We are delighted to announce a new collaboration between the National Institutes of Health (NIH) and the National Science Foundation (NSF) to empower entrepreneurial scientists and advance the Lab-to-Market priorities set forth in the President’s Management Agenda. The Federal government invests over $130 billion on research and development (R&D) each year, and the President’s 2015 budget supports a sustained commitment to accelerate the transfer of promising Federally-funded technologies from the laboratory to the commercial marketplace.

Some academic researchers and entrepreneurs who receive SBIR or STTR funding from NIH will now be eligible to participate in a pilot of the NSF Innovation Corps (I-Corps™) program that is specially tailored for biomedical technologies. First launched in 2011, the NSF I-Corps program is based on the “Lean Launchpad” curriculum developed by entrepreneurship expert Steve Blank to improve how tech start-ups bring their products into the marketplace. This intensive, mentor-driven experience is changing the way that NSF-funded researchers think about the commercialization process, and now it will be available for NIH-funded researchers as well.

When Mike Oberst walks through the doors of MedImmune in Gaithersburg each day, he resumes his important work on developing a newer, promising type of cancer treatment.

The scientist has focused his attention on immunotherapy as a way to eliminate cancer cells in patients. The treatment aims to harness the power of one’s immune system to fight cancer.

The ETC (Emerging Technology Centers: http://www.etcbaltimore.com) -- Baltimore City’s award-winning technology innovation center–welcomed last week a European Delegation of entrepreneurs, policy makers and Members of Parliament who were invited to the United States under the auspices of the Department of State's International Visitor Leadership Program and coordinated by the World Trade Center Institute (WTCI) in Baltimore, Maryland. Two weeks ago, the ETC hosted another European Delegation led by Dr. Rob de Wijk, Director of The Hague Security Delta.

“At ETC, we have always been pioneers,” said Deb Tillett, ETC’s President. “We work hard every day to innovate and move forward. We are so pleased that these distinguished delegations chose to visit us to see how we do what we do in Baltimore and how we stay on the leading edge of technology and best practices to help our emerging companies grow and become successful, all business is global these days and our companies are always looking for the next customer and opportunity,” she added.

Medtronic Inc., an active acquirer and financial backer of new medical technologies, has moved its tax domicile overseas with the $42.9 billion acquisition of rival Covidien PLC, a deal that Medtronic says will free up billions of dollars that can be more easily and flexibly deployed to technologies being developed in the U.S.

Medtronic headquarters in Minneapolis Bloomberg News But investors in these U.S.-based technologies see things differently. The merger means that the medical-technology industry is consolidating, several venture capitalists said, which takes options off the table for young companies struggling to bring new treatments onto the market.

Tuesday, July 8, 2014 6:00 PM - Johns Hopkins University Montgomery County Campus, Rockville, MD

Guest Speakers:  

GAUTAM GULATI, MD, MBA, MPH
Dr. Gulati is the Chief Medical Officer and Head of Product Innovation for Physicians Interactive Holdings, where he leads a world-class team to ideate, design, build, and deploy disruptive solutions for a health audience. In addition to his executive role, he serves as an Adjunct Professor of “Medical Innovation and Entrepreneurship” at Johns Hopkins University Carey Business School, sits on numerous company boards, and speaks at a variety of events around the world.  

Over his 20+ year career, Dr. Gulati has been combining his diverse experiences, creative juices, and passionate voice to help take on a bigger challenge…to treat our troubled health system.  He has earned an impeccable reputation for his ability to transform organizations – both big and small - to meet the future innovative demands of the health industry. Along this journey, he has been dubbed both a "health hooligan" and "physician artist", encapsulating the creative characteristics that allow him to meld his various vantage points as a clinician, executive, designer, professor, advisor, entrepreneur, speaker, and technology advocate.

PAUL FEARIS, CEO Clinvue

Mr. Fearis obtained Masters Degrees in both mechanical engineering and industrial design and as a consequence has been involved in product development throughout his career. An entrepreneur at heart, with his partners, Mr. Fearis formed Clinvue, a company which marries his passion for innovation with his love of understanding people and solving worthwhile problems.

Peter Davis, JD

Mr. Davis is a partner in Whiteford, Taylor & Preston’s Technology and Intellectual Property Practice, located in Baltimore, Maryland. He is a former U.S. Patent Examiner, and for the last 23 years he has balanced his time between patent prosecution, patent litigation, and strategic patent counseling for many of the world’s best-known companies. He has worked in virtually all areas of technology, including biotechnology, pharmaceuticals, medical devices, electronic devices, software, light and heavy machinery, and automotive. He can speak the languages of both the inventor and the layman, translating inventions into terms that patent examiners, judges and juries find compelling. Mr. Davis received his bachelor’s degree from Cornell University (1987) and his JD from Catholic University (1993).

Qiagen, a Netherlands based holdings company announced that its artus CMV RGQ MDx Kit for human cytomegalovirus (CMV) has been approved by the US Food and Drug Administration (US FDA) under a full premarket approval (PMA). The test is the only FDA-approved PCR-based assay optimised for low- to mid-throughput testing of CMV. With a turn-around time of approximately three hours, the assay provides faster results than other PMA approved tests. artus CMV RGQ MDx runs on Qiagen’s Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012 and is a member of the QIAsymphony modular family of automated instruments.

“We are very pleased to add yet another FDA approved diagnostic kit to our menu of FDA approved or cleared content for a core element of our flagship QIAsymphony modular family of automated instruments. This flexible platform is driving the dissemination of molecular diagnostics by delivering efficient, reliable workflows in low- to mid-throughput settings, which represent the largest market opportunity in terms of placements,” said Peer M. Schatz, chief executive officer of Qiagen. “Our artus CMV assay is the fastest test approved for quantifying CMV viral loads in organ transplant patients. In addition to helping save lives with its clinically proven usefulness, the FDA-approved artus test creates economic value by reducing the time and money many labs and hospitals currently must spend validating lab-developed CMV tests and analyte-specific reagents. More than one million CMV tests are performed on US transplant patients each year and we believe the artus CMV kit will provide significant value for laboratories, patients and the healthcare system.”

The FLC invites you to submit images of your lab’s work for its 2015 planner! Why keep all of that hard work to yourself? Share it with the more than 10,000 planner recipients throughout the FLC community, including members of Congress, scientists, tech transfer professionals, and members of academia and industry. The FLC planner features an array of images displaying the innovative research and development that occur daily in our nation’s federal labs.

To submit images of your lab’s work, carefully read the submission criteria below. You also may want to coordinate your submission with, or through, your agency’s FLC representative or public affairs office.

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.

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.

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.

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.

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.

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.

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.

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.”

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.”

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.

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.

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.”

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.

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.

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."

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.

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.

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.

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.

London-based Index Ventures has just announced a new $542 million fund for seed-stage companies that have raised under $20 million.

The firm says it will invest in European startups mainly, but may make a few bets on companies from Israel and the U.S.

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.”

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.

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.

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.

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.

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.

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.

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.