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Qiagen NV, a leading global provider of sample & assay technologies, has received the two US Food and Drug Administration (FDA) 510(k) clearances for its real-time PCR (polymerase chain reaction) instrument Rotor-Gene Q MDx and a compatible test for the detection of Influenza A/B, the artus Infl A/B RG RT-PCR Kit, for in vitro diagnostic use (IVD).

“The FDA clearances for the Rotor-Gene Q MDx along with the first assay for use on this system represent an important milestone for Qiagen,” said Peer M Schatz, chief executive officer of Qiagen NV. “The various Rotor-Gene Q models marketed by Qiagen are not only an integral part of our revolutionary lab automation platform QIAsymphony RGQ, but are also among the most widely used stand-alone molecular detection platforms worldwide. Outside the US, our customers already have access to a broad portfolio of molecular diagnostic tests for use on these platforms. The FDA clearances now pave the way to make this market-leading assay portfolio available to clinical laboratories in the US as well.”

Open Innovation

By providing a platform for idea-sharing, Open Innovation Drug Discovery lowers the barrier for collaborations between investigators working inside and outside an organization. Free exchange of ideas between investigators across traditionally impregnable organizational walls contributes to the advancement of Science.

Through prior experience with the Phenotypic Drug Discovery program (PD2), Lilly has established a network with academic and biotech investigators outside our walls to provide them access to proprietary, disease-relevant phenotypic assays. Today, we expand this partnership with top global research talent by adding sophisticated in vitro target-based assays (TargetD2) through our Open Innovation Drug Discovery program.

Johns Hopkins University

Johns Hopkins University dedicated its new $1.1 billion hospital this month and Hopkins alum and major donor New York City Mayor Michael Bloomberg was on hand for the ceremony.

"The 205-room Charlotte R. Bloomberg Children’s Center features 10 surgical suites, a 45-bed neonatal intensive care unit," the Wall Street Journal writes.

Bendis

Tech Transfer Speaker's Series FREE monthly program (2nd Wednesday of each month) offered through the Gateway to Innovation: Montgomery County Welcome Center for Federal and Academic Tech Transfer. For more information and additional calendar items, please visit www.techtransferconnection.com.

Engage with others in the tech transfer field by joining the Gateway to Innovation LinkedIn Group.  To register go to http://www.linkedin.com/groupRegistration?gid=3805575

Location: Shady Grove Innovation Center 9700 Great Seneca Highway Rockville, Maryland 20850

Time: May 9, 2012 3:30 - 5:00pm

Presenters: Richard A. Bendis, Interim CEO BioHealth Innovation, Inc. and Mark L. Rohrbaugh, Ph.D., J.D., Director National Institutes of Health, Office of Technology Transfer

Topic: What is a BioHealth Innovation Ecosystem and How is it Supposed to Work?

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The Tech Council of Maryland (TCM), Maryland's largest technology and life science association, announced the finalists for its 24th annual TCM Tech Awards. Winners will be announced during the awards gala on April 26 at the Bethesda North Marriott Hotel and Conference Center.

"The TCM Tech Awards celebration is one of the preeminent events in Maryland, where more than 900 leaders in the state's high tech and life sciences communities convene for networking, entertainment, and to honor the best-of-the-best in our industries," said Art Jacoby, TCM's CEO. "Maryland's Life Science and Technology companies are leading the way to a healthier world and a higher standard of living for all. We celebrate the collective success of our region and the special contributions of our finalists and award winners."

Mikulski

U.S. Senator Barbara A. Mikulski (D-Md.), a senior member of the Senate Health, Education, Labor and Pensions (HELP) Committee, continued her Maryland biotechnology listening tour at a roundtable discussion with Frederick County pharmaceutical companies at MedImmune. Senator Mikulski has continued to meet with members of the Maryland medical industry as the Senate HELP Committee examines reauthorizing user fee legislation, which supports the biotechnology, pharmaceutical and medical device industries that account for nearly 90,000 Maryland jobs and works to keep families safe and healthy.

"In Maryland, biotech means jobs, jobs, job," said Senator Mikulski, a senior member of the Senate HELP Committee and a member of the Drug Shortage Working Group. "I have heard from Maryland pharmaceutical companies, hospitals, doctors, nurses and patients about the need for safe and effective treatments that are both readily available and affordable. I'm proud to support research and innovation jobs in Maryland's biotech industry keeping our state competitive in the global economy. By working to develop safe and effective treatments, we can ensure that our nation's health care providers have the tools they need to keep families healthy."

Barbara Mikulski

Nearly 90,000 Maryland jobs come from the state's 400 biotechnology companies, so when a senior Democrat on the Senate committee looking into industry regulations asks for a meeting, local businesses are the first to the table.

Sen. Barbara Mikulski, D-Md., met with representatives from several Frederick County biotech companies Tuesday at MedImmune, a Frederick-based pharmaceutical firm. The discussion, the third stop on Mikulski's Maryland biotech listening tour, focused on the Prescription Drug User Fee Act and the Medical Device User Fee Act.

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This day-long event will explore the opportunities for accelerating technology transfer in those universities that have not traditionally focused on this activity. It will demonstrate how this has been successfully achieved at places like Johns Hopkins.

Johns Hopkins Technology Transfer rose from 98th to 26th in the AUTM rankings within 4 years. It has increased disclosures from less than 100 to more than 300 a year and start ups from less than 5 to more than 10 a year. Other institutions like The Ohio State University are doing similar things. These newly emerged academic centers in technology transfer are showing how even late-comers can make the quantum leap in technology transfer.

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In recent months, state and federal policy makers have launched a broad set of innovative programs aimed at accelerating technology transfer, the commercialization of government- and university-created intellectual property, or IP, through licenses and business startups. This fall, for example, the Obama administration directed federal agencies and labs to measure and expand their technology transfer efforts. At the state level, Gov. Martin O’Malley’s (D-MD) Maryland Innovation Initiative, announced in January, would provide seed funding and foster greater cross-university collaboration to help close the state’s gap between its research levels and commercialization results.

Some universities, too, are rethinking their policies. Penn State, for example, announced in December that the university is no longer required to own intellectual property created by industry-sponsored research. “In short we consider the net present value of the interactions and relationships that our faculty and students have with industrial professionals to be real and therefore greater than the apparent future value of the proceeds from such IP,” wrote Hank Foley, Penn State’s vice president for research, in announcing this news. “Our goal … is to flatten any and all barriers or impediments to innovation and that includes our own past stance on intellectual property.”

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Emerging Technology Center JHU Eastern, 1101 East 33rd Street, Baltimore, MD

Join Governor Martin O'Malley for a reception and press conference celebrating Innovate Maryland.

Inspiring collaboration, commercialization and job creation in public and private universities.

Please register to This email address is being protected from spambots. You need JavaScript enabled to view it.

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The National Capitol Area Chapter of SoPE in concert with Johns Hopkins Carey Business School, MedChi, and Medical Society of Northern Virginia presents:

"Beyond the Stethoscope--How MD-MBAs Influence the Current Challenges in Healthcare"

Telling Our Stories: How physicians have taken the science of business and integrated it with their medical training to accelerate their faculty positions, redefine their careers, change their perspectives and leave a bigger footprint.

HIG

H.I.G. BioVentures, a Miami-based venture firm with ties to Maryland’s biotech cluster, has raised a fresh $268 million to invest in drug, medical device and diagnostics companies.

Managing Director Bruce Robertson, who lives in Maryland and is a familiar face in the I-270 life sciences community, said he’s “very optimistic” the firm will be able to deploy some of that capital in the D.C. region – something that hasn't happened with H.I.G’s last $150 million bio fund.

FLC

The President has issued an innovation challenge, and the Federal Laboratory Consortium for Technology Transfer (FLC) can help you answer it! Join the FLC at its 2012 national meeting, Bridging Federal Technologies and Industry, in Pittsburgh, Pa., April 30-May 3, at the Sheraton Station Square Hotel.

The meeting offers technology transfer (T2) training, as well as informational sessions such as:

  • Partnering with federal laboratories
  • Leveraging social media • Available entrepreneur programs
  • Case studies
  • And much more!

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With President Barack Obama signing the Jumpstart Our Business Startups Bill into law today, the crowdfunding provision could mark a new era for startups and make it easier to raise money with more investment from new investors who fuel early and later-stage healthcare companies.

But some investors believe that with less-rigorous regulatory checks and balances on company finances, the risk of investors getting burned by fraud will lead to new dynamics in the investment landscape, like novice investors partnering with individuals and groups with more experience. Three individuals from the investment landscape share their thoughts.

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For scientists pursuing careers in biotech, clusters of life science-related companies and research institutions in the eastern United States may be a promising place to look for jobs. These so-called bioclusters have a 30-year history in the region and, in recent years, have seen an uptick in active support from academic institutions and state and local governments. We focus on three leaders in the region, the bioclusters in Massachusetts, Maryland/Washington, DC, and North Carolina. By Shawna Williams

Bioclusters have their roots in a pair of 1980 government decisions, explains Peter Abair, head of economic development and global affairs at the Massachusetts Biotechnology Council, an industry group. One of these, the Bayh-Dole Act, for the first time allowed discoveries made with federal dollars to be licensed for commercial purposes. The other was a Supreme Court decision that DNA could be patented.

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Join us on April 25th at Stella Restaurant for another BioBuzz in Montgomery County!

This month's corporate sponsor, BioHealth Innovation, inc. (BHI) is an innovation intermediary that translates market-relevant research into commercial success by connecting management, funding and markets. BHI's vision is to transform the Central Maryland region into a leading global bio-health entrepreneurial and commercialization hub. BHI will identify and translate market relevant research into commercial success by connecting research assets to appropriate funding, management and markets.

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When the Human Genome Project got underway in 1990 it was expected to take 15 years to sequence the over 3 billion chemical base pairs that spell out our genetic code. In true Moore’s Law tradition the emergence of faster and more efficient sequencing technologies along the way led to the Project’s early completion in 2003. Today, 22 years after scientists first committed to the audacious goal of sequencing the genome, the next generation of sequencers are setting their sites much higher.

 

About a thousand times higher.

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In the world of drug development, honing an effective molecule is just the first step. As everyone in the drug delivery business knows, issues like solubility, permeability and targeting can be vexing challenges to getting treatment where it needs to go. But what if you could deliver drugs the same way the body dispatches white blood cells to fight infection, or the same way a virus proliferates throughout the body?

That's what researchers at U.S. universities are working on, aiming to develop synthetic cells that could target ailments and release drugs to treat them. As Popular Mechanics reports, scientists at the University of Pennsylvania are using plastics to build artificial white blood cells called leuko-polymersomes, which would be guided by synthetic molecules designed to mimic the natural receptors white blood cells use to find enflamed tissues and stick to them.

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Dr. Charles Hamner has been researching the nanotechnology industry since, as he puts it, “before they called it nanotechnology.”

But he says it’s not an industry – “It’s a community, because the technology is going to spread across all industries,” particularly into biotechnology.

 

Nanotech deals with small particles, at the molecular level, and is applied by companies to create technological innovation. An example is Liquidia, a biotech that uses the nanoparticles in its vaccines.

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Maryland has chosen a London firm to oversee the selection of venture capital firms interested in making investments in young state companies through the InvestMaryland program.

Altius Associates was tapped to ensure the process is open and transparent and not influenced by the state, the Maryland Department of Business and Economic Development said in a statement.

NCATS

Over the past decade, collaborative research efforts to support the discovery and development of medicines has increased dramatically. Last month, the National Institutes of Health and Eli Lilly and Company announced a new collaboration: they will generate a publicly available resource to profile the effects of thousands of approved and investigational medicines in a variety of advanced disease-relevant testing systems [1]. In-depth knowledge of the biological profiles of these medicines may enable researchers to better predict treatment outcomes, improve drug development, and lead to more specific and effective approaches.

MedImmune

Pharmaceutical giants AstraZeneca PLC and Amgen Inc. just announced a deal to co-develop and co-commercialize five product candidates, all monoclonal antibodies. No surprise here: LLC    – AZ’s Gaithersburg-based biologics arm that specializes in antibody-based products — will be taking on a good deal of the work.

The Maryland biotech took the lead on negotiating the transaction with Amgen and will lead the development of three of the five compounds, President Peter Greenleaf said in an interview Monday afternoon.

BioBeat

Back in the old days of biotech, the business was pretty straightforward. You’d craft your scientific idea, aim a new drug at patients in need, charm investors to give you some money, run bang-up clinical trials, win FDA approval. Do all that, and you’re good as gold. Charge insurers whatever the market will bear, and count the money.

That model worked for a long time, but there’s another hoop everyone needs to jump through now, and I’m not sure everyone in the industry has fully come to terms with it. No matter what happens with President Obama’s healthcare reform in the Supreme Court or Congress, there are forces now that limit what society will pay for new drugs. We don’t have actual price controls in the law, but the pressure to wring costs out of the $2.6 trillion U.S. healthcare system is intense and will only grow as the baby boomers get older. Drugmakers can’t duck and hide from this issue anymore.

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Companies like Starbucks (NASDAQ:SBUX), Amazon.com (NASDAQ:AMZN) and Apple (NASDAQ:AAPL) aren’t healthcare companies, but one venture capitalist believes their example can guide personalized medicine.

Bob Kocher, a partner at venture capital firm Venrock, said that these consumer-focused companies have all taken steps toward personalizing their offerings. Personalization increases the value of those offerings and helps the companies make delivery of services and products more efficient.

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Gene scans for everyone? Not so fast. New research suggests that for the average person, decoding your own DNA may not turn out to be a really useful crystal ball for future health.

Today, scientists map entire genomes mostly for research, as they study which genetic mutations play a role in different diseases. Or they use it to try to diagnose mystery illnesses that plague families. It's different from getting a genetic test to see if you carry, say, a particular cancer-causing gene.

But as genome mapping gets faster and cheaper, scientists and consumers have wondered about possible broader use: Would finding all the glitches hidden in your DNA predict which diseases you'll face decades later?

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Fuad El-Hibri has started a financial consulting business. He’s started telecommunications businesses.

But his most challenging venture has been the Rockville biotech he helped launch 14 years ago.

Still, El-Hibri — CEO and board chairman of Emergent BioSolutions — says the challenges are worth it, because the rewards are so great from protecting and saving lives.

 

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Following a considerable contraction in investment dollars in 2008 and 2009, the U.S. angel investor market continued to recover in 2011, a trend that began in 2010 in investment dollars and in the number of investments, according to the 2011 Angel Market Analysis released by the Center for Venture Research at the University of New Hampshire.

Total investments in 2011 were $22.5 billion, an increase of 12.1 percent over 2010 when investments totaled $20.1 billion. A total of 66,230 entrepreneurial ventures received angel funding in 2011, an increase of 7.3 percent over 2010 investments, and the number of active investors in 2011 reached 318,480 individuals, a substantial growth of 20 percent from 2010.

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Shares in AstraZeneca ticked up after the Anglo-Swedish drugs giant announced a tie-up with biotechnology giant Amgen to develop and commercialise five treatments.

Under the terms of the agreement, Astra will make a one-off upfront payment of $50m and the companies will share costs and profits on the drugs for a variety of inflammatory, respiratory and auto-immune diseases.

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Pharmaceuticals have figured that out that if they can't be as innovative or nimble as biotechs, the next best option is to pay for their good ideas with licensing deals and acquisitions.

And what better way to identify those potential deals than to cozy up to the biotechs?

Invite them into your homes

Earlier this year, Johnson & Johnson (NYS: JNJ) opened an incubator within its San Diego campus to house biotech startups. Janssen Labs -- named after one of Johnson & Johnson's drug divisions, Janssen Pharmaceutical -- is a no-strings-attached affair with startups free either to develop the products on their own or partner with Johnson & Johnson or another company.

Johns Hopkins University was tops for research and development spending in 2010.

Surprise, surprise — Johns Hopkins University    spent more money on medical, science and engineering research than any other university in fiscal 2010.

Hopkins topped the research and development spending list, compiled by the National Science Foundation    , for the 32nd consecutive year. The 2010 data is the most recent available.

Hopkins also tops the foundation’s list for federally funded research and development.

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No matter how privatized healthcare is in America, at the end of the day it remains a social sustainability issue and a government concern. That’s why America’s newly minted CTO Todd Park is sparking health care innovation and reform through liberation of data from the vaults of NIH, FDA, CMS, USDA, CDC and other government health agencies.  Park believes that de-centralization and data liberation leads to empowerment and innovation.  In this interview at the Healthcare Experience Design Conference in Boston, Park outlines his initiatives to catalyze the ecosystem of health services by unlocking data.

Prior to being appointed the CTO of America to the White House, Park was a successful health IT entrepreneur who co-founded Athenahealth and Castlight, then served as the CTO at Health and Human Services (HHS). His Health Data Initiative (HDI) is mandating that HHS agency data be publicly accessible in machine readable format using APIs.

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Dingman Center Angels

The Dingman Center Angels connects regional start-up companies seeking seed and early-stage funding with angel investors.

Facts About Dingman Center Angels

  • Over 150 companies submit applications to Dingman Center Angels each year
  • $4M invested in start-ups since our inception in 2005
  • 50 qualified angel investors and venture capitalists comprise our network
  • Partnerships with incubators, economic development orgs and service providers in the region
  • Companies receive coaching to prepare for their pitch

Barbara Mikulski

U.S. Senator Barbara A. Mikulski (D-Md.)

U.S. Senator Barbara A. Mikulski (D-Md.), a senior member of the Senate Appropriations Committee, today spoke out in support of Maryland's health research and innovation economy at a fiscal year 2013 oversight and budgetary hearing of the Senate  Appropriations Subcommittee on Labor, Health, and Human Services, Education, and Related Agencies for the National Institutes of Health (NIH). The hearing included testimony from NIH Director Dr. Francis Collins, MD.

"I am for being frugal but we must not jeopardize or hamper America's gold standard as the worldwide leader in medical research and innovation," Senator Mikulski said. "NIH invests in the best and brightest scientific minds at universities, in the public and private sector, and with our federal employees."