President Obama signed the Jumpstart Our Business Startups (JOBS) Act into law on April 5, 2012.  BIO advocated strongly for this new law, which includes several important policies designed to stimulate capital formation for growing businesses, including those in the biotech industry.  Some of the new policies were self-effectuating, while others are awaiting rulemaking at the SEC.  Below is a summary of the relevant provisions in the new law, along with a status update on the implementation process for each.

Newt Fowler looked across Baltimore’s Renaissance Hotel ballroom and noted who was missing from the tables.

Sure, there are plenty of leaders in today’s innovation economy in Baltimore, Fowler told the crowd Thursday at the Greater Baltimore Committee’s Economic Outlook Conference.

“They’re just not in this room today,” he said.

What we’ve got in our corner: Everything from good schools to a really funky music scene.

What we need to do: Everything from reform our corporate tax structure to rearrange our offices.

What’s at stake: The economic drivers who will keep Baltimore, and Maryland, competitive with the rest of the country and the rest of the world.

Baltimore’s Sage Growth Partners sees opportunity where others see a headache.

Over the past few years Sage, a health care technology consulting firm, has seen business pick up as more health care providers look for help installing and managing the new electronic record systems. CEO Don McDaniel declined to disclose the company’s revenue but said Sage has seen 50 percent annual growth for the past five years. That’s a trend he expects to continue as the company makes a move to break into consulting for startup companies in the health IT sector.

Companies spent $294 billion on research and development performed in the United States during 2011, compared with $279 billion during 2010 (table 1). Funding from the companies’ own sources was $222 billion during 2010 and $239 billion during 2011; funding from other sources was $57 billion in 2010 and $55 billion in 2011 (table 2). Data for this InfoBrief are from the Business R&D and Innovation Survey (BRDIS), which was developed and cosponsored by the National Science Foundation and Census Bureau.

The National Institutes of Health is making available approximately $3.7 million for awards to enhance training opportunities for graduate students and postdoctoral scholars to prepare them for careers in the biomedical research workforce that could take them outside of conventional academic research.

The first set of NIH Director’s Broadening Experience in Scientific Training (BEST) awards are supported through the NIH Common Fund’s Strengthening the Biomedical Research Workforce program.

University of Maryland, Baltimore and MedImmune are pairing up for a five-year, $6 million collaboration on bioscience research.

The Gaithersburg-based drug company and the university will both put money and scientists toward joint research projects. The projects will focus on medical conditions and diseases in MedImmune’s wheelhouse, such as cardiovascular disease, respiratory problems and inflammation.

The success of MenAfriVac shows vaccines can be developed outside Big Pharma's walls, but, in most cases, the cost of late-phase trials is too great for charities. Recognizing this, JPMorgan Chase and the Bill & Melinda Gates Foundation have set up a Big Pharma-backed investment fund. 

GlaxoSmithKline ($GSK), Merck ($MRK) and Pfizer's ($PFE) foundation are among the investors in the fund, which will back late-stage development of technologies to fight disease in low-income countries. Having raised $94 million from its initial backers, the Global Health Investment Fund (GHIF) will now start trying to give vaccines and other technologies the financial clout to navigate Phase III trials.

The National Institutes of Health has launched a major initiative to improve how basic science advances and discoveries are translated into commercially viable products that improve patient care and advance public health.

The NIH Centers for Accelerated Innovations (NCAIs), funded by the NIH’s National Heart, Lung, and Blood Institute (NHLBI), will target technologies to improve the diagnosis, treatment, management, and prevention of heart, lung, blood, and sleep disorders and diseases. 

Venture capital for early-stage medical device companies is drying up. At Advamed 2013, I was able to sit down and talk to Paul Grand, managing director at Research Corporation Technologies Ventures, a life sciences firm focused primarily on medical devices. When I asked him what the three main mistakes startups make when pitching him, he sighed. His first response: “Only three?”

Ouch. So be sure to avoid these blunders when pitching VCs, startup CEOs:

With the enforcement of the HIPAA Omnibus final rule starting this week, health IT companies face liability for breaches of patients’ protected health information that they may never have faced before. It’s also making issues like Bring Your Own Device even mores stressful for CIOs as they figure out how to make any instances of PHI on these devices secure enough to withstand an audit if the devices get lost or stolen. Although the strategy is not without risks, providers and payers are turning to cloud-based solutions from data security companies to ensure HIPAA compliance.

Here are a few health IT companies taking this approach. Their data security measures are designed to help providers serving as covered entities and HIT companies who are business associates comply with HIPAA.

Covidien President and CEO Joe Almeida said in a little more than a decade, sub-Saharan Africa could be the big opportunity for medical device companies’ solution investments.

“It is a 10- or 15-year play. . . . The middle class will rise and you will have an opportunity,” Almeida said during the CEOs Unplugged series at Advamed 2013.

Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

NIH Guide Notices (NOT):

• NOT-OD-13-117: Review of Grants Information for Fiscal Year 2013
• NOT-OD-13-116: New Program Certifications Required for SBIR and STTR Awards
• NOT-OD-13-115: Notice of Intent to Publish the Reissuance of the Funding Opportunity Announcement Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (Parent T32)

Requests for Applications (RFAs):

• RFA-RM-13-014: Defining A Comprehensive Reference Profile of Circulating Human Extracellular RNA (U01)

Program Announcements (PA):

• PAR-13-358: Opportunities for Collaborative Research at the NIH Clinical Center (U01) (expires March 21, 2015 )
• PAR-13-357: Pre-application: Opportunities for Collaborative Research at the NIH Clinical Center (X02) (expires November 21, 2014)

At Rock Health, entrepreneurs are developing innovative products to keep us healthier, and lower medical care costs.

Ten health startups in Rock Health’s current accelerator class presented to a roomful of investors and the press today. Rock Health is a startup accelerator that focuses on health care technology.

The current class of startups are tackling huge challenges in health care, such as cancer treatment or eating disorders.

mHealth advocates are giving good early reviews to the U.S. Food and Drug Administration's final guidance document on the regulation of mobile medical apps, with one expert calling it "an expansive document that truly seeks to deregulate our nimble and innovative industry, while ensuring patient safety."

"The guidance goes much further than I thought it would," said Robert Jarrin, senior director of government affairs for Qualcomm, who noted that the agency has taken a new and novel approach in launching a consumer-facing website with an adjoining list of regulated apps that may be updated on a regular basis. In addition, he said, the FDA is creating a team that will be tasked with answering public inquiries about mobile medical apps submitted through This email address is being protected from spambots. You need JavaScript enabled to view it..

October 1 and 2, 2013 8:00pm ET/5:00pm PT

Now on its eighth run, the NIH SBIR Phase I Program for First-Time Applicants is a very practical step-by-step, four-hour online "How-To" workshop over two evenings to help researchers, faculty members, graduate students, post-docs and entrepreneurs create a SBIR company and apply to the NIH SBIR program in December of 2013. This workshop includes a post-course review of the applicant's proposed SBIR application by our experts before submission to the NIH. As an added benefit, your SBIR companies will be included on NCET2's newsletters that is sent out to VCs, angel investors, Global 1000 companies, and government funders.

The NIH SBIR/STTR program is one of the federal government's best mechanisms to continue funding innovative life science research after traditional research funding has been exhausted. The objective of the program is to dramatically increase the impact of innovations derived from original federally funded R&D, and as such is an ideal program to fund university commercialization of research through new university/faculty/student startup companies. Phase I can be for up to $150,000 for 6 months. Phase II can be for up to $1 million for 2 years. After Phase I and II, the company should have eliminated enough technical and scientific risk of the original research that the company is ready for outside investor funding or product sales in the company sustainability final Phase III of the SBIR program.

Something as mundane and common as giving and receiving compliments may be a serious challenge if you are an immigrant.

Over the years, I have learned, often the hard way, the essential importance of receiving and giving compliments, at home, at work, and in social or semi-social environment. Generally speaking, East Asian cultures tend to be more reserved in expressing appreciations or affection toward others compared to the American culture (some generalization here).  We have all heard of such jokes about Asian parents singling out the only “B” in the child’s report card amidst all other “A”s and demand to know why the child had failed to get straight “A”s, while American-born parents would emphasize on the progress or efforts rather than the outcome.

Health IT groups and mobile application developers' reaction to FDA's release of final guidance for mobile health apps is mixed, the Baltimore Sun reports (Wells/Clarke, Baltimore Sun, 9/23).

Details of Final Rule

According to the final guidance issued Monday, FDA will focus oversight on apps that:

• Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or 
• Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine (iHealthBeat, 9/23).

The United States Food and Drug Administration has finally released guidelines on how it plans to regulate thousands of new health-related smartphone applications.

After months of delaying its decision, the agency has determined that the vast majority of these health-related apps pose a negligible threat to consumers. Most of these “mobile medical” apps do not need federal regulation, the FDA found, so developers and investors can breathe a bit easier.

Wednesday, October 30, 2013
8:30 AM to 11:30 AM

Do you love health technology? Do you want to learn more about it? Do you want to teach others and collaborate with local experts?

Call it what you want--mobile health, digital health, health IT--it's all about using innovative technology to improve the lives of you, me, and the people we care about. Let's build an ecosystem dedicated to making health technology part of everyday life and the standard of care! Being located in the Maryland area, we have all the pieces to the puzzle to promote innovation, collaboration, and investment in an industry that will revolutionize healthcare and impact the lives of all 7+ billion people around the world.

Join our ecosystem for the MD HealthTech Coalition Kickoff Event and hear from a panel of experts about the challenges, opportunities, and innovative solutions. More details to follow...

How can you tell Maryland is becoming a hotbed for cyber security business?

Ellen J. Hemmerly said it’s obvious from the companies looking into University of Maryland, Baltimore County’s technology incubator.

“We’re attracting not only local and regional entrepreneurs,” Hemmerly said. “We’re getting more and more inquiries and tenants from out of state.”

Montgomery County’s largest biotechnology company, which is celebrating its 25th anniversary this week, actually hatched from a meeting in the Big Apple.

In the late 1980s, Wayne T. Hockmeyer was an executive with Praxis Biologics in Rochester, N.Y., with an inkling to branch out on his own. He had spent two decades in the U.S. Army, including as chairman of the Department of Immunology at Walter Reed Army Institute of Research in Washington, D.C., from 1980 to 1986.

The state's two major research institutions, Johns Hopkins University and the University of Maryland, College Park , are partnering to build a research and science center in East Baltimore opening September 2014. The state is spending $27 million and Hopkins is contributing $3 million toward the $30 million public/private venture whose goal is to make Maryland’s universities and private industry more competitive in the sciences.

The High Performance Research Computing Facility will consist of multiple buildings on land leased from Hopkins on its 350-acre Bayview Medical campus, at 4940 Eastern Ave. Expected to break ground in November, the center will be set off from other buildings and have its own separate entrance. The universities will finish site design this month and then bid the project to vendors. 

GlaxoSmithKline announced on Thursday that it has signed a four-year contract with the Biomedical Advanced Research and Development Authority for the provision of its inhalation anthrax treatment, raxibacumab.

In the new contract, GSK will give the United States government 60,000 doses of raxibacumab over a four year period. The estimated value of these shipments total $196 million.

Sprint (NYSE: S) is upping its mobile health game in a new partnership with Techstars. The mobile service provider and its startup accelerator partner will fund and mentor 10 health technology ventures next spring as they launch the Sprint Mobile Health Accelerator.

Based in Sprint’s hometown of Kansas City, the accelerator will provide selected companies with three months of mentorship, work space, technical support, hosting services and testing labs. Companies will receive $20,000 in exchange for 6 percent equity given to Techstars. They will also have the option of accepting a $100,000 convertible debt note from Sprint, which would take an undisclosed percentage of equity as well.

A Maryland patient with a fever could one day enter a photo booth-like facility and leave with a diagnosis and prescription.

A Severna Park firm is part of an international effort to send less-critical patients to these so-called medical cabins instead of doctors’ offices and hospitals. Link International Group has been working with VideoKall — which has offices in Montgomery County and Ventura, Calif. — to produce the MEDEX Spot Unmanned Micro Clinic. The cabins use satellite equipment and cameras to conduct medical tests on patients and connect them to practitioners working at 24-hour medical centers around the country.

Drug giant GlaxoSmithKline is joining the Bill & Melinda Gates Foundation, JPMorgan Chase, other firms and other individual investors in launching a $94 million global fund that will focus on combating diseases.

The launch of the Global Health Investment Fund was disclosed early Monday. 

Noted Dr. Moncef Slaoui, chairman Vaccines and R&D at GSK (Nyse: GSK): "I am convinced the GHIF will be instrumental in helping bring cutting edge innovation and solutions to diseases of the developing world and this is one reason why we are participating. This collaboration demonstrates that with an innovative structure, a fund with a humanitarian focus can appeal to a broader range of investors."

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

A health IT accelerator is launching in Baltimore with the aim of pulling more technology out of Baltimore’s biggest research university and drawing more companies into the city. DreamIt Health Baltimore will host a class of 10 startup companies for a four-month accelerator program in Baltimore beginning in January. The accelerator is part of DreamIt Ventures outside Philadelphia.

The University of Maryland has once again made The Princeton Review's list of the country's top entrepreneurship programs. In the 2014 list of the "Top 50 Schools For Entrepreneurship Programs," published in Entrepreneur magazine, UMD ranks No. 15 for its undergraduate program. The university also ranks No. 16 for its graduate program, up eight spots from the 2013 rankings.

Aris Melissaratos is being replaced as Johns Hopkins University’s top technology commercialization adviser, as the university looks to delve deeper into entrepreneurship. Christy Wyskiel, an entrepreneur and investor, has been named senior adviser to the president for enterprise development at Hopkins. Beginning Jan. 1, Wyskiel will oversee Hopkins’ efforts to commercialize technology and research of faculty members.

As a result of a strategic collaboration among the Maryland, Montgomery County and City of Gaithersburg economic development offices, Emergent Biosolutions - maker of the only FDA-licensed anthrax vaccine to protect against anthrax disease - will expand its headquarters in Montgomery County. 

  "Montgomery County was thrilled to partner with the State of Maryland and the City of Gaithersburg to provide Emergent Biosolutions with strategic funding to assist with their significant headquarters expansion in the County," said Montgomery County Executive Isiah Leggett. "Emergent has the only FDA-licensed anthrax vaccine on the market, 235 current jobs, plans to add 133 new jobs over five years and was in the top 20 on the Washington Business Journal's recent list of top 100 largest publicly traded companies; they are a poster-child for smart government investment, investment that will support both their continued contributions to global health and their continued contributions to the health of our local economy." 

The idea that technology will change medicine is as old as the electronic computer itself. Actually, even older. In 1945, Vannevar Bush, the man with the vision for the National Institutes of Health, foresaw a Memex computer program that would allow access to past books and records. A lone physician searching for a diagnosis in far-flung case histories was one of the applications Bush imagined.

Medicine is an information intensive industry. Yet there’s still no medical Memex. Even though the Internet teems with health information, study after study shows that medical care often differs greatly from what the guidelines say—when there are guidelines. Doctors frequently rely on their own experience, rather than the experience of millions of patients who have seen thousands of doctors. Not only is the past lost, the present is missing. How many times has a patient received a drug that causes an allergic reaction, just because that information is not available at the time it is needed?

The University System of Maryland played a role in launching or propelling about 180 startup companies in fiscal 2013, according to a new report from the university system.

The companies’ ties to a state university varied — some licensed technology developed at a university, others leased office space at a university research park and took advantage of the resources there, and still others were heavily coached and mentored by university experts.

When GlaxoSmithKline made a clean sweep of Human Genome Sciences execs last year following its $3.6 billion buyout of the Rockville biotech, one big question (among many) was where would they land?

At least two have found their way back into Maryland biotechs. Last month, former HGS chief commercial officer Barry Labinger joined Anthrax-vaccine-maker Emergent BioSolutions as head of its bioscience division. And on Thursday, pre-IPO biotech MacroGenics announced the appointment of David Stump, formerly executive vice president for research and development at Human Genome, to its board of directors.