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Top pharmaceuticals face a dilemma in that many blockbuster drugs are losing patent protection and existing pipelines may not compensate for lost revenues. The choice for many is layoffs, office closings, downsizing or to innovate with new products. Most companies will do the former if they must but prefer the latter. Rather than the megamergers that achieve big cost savings through layoffs and factory closings, most drug companies are aiming for transactions that grow their bottom line. In the last few years, this trend has resulted in a complex series of deals and transactions, ranging from complete buyouts to licensing transactions to a variety of collaborative arrangements.

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The Nasdaq Biotechnology Index (NBI) has been on a wild ride in 2014 with a 20 percent gain in the first two months, a 24 percent drop from late February to mid-April, and a rebound of 16 percent off April lows by early June. This recent sell-off follows a 130 percent gain over the last three years and the debut of 100 biotech IPOs, leading some investors to ask if the recent sell-off is the start of a bubble bursting.

Indeed, the biotech sector has been hot for the last couple of years, but there is very little evidence to support that biotech has been forming a bubble ready to pop.

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Over the last two and a half years the National Science Foundation I-Corps has taught over 300 teams of scientists how to commercialize their technology and how to fail less, increasing their odds for commercial success.

After seeing the process work so well for scientists and engineers in the NSF, we hypothesized that we could increase productivity and stave the capital flight by helping Life Sciences startups build their companies more efficiently.

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Just how valuable is "technology transfer" for universities?   This question is addressed in "More than Money: The Exponential Impact of Academic Technology Transfer," an article from the National Academy of Inventors (NAI) that examines the impact of landmark 1980 legislation that facilitated technology transfer from the academic inventors' "bench" to commercialization and the far-reaching and beneficial changes for universities and communities that have resulted.

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A collaboration between the National Science Foundation (NSF) and the National Institutes of Health will give NIH-funded researchers training to help them evaluate their scientific discoveries for commercial potential, with the aim of accelerating biomedical innovations into applied health technologies.

I-Corps at NIH is a pilot of the NSF Innovation Corps (I-Corps) program specially tailored for biomedical research. Academic researchers and entrepreneurs with Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Phase I awards – awards that establish feasibility of proof of concept for commercializable technology – from participating NIH institutes will be eligible to apply to I-Corps at NIH. NIH will begin outreach to the small business research community with a June 25 program briefing at the 2014 BIO International Convention in San Diego, and a webinar on July 2.

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The U.S. Food and Drug Administration on Tuesday issued proposed guidelines for the pharmaceutical and medical device industries for posting information on social media networks and correcting misinformation posted by others.

The long-awaited guidance would effectively limit the amount of product advertising a company can do on sites where character space is limited, such as Twitter.

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At Novartis’s research lab in Cambridge, Massachusetts, a large incubator-like piece of equipment is helping give birth to a new era of psychiatric drug discovery. Inside it, bathed in soft light, lab plates hold living human stem cells; robotic arms systematically squirt nurturing compounds into the plates. Thanks to a series of techniques perfected over the last few years in labs around the world, such stem cells—capable of developing into specialized cell types—can now be created from skin cells. When stem cells derived from people with, say, autism or schizophrenia are grown inside the incubator, Novartis researchers can nudge them to develop into functioning brain cells by precisely varying the chemicals in the cell cultures.

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Governor Martin O’Malley and The Maryland Department of Business and Economic Development announced today that Cellphire, a Rockville biotechnology company, has received a $1 million investment through the State’s InvestMaryland program. Cellphire is developing stabilized cellular products, including freeze-dried platelets that can be stored for years, for use in a range of advanced therapeutic and diagnostic applications.

“Supporting entrepreneurs and innovators like those at Cellphire is a central piece of Maryland’s broad support of the startups and small businesses that move our Innovation Economy forward and keep our State competitive in the 21st Century,” said Governor O’Malley. “Maryland is a center of healing and discovery. The technology being developed by Cellphire has the potential to improve care and save lives around the globe.”

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Researchers at WellDoc® today presented updated results of its hypoglycemia prediction technology at this week’s 2014 American Diabetes Association 74th Scientific Sessions. In previous work, using just one week of blood glucose data, WellDoc’s models were shown to predict correctly 90 percent of the time that hypoglycemia would occur the following day. Today, WellDoc announced an enhanced model that incorporates both glucose and medication data has demonstrated the ability to predict hypoglycemia within a specific hour.

“The challenge in predicting hypoglycemia is that most patients with type 2 diabetes measure their blood glucose once or twice per day. This so-called ‘sparse data’ makes mathematical forecasting difficult,” states WellDoc Chief Data Science Officer, Anand Iyer, Ph.D. “We used machine learning algorithms which allow the computer to detect patterns and make predictions after being trained on thousands of data points.”

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MedImmune, its parent company AstraZeneca and a handful of other pharma companies and health groups announced a broad lung cancer trial on Monday, looking to use patients' genomic profiles to match them with therapies.

The Lung Cancer Master Protocol, or Lung-MAP, trial will explore five product candidates as treatments for advanced squamous cell lung cancer. That includes MedImmune's MEDI4736, according to spokeswoman Tracy Rossin.

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America is still the world leader in creating new medical technologies that have the potential to save lives. So why is it so tough for the entrepreneurs and investors behind these new products to make a living here?

One reason, according to venture capitalists, is long, costly delays before getting new treatments to market, in some cases caused by health insurers dragging their feet when it comes to agreeing to reimburse doctors for using new medical products.

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A new report from Rock Health looking at the future of the biosensor wearables market shows a market in transition. The next generation of wearables is more targeted towards patient populations, particularly chronic conditions. In a Google hangout about the report, Malay Gandhi, a co-author of the report, talked about some of the qualities that are making these wearables more appealing to consumers and the b2b market and features that will give them staying power.

Athletic trackers aimed at the mass market have lost ground Nike’s exit from the wearables market shows there are far more fitness tracking devices than the market can support. There’s also a certain amount of consumer fatigue because the accuracy of fitness bands can vary. It’s difficult to keep most consumers interested in using them after six months. That prompted The New York Times article comparing these wristbands to “digital snake oil.”

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Rockville-based CytImmune received $100,000 from Montgomery County's equity investment program to help the company advance its industry-leading work in the development of tumor targeted nanomedicines.

The County's investment was made by the Montgomery County Department of Economic Development, in conjunction with a $200,000 equity investment made by the Maryland Venture Fund, which is administered by the Maryland Department of Business and Economic Development (DBED). Both the County's and State's investments in CytImmune are part of a broader strategy to support the growth and development of innovative companies.

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EntreMed (Nasdaq: EMND) has been through plenty of turbulence. In 1998, it was the subject of a breathless front page New York Times story suggesting the biotech was on the verge of curing cancer, based on promising mice studies. Those hopes (and EntreMed's share price) deflated in the coming years, when the company found itself shedding jobs and executives and struggling to survive.

But through it all, EntreMed remained EntreMed. No longer: the Rockville company's shareholders have voted to change its name to CASI Pharmaceuticals, as of June 16. The company will now trade under the ticker symbol CASI.

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kloudtrack®, a leader in cybersecurity and cloud computing (cyber|cloud) technologies and solution services for sensitive data, process management and Governance, Risk and Compliance (GRC), will team up with the University of Maryland'sRobert H. Smith School of Business and Cisco Systems (NASDAQ:CSCO) to establish the first Innovation Sandbox™ exchange catering to the innovation, workforce development and technology roadmapping needs of public and private sector healthcare, and medical and life science (HealthTech) organizations.   

The project was announced as part of today's Maryland Economic Development Association Summer Conference at UMD, themed "Health Innovations: Impact on Economic and Workforce Development."

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After all the angst generated by the Affordable Care Act, and all the punditry, noise, and debate that accompanied its rollout, you might conclude that there are no practical solutions to our healthcare challenges.  But, of course, there are new answers and solutions and new, creative approaches to solving healthcare problems. You just have to look at innovative, private sector enterprises.  And if you do, you might find one of the more innovative answers to eldercare right there in your old-fashioned television set.  Just ask Kian Saneii, CEO of Independa.

But first, a little background.  One of the more troubling and difficult areas of healthcare is the growing needs of the elderly, including both preventive care and the management  of long-term, chronic illnesses.   This has been a well-understood fact for quite some time.  Saneii and the Independa team he began assembling in 2009 set out to find practical real-world solutions to these challenges.  How they did this is an instructive case study in innovation, pragmatism and common sense.

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EY unveiled on Thursday evening its 2014 Entrepreneur of the Year Maryland winners in eight categories.

The honorees were announced in front of a packed crowd at a black-tie event at the Hilton Baltimore. The awards program recognizes high-growth entrepreneurs who demonstrate excellence and success in such areas as innovation, financial performance and personal commitment to their businesses and communities.

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Maryland has retained top rankings in the U.S. Chamber of Commerce Foundation’s annual Enterprising States study released Wednesday.

For the third consecutive year, the State ranked No. 1 in Innovation and Entrepreneurship. For the second year in a row, Maryland ranked third in the nation for its Talent Pipeline.

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Maryland is missing out on as many as 7,000 jobs and millions of dollars of investment as companies build data centers in neighboring Virginia, according to a report from Baltimore accounting firm Glass Jacobson.

Data centers provide cloud storage and are crucial to supporting the kinds of technology firms that have been opening in and relocating to Baltimore.

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I read an interesting Wall Street Journal article recently that discussed the war between tech companies to control future consumer distribution platforms. The article explains that the cash-flush giants “…each want to own the digital platform where people communicate, shop and seek entertainment.” This got me thinking about platforms in healthcare.

Right now, it’s fair to say that there are three major healthcare platforms. Insurance companies such as Aetna, WellPoint, United Healthcare and Humana have substantial members. However, mentioned in the article is the continual need for innovation. Tech behemoths are“…aware of all the big companies that died because they rested on their laurels.”

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Novavax Inc. (Nasdaq: NVAX) said Wednesday it has raised $115 million in gross proceeds by selling 28.75 million shares of its common stock, which the Gaithersburg biotech plans to pour into its pipeline.

Some of the net proceeds will go toward advancing Novavax's Respiratory Syncytial Virus (RSV) nanoparticle vaccine into a Phase 2 trial in elderly subjects this year. The biotech is also studying its RSV vaccine for pediatric and maternal populations.

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The University of Maryland, along with the George Washington University and Virginia Tech, have added the Johns Hopkins University to the National Science Foundation's  Innovation Corps (I-Corps ™) regional collaboration called DC I-Corps.  JHU becomes the newest member university of the National Science Foundation's National Innovation Network.

The NSF has approved a request from the three original universities to officially include Johns Hopkins in the I-Corps program's "node" in the Mid-Atlantic called DC I-Corps, which was formed last year with $3.75 million in NSF funding. It is one of five regional nodes established nationwide by the NSF, and the first to expand its membership. Together, these five nodes currently form the basis of the National Innovation Network, which links together select universities with established entrepreneurs and venture capitalists to train faculty and student researchers from throughout the U.S. to transform ideas into products and get them on the market.

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This brief analyzes entrepreneurship and job creation in the U.S. life sciences sector—defined as the group of industries engaged in the application of biological science and related knowledge for commercial purposes, primarily for human health care. This definition contains three major subgroups: drugs and pharmaceuticals; medical devices and equipment; and research, testing, and medical laboratories.

Building on previous research that highlights the importance of entrepreneurship and business dynamism to innovation, productivity, and net job creation, this brief analyzes how those trends apply to the life sciences sector. Overall, the life sciences sector plays an outsized role in new job creation and makes important contributions to entrepreneurship—not to mention the perhaps immeasurable benefits these firms play in enhancing and extending human life.

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Tiny biotech startups will have a new place to germinate in the San Francisco Bay Area. Healthcare giant Johnson & Johnson’s Janssen Labs division is opening a new 30,000 square foot incubator in the biotech-rich suburb of South San Francisco.

The flexible space, complete with common rooms, wet labs, and offices, could hold as many as 50 companies, according to Melinda Richter, a Bay Area incubator veteran tapped last year to head Janssen Labs nationwide. That would roughly double the group’s nationwide capacity, part of the international company’s aggressive reach beyond its walls to find, and fund, new science and technology. “We’re taking a big footprint,” Richter said, with half devoted to shared research equipment and services and half to space that can be customized to individual tenants.

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The heightened private equity and venture capital (PEVC) deal activity in the global healthcare industry during the recession years, 2008-2010, witnessed a decline post-2010. However, the fall in deals was not uniform among the constituent sectors, with the pharmaceutical, biotechnology and healthcare equipment sectors experiencing a much sharper decline in investor interest than the healthcare technology and provider segments. Investors started to bet on providers based with the conviction they can provide quicker and safer returns than the pharmaceutical and biotechnology space, which is ridden with regulatory challenges and patent expiries.

New analysis from Frost & Sullivan's Private Equity and Venture Capital Investment in the Global Pharmaceutical and Biotechnology Industry reveals the total number of PEVC deals in the pharmaceutical and biotechnology industry decreased from 1063 in 2010 to 480 in 2013. Though the returns from the pharmaceutical and biotechnology industry have been dwindling, they are better compared to the performance of other industries.

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Although it seems raising as much venture capital as humanly possible is Silicon Valley’s mantra, there are reasons to be cautious when signing termsheets. Startups raising a couple of million dollars had a median exit price of more than $10 million, while the outcome for those raising double that was actually worse, a recent study shows.

The report, by San Francisco-based Exitround, a marketplace for M&A deals for small tech companies, found companies raising $2 million to $3 million were more likely to exit at a valuation over $10 million, while for startups raising $3 million to $10 million the median exit price was less.

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Several Baltimore startups are among the winners of this year’s Maryland Incubator Company of the Year awards.

The winners were announced Tuesday evening at an awards ceremony at the American Art Visionary Museum in Baltimore. The awards are supported by the Maryland Technology Development Corp., the Maryland Department of Business and Economic Development, the Maryland Business Incubation Association, M&T Bank and several other state companies.

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A U.S. Senate panel on Tuesday approved a budget bill that would increase funding for the National Institutes of Health by $605 million for the fiscal year that begins October 1.

Lawmakers on the Senate’s appropriations subcommittee that oversees education, health and labor programs passed legislation that would increase the NIH’s budget to nearly $30.5 billion in the coming year. That $605 million jump represents a greater increase than the $198-million increase the Obama administration had requested.

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When GlycoMimetics Inc. announced a license agreement with Pfizer three years ago, the decision seemed like a no-brainer. This deal, which surrounded the sickle cell drug candidate GMI-1070, was worth up to $340 million, after all. The Gaithersburg company seemed to be in an enviable spot, while some of its Maryland counterparts struggled.

Behind the scenes, the decision to partner with big pharma didn't come easy. CEO Rachel King, speaking this morning at a Tech Council of Maryland panel in Bethesda, recounted the calculus behind the move.

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September 2014 is bringing 5 NEW CLASSES to our schedule that will help you

BE THE ENTREPRENEUR THAT YOU WANT TO BE!

Aspiring Entrepreneurs:

1. The Intentional Entrepreneur: This one day class will help you identify your entrepreneurial skills and abilities, as well as address any concerns you may have about owning your own business. This class is a must for anyone considering starting their own business!

2. The Intentional Entrepreneur for Veterans: For veterans thinking about starting a business.

Early Stage Entrepreneurs:

3. New Venture: For the entrepreneurs in the early stages of business development.

4. New Venture for Veterans: For veterans seeking to launch an idea.

5. Tech Venture: For entrepreneurs in the tech or life sciences field seeking to start a business. (BHI EIR Todd Chappell will be one of the instructors teaching this class)

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Two early career physician-scientists, Peter de Blank and Matthew R. Steensma, have been named inaugural winners of the Francis S. Collins Scholars Program in Neurofibromatosis Clinical and Translational Research, sponsored by the Neurofibromatosis Therapeutic Acceleration Program (NTAP) at The Johns Hopkins University. The program will create a community of expert clinician-scientists and groom them to be leaders in neurofibromatosis type 1 (NF1) research and clinical care. The awards will be presented at a ceremony on Tuesday, June 10, at the Whittemore House in Washington, D.C.

“It has become increasingly hard for young clinician-scientists to get the funding and dedicated time necessary to become leaders in translational science for rare diseases such as NF1,” says Jaishri Blakeley, M.D., director of the Johns Hopkins Comprehensive Neurofibromatosis Center and NTAP. “We created the Francis S. Collins Scholars Program, recognizing that a cadre of well-trained and dedicated clinician-scientists focused on NF1 is critical in order to make the scientific leaps that are possible in this modern era.”

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A highly personalized medical technique is allowing patients with advanced kidney cancer to live nearly three times as long as they normally do. In an experiment involving 21 patients, around half lived more than two and half years after diagnosis with kidney cancer that had begun to spread. Five patients are alive after more than five years.

“That seems to be out of proportion with what you would expect for any commercial therapy and longer than what you would expect from patients with similar prognostic variables,” says Robert Figlin, an oncologist at Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute in Los Angeles, who is leading the study.

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Upcoming Funding Opportunity Deadlines -NEW FORMS-C Required for SBIR/STTR applications

The next NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Omnibus deadline is only two months away on August 5, 2014, which means your small business should be preparing your application.

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As the United States slowly emerges from the Great Recession, led by our cities and metropolitan areas, a remarkable shift is occurring in the spatial geography of innovation.

For the past 50 years, the landscape of innovation has been epitomized by regions like Silicon Valley — suburban corridors of spatially isolated corporate campuses, accessible only by car, with little emphasis on the quality of life or on integrating work, housing and recreation.