What happens when policymakers and the life science industry come together to develop a strategy for smart investments that address economic competitiveness?

Growth, jobs, and better living for all. 

That’s precisely what has occurred in Pennsylvania during the last decade. Public-private partnerships have created a strong foundation for the life science industry, providing millions in loans, grants and other incentives to help attract private capital.

Because of this, Pennsylvania is a hotbed for the innovative life science industry — directly employing more than 79,000 Pennsylvanians and generating $7.2 billion in annual wages.

An example of this growth can be found right here in central Pennsylvania, which is now home to more than 200 established life sciencesA cluster of scientific disciplines concerned with human life and health. Included are many branches of biology (e.g., molecular biology, cell biology) and chemistry (e.g., biochemistry), as well as some areas of genetics, physics and materials science, among others. companies and more than 400 other companies classified as “life-sciences related,” participating in various stages of development of human health-enhancing products or services.

This local impact would not be possible without the strategic vision of our policymakers more than a decade ago, setting the stage for economic growth engines such as the Life Sciences Greenhouse of Central PA and the Hershey Center for Applied Research.

Today, our life science sector is the envy of much of the rest of the United States and the world. From 2001 to 2008, Pennsylvania’s life science sector grew almost five times as fast as the rest of the state economy. But it wasn’t always this way.

In the 1980s and ’90s, Europeans dominated the biomedical sector. In response, American policymakers worked with the leaders from the life science sector to implement a series of reforms designed to encourage innovation and protect intellectual property. The result? The United States took the crown from Europe and became the global leader in the biomedical arena.

But policymakers in Asia and Europe can’t help but notice our success. Now they’re pushing to attract biomedical firms with their own tax and regulatory reforms. To make this situation even more tenuous, the life science industry in Pennsylvania is at an inflection point.

Even though our life science industry is an economic powerhouse, a convergence of factors is limiting the potential growth of the industry in the commonwealth — including longer R&D cycles, unpredictable regulatory and reimbursement structures and an uncertain economic environment.

For Pennsylvania to keep its lead, we know that another round of smart, strategic thinking is necessary to nurture our life science ecosystem through the next decade. In October, the Pennsylvania Life Science Leadership Advisory Council convened around this common goal: Create a strategic plan for Pennsylvania that provides a road map to global leadership in the life sciences.

The council is composed of more than 40 individuals, including key industry leaders, business and health care groups, representatives of the Corbett administration and the co-chairs of the Life Science Caucuses.

Members of the council provided input, and the council identified five high-priority goals:

1. Promote the life science industry as a key driver of Pennsylvania’s economic competitiveness.

2. Ensure continued growth and vitality of the Pennsylvania life science community through ongoing monitoring, evaluation and action of its stakeholders to maintain competitiveness.

3. Support research and development of emerging life science technologies.

4. Seek investment capital to support early and midstage life science companies.

5. Encourage the creation of a tax system that provides a supportive environment for life science and other technology-based industry job creation.

The report is a plan to advance the life sciences over the next decade — and it is not lost that some of these recommendations will face funding challenges in the short term. However, the good news is that some of the proposals are already under way. Others require new public-private partnerships to succeed. Still others call for new private investment as well as resources from the commonwealth.

It also is important to recognize that this report is a living document that requires months and years of follow-through before it can be fully realized. It will evolve as the industry and the environment evolve — and will become a tool for continued action.

But most important, the recommendations delivered from the LSLAC report provide a road map to make Pennsylvania the most attractive place to operate a life sciences company.

With a collaborative effort, highlighted by the work of the council, Pennsylvania will undoubtedly continue its leadership throughout the U.S. and the global economy.

JRC-LAMP-Vax is a plasmid-based DNA vaccine that will be studied for the treatment of patients with rhino-conjunctivitis (runny nose) symptoms caused by allergic reaction to Japanese red cedar pollen. Almost 45% of the Japanese people are allergic to Japanese red cedar pollen. In North America, there is allergic rhinitis to mountain cedar pollen, which is 80% cross-reactive with Japanese red cedar pollen allergen.  ITI intends to partner with a Japanese pharmaceutical company for studies in Japan and will seek FDA approval of the vaccine in the US.

ITI provided FDA with animal studies of JRC-LAMP-Vax, showing no alteration of the routine clinical pathology, body weight, food consumption, temperature, ophthalmology, dermal irritation or the histopathology of any tissue examined microscopically. Overall, JRC-LAMP-Vax caused no abnormal safety issues in bio-distribution and toxicology studies in animals. This data was consistent with other reported animal and human studies of components of its vaccine.

Animal safety studies and human clinical studies have documented that LAMP DNA vaccine induces a protective antibody immune response consistent with a preferential MHC-II immune system presentation induced by the LAMP component. LAMP-based vaccines hold potential for the development of potent vaccines for treatment of allergies, infectious disease and cancer.  Previous research has specifically indicated that LAMP in the DNA vaccine molecule induces IgG protective antibodies and greatly diminishes the production of the allergy antibody, IgE. This represents a shift of the immune response to the vaccine from Th2 to Th1, the underlying concept for classic allergy desensitization. This re-education of the immune system response is the basis of the medically accepted paradigm for treating allergy by conventional allergy immunotherapy.

Dr. William G. Hearl, CEO of Immunomic Therapeutics, Inc., stated, “The IND authorization is the result of the long-term commitment and support of ITI and the continuous efforts contributed by its researchers and regulatory team.  It cannot be overstated what a significant accomplishment this is for our Company.  The expeditious FDA review and approval of our Phase I study plan is a testament to a strong scientific foundation and well-planned regulatory strategy.”

ITI has begun enrollment for the open label, Phase I, clinical study designed to establish the safety of the LAMP-vax platform and to provide important immune response data as it applies to allergy patients. The study will be conducted in allergy clinical centers based in Atlanta, GA and is expected to begin in June 2012. The primary objective of this Phase I Study is to evaluate both the safety and immunological response of therapeutic doses and the dosing regimen of JRC-LAMP-Vax vaccine.

About Immunomic Therapeutics
Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company headquartered in Lancaster, PA with lab facilities in Rockville, MD.  ITI is developing next generation vaccines based on the patented LAMP Technology. Our LAMP-vax platform significantly increases the effectiveness of the immune response to nucleic acid vaccines while simplifying overall vaccine design and delivery, yielding safer, more cost-effective human and animal therapies. Our LAMP constructs have been validated in human clinical trials for cancer and have been applied to a wide breadth of targets including allergy, cancer and infectious diseases.   For more information about ITI and LAMP Technology please contact Dr. Bill Hearl at 1-717-327-1919 or email Immunomix@gmail.com, or visit the IMMUNOMIX web site.

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“We are fortunate to have someone of Christophe’s caliber and experience and who has the passion and vision to drive game‐changing technology into products,” said Russo.

“Electro‐Mechanical Polymer is a revolutionary material,” said Ramstein. “It’s an inexpensive flexible plastic film that deforms under digital control, the world’s thinnest actuator. Its applications go beyond the imagination. My goal is to bring this actuator technology into production and deploy it in a wide variety of devices. We have great customer traction, sustainable differentiators, scalability, and a talented and passionate team.”

As CTO and SVP of research and enginering at Immersion Corporation (Nasdaq:IMMR), a leading developer and licensor of touch feedback technology, Ramstein led the development of haptic solutions for smartphones and tablets, as well as medical, automotive and gaming systems. He is the founder of Haptic Technologies Inc., a leading‐edge award‐winning haptics company acquired by Immersion in 2000. Ramstein is the author of numerous haptic patents and of a number of papers on haptics and multimodal user interfaces.

Dr. Ramstein holds a Master’s degree from the Institute Joseph Fourier (Grenoble, France) as well as a PhD in Applied Mathematics from the Polytechnic Institute (Grenoble, France).

About Strategic Polymers
Founded in 2006, Strategic Polymers (SPS) is the world¹s source of Electro‐Mechanical Polymers and developer of the world’s thinnest actuator. SPS is focused on designing, producing and delivering actuators to enable OEMS worldwide to deliver the most advanced multimodal user experience to their customers. SPS actuators are designed to animate mobile devices with better haptics and sounds, enrich the user experience and make any device more intuitive, realistic and more attractive to end users.

Connect with SPS on the web at www.strategicpolymers.com and on LinkedIn.

Contact Information:

SPS Investor Relations
Christophe Ramstein
cramstein@strategicpolymers.com

SPS Public Relations
Ausra Liaukeviciute
Mobile +1‐410‐802‐6999
aliaukeviciute@strategicpolymers.com

Williamsport, Erie, Harrisburg, Lancaster-York, State College

New and expanding businesses in the central and northern parts of the state now have more of a shot at getting the money they need to reach their goals.

The Commonwealth Financing Authority recently approved a $3 million loan to Penn Venture Partners, a Harrisburg venture capital firm that invests in companies in the Northern Tier, along with the central and south-central parts of the state. Steven Fishman, venture capital investment advisor with the state, says this loan made sense because the portions of the state outside of the Pittsburgh and Philadelphia areas – affectionately known as the T – often don’t get as much attention from traditional investors. “There’s a unique need for venture capital in the T,” Fishman says.

The $3 million is expected to fund investments in between three and six companies. Plans call for each investment to be between $500,000 and $1 million.

The companies that receive venture capital contributions will be chosen in part on their expectations to create jobs, Fishman says. The money is targeted at new and expanding businesses in sectors including education, software, energy and manufacturing.

The funders are expected to start examining investment opportunities in the coming months and could make their decisions in the next year or so, Fishman says.

Source: Steven Fishman, Department of Community and Economic Development
Writer: Rebecca VanderMeulen

Bethlehem, PA, March 12, 2012 – Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today it has entered into a distribution agreement with INyDIA Labs, based in Madrid, Spain, for My5-FU™, a test that measures levels of a widely-used anti-cancer drug, 5-fluorouracil (5-FU), in the blood of cancer patients.

“Our collaboration with INyDIA will allow us to provide cancer patients in Spain and Portugal more personalized treatment,” said Adrienne Choma, Esq., Sr. VP and chief marketing officer of Saladax. “With this agreement, we expandavailability of Saladax’s My5-FU diagnostic assay in the global market.”

INyDIA will be the exclusive provider of My5-FU test kits to laboratories in Spain and Portugal, enabling oncologists to individualize 5-FU dosing to optimize therapeutic efficacy and reduce toxicity for their patients. INyDIA, which specializes in producing in vitro diagnostic reagents and instrumentation, including array readers and liquid handling platforms, also offers its customers other manufacturers’ products focused in personalized medicine.

“We’re pleased to offer Saladax’s unique technology to oncologists in Spain and Portugal to ensure personalized care is provided to their patient populations,” said Santiago R. Maceira, country manager for INyDIA.

About My5-FU

Saladax’s first commercially available test for innovative dose management; My5-FU measures levels of 5-fluorouracil (5-FU), a widely used chemotherapy drug used in conjunction with other drugs in first-line therapy for colorectal cancer and other solid tumors. The assay technology enables oncologists to determine the optimal dose of 5-FU for each individual patient, thereby increasing the effectiveness of the drug and lessening the risk of severe toxicity and side effects.

About Saladax Biomedical, Inc.

Saladax Biomedical develops and commercializes novel diagnostic assays to achieve the promise of personalized medicine through dose management and companion diagnostic products for existing and new therapeutics. The Company’s dose management technology enables physicians to optimize drug dosing to meet individual patient needs, leading to improved response and quality of life. The Company’s 15 MyCare^TM dose management assays are comprised of proprietary, automated and cost-effective in vitro diagnostic tests, with a principal focus in oncology. The first MyCare assay available is for one of the most common anticancer drugs, 5-fluorouracil (5-FU). This assay is sold in the European Union by Saladax and its distribution partners as a CE-marked product and will be distributed in Japan by FALCO biosystems. In the United States and Canada, Myriad Genetic Laboratories, Inc. provides testing for 5-FU dose optimization under the trademark OnDose® through a license to Saladax proprietary technology. Saladax also works with pharmaceutical companies to develop companion diagnostics to provide important clinical information to assist in developing and administering new and existing compounds. For more information, visit www.saladax.com.

My5-FU is a registered trademark of Saladax Biomedical, Inc.

OnDose is a registered trademark of Myriad Genetics, Inc.

Saladax Biomedical, Inc.
Adrienne Choma, Esq.
Sr. VP & Chief Marketing Officer
achoma@saladax.com

Media Contact:

Tiberend Strategic Advisors, Inc.
212-827-0020
Andrew Mielach, amielach@tiberend.com or Jason Rando, jrando@tiberend.com

The following article was posted on PennLive on Monday, March 5, 2012

Penn State College of Medicine announced this morning it has been awarded a $425,000 grant as part of the Discovered in PA, Developed in PA program, from the Pennsylvania Department of Community and Economic Development.

Read the full article here:   http://www.pennlive.com/midstate/index.ssf/2012/03/penn_state_college_of_medicine_7.html

MID’s initial product offering is a minimally invasive device known as Permaseal™, which provides access and wound closure during structural heart repair procedures.  Designed to move with the beating heart while still keeping the edges of the wound closed, the Permaseal device not only enables wound healing without the use of sutures, it is cost- and time-efficient.

“The Permaseal access and closure device will enable unprecedented safe and reliable transmyocardial access for structural heart repair procedures,” says Michael Whitman, President & CEO.  “It is our hope that Permaseal becomes the new standard of care for access and closure for these procedures.”

The patent pending Permaseal technology allows the surgeon to remotely affix a biocompatible implant to the apex of the heart, creating an “access site” on the myocardial surface of the heart. This provides sutureless access for a wide range of structural heart repair procedures including transcatheter aortic valve implantation (TAVI), transcatheter mitral valve replacement, mitral valve repair and other emerging structural heart repair procedures.

About LSGPA

The Life Sciences Greenhouse of Central Pennsylvania (LSGPA) is advancing life sciencesA cluster of scientific disciplines concerned with human life and health. Included are many branches of biology (e.g., molecular biology, cell biology) and chemistry (e.g., biochemistry), as well as some areas of genetics, physics and materials science, among others. technologies and improving the lives of Pennsylvanians through investment in healthcare innovations. In addition to seed and pre-seed life sciences funding, LSGPA provides high-level, industry-specific consulting expertise and connections to angel investors, strategic partners, and resources. To learn more about LSGPA’s services and investment philosophy, visit www.LSGPA.com

About Micro Interventional Devices, Inc.

Micro Interventional Devices, Inc. (MID) is an early stage cardiovascular medical device company founded in May of 2010. MID is developing solutions to unmet needs in structural heart repair procedures, including transcatheter aortic valve implantation (TAVI), transcatheter mitral valve replacement, LVAD placement, mitral valve repair, valvuloplasty, aortic arch repair, ASD and VSD closure, left atrial appendage closure, ablation of arrhythmia and other emerging structural heart repair procedures. Located in Bethlehem, PA, MID is developing proprietary technology based on a breakthrough in soft-tissue anchoring and associated delivery devices that enable off-pump procedures. To learn more, please visit www.microinterventional.com.

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“It’s all about the tenacious execution of the value proposition that HCAR and our Region possesses that has made the difference with Pacific Edge and the other Australian companies, says Jack Atchason, Executive Director at HCAR.

Facing the proposition of launching a business in the US there is much to consider. Having a credible presence on the ground to assist with the planning and evaluation process makes a big difference. The HCAR staff fills that need. From the earliest engagement and continuously throughout the process the company must feel your desire to understand their needs, concerns, challenges, opportunities, and be able to design solutions directly or bring resources to the table to help in this regard. Understanding the resources available and how to generate new resources if unavailable, that helps the prospect company overcome a challenge or fill a need is critical. Also, making direct business connections for early business opportunities are also critical. The HCAR staff worked diligently to assist Pacific Edge in critical elements of their work.

This took coordination and teamwork of public and private elements in the economic development community of our region. The Commonwealth of PA and specifically The Department of Community and Economic Development and The Office of International Business Development helped considerably. CREDC, the LSGPA, Unilife, Penn State Milton S. Hershey Medical Center and College of Medicine, all played a part.  If we can continue to work together in a coordinated fashion we will be successful in continuing this momentum. Our region has so much going for it as a strategic location for emerging technology companies; we just have to continue to collaborate.

Pacific Edge Diagnostics, Ltd. is a leading developer of cancer diagnostic and prognostic tests. Its first product offering Cxbladder® has diagnostic and prognostic capabilities to Bladder Cancer, one of the most costly types of cancer to diagnose and treat.

Click here to view the video:  http://www.wgal.com/video/30338072/detail.html

- Steve Tullman named winner of Baldino CEO Award –

 - Awardees to be honored March 20 at PA Bio Annual Dinner –

Wayne, PA, February 9, 2012 — Pennsylvania Bio, the only statewide trade association representing Pennsylvania’s entire bioscience industry, announced today the winners of two of the association’s most prestigious awards: the Hubert J.P. Schoemaker Leadership Award and the Frank Baldino CEO of the Year Award.  Industry icon and longtime Chairman and CEO of Safeguard Scientifics, Warren V. “Pete” Musser, was named recipient of the Schoemaker award; Steve Tullman, serial entrepreneur and CEO of Ceptaris Therapeutics, was named recipient of the Baldino award.

Musser and Tullman will be honored at Pennsylvania Bio’s Annual Dinner and Awards Celebration March 20 at the Pennsylvania Convention Center.

The Hubert J.P. Schoemaker Leadership award recognizes an outstanding leader in the bioscience community who best exemplifies the spirit of innovation in the Commonwealth of Pennsylvania.  Dr. Hubert J.P. Schoemaker was one of the bioscience industry’s leading scientists and entrepreneurs, founding Centocor (now Janssen Biotech Inc.) and Garnet Biotherapeutics (formerly Neuronyx, Inc.).  He is widely noted as an inspiration and mentor to many industry CEOs, scientists, and executives.  His vision for the industry and for the region, as well as his spirit and will to succeed, remain among his great legacies.  The recipient of the Hubert J.P. Schoemaker Leadership award demonstrates a vision for the industry and for improving the lives of patients in the spirit that Dr. Schoemaker dedicated his professional career, and is selected by the Pennsylvania Bio Executive Committee based on nominations submitted by the Board of Directors.  Past winners of the Hubert J.P. Schoemaker Leadership award include: Frank Baldino, Jr. Ph.D., founder, former Chairman and CEO, Cephalon (2006); David Holveck, President & CEO, Endo Pharmaceuticals (2007);  Jean-Pierre Garnier, Ph.D., former CEO, GlaxoSmithKline (2008); Joseph Scodari, former Worldwide Chairman, Johnson & Johnson Pharmaceuticals (2009); Brenda Gavin, Partner, Quaker BioVentures (2010); and Bruce Peacock, Partner, SV Life Sciences Advisors (2011).

The Frank Baldino CEO of the Year award recognizes a CEO who has demonstrated visionary leadership and active participation to advance the industry.  He or she will have a record of proven, exceptional achievement as well as a commitment to the biosciences for the benefit of patients.  Frank Baldino, Jr., founder and CEO of Cephalon, Inc., was a pillar of the Life Sciences community in the Greater Philadelphia region and of the biotechnology industry as a whole, fostering a scientific idea from a small start-up into an international leader hailed for its dedication to providing medicines that answer unmet medical needs.  In addition to his work growing Cephalon into a global leader, Frank Baldino was an active community leader providing his personal time and resources to causes ranging from education to the arts.  The recipient of the Frank Baldino CEO of the Year award must be from a small company with less than 250 employees and exhibit these leadership qualities.  The honoree is selected by the Pennsylvania Bio Executive Committee from nominations provided by the Board of Directors.  The winner of the inaugural Frank Baldino CEO of the Year award was Dr. Philip P. Gerbino, President Emeritus of the University of the Sciences in Philadelphia.

“Pete and Steve truly embody the definition of the awards they are receiving,” said Christopher P. Molineaux, President of Pennsylvania Bio.  “For Pete, this comes ‘full circle’ as he invested heavily in Dr. Schoemaker’s success story, Centocor, through Safeguard Scientifics.”

“We are thrilled to honor these two great industry leaders,” added Vincent Milano, President & Chief Executive Officer of ViroPharma Incorporated and Chairman, Pennsylvania Bio Board of Directors.  “Pete has long been a leader for our industry in the Commonwealth and globally, and Steve represents many of the attributes that Frank Baldino passed down to those of us fortunate to know him and work with him.”

Pennsylvania Bio’s annual dinner and awards celebration is the region’s most anticipated and highly attended events for top life science professionals and business executives.  More than 900 attendees come together to celebrate our industry’s successes and its outstanding leaders.  The Hubert J.P. Schoemaker Leadership Award and the Frank Baldino CEO of the Year Award are the evening’s premier honors.

For more information on the annual dinner and to purchase tickets, please visit http://www.pabio.org/?page_id=646.

About Pennsylvania Bio

Pennsylvania Bio is the only state-wide trade association for the life sciencesA cluster of scientific disciplines concerned with human life and health. Included are many branches of biology (e.g., molecular biology, cell biology) and chemistry (e.g., biochemistry), as well as some areas of genetics, physics and materials science, among others. in Pennsylvania and serves as a catalyst to ensure Pennsylvania is the global leader in the biosciences by creating a cohesive community that unites our biotechnology, medical device, diagnostic, pharmaceutical, research, and financial strengths.  More information is available at http://www.pabio.org.

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Saladax Biomedical announced today a collaborative study of metastatic colorectal cancer patients treated with 5-fluorouracil, or 5-FU, and whose doses will be optimized based on actual 5-FU blood levels.

As part of the collaboration with the Central European Society for Anticancer Drug Research, or CESAR, Saladax’s My5-FU immunoassay technology will be used to measure 5-FU levels.

CESAR is sponsoring the single-arm study, which is designed “to determine whether target blood levels of 5-FU can be maintained during the course of treatment by optimizing the dose administered to individual patients at each infusion,” the Bethlehem, Penn.-based company said in a statement. The two partners aim to achieve a stable target blood level of the chemotherapeutic and investigate whether this dose optimization can reduce 5-FU-related toxicities.

Financial and other terms of the deal were not disclosed.

The study, which involves four centers and will enroll 80 patients with metastatic colorectal cancer, is expected to last one year. Patients will remain in the study until a total of six doses of 5-FU treatment has been administered and the end-of-treatment visit has been conducted, Saladax said.