Saturday, November 8, 2014 9 a.m. - 2 p.m.

University of Maryland, College ParkVan Munching Hall/ Smith School of Business

Advancing Tomorrow’s Leaders + STEM (ATLAS) is a one-day college and career symposium hosted by the MdBio Foundation and Tech Council of Maryland, in partnership with Prince George’s County Public Schools (PGCPS), the University of Maryland’s Office of Corporate and Foundation Relations and Elizabeth Seton High School. This inaugural Prince George’s County-based symposium is the third ATLAS event in Maryland, and is part of a larger initiative and formal partnership with PGCPS to encourage interest of high school juniors, seniors and college undergrads, who are typically underrepresented in Science Technology Engineering and Math (STEM) fields.

Baltimore health IT startup Emocha Mobile Health Inc. is partnering with Baltimore City to test out its medication adherence application with tuberculosis patients.

Emocha's miDOT records video of patients taking their medication, notes symptoms and sends a report to doctors. The company is letting Balitmore's health department use the program for free in an effort to begin building market interest and credibility for the program.

Antti Korhonen - NIST-TEDCO* Entrepreneur-in-Residence

Thursday, November 6, 2014 10:30 AM - 12:00 Noon Admin Bldg (Bldg 101), Lecture Room A

Recognize an invention’s value by developing its “Value Proposition”

Learn about discovering the “Value Proposition.” Something every NIST researcher and manager needs to know

• Inventions can be 
• smart and clever—and stay in the lab forever
• scientific breakthroughs—but still have no commercial value
• Inventions that are patented are well protected in the market—assuming they have market value that needs protection
• Inventions with the greatest social and economic impact are those having clearly defined market value

Swiss pharmaceutical group Roche hopes to obtain fast-track US approval for a rapid diagnostic test for Ebola, its director general said in an interview published Sunday, amid the worst-ever outbreak of the killer disease.

The diagnostic test is ready for use in scientific research but the company now wants to register it for clinical use.

As a partner at Norwest Venture Partners (NVP), Casper de Clercq has seen countless digital health startups try to get solutions off the ground. He’s also seen many fail.

According to de Clercq, 60 to 70 percent of digital health startups are likely to fail because they are unclear about their go-to market strategy, and don’t have a good understanding of who’s ultimately going to pay for their product.

The University of California recently announced its entry into the venture capital arena with a $250 million commitment to spinning promising technologies out of its top-notch, 10-campus system. Perhaps every major research university in the US — collectively, recipients of over $40 billion in federal research funding yearly, not to mention the inflows of corporate research funds — wishes to emulate Stanford’s success in capitalizing on the market successes of university-developed technology (think Google).

Pharma giant GlaxoSmithKline (GSK) might plan an initial public offering (IPO) of a minority stake in ViiV Healthcare, a global business focused on developing treatments for HIV, reports FierceBiotech.

Created five years ago, ViiV is GSK’s majority-owned joint venture with Pfizer and Shionogi. In the past 18 months, the Food and Drug Administration (FDA) approved two new HIV treatments from ViiV: Tivicay (dolutegravir) and the combo-tablet Triumeq, which includes Tivicay. These successes come at a time when GSK is planning to slash nearly $1.6 billion from its annual budget.

It’s no secret that Washington has a funding problem, with lawmakers and federal departments currently operating under unprecedented fiscal constraints.

It’s a very different story for the city’s entrepreneurs.

Pfizer Inc. has officially transferred an unused building on its campus here to Connecticut United for Research Excellence for use as a bioscience incubator hub, Gov. Dannel P. Malloy announced Friday.

The 24,000-square-foot Building 286 will become CURE Innovation Commons, which is expected to be fully operational by July 1, 2015.

Sucampo Pharmaceuticals Inc. on Thursday named Peter Kiener — whose past roles includes CEO of Zyngenia and head of biologics R&D for MedImmune — as its chief scientific officer.

Kiener, a heavyweight research hire, worked alongside Sucampo CEO Peter Greenleaf at MedImmune, where Greenleaf served as president until early 2013. Kiener then departed to launch Zyngenia Inc., a New Enterprise Associates-funded biotech focusing on antibody-based therapeutics, which he departed last year.

In early drug dis­covery, you need a starting point, says North­eastern Uni­ver­sity asso­ciate pro­fessor of chem­istry and chem­ical biology Michael Pollastri.

In a new research paper pub­lished Thursday in the journal PLOS-Neglected Trop­ical Dis­eases, Pol­lastri and his col­leagues present hun­dreds of such starting points for poten­tially treating Human African try­panoso­mi­asis, or sleeping sick­ness, a deadly dis­ease that affects thou­sands of people annually.

The technology for creating new tissues from stem cells has taken a giant leap forward. Two tablespoons of blood are all that is needed to grow a brand new blood vessel in just seven days. This is shown in a new study from Sahlgrenska Acadedmy and Sahlgrenska University Hospital published in EBioMedicine. Just three years ago, a patient at Sahlgrenska University Hospital received a blood vessel transplant grown from her own stem cells.

Suchitra Sumitran-Holgersson, Professor of Transplantation Biology at Sahlgrenska Academy, and Michael Olausson, Surgeon/Medical Director of the Transplant Center and Professor at Sahlgrenska Academy, came up with the idea, planned and carried out the procedure.

Qiagen has announced the introduction of expanded functionality for its range of bioinformatics workflow solutions.

New capabilities for the Ingenuity Variant Analysis and CLC Cancer Research Workbench solutions were unveiled at the American Society of Human Genetics annual meeting, which recently concluded in San Diego.

Regression models, Monte Carlo simulations, and other methods for predicting what’s around the corner have been in use for decades. It’s only recently, though, that advances in information technology have made it possible for predictive tools to access and manipulate big data, and to do so continuously — accelerating the generation of insights, and opening up opportunities to anticipate issues with unprecedented precision. Think of the colleges that are increasingly able to identify students at risk of dropping out and intervene before they do. Or lenders’ enhanced abilities to gauge credit risk. Energy, agriculture, insurance, retail, human resources — no industry is unaffected. But nowhere is the potential of this new era of opportunity more apparent and exciting than it is in health care.

Roche plans to spend around $3bn updating and expanding its Basal site, home to the Swiss company's headquarters, over the next 10 years.

The company is set to build a new R&D centre for 1,900 employees and an office building for 1,700 employees, and will also upgrade its existing infrastructure.

New initiative will support networks that help doctors access information and improve health outcomes

Health and Human Services Secretary Sylvia M. Burwell today announced an initiative that will fund successful applicants who work directly with medical providers to rethink and redesign their practices, moving from systems driven by quantity of care to ones focused on patients’ health outcomes, and coordinated health care systems. These applicants could include group practices, health care systems, medical provider associations and others. This effort will help clinicians develop strategies to share, adapt and further improve the quality of care they provide, while holding down costs. Strategies could include:

Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, and Takeda Pharmaceutical Company Limited (Takeda) today announced that on October 17, 2014, they entered into a global license, development, commercialization and supply agreement for AMITIZA® (lubiprostone). Through this agreement, Takeda expanded its exclusive rights beyond the United States (U.S.) and Canada to further develop and commercialize AMITIZA in all global markets, except Japan and the People's Republic of China.

"Takeda is committed to being a patient and customer-centric organization, making quality health products available to the patients who need them. Through this agreement, AMITIZA can now be made available to patients worldwide," said Shinji Honda, Senior Managing Director and Corporate Strategy Officer. "Takeda forms partnerships to advance science and to provide innovative treatment options for patients, and this global agreement is an excellent example. This global collaboration leverages the expertise we have established through our gastroenterology portfolio of products."

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.