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.

Sure, Johns Hopkins University is known for its medicinal prowess, but what better way to increase the university's influence on the health care sector than by cosponsoring an accelerator aimed toward spurring the growth of more health information technology companies.

Johns Hopkins announced its plans  to work with DreamIt Health Baltimore on Wednesday, a four-month long boot camp for innovators in the health IT business. Teaming up with BioHealth Innovation and DreamIT Ventures, Johns Hopkins will be powering the accelerator designed to fast-track promising ideas aimed at solving problems in America and abroad.

Arizona State University and Mayo Clinic announced today that Mayo will become a technology transfer participant to join Arizona Furnace, the startup accelerator that supports entrepreneurial teams using designated research discoveries and intellectual property as the basis for new companies.

As ASU and its current partners prepare to launch the second application season for AZ Furnace, Mayo Clinic will provide access to high potential technologies in their extensive intellectual property vault. These technologies, as well as those from ASU, Northern Arizona University and Dignity Health in Arizona, will be made available to entrepreneurs interested in using those discoveries to create products, services and new companies.

To us, biomedical research is not an abstract idea funded by wasteful government spending. It is work done by driven and passionate young people like ourselves who want to save lives -- but that work requires money, resources, and time.

We are a group of graduate students at the Johns Hopkins University School of Medicine’s Medical Scientist Training Program, earning our joint MD-PhD degrees with the goal of becoming physician scientists. We aim to be well versed in both scientific research methods and clinical practice so that we can expand and improve medical care, save lives, decrease the cost of health care and drive medicine forward. Thus far, the discussion surrounding the sequestration has lacked the perspective of trainees in biomedical research and the implications that budget cuts have had on our training and future careers.

The University of Maryland, Baltimore, has broken ground on its largest building ever, a $305.4 million, 10-story, 428,970-square-foot biomedical research facility called the Health Sciences Facility (HSF) III. University of Maryland President Jay A. Perman, MD, was joined by Gov. Martin O'Malley, Lt. Gov. Anthony Brown, University of Maryland School of Medicine Dean E. Albert Reece, MD, PhD, MBA, and several hundred invited guests at a groundbreaking ceremony Sept. 17 on the site of the new building ý the old dental school facility on North Pine Street.

"This is a proud day for the University of Maryland, Baltimore," Dr. Perman told the crowd. The campus has expanded from 1.9 million square feet in 1975 to occupy 5.9 million square feet in 2013, he noted. "The University of Maryland, Baltimore, the University System of Maryland's founding campus, has experienced robust growth in recent years. The Health Sciences Facility III further strengthens our footprint in west Baltimore and, as a result, our economic impact on the city and the state. We're privileged to be able to help revitalize our critical important Baltimore neighborhoods and the state of Maryland as a whole, and at the same time, enable biomedical research and education that has the potential to save lives."

The Tech Council of Maryland (TCM), Maryland’s largest trade association for bioscience and technology companies employing more than 200,000 in the region, today announced that Philip Schiff, formerly chief strategy officer of the American Association of Blood Banks (AABB), has been named CEO.

“Maryland has a dynamic technology sector, which has been leading the state’s economic recovery during the past few years," said Doug Doerfler, chairman of TCM’s Board and founding president and CEO of MaxCyte, Inc. "Phil understands the major role our enterprises play today, and will use his extensive experience managing a national association, combined with his understanding of complex technology, to execute TCM's vision and lead critical advocacy efforts on behalf of Maryland's technology entrepreneurs for the future.”

Rockville biotechnology company Emergent BioSolutions plans to buy a Gaithersburg building and move its 112 employees at its headquarters there, as well as add 133 jobs over the next five years, executives said Monday.

As part of the deal, the Gaithersburg City Council was expected to consider awarding a $250,000 economic development grant to Emergent during its meeting Monday evening.

The University of Maryland (UMD) and Siemens Corporation announced today the largest ever in-kind software grant from Siemens PLM Software. The in-kind grant has a commercial value of more than $750 million. Siemens' product lifecycle management (PLM) software will provide UMD students and researchers with a uniquely valuable and sophisticated design and simulation tool for course work, research, academic projects and team-based competitions.

This in-kind grant from Siemens gives students and faculty access to the same technology that companies around the world depend on every day to develop and manufacture innovative products in a wide variety of industries, including automotive, aerospace, biotechnology, machinery, shipbuilding, and high-tech electronics, among others.

Fenwick & West LLP, one of the nation's premier law firms providing comprehensive legal services to high technology and life science clients, today announced the results of its First Half 2013 Life Science Venture Capital Survey.

The survey analyzes the valuations and terms of venture financings for 149 life science companies headquartered in the United States that reported raising capital during the first half of 2013, as well as trends in venture capital financings, fundraising and exit events.

Winning a $1.6 million federal grant to buy a robotic system to store 1 million blood, urine and tissue samples was easy compared to finding space for it at the University of Maryland School of Medicine.

The "monster" machine, to be known as the university's "bio bank," is 13 feet wide, 20 feet deep and 10 feet high, said Dr. Alan Shuldiner, associate dean for personalized medicine.

But free lab space is scarce on the school's West Baltimore campus.

A report from the Agency for Healthcare Research and Quality (AHRQ), “Health IT-Enabled Quality Measurement: Perspectives, Pathways, and Practical Guidance,” outlines experts’ viewpoints on how information technologies are advancing the science of quality measurement. Over the course of the 2-year project, diverse perspectives were identified regarding how to operationalize quality measurement as well how to prioritize iterative advancements in health IT-enabled quality measurement.

Stakeholders agreed on the importance of addressing measure development, implementation, and testing; data elements and data capture; data access, sharing, aggregation, and integration; patient engagement; and collaboration and education. They also agreed that they would like to see quality measurement move beyond “checking the box” to truly support the quality improvement process. They suggested that quality measurement should be actionable and timely to allow patients and providers opportunities to improve care.

While the first half of 2013 saw a surge in initial public offerings (IPOs) by venture-backed biopharma companies, the overall financing environment for privately held life science companies remains slow.

The average valuation increase for life science companies receiving venture capital financing during the first half of 2013 was roughly even with 2012 results, and the percentage of "up round" financings declined slightly. Fundraising by life science venture capitalists continued to decline as well.

In investing, comedy, and business, timing is a key component of success.  It’s not enough to have a sense of where the future is going, directionally – you have to have some sense of when it’s likely to arrive.

In investing, this challenge is perhaps seen most vividly in bubbles, as Gregory Zuckerman details in The Greatest Trade Ever, providing example after example of exceptionally smart people — from Isaac Newton to Stanley Druckenmiller — who were able to correctly perceive a bubble, but who nevertheless lost huge sums of money by inaccurately estimating when it would burst.

Virginia’s Center for Innovative Technology (CIT) has launched the first cyber-security technology startup accelerator program in the U.S. The Mach37 Cyber Accelerator is intended to locate and leverage the wealth of cyber security talent in Virginia to create companies that will develop and launch new products.

Mach 37 represents 37 times the speed of sound, which is approximately the same as the Earth’s escape velocity.

Cars entering UMBC’s campus from I-195 will pass by a collection of nice looking buildings and a Subway restaurant. When temporarily stopped to obey the four-way stop before crossing the intersection, passengers may notice the sign that says bwtech@UMBC.

While the buildings and the sign are a familiar sight to many, their significance may remain unknown to those who pass by. These buildings house part of a research park run by UMBC named bwtech@UMBC.

The National Cancer Institute (NCI) is interested in fostering communication between eligible small businesses and prime contractors.

The event, held in Rockville MD, will provide information about upcoming subcontractor opportunities for eligible small businesses, while assisting primes with meeting their subcontracting goals. NCI is interested in identifying a variety of small businesses that have expertise and capabilities in a range of specific NAICS codes listed.

University of Maryland Received a 2013 NIH Grant for $219,084 for Age-Related Changes in Renal Morphology and Function in Chronic Kidney Disease. The principal investigator is Yu Chen. The program begain in 2012 and ends in 2014. Below is a summary of the proposed work.

This application is in response to PA-09-166 "Renal Function and Chronic Kidney Disease (CKD) in Aging (R21)". CKD is a growing problem among the aging population. According to the United States Renal Data System, the number of older patients with end-stage renal disease (ESRD) has almost doubled over the last 25 years.

I don’t think I’ve ever (in 20+ years of writing) reprinted a press release verbatim. Often I don’t even get to the end of them because of all the PR speak. However, today the Mayo Clinic sent out this list. It is concise, compelling and I can’t think of any way to improve it. The 10 ways the human genome map can affect diagnosis and treatment is an important reminder that we have come a long way in a short time, and that healthcare in the United States is not all about arguing about who gets care and who pays for it.

In case you had any doubts that the $3.8 billion investment in the genome mapping project was worth it, consider these 10 advancements compiled by the Mayo Clinic.

United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension. The FDA classified the resubmission as a complete, class 2 response to its March 22, 2013 complete response letter, and set a user fee goal date of February 16, 2014.

About United TherapeuticsUnited Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.