The WHO uses its Department of Immunization, Vaccines and Biologicals to pre-qualify vaccines and devices for safe immunizations.  The Quality, Safety and Standards Team pre-qualifies a comprehensive range of cold chain equipment, injection devices and other products needed for safe and effective immunization delivery.  PQS certification allows purchase and use of Stratis® jet injectors for mass immunization campaigns by WHO, The Global Alliance for Vaccines and Immunization (GAVI) and UNICEF worldwide.

Vaccine journal’s July 2012 issue reported that 24% of adults and 63% of children in the U.S. are fearful of needles and this has a direct impact on immunization non-compliance.¹  It is estimated that 7% to 17% of the US population choose to forego vaccinations due to fear of needles.²   Needle-free jet injectors have been used in the U.S. and other countries to deliver millions of vaccinations.³

The PharmaJet Stratis® needle-free injection system received FDA 510(k) clearance in July 2011 for delivery of various medications and vaccines and also achieved CE Marking in 2012 allowing use in the European Economic Area.

About PharmaJet Inc. and Needle-free Injection Technology:

PharmaJet’s innovative needle-free injection technology delivers drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths.  PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating risks of needle-stick injuries and the cost burden of “sharps” waste management.  PharmaJet’s needle-free injectors have received FDA 510(k) marketing clearances for use to deliver various liquid medicines and vaccines.  The PharmaJet system has been well received in the developed world, and is also advantageous in the developing world due to its usability, affordability and inherent safety features.  For more information on PharmaJet’s needle-free injection technology, please visit http://www.pharmajet.com/.

PharmaJet® and Stratis® are trademarks of PharmaJet Inc.

Contact:

PharmaJet Inc.

1.303.526.4278

support@pharmajet.com

References

1.Vaccine, Volume 30, Issue 32, 6 July 2012, pp 4807-4812, “Survey of the Prevalence of Immunization Non-compliance Due to Needle Fears in Children and Adults“.

2.The American Journal of Medicine, Vol. 121, No. 7B, July 2008, Johnson et al, “Barriers to Adult Immunization”, pp S28-S35.

3.Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008; 1357-1392, Weniger BG, Papania MJ, “Alternative Vaccine Delivery Methods” [Chapter 61].

GOLDEN, CO, USA ‐ November 29, 2012 – PharmaJet Inc. has entered into a collaboration with CSL
Limited to enable Afluria® influenza vaccine to be delivered with the PharmaJet Stratis® needle‐free
jet injector, as soon as the 2013‐2014 flu season. Adding PharmaJet jet injectors to the Afluria® label
will expand the delivery options for flu vaccine administration, thereby helping to broaden
immunization coverage.

The Centers for Disease Control and Prevention (CDC) recommends an annual flu vaccination for all
US citizens over 6 months old. Flu shots have proven to reduce illness, absenteeism and flu‐related
medical expenses. For many people, the fear of needles is enough to deter receiving a seasonal flu
shot, despite the risk of contracting and spreading the illness.

Vaccine magazine’s July 2012 issue reported that 24% of adults and 63% of children are fearful of
needles and this has a direct relationship to immunization non‐compliance.(1) It is estimated that 7%
to 17% of the US population choose to forego vaccinations due to fear of needle injections.(2)

Needle‐free jet injectors have been used in the U.S. and other countries to deliver millions of
vaccinations.(3) PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the
skin, delivering doses to the desired depth, while eliminating needle‐stick injuries, needle anxiety and
the cost burden of “sharps” disposal management. The PharmaJet Stratis® device has received FDA
510(k) marketing clearance and provides easy and affordable injections, delivering vaccine in 1/5th of
a second and with reduced pain sensation.

Afluria®, a CSL product, is a non‐adjuvanted seasonal influenza vaccine sold in two different
formulations: thimerosal‐free, pre‐filled syringes, and in multi‐dose vials. CSL Biotherapies and
PharmaJet are working to include jet injectors as a method of administration on the Afluria® label in
time for the 2013‐2014 flu season.

PharmaJet’s collaboration with CSL involves conducting a Phase IV clinical study to demonstrate the
immunogenicity and safety of Afluria®, presented in multi‐dose vials, when administered with
PharmaJet Stratis® needle‐free device. Pending favorable clinical results, CSL will submit a
Supplement to Afluria®’s BLA to include the option of needle‐free jet injection on the Afluria®
labeling.

About PharmaJet Inc. and Needle‐free Injection Technology:

_
PharmaJet’s innovative needle‐free injection technology delivers drugs and vaccines to
intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to
create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while
eliminating risks of needle‐stick injuries and the cost burden of “sharps” waste management. Further
benefits of PharmaJet injectors include the potential for dose‐sparing of vaccines, reducing the
overall cost of vaccine delivery. PharmaJet’s needle‐free injectors have received FDA 510(k)
marketing clearances for use to deliver various liquid medicines and vaccines. The PharmaJet system
has been well received in the developed world, and is also advantageous in the developing world due
to its usability, affordability and inherent safety features. For more information on PharmaJet’s
needle‐free injection technology, please visit http://www.pharmajet.com/.

PharmaJet® and Stratis® are trademarks of PharmaJet Inc.

_
About Afluria®

_
Afluria® is an inactivated split influenza virus vaccine indicated for active immunization of persons
aged 5 years and older against influenza disease caused by influenza virus subtypes A and type B
present in the vaccine. Afluria® is contraindicated in individuals with hypersensitivity to eggs,
neomycin, or polymyxin, or in anyone who has had a life‐threatening reaction to previous influenza
vaccination. Immunocompromised persons may have a diminished immune response. If Guillain‐
Barré syndrome (GBS) has occurred within 6 weeks of prior influenza vaccination, the decision to give
Afluria® should be based on careful consideration of the potential benefits and risks. Administration
of CSL's 2010 Southern Hemisphere influenza vaccine has been associated with increased
postmarketing reports of high fever and febrile seizures in children predominantly below the age of 5
years as compared to previous years. Serious allergic reactions, including anaphylactic shock, have
been observed during postmarketing surveillance in individuals receiving Afluria®. In adults, the most
common local (injection‐site) adverse reactions observed in clinical studies with Afluria® were

tenderness, pain, redness (erythema), and swelling. The most common systemic adverse reactions
observed were headache, malaise, and muscle aches (myalgia). In children, the most common local
(injection‐site) adverse reactions observed in a clinical study with Afluria® were pain, redness, and
swelling. The most common systemic adverse reactions observed were irritability, rhinitis, fever, and
cough, loss of appetite, vomiting /diarrhea, headache, muscle aches and sore throat. Afluria® should
be given to a pregnant woman only if clearly needed. Safety and effectiveness of Afluria® in children
below 5 years of age have not been established. Antibody responses in geriatric subjects were lower
after administration of AFLURIA in comparison to younger adult subjects. Vaccination with Afluria®
may not protect all individuals.

Afluria® is a trademark of CSL Limited.

Afluria® is distributed by Merck in the United States.

About CSL Limited and CSL Biotherapies

_
CSL Biotherapies has been manufacturing flu vaccine for over 45 years and its seasonal influenza
vaccine is licensed in 28 countries. The United States headquarters of CSL Biotherapies are located in
King of Prussia, PA. Its parent company, CSL Limited,in Melbourne, Australia (ASX:CSL) has invested
USD $80 million to double the company’s influenza manufacturing capacity to 40 million trivalent
influenza vaccine doses per season, making it one of the largest influenza vaccine facilities for global
markets. CSL Biotherapies, which shares its United States headquarters with its sister company, is
commercializing influenza vaccine products globally. The CSL Group employs more than
11,000 people and operates in 27 countries worldwide.

_
For more information on CSL Limited, visit us at www.csl.com.au.
For more information on CSL Biotherapies, visit us at www.cslbiotherapies‐us.com.

References

_
1. Vaccine, Volume 30, Issue 32, 6 July 2012, pp 4807‐4812, “Survey of the Prevalence of
Immunization Non‐compliance Due to Needle Fears in Children and Adults“.

_
2. The American Journal of Medicine, Vol. 121, No. 7B, July 2008, Johnson et al, “Barriers to Adult
Immunization”, pp S28‐S35.

_
3. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008;1357‐1392. Weniger BG, Papania
MJ. “Alternative Vaccine Delivery Methods” [Chapter 61].

“The PharmaJet Stratis Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.”

FDA’s regulation 21 CFR 880.5430, specifically states that such devices “may be used for mass inoculations.”

Refer to the STRATIS® Jet Injector Instructions for Use and the individual device and vaccine labeling to ensure safe injections and to review risks. For further information please contact PharmaJet Regulatory Affairs at 303.526.4278.

According to the Centers for Disease Control and Prevention (CDC) General Recommendations on Immunizations - 2011

“Jet injectors prevent needle-stick injuries to health-care providers and can overcome improper, unsterile reuse and other drawbacks of needles and syringes in developing countries. Immune responses generated by jet injectors against both attenuated and inactivated viral and bacterial antigens are usually equivalent to, and occasionally greater than, immune responses induced by needle injection.”

Ref: 2011 CDC General Recommendations on Immunizations

 About PharmaJet Inc. and Needle-free Injection Technology:

PharmaJet’s needle-free injection technology delivers liquid drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick injuries, needle reuse and the burden of sharps waste management. For additional information on PharmaJet and Needle-free technology, please visit www.pharmajet.com.

   Download the full .pdf here.

Arvada, Colo. – The Jefferson County Economic Development Corporation (Jeffco EDC) honored leading businesses in Jefferson County this morning at the 19th Annual Industry Appreciation Awards breakfast. This awards program honors impressive businesses each year that have proven to be outstanding and innovative. These companies help fuel the economy in Jefferson County through their many contributions, including increased capital investment and primary employment.
“As we try to encourage job growth and capital investment in Jefferson County, it is important for us to recognize the businesses and individuals who have made significant contributions in these areas over the past year. In Jeffco, we are fortunate to have a healthy mix of innovative and growing businesses. They have earned this recognition,” said Kevin McCasky, President and CEO of Jeffco EDC.
APC Construction was awarded the highest honor- the Pioneer Award. This award is given to a company demonstrating a pioneer attitude within their industry and among businesses in the county. Past recipients of this award have provided standards for other businesses to follow in today’s rapidly changing world and have demonstrated significant and sustained growth, which APC Construction has done in Jefferson County.
Additional awards at this morning’s event included the Genesis award, which honors a company that has contributed to the economic vitality of Jefferson County through creative leadership, innovation, facilitation, and collaboration in the community. This year’s Genesis award recipient was Xcel Energy.

Other awards included:

• Innovative Technology Award –given to companies that are on the forefront of new and advanced technologies. Award recipients: Lockheed Martin Space Systems and PharmaJet
• Business Recognition Award – given to companies showing growth in primary employment and/or capital investment. Award recipients: Ball Aerospace & Technologies, Bentek Energy, Environmental Resource Associates, Lifeloc Technologies, Piper Electric and Vforge, Inc.
• Jeffco EDC’s Board Chair, Buddy Douglass, President, FirstBank of Lakewood, awarded Colorado Christian University the 2011 Chairman’s Choice Award for its contribution to the Jeffco economy and its continued efforts to being an outstanding community partner.

Critic at Large, Greg Moody from CBS4 News was the emcee for this year’s event held at the Arvada Center for the Arts and Humanities.
Platinum Sponsors: Denver West Office Park
Silver Sponsors: Kaiser Permanente, Lockheed Martin
Gold Sponsors: Exempla Lutheran Medical Center, Xcel Energy
Media Sponsor: Colorado Real Estate Journal
Jefferson County Economic Development Corporation is an economic development organization in Jefferson County, CO, with public and private members. The organization concentrates on creating, expanding, and retaining high-paying primary jobs that fuel the economic health and vitality of Jefferson County. Jeffco EDC is governed by a Board of Directors consisting of local business leaders and elected officials. For more information please call 303-202-2965 or visit our website at www.jeffcoedc.org

Please return to this page for the latest updates on our current openings.

Dr. Linda McAllister, MD, PhD, Chief Medical Officer, Vice President of Research and Development, will pursue an innovative global health research project, titled "Elucidating the Mechanism of Intradermal Delivery."

Grand Challenges Explorations funds scientists and researchers worldwide to explore ideas that can break the mold in how we solve persistent global health and development challenges. Dr. McAllister's project is one of 110 Grand Challenges Explorations grants announced this week.

"We believe in the power of innovation—that a single bold idea can pioneer solutions to our greatest health and development challenges," said Chris Wilson, Director of Global Health Discovery for the Bill & Melinda Gates Foundation. "Grand Challenges Explorations seeks to identify and fund these new ideas wherever they come from, allowing scientists, innovators and entrepreneurs to pursue the kinds of creative ideas and novel approaches that could help to accelerate the end of polio, cure HIV infection or improve sanitation."

Projects that are receiving funding show promise in tackling priority global health issues where solutions do not yet exist. This includes finding effective methods to eliminate or control infectious diseases such as polio and HIV as well as discovering new sanitation technologies.

To learn more about Grand Challenges Explorations, visit www.grandchallenges.org.

Global polio eradication is within reach. The oral polio vaccine (OPV) currently in use leads to vaccine- associated poliomyelitis at a rate of 1 to 2 cases per million vaccine doses delivered. A global switch to inactivated polio vaccine (IPV) is critical and long overdue, however this transition is challenged by the increased cost of IPV, as well as the requirement for a needle to deliver IPV. PharmaJet plans to address these challenges by delivery of a reduced dose IPV vaccine into the skin (dermis) with an easy-to-use needle-free jet injection technology.

In contrast to muscle, the dermis is more immunologically active, allowing for dose reduction with a variety of vaccines however, it is unknown what drives the efficacy of intradermal (ID) delivery. With this funding PharmaJet hopes to elucidate the specific drivers of intradermal effectiveness, enabling further optimization of the needle-free technology and vaccine formulation to deliver the most cost effective strategies for global polio eradication.

About Grand Challenges Explorations
Grand Challenges Explorations is a US$100 million initiative funded by the Bill & Melinda Gates Foundation. Launched in 2008, Grand Challenge Explorations grants have already been awarded to nearly 500 researchers from over 40 countries. The grant program is open to anyone from any discipline and from any organization. The initiative uses an agile, accelerated grant-making process with short, two-page online applications and no preliminary data required. Initial grants of $100,000 are awarded two times a year. Successful projects have an opportunity to receive a follow-on grant of up to US$1 million.

About PharmaJet Inc. and Needle-free Injection Technology
PharmaJet's needle-free injection technology delivers liquid drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick risk and the burden of sharps waste management. Further benefits of PharmaJet injectors include the potential for dose-sparing of vaccines, reducing the overall cost of vaccine delivery. The PharmaJet system has been well received in the developed world, and is also extremely advantageous in the developing world due to its usability, affordability and inherent safety features.

Genius Lunch - PharmaJet from Genius Lunch on Vimeo.

Kathy Callender and Heather Potters are out to change the world by transforming the way health care workers deliver vaccines. Their company, PharmaJet, has developed a needle-free syringe that is positioned to save both lives and money at a massive scale, from Southern California to South Africa.

Heather Potters’ presentation blew the team away. The impact of PharmaJet’s relatively simple device has far-reaching implications, particularly in the developing world. In Sub-Saharan African, for example, Potters reports that 50 percent of needles are reused in the delivery of vaccines and medical treatment, while in China, the rate is 70 percent. In India, needles are often fished from the garbage, washed and repackaged to appear new. As a result, Hepatitis B and C and HIV/AIDS spread rampantly, as does the very disease that the injection is meant to prevent.

With the needle-free syringe, medicine gets delivered intra-dermally—just beneath the top layer of skin—and painlessly, which puts both the patient and the caretaker at ease. Potters even tested it out on our own Michael Pollack, who reported he felt nothing. There is no sharp needle to dispose of, which means no hazardous waste and a drastic reduction in overall cost by eliminating the fee associated with removing medical waste.

Because the PharmaJet device is easy and safe to use, it enables a greater number of people to deliver patient treatment—a huge benefit where doctors are scarce. In addition, the design of the vial and syringe means the contents of each vial can be used up entirely and dosages can be significantly reduced, so quantities can be stretched further and the risk of vaccine shortages goes down.

The Golden, Colorado based company has already made an impact around the world, and they have established strategic partnerships with numerous large NGOs and medical companies who are helping them to deploy their solution widely. Potters and Callender aspire to scale significantly in the coming years, and to continue to broaden their applications (Potters even mentioned using the device for Botox). For now, they are addressing everything from standard flu to HPV to rabies, as they continue to listen to patient and caretaker feedback, and to improve the efficiency and effectiveness of their design.

For more information please check: PharmaJet

Thumbnail images by Nigel Cox and Jamie Kripke

source: http://geniuslunch.com

The American Correctional Association is the oldest and largest international correctional association in the world. ACA serves all disciplines within the corrections profession and is dedicated to excellence in every aspect of the field.  From professional development and certification to standards and accreditation, from networking and consulting to research and publications, and from conferences and exhibits to technology and testing - ACA is your resource and the world-wide authority in correction

Learn More Here

Franchising in Health Care Conference, PharmaJet's Chairman, Heather Callender-Potters, Speaker. Offices of Faegre & Benson LLP, Minneapolis, MN.

About the Conference

Faegre & Benson LLP is pleased to host the 2011 Franchising in Health Care Conference, held July 27-28, 2011, at the offices of Faegre & Benson in Minneapolis.

By 2020, health care spending in the United States is expected to increase to $4.5 trillion – or 19.3 percent of the nation’s gross domestic product. This growth offers tremendous opportunity to both franchisors and medical professionals.

Currently, more than 100 franchise systems offer franchisees the opportunity to provide some form of medical services, including in-home health care and senior care. However, current franchise models merely scratch the surface of available opportunities.

Franchising in health care requires compliance with franchise laws and numerous state and federal health care laws. Franchisors that proactively anticipate the complexity of this regulatory landscape – and design appropriate models – will be well-positioned to take advantage of unprecedented market opportunities.

The event, Franchising in Health Care Conference: Expand Access – Deliver Quality – Improve Lives™, brings together senior industry leaders from the franchise and medical fields to examine current franchise models, explore new patient care delivery methods, and discuss best practices for offering franchised services in the health care industry.

Learn More Here