barack-obama

President Barack Obama signed the US Food and Drug Administration Safety and Innovation Act (S. 3187) into law, reauthorizing user fees that the FDA charges pharmaceutical and device manufacturers as they gain approval for their products.

The law also establishes a new user fee program—raised as part of Obama’s newly-legitimized health care legislation—that will require companies making generic versions of protein-based drugs, or biologics, called biosimilars, to pay upon approval of their generic products. The newly signed law also makes several changes to FDA policy meant to speed the approval process for drugs and devices, enacts changes aimed to increase the safety of the drug supply chain, and incentivizes the development of new antibiotics.

med-startr-logo

A couple years ago, when Alex Fair was tossing around ideas on how to raise money for his new healthcare marketplace, FairCareMD, he knew that putting the startup on the uber-popular crowdfunding platform Kickstarter would be out of the question. Kickstarter has collected $250 million for 24,000 projects since it was founded three years ago, but virtually none of that has gone to health-related companies. “I said, ‘Hey, there’s an opportunity here,’” Fair says. “No one’s really doing health care crowdfunding.”

Enter MedStartr, Fair’s New York-based site that’s making its debut today. MedStartr allows entrepreneurs to find backers for healthcare technologies and services. The site, which Fair says ran a brief alpha test starting in April, is launching with six projects, including MedStartr itself. During that early project, which was designed to test the concept, Fair was surprised to find MedStartr was able to raise enough capital to run the company. “Of the 71 people we invited to view the alpha, six invested,” he says. It’s a sign, he believes, that “crowdfunding has hit the public consciousness.”

dollar-bills

Venture capital fundraising for early stage funds doubled in the first half of the year to $3 billion compared with the same period last year, according to a report by Dow Jones.

Among the firms that have raised funds were Felicis Ventures, a well-respected early stage investment group with a new $70 million fund targeting bioinformatics, and other sectors.

Healthcare IT companies are likely to benefit from the increase as healthcare facilities shift to electronic medical records.

DHHS

Today, the President signed into law S. 3187, the “Food and Drug Administration Safety and Innovation Act.”  This legislation, which passed both the House and Senate with overwhelming bipartisan majorities, will help speed safe and effective medical products to patients and maintain our Nation’s role as a leader in biomedical innovation.

S. 3187 is the culmination of the work of the administration and Congress, in partnership with patients, the pharmaceutical and medical device industries, the clinical community, and other stakeholders, to provide the Food and Drug Administration with the tools needed to continue to bring drugs and devices to market safely and quickly and promote innovation in the biomedical industry, and to help secure the jobs supported by drug and device development.

brain-to-bunker

In a small, anonymous office in the Trump Tower, 28 floors above Wall Street, a man sits in front of a computer screen sifting through satellite images of a foreign desert. The images depict a vast, sandy emptiness, marked every so often by dunes and hills. He is searching for man-made structures: houses, compounds, airfields, any sign of civilization that might be visible from the sky. The images flash at a rate of 20 per second, so fast that before he can truly perceive the details of each landscape, it is gone. He pushes no buttons, takes no notes. His performance is near perfect.

Or rather, his brain's performance is near perfect. The man has a machine strapped to his head, an array of electrodes called an electroencephalogram, or EEG, which is recording his brain activity as each image skips by. It then sends the brain-activity data wirelessly to a large computer. The computer has learned what the man's brain activity looks like when he sees one of the visual targets, and, based on that information, it quickly reshuffles the images. When the man sorts back through the hundreds of images—most without structures, but some with—almost all the ones with buildings in them pop to the front of the pack. His brain and the computer have done good work.

maryland-biotechnology-center

SNNLive had the pleasure of speaking with Dr. Judith Britz, Executive Director of Maryland Biotechnology Center and Francois Chevillard, CEO of the Medicen Paris Region to announce the two organizations’ Memorandum of Understanding at the BIO International Convention 2012 in Boston, MA.

The Maryland Biotechnology Center is an organization within the Maryland Department of Business and Economic Development (DBED) that consolidates and coordinates a host of state, university and private sector initiatives to better showcase and support biotechnology innovation and entrepreneurship in Maryland. The Medicen Paris Region facilitates the transfer of innovation to industry, the market and patients in human healthcare sectors.

venture-debt

Cash-burning R&D-stage biotechs have big appetites for cash, which is typically addressed with an equity-based diet.  It’s also supported through corporate partnerships and other less dilutive means such as grants and foundation funding.  But another important and often under-appreciated source of capital are the debt markets – taking a loan out to provide working capital for further R&D.

One might ask why and how a company that won’t have profits for a decade can raise any money through the issuance of debt, but it happens frequently, and the “venture lending” business is actually very robust.  Players like Silicon Valley Bank (SVB), Oxford Finance, Hercules Technology Growth Capital, and Horizon Technology Finance (and many others) are all very active supporters of emerging life science companies.

dreamit-ventures

Healthcare IT has become a new priority for East Coast accelerator DreamIt Ventures with the hire of a veteran angel investor group director.

Karen Griffith Gryga recently joined the accelerator’s Philadelphia office. Earlier this year it added a minority-led business component and started a program to work with startups based in Israel.

She has worked as executive director of Mid-Atlantic Angel Group, which has invested in life science and technology companies.

mass-life-sciences-center

The Commonwealth of Massachusetts’ quasi-public agency, the Massachusetts Life Sciences Center, has opened its 2012-2013 Accelerator Loan Program, the agency announced Monday.

MLSC launched the program in 2009 as a way to help startup businesses who need working capital or funding to pay for capital assets. A loan of up to $1 million per company is provided, an increase from the maximum amount of $750,000 offered in the past. The decision to increase the amount available was made during a June meeting of the board of directors, according to Angus McQuilken, vice president of communications at the MLSC. Companies still will only be able to borrow a dollar-for-dollar match, he said.

bio-org-logo

On June 21 the Biotechnology Industry Organization (BIO), which represents biotechnology companies, issued a report on the economic impact of patent licensing from universities and non-profit institutions (PDF), analyzing data from 1996 to 2010 gathered by the Association of University Technology Managers (AUTM). The data show that patent licensing resulting from federally-funded research at universities and non-profits resulted in contributions to GDP somewhere between $86 billion and $388 billion in 2005 U.S. dollars, and between 900,000 to 3,000,000 person-years of employment in that period.

bill and melinda gates foundation

Seven pharmaceutical companies and four research institutions, working with the Bill & Melinda Gates Foundation, have launched a groundbreaking partnership, to expedite the discovery of new treatments for tuberculosis. The partnership, known as the TB Drug Accelerator (TBDA), will target the discovery of new TB drugs by collaborating on an early-stage research. The long-term goal of the TBDA is to create a drug regimen that cures patients in just one month. Existing drugs, which are all at least 50 years old, require six months to cure the disease — a lengthy process, during which at least 20 to 30 per cent of patients end up discontinuing the treatment before the completion of the course.

BioBeat

Imagine for a moment you’re a hotshot biomedical scientist at a university. You have invented a technology in your lab that you think has potential to make a big difference for the world of medicine. Despite all the accolades you might be getting in Nature, you are savvy enough to know you still have a pretty raw concept. Your idea needs someone who can build a business around it, and invest a lot of time, money, and talent to prove it’s the real thing.

Who would you call?

There aren’t that many people who you can call anymore, and the number is shrinking. This question has been gnawing at me for a while, as I’ve sought to understand the historic contraction that’s occurring in the biotech venture capital business, and what effect it will have on the biotech industry’s ability to turn bright ideas into valuable new healthcare products.

Maryland

Maryland's secretary for business and economic development rallied Lower Shore leaders behind a state venture capital initiative that seeks to invest millions of dollars into companies and entrepreneurs with innovative ideas.

The state is poised to award a total of $84 million raised through an online tax credit auction earlier this year, but Lower Shore companies that don't apply cannot benefit from the infusion known as InvestMaryland, Christian S. Johansson, secretary of the Maryland Department of Business and Economic Development, told leaders gathered in Salisbury on Monday to unveil the new facility of the Tri-County Council for the Lower Eastern Shore of Maryland.

med-startr-logo

Crowdfunding—the new, hip way to raise money for early-stage technologies and interesting projects—has found a happy home in the world of high-tech, where many people are eager to experiment with new models and new approaches.

But can the same model work for the much stodgier health-care industry?

The founders of MedStartr, a crowdfunding platform for medical technologies, say that it will. On the 4th of July, the site will go live, with dozens of health-related technologies and services looking for benefactors.

Qiagen

Aim to expand next-generation sequencing beyond current focus on life sciences research.

QIAGEN plans to offer sample-to-result workflows that integrate its sample preparation and assay products with a next-generation benchtop sequencer and new bioinformatics

Initiative combines broad range of QIAGEN products with acquisition of sequencing specialist Intelligent Bio-Systems, Inc. and a new strategic collaboration with SAP AG QIAGEN N.V. QGEN today unveiled an advanced initiative to enter the field of next-generation sequencing (NGS) that aims to establish these technologies as routine processes used in new areas such as clinical research and molecular diagnostics.

post-doc-conf-logo

July 12, 2012 - Bethesda North Marriott/Montgomery County Conference Center

A conference and career fair for current postdoctoral fellows working in Washington, D.C. area federal labs and universities, and for companies recruiting high-level S.T.E.M. (Science, Technology, Engineering and Mathematics) professionals.

This event exposes area postdoctoral fellows in the S.T.E.M. fields to the many career options (e.g., government, private sector, entrepreneurship) that are available to them.

The career fair portion connects local job-seeking postdocs with companies seeking that level of talent.

md-dbed

The registration date for Maryland’s popular biotechnology tax credit program has been rescheduled because of wide-spread power outages.

Online registration for the Maryland Biotechnology Investment Incentive Tax Credit will open at 9 a.m. July 9. Registration was moved from July 2 out of concern that some investors would not be able to participate because of the power outages affecting hundreds of thousands of homes and businesses in the Baltimore area.

glaxosmithkline

GlaxoSmithKline PLC said Friday it has again extended its $2.6 billion hostile offer for shares of Human Genome Sciences Inc., its collaborator on the lupus drug Benlysta.

GlaxoSmithKline of London said its offer will expire July 20. The bid values Human Genome Sciences at $13 per share and was scheduled to expire Friday. Around 375,000 shares of Human Genome Sciences have been tendered in support of GlaxoSmithKline's offer. That's less than 0.2 percent of the 199.1 million Human Genome Sciences shares on the market and represents a small decrease in support from June 8.

EAGB Logo

The Economic Alliance of Greater Baltimore (EAGB) announced today that it has completed a formal agreement to serve as Greater Baltimore's primary business partner with BioHealth Innovation (BHI), Maryland's private-public collaborative that focuses on commercializing market-relevant bio health innovations and increasing access to early-stage funding in central Maryland.

BHI is the first regionally focused innovation intermediary created to connect the university and hospital bio health research strengths of Baltimore with the bioscience industry and federal laboratory strengths of Montgomery County.

Fraunhofer

The Johns Hopkins University (JHU), America’s first research university, in Baltimore, Md., USA, and the Fraunhofer Heinrich Hertz Institute (HHI), a mobile and information technology development leader based in Berlin, Germany, have signed a Memorandum of Understanding to jointly research the innovative medical applications of integrated optical sensors: small, highly sensitive devices with disease-recognition capabilities.

Under the terms of this agreement — signed on June 19 at the 2012 BIO International Convention in Boston, Mass., USA — the two entities will study how the technology developed by HHI can be used in the detection, diagnosis and treatment of medical conditions. Johns Hopkins University School of Medicine researchers with clinical expertise in a variety of specialty areas, including oncology and infectious diseases, will collaborate with HHI’s scientists and engineers.

UMD BioPark

Two new companies are moving in to the University of Maryland    BioPark, university officials said Tuesday.

Biogen Diagnostics Ltd., based in the United Kingdom, has opened a satellite office at the BioPark. Global Scientific Solutions for Health Inc., a new laboratory testing company that operates in southeast Asia and Africa, has set up its headquarters there.

The 12-acre west side BioPark houses life sciences companies that work with University of Maryland researchers. BioPark leaders said they want to attract international companies to broaden the reach of the university’s research and the BioPark’s development beyond the Baltimore region.

As you may know, the Montgomery County Department of Economic Development (MCDED) led the County's participation at the 2012 BIO International Convention held June 18-21 in Boston, MA.

Our team of business development professionals participated in dozens of business partnering forum meetings with national and international biotech companies during the course of the Convention.  On June 19,  MCDED held a press conference from the floor of the BIOMaryland Pavilion, kicked off by Human Genome Sciences CEO and Biotechnology Industry Organization (BIO) Board Chairman Tom Watkins and Montgomery County Executive Isiah Leggett.  The press conference highlighted the success of the County's biotech investment incentive program - the nation's ONLY such local program which helped spur more than $6 million in investments to 10 County-based biotech companies in 2011 -  and the creation of the County-inspired, regional biotech intermediary BioHealth Innovation, Inc. (BHI).  BHI is chaired by Scott Carmer, Executive Vice President, Commercial Operations, MedImmune and sponsored by Human Genome Sciences and several other local private-sector companies and academic institutions.  The press conference also featured a panel, moderated by MedImmune CEO Peter Greenleaf, of County-based, serial biotech entrepreneurs discussing why and how they started companies in Montgomery County.

bio-internation-convention

Maryland’s biotechs continued to leave their mark on the industry at this week’s global convention in Boston, with several executives claiming prominent board positions and a new report showing the state outpacing national growth in life science employment.

More than 15,000 executives and others were expected at this year’s Biotechnology Industry Organization International Convention, which started Monday and ended Thursday. More than 31 state companies sought the world’s attention at the Bio Maryland 2012 pavillion, which the state also had at last year’s convention in Washington, D.C.

md-dbed

Maryland’s economic development office has formed a partnership with a Paris region to team on disease research and translational medicine.

The letter of intent for the partnership was signed Wednesday at the Bio 2012 International Convention in Boston by Christian Johansson, secretary of the Maryland Department of Business and Economic Development, and Paris Medicen Del. Gen. Francois Chevillard. The Paris Medicen region is considered a life sciences hub in France’s capital city.

emergent biosolutions

Rockville-based Emergent BioSolutions Inc.    has formed a public-private partnership with the Department of Health and Human Services to establish a Center for Innovation in Advanced Development and Manufacturing.

The contract has an initial run of eight years worth $220 million with up to 17 additional one-year options. The partnership, with HHS’s Biomedial Advanced Research and Development Authority, will initially develop a new pandemic influenza vaccine and construct facilities to produce it.

united-therapeutics

United Therapeutics Corporation (NASDAQ: UTHR) today announced  that its Board of Directors authorized the repurchase of up to an additional $100 million of the company's common stock.  This program will become effective on July 31, 2012, and will remain open for up to one year.  Purchases may be made in the open market or in privately negotiated transactions from time to time as determined by United Therapeutics' management and in accordance with the requirements of the U.S. Securities and Exchange Commission.

The company also announced that it had recently completed its previously-announced $300 million repurchase program by purchasing 2,045,192 shares of common stock for $88 million during the second quarter of 2012.

MedImmune

MedImmune, the global biologics arm of AstraZeneca, today announced that the company’s expansion project at its Frederick, Md., Manufacturing Center (FMC) won the International Society for Pharmaceutical Engineering’s overall 2011 Facility of the Year Award.  This is the first time MedImmune has won this prestigious internationally renowned accolade.    

The annual Facility of the Year Awards (FOYA), sponsored by the ISPE, INTERPHEX and Pharmaceutical Processing magazine, recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.

Human Genome

US biotechnology firm Human Genome Sciences (HGS) has set a deadline of 16 July 2012 for offers to acquire the company, but has failed to tempt GlaxoSmithKline (GSK) into the process.

HGS has undertaken the strategic alternative review to sound out potential buyers who now have until the deadline to submit definitive proposals to purchase all outstanding common shares in the company.

The company adopted the strategy immediately after GSK made its offer to acquire HGS, valuing the company at $2.6bn.

johns-hopkins-center-bio-ed

The Johns Hopkins Center for Biotechnology Education (CBE) welcomed more than 20 academicians onto campus last weekend for the 1st Annual International Bioentrepreneurship Education Conference (BEC). During the one-day event, bioentrepreneurship education leaders from as far away as South Africa, South Wales, Sweden and Denmark – as well as a number of stateside leaders – met to share information and assess where bioentrepreneurship education currently stands.

One of the biggest takeaways: Similar to entrepreneurs, academic leaders are concerned about funding resources. In the case of academia, the concern was identifying resources that can help support these exciting, and in many cases, new programs.

Startup maryland

The entrepreneur support and advocacy group founded this spring will crisscross the state on a two-and-a-half-week bus tour in September. The trip starts Sept. 11 with a trek to Ocean City and is scheduled to wrap up Sept. 28 in Howard County after canvassing the rest of the state.

At stops along the way, Startup Maryland will roll out the first round of its business pitch competition. Organizers said they are still working out how much prize money will be distributed and how it will be divvied up.

johns-hopkins-medicine

The Johns Hopkins University School of Medicine, in collaboration with the Johns Hopkins Health System (together known as Johns Hopkins Medicine, or JHM), has been awarded a $19.9 million grant by the Centers for Medicare & Medicaid Services (CMS), over a three-year period, to improve the quality and efficiency of health care delivered to JHM patients.

The grant is part of CMS’s $1 billion Healthcare Innovation Challenge, a competitive initiative that seeks to identify and support innovative opportunities to improve care delivery and achieve its three-part aim of “improving the individual experience of care, improving the health of populations, and reducing the per capita costs of care for populations.”

Md bio enterprise

Trying to meet the future work force where it is, some Maryland biotech executives are backing a unique strategy to help market an educational video game to students.

A version of one game, developed by Hunt Valley gaming company BreakAway Ltd., is being previewed at the annual Biotechnology Industry Organization International Convention this week in Boston. The MdBio Foundation, an affiliate of the Tech Council of Maryland, will offer the game to science teachers free of charge beginning next year, with help from financial partners.

Anthony Coyle

The drug discovery business is going through tough times. Drug candidates aren't moving through the pharmaceutical industry's pipelines fast enough. Meanwhile, entrepreneurs struggle to get the funding they need to bring their new ideas to fruition. These issues are driving new alliances and partnerships between academic researchers, venture capitalists, and big pharma, but whether the new models will solve the problem was a question on the minds of many of the 15,000 attendees at this week's BIO International Convention in Boston.

The themes are familiar: venture capitalists are limiting their investments in biotech, in part because it's hard for fledgling life-science companies to go public, and although big pharma is desperate for innovative ideas and depends heavily on small biotechs for new drug candidates, these larger companies don't want to take on risky, early-stage projects. The new alliances, some of which involve direct collaborations between pharmaceutical companies and academics, are a response to what one panelist called this "crisis."

California

At least 68 “big” deals — investments of at least $2 million — have been done in digital health so far in 2012, according to a new report by the healthcare accelerator Rock Health. Nineteen states were in on the action.

Not so surprising, California lead the way in both the number of deals done and the overall investment. And traditional healthcare investing strongholds like Massachusetts were among those that did the most deals. But there were lesser known regions involved as well that invested significant dollars and did a notable number of deals, namely Texas, Illinois, Georgia and Connecticut.

Here’s a list of every region that did digital health deals so far this year.