When Kathleen Sebelius took the helm of one of the largest civilian departments in the federal government, the first thorny issue on her desk was responding to the H1N1 flu virus, a new pandemic flu strain that seemed to target otherwise healthy young people. After less than week on the job her first public speech focused on how the Department of Health and Human Services (HHS), which oversees the Centers for Disease Control and Prevention and Food and Drug Administration, was responding to the public health emergency. She released millions of antiviral drugs from the national stockpile and warned against fake flu cures while calling for continual investment into research to stay ahead of future flu outbreaks. Talks about women’s and children’s health, obesity and AIDS soon followed.

Emergent BioSolutions Inc. today announced successful completion of the last licensure-enabling study in its BioThrax® (Anthrax Vaccine Adsorbed) Post-Exposure Prophylaxis (PEP) program. This clinical study, also known as the non-interference study, was designed to evaluate the pharmacokinetic profile of the antimicrobial ciprofloxacin when administered prior to and following the administration of a three-dose series of BioThrax. It was also designed to evaluate the immune response to BioThrax when administered with or without ciprofloxacin. The primary endpoints were the ratio of the maximum concentration (Cmax) and area under the curve (AUC) for ciprofloxacin and the secondary endpoint was the ratio of the geometric mean titer of the antibody response to BioThrax two weeks following the last dose. The study met the prospectively defined success criteria for both the primary and secondary endpoints. Data from this study show no interaction between ciprofloxacin and BioThrax.

Emergent has submitted the final clinical study report to the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Food and Drug Administration (FDA). Results from this study will be used to support a supplemental Biologics License Application (sBLA) seeking licensure of a PEP indication for BioThrax to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores. BioThrax is currently licensed for a pre-exposure prophylaxis indication only.

Qiagen NV, the Dutch diagnostics technology company that bought  Gaithersburg-based Digene for $1.6 billion in 2007, is preparing to clear out of Digene's old offices and move staff to an expanded Germantown headquarters.

The move has  been in the works for years, but Qiagen can finally push forward following recent FDA clearance of its 270,000-square-foot Germantown site for manufacturing the company's human papillomavirus (HPV) test. That HPV test, developed by Digene, was the impetus for the 2007 acquisition.

The University of Maryland announced today that the 2014 University of Maryland Corporate Connector of the Year Award recipient will be Dr. Michael Pecht and the UMD Center for Advanced Life Cycle Engineering (CALCE).  The UMD Corporate Connect Council annually recognizes a University of Maryland researcher, staff or unit that has achieved significant engagement with the private sector in corporate research, philanthropy, or student support.

Pecht will receive his award as part of the University’s Celebration of Innovation and Partnerships on Tuesday, April 29, 2014 at University House in College Park, Maryland. Pecht’s engagement with the private sector has played a large role in making UMD CALCE, headquartered at the College Park campus, the world’s largest manufacturing consortium in electronic parts reliability engineering, accelerated testing, and supply chain management. Over 150 corporations, federal labs, universities and leading international research centers are members. 

The Maryland Technology Development Corporation (TEDCO) announced today that nine finalists have been selected in the organization’s fourth annual ICE Awards. The awards program, which recognizes Innovation, Corporate Excellence and Entrepreneurship, will reward outstanding businesses and individuals from TEDCO’s diverse portfolio of more than 300 seed and early-stage companies. Winners will be announced on Thursday, May 15 from 8:30 am – 11:30 am during the awards ceremony at the Sheraton Columbia Town Center Hotel in Columbia, Md.  

“TEDCO’s portfolio companies encompass an incredibly diverse range of industries, technologies and innovations,” said Rob Rosenbaum, president and executive director of TEDCO. “We are pleased to announce this year’s ICE Awards finalists and congratulate them on their continued success in some of the fastest-growing and most competitive fields out there. Most importantly, we look forward to continuing to support leading Maryland innovators.”

On Friday, March 28th, a contingent of Johns Hopkins University Depart­ment of Biomedical Engineering (JHU BME) undergraduate students and faculty visited the University of Maryland campus in College Park, Md. to participate in the second annual JHU–UMD Under­graduate Research Day with undergraduates from the University of Maryland’s Fischell Department of Bio­engineering (UMD BioE).

This event is organized by the two universities’ student Biomedical Engineering Society (BMES) chapters — under the leadership of chapter presidents Anvesh Annadanam (JHU BME), and Luke Peterken (UMD BioE).

Now that the Maryland General Assembly has adjourned for the year, it is time to take a quick review of significant accomplishments. Amid the hotly-contested debate on honoring soft shell crabs, kudos to the legislature for passing two little-noticed initiatives to create jobs and spur local economic development by leveraging the state's huge academic, federal and private research sectors.

The first initiative, the "E-nnovate" bill, creates a $100 million matching fund to recruit the world's best scholars to Maryland in areas as diverse as cyber security, biotechnology, STEM education, autonomous systems, language science and food safety. The fund will require these scholars to work with other Maryland universities, federal labs or with innovative startup companies, ensuring integration of research into economic development.

The University of Maryland, College Park, has announced a new master's degree program that will focus on technology entrepreneurship — and, appropriately, it will be offered online.

The program will be part of the university's Maryland Technology Enterprise Institute (Mtech), and enrollees will have access to the institute's Technology Advancement and Venture Accelerator programs in addition to their online curriculum.

Governor Deval Patrick announced Thursday a plan to keep highly-skilled international students in Massachusetts post-graduation. Under his proposed Global Entrepreneur in Residence program, however, the "highly-skilled" appear to have one trait in common: technical talent. And now is not the time to be focusing solely on science, technology, engineering and math.

Patrick's proposed legislation exploits a loophole in federal immigration law, and could bolster the number of H-1B visas the state is allotted. Students eligible for a nonimmigrant visa but unable to obtain it due to a federal cap will be designated an "entrepreneur in residence" if they have plans to start or grow a business locally.

As early as February, analysts were saying that it would be a good year for healthcare IT companies looking for venture capital.

Communications and consulting firm Mercom Capital echoed that today with results from its first-quarter investment analysis which found that healthcare IT companies raised more VC money last quarter than in any quarter before.

The most extensive collaboration between the patient social network and a drug company to-date is likely to be just the first of its kind.

PatientsLikeMe, the largest online network for patients, has established its first broad partnership with a drug company. Genentech, the South San Francisco biotechnology company bought by Roche in 2009, now has access to PatientsLikeMe’s full database for five years.

If you have been around UMBC at all in the past few years and involved with the Alex. Brown Center for Entrepreneurship, you have heard about or met Greg Cangialosi. Some were even lucky enough to take the Digital Marketing class taught by him last Spring (2013). 

Cangialosi is also the benefactor and namesake of the Cangialosi Business Innovation Competition getting ready to make it's debut in a just a few weeks. 

GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that data for its lead clinical drug candidate, rivipansel (GMI-1070), was highlighted via one oral presentation and one poster at the 8th Annual Sickle Cell Disease Research and Educational Symposium and 37th National Sickle Cell Disease Scientific Meeting, held April 11-14, 2014, at the InterContinental Miami.

Rivipansel is in clinical trials as a potential therapy for the treatment of vaso-occlusive crisis (VOC) in people with sickle cell disease. It has previously received both Orphan Drug and Fast Track status for the treatment of VOC from the U.S. Food & Drug Administration (FDA), and Orphan Product status in the European Union. GlycoMimetics is developing rivipansel in collaboration with Pfizer, Inc.

Fifty-four weeks after it opened, 1776 serves as a packed and noisy hub for Washington’s startup community.

Evan Burfield and Donna Harris founded the business incubator in January 2013, and 1776 moved into its 12th-floor offices, which are a 10-minute walk north of the White House, on April 1, 2013.

In a bid to expand its pipeline of Personalized Healthcare assays, Qiagen NV (QGEN - Snapshot Report) acquired an exclusive worldwide license for the calreticulin (CALR) biomarker from CeMM Vienna, the Research Center for Molecular Medicine of the Austrian Academy of Sciences.

Qiagen retains a strong pipeline of promising biomarkers under development for Personalized Healthcare tests pertaining to rheumatoid arthritis, lung cancer, colorectal cancer, glioblastoma, lymphoma and other cancers. Post acquisition of the license, Qiagen will develop a molecular diagnostic test for CALR mutations that will help healthcare providers to make more informed therapeutic decisions.  

If you were to ask most early-stage companies what they’d consider to be a decent prize from a group of investors for a well pitched device or service, they’d probably say money. But at an entrepreneur forum at Penn Medicine, the rewards were as varied as the groups offering them. Venture capitalists, angel investors, accelerators and incubators each offered a different take on what a reward should look like.

Philadelphia has been working to build a better entrepreneur ecosystem to grow companies and stimulate job growth. As part of that trend, institutions are looking for ways to get more investors involved.

Today the Pharmaceutical Research and Manufacturers of America (PhRMA) released a report that outlines two potential growth trajectories for the U.S. biopharmaceutical sector and the top policy factors that enable the industry to innovate and, in turn, contribute to the U.S. economy.

Developed by the Battelle Technology Partnership Practice, the report finds that coverage and payment policies, a well-functioning, science-based regulatory system and strong intellectual property (IP) protections drive U.S. leadership in biopharmaceutical innovation, and if negative trends in these key policy areas continue, jobs supported by the industry would decrease over the next decade. However, if reasonable pro-innovation policies are pursued, the U.S. biopharmaceutical sector stands to retain and add well over 300,000 jobs to the U.S. economy by 2021.

QIAGEN N.V.  today announced it has acquired an exclusive worldwide license to the biomarker calreticulin (CALR), whose recently discovered mutations are found in an estimated 15% of cases of myeloproliferative neoplasms (MPNs), a group of blood disorders. QIAGEN licensed the technology from CeMM Vienna, the Research Center for Molecular Medicine of the Austrian Academy of Sciences, whose scientists led a team that discovered the presence of mutations of the CALR protein in MPNs. QIAGEN plans to develop a molecular diagnostic test for the CALR mutations to offer each patient a clearer prognostic profile and to guide disease management. Development of a CALR diagnostic test is expected to be highly complementary to QIAGEN's kits for a key mutation of the Janus kinase 2 (JAK2) gene.

Myeloproliferative neoplasms, a group of blood disorders involving overproduction of blood cells, are chronic diseases that can lead to several complications including thrombosis (blood clots) and in some cases difficult-to-treat acute leukemia. QIAGEN already has an exclusive license for the JAK2 V617F mutation, which is present in about 75% of patients with MPNs. According to an article published in the New England Journal of Medicine in December 2013 by the CeMM team led by Robert Kralovics, patients with CALR mutations suffer from a milder form of the disease than those with the JAK2V617F mutation, including a lower risk of thrombosis and a higher survival rate.

The University of Texas MD Anderson Cancer Center announced its new collaboration with GlaxoSmithKline to advance development of cancer immunotherapies.

The collaboration will focus on the identification of new therapeutic approaches, evaluation of patient outcomes in clinical testing, and utilization of resulting information to develop drugs that recruit the body’s own immune system against cancer.

Health care is a misnomer for our medical system.  It should be called sick care. Doctors, hospitals and pharmaceutical companies only make money when we are in bad health.  If we could instead prevent illness and disease, it would turn the entire medical system on its head and increase the quality of our lives.

The good news is that technology is on its way to letting us do this.  It is now moving so rapidly that within a decade the small handheld medical reader used by Dr. Leonard McCoy in Star Trek — the tricorder — will look primitive. We are moving into an era of data-driven, crowdsourced, participatory, genomics-based medicine.  Just as our bathroom scales give us instant readings of our weight, wearable devices will monitor our health and warn us when we are about to get sick.  Our doctors—or their artificial intelligence replacements—will prescribe medicines or lifestyle changes based on our full medical history, holistic self, and genetic composition.

The National Heart, Lung, and Blood Institute (NHLBI) seeks feedback from the small business community regarding the current state of the science and commercial feasibility of using in vitro human cellular models as an experimental tool for predicting in vivo drug responses to cystic fibrosis transmembrane conductance regulator (CFTR)-directed therapeutics for Cystic Fibrosis (CF) lung disease at the individual level.  Responses to this Request for Information (RFI) will assist NHLBI staff in assessing the value of the research in areas related to advancing precision medicine approaches to treatment.

New Enterprise Associates, Inc. (NEA), a leading global venture capital firm, today announced the kickoff of a second installment of its design mentorship program, In the Studio. Building on NEA's successful 2013 program, In the Studio will be an intensive, two-week program for up to six design teams, developed and produced in collaboration with New York City-based product studio All Tomorrows, led by Albert Lee, and with Liz Danzico, founding chairperson of the Interaction Design program at New York City's School of Visual Arts. Applications are now being accepted for the program, which will take place June 2nd through 17th, 2014.

Led by NEA Partner Dayna Grayson, the program evolved in response to a growing community of entrepreneurially minded designers, particularly in the New York City tech ecosystem. With design increasingly central in building successful consumer and enterprise applications, the program recruits talented designers with entrepreneurial or startup aspirations and provides mentorship, resources and opportunities to collaborate.

This year has been charted with the unfolding of several White House technology initiatives that involve leveraging the groundbreaking work of the nation’s federal laboratories. In 1986, the Federal Laboratory Consortium for Technology Transfer (FLC) was mandated to pursue these initiatives by facilitating the movement of technologies from labs to the marketplace, strengthening research and development by streamlining technology transfer (T2) procedures, and increasing industry partnerships and collaborations. And, given the theme of this year’s FLC national meeting, “Accelerating Innovation for Economic Impact,” coupled with its nearby capital setting at the North Bethesda Marriott in Rockville, Maryland, this year is no exception.

BVCF, a Shanghai-based life sciences investor, has closed its third fund with $188 million to back upstart biotechs on both sides of the Pacific focused on the booming Asian market. Dow Jones' VentureWire and other media outlets reported that the backers to this fund include Novartis ($NVS), BlackRock, NEA and International Finance, which is gambling $20 million on the fund at a when time drug development activities in China continue to heat up.

BVCF sits on the crossroads of a relatively small but fast-growing area in biotech. U.S. and European biopharma companies have been looking for new ways to enter the Chinese drug market as the Big Pharma giants build out large new R&D operations in Asia and start linking up with academic groups. And the trend is spawning new joint ventures and company startups with in-licensed development projects.

Drug research is a small world, where the main players often intersect repeatedly as they take on new roles at different institutions. And MD Anderson's new "moon shots" program on immuno-oncology is proving that maxim yet again as GlaxoSmithKline's immunotherapy team suits up for the last big slot in an ambitious alliance of industry giants aimed at discovering some new products in the red-hot cancer R&D field.

GlaxoSmithKline ($GSK) is taking a berth next to teams from AstraZeneca ($AZN), Pfizer ($PFE) and Johnson & Johnson ($J&J). And the pact brings together two of the key players in the development of Yervoy, the pioneering anti-CTLA-4 immune checkpoint inhibitor which helped trigger one of the most frenetic development races the industry has seen.

Historic release of data gives consumers unprecedented transparency on the medical services physicians provide and how much they are paid

Today, as part of the Obama administration’s work to make our health care system more transparent, affordable, and accountable, Health and Human Services (HHS) Secretary Kathleen Sebelius announced the release of new, privacy-protected data on services and procedures provided to Medicare beneficiaries by physicians and other health care professionals. The new data also show payment and submitted charges, or bills, for those services and procedures by provider.

The Tech Council of Maryland (TCM), Maryland’s largest technology trade association for life science and technology, today praised state lawmakers for advancing key priorities for the tech community during this year’s legislative session. The 2014 session concluded on Monday.

“We are encouraged to see Maryland lawmakers and the Administration come through on our biggest pro-growth priorities: stronger incentives for R&D, biotechnology, and cybersecurity,” said Phil Schiff, TCM’s CEO. “These industries are the catalysts for innovation and job growth in Maryland, and we are grateful to see so many policy makers in Annapolis recognize the pivotal role they will play in Maryland’s economic future.”

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced today the CE mark and launch of the BD MAX™ GC rt PCR assay in Europe. The BD MAX GC rt PCR assay is an in vitro diagnostic test intended for testing Neisseria gonorrhoeae (GC) positive results from the BD ProbeTec™ GC Qx Amplified DNA Assay performed on the BD Viper™ System with XTR™ Technology. The assay may be used for detection of GC DNA in residual male or female urine specimens, or residual endocervical, vaginal or male urethral swab specimens that have tested positive for GC using the BD ProbeTec GC Qx Amplified DNA Assay.

With a budget bill passed this weekend and the University System of Maryland successfully lobbying for limited cuts to its state funding, the final day of the state’s legislative session was less intense for the higher education lobby.

The most significant bills for this university and the university system received support in both chambers of the legislature and passed with little controversy.

But for what amounted to a quiet day, the university system secured significant victories, with measures that use university resources to spur economic development and a state grant program aimed at attracting talented faculty to state universities passing one right after the other on the morning of sine die.

A less-invasive brain diagnostic test, a surface so slippery bacteria can’t stick to it, and a low-cost mylar wrap to help warm babies’ heads after surgery were three of the projects on display at Boston Children’s Hospital’s first-ever Innovators Showcase Friday.

The event is part of a larger push by Chief Innovation Officer Naomi Fried’s office to seek out innovators across the organization, support them with advice and sometimes money, and help guide them towards commercialization.

A group of University of Maryland undergraduates put together a spectacular hackathon this weekend, attracting more than 750 college students from across the country to take part in the 36-hour long event. The hackathon, which went by the name of Bitcamp, lasted from April 4-6 in Cole Field House on school grounds, providing students with the opportunity to collaborate with fellow innovators in creating brilliant new hardware and applications for mobile devices, computers or the Web. 

Health technology is advancing so rapidly that within a decade the small handheld medical reader used by Dr. Leonard McCoy in Star Trek — the tricorder — will look primitive.

We are moving into an era of data-driven, crowdsourced, participatory, genomics-based medicine. Just as our bathroom scales give us instant readings of our weight, wearable devices will monitor our health and warn us when we are about to get sick. Our doctors — or their artificial intelligence replacements — will prescribe medicines or lifestyle changes based on our full medical history, holistic self, and genetic composition.

After seeing how the federal agencies intend to implement the recommendations from The White House Lab to Market Summit the difference between product and process oriented people really hit home.

Product people burn with a passion to get the job done. Process people focus on rules and procedures to minimize risk.  Thus, product people are like the accelerator and process people are the brakes.  You need both in your car, but if the brakes run the show you’ll never get out of the driveway.  Similarly, whenever deal makers are subservient in a system to process people, frustration is sure to follow.

A blood sample could one day be enough to diagnose many types of solid cancers, or to monitor the amount of cancer in a patient’s body and responses to treatment. Previous versions of the approach, which relies on monitoring levels of tumor DNA circulating in the blood, have required cumbersome and time-consuming steps to customize it to each patient or have not been sufficiently sensitive.

Now, researchers at the Stanford University School of Medicine have devised a way to quickly bring the technique to the clinic. Their approach, which should be broadly applicable to many types of cancers, is highly sensitive and specific. With it they were able to accurately identify about 50 percent of people in the study with stage-1 lung cancer and all patients whose cancers were more advanced.

Alios BioPharma, Inc., a biotechnology company developing proprietary therapeutics for respiratory viral diseases, today announced it has completed a $41 Million Series B financing. All existing investors -- Novo Ventures, SR One, Roche Venture Fund and Novartis Ventures -- participated in this round, which was led by a new, undisclosed investor.

"We are pleased to welcome our newest investor and to have the continued support from our current investors for this round of financing," stated Lawrence M. Blatt, PhD, President and Chief Executive Officer of Alios BioPharma. "This funding will allow Alios to retain ownership and control of our novel, first-in-class anti-respiratory virus development programs."