It’s not just the FDA that is making life difficult for medical device companies. Executives are having to follow sales opportunities as medical care shifts out of hospitals into homes and physician offices. They are having to revamp their entire business model to survive in the new world of the ACA.

A.T. Kearney has identified the five forces that are forcing the device industry to evolve in this new report: Medical Devices: Equipped for the Future? In addition to spelling out the threats, the analysts have a guide for how to start building a new business model.

Stapling up skin post-surgery is pretty much the norm to quickly seal up wounds, but it runs a risk of infection and injury from the extra damage to already sensitive skin.

Bay Area startup ZipLine Medical has developed a non-invasive but suture-like alternative that it’s positioning as a quicker, simpler and more desirable way to close small surgical wounds. To boot, clinical trials have shown the method decreases both infection likelihood as well as scarring. The company just closed a $5.7 million extension to its Series C financing round, led by a new venture firm in Shanghai called China Materialia that wants to expand the technology there.

Colleen Worthington has been working at this university for more than 24 years. It wasn’t until this year, however, that she received her first promotion.

“No matter how much better I got or more I contributed, it was the same title from 1990 until last [semester],” Worthington said.

Tuberculosis is both tough to treat and medically cumbersome to manage. Under directly observed therapy, a medical professional has to watch a patient take his or her medication for at least six months. A Baltimore health IT startup may help lighten that load.

The Baltimore City Health Department is launching a pilot with emocha Mobile Health’s app miDOT, according to a release from the Highlandtown firm.

Baltimore biopharmaceutical company Profectus BioSciences Inc. has received a three-year, $8.5 million grant from the U.S. Army for work on an Ebola vaccine.

Profectus will share the grant with the Galveston National Laboratory at the University of Texas Medical Branch at Galveston. The grant is Profectus' second in recent days. The company also announced a $5.8 million grant from the Biomedical Advanced Research and Development Authority (BARDA) to conduct safety studies of the company's VesiculoVax, a potential Ebola vaccine.

Earlier this year, the Secretary of the Department of Health and Human Services (HHS) launched the HHS IDEA Lab. With it, we unveiled a consolidated structure for the innovation activities at the Department of Health and Human Services, flashy new branding and a website. But when we launched, we weren’t totally clear on what the main message for the HHS IDEA Lab was, and over the past 6 months we heard the question – what is the HHS IDEA Lab all about? So we have looked at ourselves, focused on what your needs are to solve problems, become an entrepreneur, or just learn new skills, and have clearly defined what the HHS IDEA Lab is.

Massachusetts General Hospital and MIT have formed a $3 million strategic alliance in an attempt to address three “major challenges” that persist in healthcare: improving diagnoses, developing new approaches to prevent and treat infectious diseases and developing more accurate methods of diagnosing and treating neurodegenerative and psychiatric diseases.

The alliance, officials said, will add further heft to already existing efforts between individual collaborations between the two institutions, particularly as they relate to development of diagnostic tools and therapies.

The U.S. government invested $440 million in three vaccine plants in the U.S. in 2012 with the proviso that if something like a pandemic occurred, it could call on them to produce drugs that it required. With Ebola spreading, those calls have now been made.

The Ebola crisis has prompted the Biomedical Advanced Research and Development Authority (BARDA) to ask the three plant owners--Novartis ($NVS), GlaxoSmithKline ($GSK) and Emergent Biosolutions ($EBS) and their partners--to tell it what it would take for them to produce ZMapp, an experimental drug currently being produced through a novel approach using tobacco plants. BARDA wants detailed timetables and budgets for making ZMapp, Reuters reports. They are supposed to respond by Nov. 10.

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:

Notice of Special Accommodations for Submission and Reporting Requirements for Program Directors/Principal Investigators Responding to the West Africa Ebola Outbreak
(NOT-OD-15-010) Office of the Director, NIH

Notice to Extend the Response Date for NOT-OD-14-128 "Request for Information (RFI): Consideration of Sex As a Biological Variable in Biomedical Research"
(NOT-OD-15-012) Office of the Director, NIH

Reminder: NIH Requires the Research Performance Progress Report (RPPR) for All Type 5 Progress Reports
(NOT-OD-15-014) Office of the Director, NIH

Notice of Participation of the National Institute on Drug Abuse in PA-14-334 "Advancing Interventions to Improve Medication Adherence (R01)"
(NOT-DA-14-052)
National Institute on Drug Abuse

NHLBI Announces Frequently Asked Questions (FAQs) for RFA-HL-15-015 "Multi-Site Clinical Trials for the Pulmonary Trials Cooperative (U01)" and RFA-HL-15-016 "Network Management Core (NEMO) for the Pulmonary Trials Cooperative (U01)"
(NOT-HL-14-240)
National Heart, Lung, and Blood Institute

Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.

Italian drugmaker Sigma-Tau is in advanced talks to sell part of its Italian operations to domestic peer Alfa Wassermann that would create an over-the-counter (OTC) powerhouse, several sources familiar with the situation said.

Sigma-Tau is working with Milan-based Four Partners, an advisory firm led by Sigma board member Guido Tugnoli, said the sources, who declined to be identified because the matter is private.

NewLink Genetics Corp (NLNK.O) said it entered into an agreement with Roche Holding AG (ROG.VX) to develop NewLink's cancer immunotherapy, making the Ebola vaccine developer eligible to receive over $1 billion in milestone payments.

NewLink's shares jumped nearly 30 percent before the bell on Monday.

Biopharmaceutical company Emergent BioSolutions could begin manufacturing an experimental Ebola drug at its Baltimore facility.

Rockville-based Emergent is one of three advanced laboratories asked by the Biomedical Advanced Research and Development Authority (BARDA) to submit a plan for manufacturing ZMapp. The drug has been used among infected health workers in Africa but supplies have run out. BARDA will select one or more of the labs to make more of the drug.

ATCC, the premier global biological materials resource and standards organization, announces the release of ATCC® Minis to support quality control (QC) testing in pharmaceutical and industrial labs, during the PDA 9th Annual Global Conference on Pharmaceutical Microbiology in Bethesda, MD, Booth # 304.

Healthcare, personal care product, and cosmetic manufacturers are required to test the bio-burden and sterility of their products and production environments to ensure consumer safety. Global alignment and harmonization of microbial testing requirements among the United States Pharmacopeia (USP), Japanese Pharmacopeia (JP), and European Pharmacopeia (EP), have resulted in the need for consistent and reliable control organisms at less than five passages from the ATCC reference stock for reproducible results.

A BIOTECHNOLOGY company founded by Limerick man Kieran Curran has been snapped up for $150m by a US firm.

GenCell Biosystems, a company based in Raheen with offices in the US, was acquired late last week by Becton Dickinson, a company listed on the New York Stock Exchange.

One of the two Ebola-infected Dallas nurses was admitted to a National Institutes of Health biocontainment unit in Bethesda on Thursday, just as researchers at the University of Maryland School of Medicine in Baltimore are beginning the first human trials of an Ebola vaccine in Africa.

Dr. Myron Levine, a researcher at the medical school, is a member of the international medical group leading the efforts to end the outbreak. Ebola has infected more than 8,000 people since the first reported case in March, according to the Centers for Disease Control and Prevention.

Venture capital investments in Maryland are still working their way back up, according to a report released this week by PricewaterhouseCoopers and the National Venture Capital Association.

In the third quarter of 2014, venture capitalists spent $89 million, up 34 percent from the second quarter’s $66.5 million, but far off the third quarter number from last year, which hit $142 million, according to the report.

In the Boston-versus-New York rivalry, the Red Sox and the Yankees were also-rans this baseball season. Now, Massachusetts and New York are in another battle for the No. 2 spot: U.S. venture capital investment.

New York is leading Massachusetts in total venture capital invested so far this year, which if it held up would be the first time the Empire State edged out its East Coast rival and took second place behind industry leader California since at least 1992.

Applications are now open for DreamIt Health’s second Baltimore cohort.

DreamIt Ventures will accept applications through Dec. 5, according to a DreamIt blog post. The first cohort last year included startups like Protenus, Aegle and Quantified Care.

A $5 million Innovation Challenge Fund (ICF), to encourage and support academic groups and small companies in collaborative efforts in the development of bioelectronic medicines, has been announced by GSK. This funding programme is in addition to the company’s prior commitment of a $1 million award (December 2013), for the team that first solves the GSK Bioelectronics Challenge.

Bioelectronic medicine is focused on producing miniaturised, implantable devices that could be programmed to read and correct electrical signals passing along the nerves of the body, to treat disorders as diverse as inflammatory bowel disease, arthritis, asthma, hypertension and diabetes. The ICF funded work and the Innovation Challenge’s winning entry will be made freely available to the global research community.

A jaw-dropping report released by the World Health Organization on October 14, 2014 reveals that 1 in 20 Ebola infections has an incubation period longer than the 21 days which has been repeatedly claimed by the U.S. Centers for Disease Control.

This may be the single most important -- and blatantly honest -- research report released by any official body since the beginning of the Ebola outbreak. The WHO's "Ebola situation assessment" report, found here, explains that only 95% of Ebola infections experience incubation within the widely-reported 21-day period.

ASTRAZENECA has announced a four-way collaboration which will strengthen the pharmaceutical giant's link with Cambridge University.

The firm, together with its biologics research and development arm MedImmune, has agreed the new collaboration as it prepares to move its global headquarters to the city. It builds on an existing strategic partnership between the organisations.

I joined J&J Consumer Companies about four years ago to start its Digital Center of Excellence. Our role initially was to build capabilities and develop strategy that served multiple brands in multiple regions, so I did a landscape overview to help develop the approach. What I saw was that we had hundreds of different websites and digital platforms that we were operating upon globally. If you want to get a message across globally on your owned assets, you need to do that in the same way across the world.

Bicycle’s founding venture capitalist (VC), Atlas Ventures joined forces this month with SV Life Sciences and three corporate VCs – Novartis (NVS) Venture Fund, GlaxoSmithKline’s (GSK) SR One and Astellas Venture Management to invest $32m (€25m) in the Cambridge-based biotech company.

Bicycle Therapeutics was established in 2009 as a spin-off of the Medical Research Council Laboratory of Molecular Biology (Cambridge), based on the work of the scientific founders Sir Gregory Winter and Professor Christian Heinis from Trinity College, Cambridge. Winter, a renowned scientist in the biotech industry, also founded Domantis and Cambridge Antibody Technology. Founded in the 80s, Cambridge Antibody Technology was a pioneer in British biotechnology, and was listed on the UK stock exchange in 1997, raising £43m. In 2006, AstraZeneca bought the company.

Bioinformatics giant Illumina (NASDAQ: ILMN) is getting into the accelerator game, along with other players in the life sciences and other fields. On Wednesday it announced the first three startups chosen to start the program this fall at its San Francisco lab space.

San Diego-based Illumina, which makes genomic analysis systems, unveiled the program in February, joining the growing list of academic institutions, venture-backed groups, and life science corporations building start-up space in the Bay Area and beyond. Not least among the benefits of the Illumina accelerator program is access to the company’s high-end gene sequencing systems, which are installed  in the lab space Illumina has leased near the Mission Bay campus of the University of California, San Francisco.

The Center for Innovative Technology (CIT) announced this week the release of the Commonwealth Research Commercialization Fund (CRCF) annual report for FY2014, showing growth in new patents, products and innovative companies.

Karen Jackson, Virginia’s Secretary of Technology, said, “CRCF plays an important role in the acceleration of innovation in the Commonwealth by funding essential research and commercialization projects. The investments we make in research commercialization plant the seeds that are growing the New Virginia Economy.”

The Tech Council of Maryland (TCM), Maryland’s largest technology trade association for life science and technology, has been awarded a three-year, $225,000 federal grant designed to help job seekers gain skills in the growing fields of cyber technology and cyber security.

The grant is part of a $15 million federal investment in the Cyber-Technology Pathways Across Maryland (C-PAM) Consortium, spearheaded by Montgomery College. The consortium, which is comprised of 14 community colleges and trade associations, aims to prepare women and other underrepresented populations for jobs in the rapidly growing cyber industry.

Sucampo Pharmaceuticals has announced that it signed an amendment to the existing collaboration and license agreement (Collaboration Agreement) covering the United States and Canada for AMITIZA(R) (lubiprostone) with Takeda Pharmaceutical Company Ltd. The amendment includes various modifications to the Collaboration Agreement including the extension of the current term, minimum commercial investment during the current term and various governance changes allowing Takeda additional flexibility in commercializing AMITIZA.

During the extended term, which will begin on January 1, 2021, Takeda will split with Sucampo the gross profits of branded AMITIZA for any dosage strength and form for the existing indications in the U.S. and Canada. In addition, on April 1, 2015 Takeda will no longer reimburse Sucampo for the product details made by Sucampo sales representatives to healthcare professionals as well as other ancillary costs of the sales force.

University of Maryland, Baltimore’s $200 million proton therapy center will begin treating cancer patients in a year.

The center’s first of five treatment rooms will begin treating patients in October 2015. The entire building is expected to be complete in two years. The 110,000-square-foot building is part of the University of Maryland BioPark in Baltimore off Martin Luther King Boulevard.

The Eastern Shore Entrepreneurship Center (ESEC), Rural Maryland Council (RMC), and Maryland Capital Entreprises (MCE) have joined together to offer the third annual Eastern Shore Business Competition.  All three organizations strive to advance and expand the entrepreneurial ecosystem on Maryland's Eastern Shore, as well as throughout Maryland, and collaborate to execute a business competition that will draw greater attention to the Eastern Shore and attract entrepreneurs to the opportunities and resources available in the region.  The application process for the competition has begun and we are looking forward to your submissions!  

The purpose of the competition is to promote and encourage the startup of new businesses and in turn the creation of new jobs on Maryland's Eastern Shore.

The Center for the Advancement of Science in Space (CASIS) has announced grant awards for three projects focused on enabling technologies from the International Space Station (ISS). These awards stem from the CASIS Request for Proposals (RFP) “Enabling Technology to Support Science in Space for Life on Earth.” CASIS is the nonprofit organization managing research onboard the ISS U.S. National Laboratory.

The purpose of this RFP was to identify and support technology development projects that would enable increased use of ISS for Earth benefits—for example, improvements in hardware/capabilities or methods to improve bandwidth, throughput, or quality of future research projects.

The global accelerator DreamIt Ventures has announced that it is now accepting applications for DreamIt Health Baltimore, a four-month acceleration program based in one the country’s leading cities for health. With access to institutions like Johns Hopkins Medicine and the University of Maryland, healthtech startups chosen to participate in this class will get the opportunity to tap into resources essential to the development, improvement, and market utility of their products.

As the tech industry falls back in love with urban America, Joel Marcus, landlord to the booming biotechnology business, is perfectly positioned to strike it rich.

In Manhattan, overlooking the East River and sandwiched between New York University Langone Medical Center and Bellevue Hospital, two gleaming 16-story towers act as beacons to the booming biotech sector.

Completed in 2010, the 310,000-square-foot Alexandria Center for Life Science is already 100% occupied. It contains a hub for Eli Lilly’s cancer business and a Pfizer PFE -1.69% lab dedicated to exploring leads generated by academic researchers. The second building, some 410,000 square feet of labs and office space, was finished in January and is already 60% full. Roche, the anchor tenant, says moving 250 clinical trial specialists there from Nutley, N.J. has resulted in 25 new collaborations with charities, biotechs and New York hospitals. There’s also an accelerator for startups, an enviro-friendly garden and fancy restaurants to feed all those scientists.

QIAGEN N.V. (NASDAQ: QGEN)(Frankfurt Prime Standard: QIA) announced today that its business area, QIAGEN Bioinformatics, has been named by Genomics England (GeL) an assessment winner for the UK100K project, along with other life science technology providers. The company will be providing project researchers access to Ingenuity® Variant Analysis™, a powerful web-application that allows users to rapidly identify and prioritize disease causing genetic variants using advanced analytics powered by published biological evidence and large numbers of sequenced genomes.

Antibiotic resistance is taking its toll on the pharmaceutical industry: Drugs are getting retired from clinical circulation, because many are starting to get rendered ineffective, according to an article from Washington University of St. Louis. It highlights the work of WUSTL’s Michael Kinch, associated vice chancellor of its Center for Research Innovation in Business:

The National Institutes of Health (NIH) has launched a pilot program to help life science entrepreneurs commercialize their technology, based on a course developed by the University of California, San Francisco. The course was first taught last fall by the Entrepreneurship Center at UCSF and Steve Blank, architect of the Lean LaunchPad framework. UCSF and Blank adapted the Lean LaunchPad methodology to be applicable for life science and healthcare ventures.