO who is willing to take the time to
understand your project can be invaluable to your organization. If
your CRO can also provide access to expertise and instrumentation
not currently available to you, hold onto them. They are one of your
best assets.
SUB-HEAD (Left-justified):
Advantages of
Outsourcing
Body:
Outsourcing provides
numerous advantages, the largest being faster release to market.
Other advantages include increased adaptability, decreased overhead
costs, improved multi-tasking of multiple projects, and the
flexibility to allocate resources to meet company goals. With these
advantages in mind, your selected CRO should have a long-term
strategic partnership with your organization. Ideally they should be
viewed as an arm of your R&D departments. If chosen properly, with
mutually agreed upon expectations, there should be few, if any,
drawbacks to outsourcing. The most common drawback is simply the
variety of available CROs. The number of contract laboratories alone
increases substantially every year.
Each CRO should be able
to clearly communicate their unique specialties. In ideal
situations, a decision making team has qualified one main supplier,
plus a back-up to meet the primary needs of the organization.
Matching the project to the CRO can be time-consuming as not all
offer full-service capabilities. But in the long-run, the financial
benefits of outsourcing far outweigh any drawbacks.
P3 Scientific, a
privately held, premier testing facility in the Twin Cities, has
been answering the needs of their customers for over 20 years. They
offer a wide array of cGMP-compliant services, including Chemistry,
Microbiology, and Physical Testing. In the last year they have
branched out to offer their unique service offerings to national, as
well as international, audiences. Their skills in inhalation and
transdermal dosage forms set them apart. P3 further differentiates
themselves with an exceptional quality system, and a company-wide
dedication to that system, which is rare for a CRO. This dedication
is illustrated by their outstanding history with the FDA.
P3 Scientific takes
customer service one step further by investing in people and new
technology so their clients don’t have to. When the FDA released
their aseptic processing guidance, many companies wondered, “What do
I do now?” P3 Scientific answered by offering genotypic bacterial
identification and characterization via ribotyping.
[ GRAPHIC ]
Quickly becoming an
industry standard, ribotyping provides sub-species level results in
as little as 8 hours. When faced with waiting up to 14 days for
results with conventional methods, the speed of ribotyping leads to
unprecedented cost savings. Plus, since a bacteria’s RiboPrint®
pattern is as unique as a fingerprint, the accuracy of the results
virtually eliminates mis-IDs.
[ GRAPHIC ]
That unique RiboPrint®
pattern is entered into a library that is exclusive to your
organization. A comprehensive, dynamic picture of any microbial
environment is possible with the tracking and trending capabilities.
Contaminants can be rapidly pinpointed with more speed, ease, and
precision than ever before possible. With ribotyping your
organization is back up and running in no time.
Ribotyping isn’t
limited to aseptic processing. Other uses include:
Clinical Trials Support
Drug Efficacy Studies
Drug Discovery Groups
QA/QC Microbiology
Facility Microbial
Mapping
Industrial Fermentation
(strain purity)
Culture integrity
confirmation
Epidemiology
Outside of the
pharmaceutical industry, ribotyping can be used for bacterial
identification and characterization in the food safety & security,
personal care, and medical device industries – anywhere
strain-level, rapid results are necessary. Ribotyping is an example
of the type of advanced capabilities you should expect from your
CRO. Clearly there are numerous advantages to outsourcing – if
you’ve selected the right supplier. As a premier testing facility,
P3 Scientific will continue to challenge the way you think about
your CRO by expanding their offerings in rapid microbiology.
Investment in new technologies is just the beginning.
Now ask yourself –
“Should I expect more from my CRO?” If the answer is yes, then maybe
P3 has the solution.
SUB-HEAD (Left-justified):
About P3
Scientific – An industry leader in inhalation and transdermal
therapies
Body:
P3 Scientific has been
providing premier testing services for over 20 years. Renowned for
their extensive capabilities in inhalation therapies, especially
metered dose inhalers (MDIs), they are further differentiating
themselves through their knowledge and experience with transdermal
delivery systems. Content, purity, and residuals are just a few of
the specialty tests they have mastered. Their expertise extends to
next generation transdermal delivery systems that have yet to hit
the market. With a reputation for integrity, P3 Scientific is the
proven choice for scientific solutions.
SECTION - SOURCES (Left-justified):
Sources:
1. Kupiec,
Thomas C., “Analytical Outsourcing: Assessing Outsource/Inhouse
Options”, Contract
Pharma, March 2003.
2. Viswanathan,
Sangita. “Are You Moving Out?”, Pharmaceutical Formulation &
Quality, May 2004.
SECTION - TRADEMARK NOTICE (Left-justified, small):
RiboPrint® is a
registered trademark of DuPont Qualicon, Inc.
# # #
Return to Portfolio Home
|
