GlaxoSmithKline plc, a research-based pharmaceutical company, recently announced the U.S. Food and Drug Administration’s approval of GSK’s FluLaval Quadrivalent influenza virus vaccine for individuals three years of age and older.

The vaccine is the second GSK intramuscular quadrivalent influenza vaccine approved by the FDA, following the approval in December of GSK’s Fluarix Quadrivalent. FluLaval Quadrivalent protects against two influenza A strains and two influenza B strains. Previous vaccines only included three strains to protect against two A virus strains and one B strain.

Corporate venture capital may be what fills in the large gaps VC has left behind, with CVC deals about 60 percent larger than VC deals on the whole.Healthcare corporate venture capital deals are up nearly 40 percent compared to Q1 and funding is up 34 percent, according to a report from CB Insights.

There were 126 CVC deals in Q2, ringing in at a combined value of $1.7 billion. Of these deals, 40 percent were at Seed or Series A-level, meaning CVCs may be willing to take risks VCs aren’t any more. According to the report, CVCs may help companies escape the Series A crunch: “One of every 4 CVC deals in Q2’13 were Series A deals ’ this represented an 800 basis point increase in Series A deal share vs. Q2’12.”

Howard County is teaming up with Johns Hopkins University to launch a new accelerator geared toward commercial technology.

The new accelerator, called the Accelerator for the Commercialization of Technology, will help bring to market technology developed at the massive Hopkins Applied Physics Laboratory in Laurel. Howard County Executive Ken Ulman plans to formally announce the new partnership between the laboratory and the Howard County Economic Development Authority at an event Thursday.

The Office of Technology Transfer (OTT), Office of the Director (OD), the National Institutes of Health (NIH), invites industry organizations (including corporations, partnerships, limited partnerships, and industrial development organizations); public and private foundations and nonprofit organizations to solicit research proposals from scientists across the NIH Intramural Research Program (IRP) for multiple focused research projects under a the NIH Cooperative Research And Development Agreement (CRADA) Program. This CRADA Program is an extension of collaboration opportunities solicited by NIH or developed on a one-on-one basis. As such, it is consistent with PHS Technology Transfer policy and the public health mission of the NIH. These collaboration opportunities are structured under the authority of 15 U.S.C. 3710a—Cooperative Research and Development Agreements. Note that the CRADA mechanism does not permit the transfer of funds from the NIH to a collaborator but does permit the collaborator to provide funding to the NIH researcher.

CareFirst BlueCross BlueShield has jumped head-first into the deep waters of mobile health. The health insurance giant has selected Cognizant, a mobile communication company, to provide a platform for getting mobile apps to its 3.3 million members.

Cognizant will help CareFirst offer its members "quick, secure and convenient ways" to manage their health coverage, access information about physicians and claims, and get information about benefits anytime, on any device, according to Cognizant officials in a news release.

Our partner, the Economic Alliance of Greater Baltimore (EAGB) is in the running for the Economic Development Organization of the Year. The award is presented by Baltimore Innovation Week, a celebration of technology and innovation in Baltimore.

Help EAGB reach the number 1 spot by heading over to the Awards Site and and selecting Economic Alliance of Greater Baltimore in category 4, Economic Development Organization of the Year.

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Rockville-based Emergent BioSolutions Inc. on Friday announced the appointment of Barry Labinger, a well-known former executive at Human Genome Sciences Inc., to head its biosciences division.

Labinger served as HGS' chief commercial officer from 2005 until last year, when GlaxoSmithKline plc snapped up the Rockville drug-maker for $3.6 billion. Glaxo made a clean sweep of Human Genome executives, including CEO Tom Watkins, shortly after.

Thursday, August 22, 2013 10:00 am

This webinar, hosted by GUIRR, will present a new resource, the Federal Laboratory Consortium (FLC) Available Technologies tool. The tool provides a free, one-stop shop to locate licensing opportunities for a particular technology anywhere within the FLC's nationwide system of federal labs and research centers. Fully equipped with Google’s advanced search capabilities, the FLC Available Technologies tool yields user-friendly results that can be saved, printed, or downloaded as a PDF with active hyperlinks that directly link to the featured technology.

Industry and academic representatives who would like to find out more about how this tool can reduce the time, effort, and guesswork needed to find federal laboratory inventions available to transfer are encouraged to participate.

Through the Advanced Studies in Technology Transfer program, students will simultaneously gain the necessary knowledge and build professional networks with respected practitioners of the field. Our objective is to serve not only the needs of scientists and engineers who wish to pursue this non-traditional career, but also those of professionals who seek additional training.

View available courses in the Advanced Studies in Technology Transfer program.

More Information

The relatively new field of Technology Transfer can trace its origins and rapid growth to the economic developments and legislation of the early 1980s, a time when the US was looking to enhance its global competitiveness. While countries like Germany and Japan were exceptionally good at translating the ideas that originated from academic labs into useful products, US academic research results were by and large relegated to mere publications in scholarly journals. Concerned about the non-use of this potential goldmine of ideas, the US lawmakers passed a series of legislation in the early 1980s culminating in the famous Bayh-Dole Act. This Act has shifted the onus of commercialization from a central granting agency to the numerous grantees that receive the research funds, and the grantees have taken very enthusiastically to this shift. The Economist has lauded this Bill as the most inspired piece of legislation in the last half century.

In the middle of 2003, Marc LaForce was having trouble sleeping. As the director of the Meningitis Vaccine Project (MVP), he was missing a vital piece of a difficult puzzle. The MVP sought to commercialize a vaccine that would help prevent Africa’s devastating epidemics of meningococcal meningitis, a bacterial infection of the brain and spinal cord. The largest documented outbreak, in 1996, sickened 250,000 people in Africa and caused 25,000 deaths. In 2002, a single West African country (Burkina Faso) had 13,000 meningitis cases and at least 1,500 deaths.

To succeed, the MVP needed a vaccine production method with two essential qualities: very effective and very affordable. But in mid-2003, that search hit a dead end. "All projects have their ups and downs," says LaForce, M.D. "We were in the downest of downs."

This week, FDA issued final guidance on incorporating and integrating radio frequency wireless technology into medical devices, Bloomberg BNA reports.

In a blog post on Tuesday, FDA Senior Policy Adviser Bakul Patel wrote, "Our goal is to help industry develop a range of innovative, safe and effective medical devices that incorporate wireless technology, which can, in turn, help reduce health care costs, enhance quality and benefit patients and providers alike" (Weixel, Bloomberg BNA, 8/14).

The new landscape for venture capital investing does not seem to leave much room for classic company formation. Investor after investor has shut down or moved beyond startups into what seem like greener pastures.

So it should come as no surprise that at least a few VC firms are now expanding into the royalty space, as shown by a deal announced this week. Aisling Capital and Clarus Ventures, two top-tier VC firms, acquired 20 percent of the royalty stream created by sales of ibrutinib, a novel tyrosine kinase inhibitor developed by Pharmacyclics (NASDAQ: PCYC) and partnered with Johnson & Johnson (NYSE: JNJ) for use in B-cell malignancies such as chronic lymphocytic leukemia (CLL).

With the global tuberculosis epidemic becoming more deadly, costly, and difficult to treat, Chinese Center for Disease Control and Prevention (China CDC) and Aeras today signed a memorandum of understanding to advance research and development of new tuberculosis vaccines. An improved TB vaccine offers the best hope for eliminating this airborne infectious disease that kills 1.4 million people worldwide each year.  

While China has achieved significant reductions in TB illness and death over the past 30 years, TB remains a major public threat, with over one million new cases in China each year. A study published in the New England Journal of Medicine last year found that one in 10 cases of TB in China are resistant to the most commonly-used drugs. Based on the World Health Organization’s estimates of global multidrug-resistant TB (MDR-TB), China has the highest annual number of cases of MDR-TB in the world—a quarter of the cases worldwide.

DreamIt Health Demo Day has gotten a lot of great press, from Philly.com to NewsWorks to Technical.ly Philly, and many more. These plaudits are well deserved: DreamIt Health was the first Philadelphia-based health care accelerator, and by all accounts it was a huge success. Ten health care startup companies participated in this venture, made possible by a collaboration between Independence Blue Cross (IBC), Penn Medicine, and DreamIt Ventures. The more than 300 attendees to the Demo Day on July 24, 2013 included potential investors and customers, mentors, and health care executives.

We at Wharton Entrepreneurship are delighted, and not only because this event was such a terrific demonstration of the robust community of heath care entrepreneurs in the Philly region. We’re proud to point out that the founders of four of the presenting companies and both of the speakers are all Wharton Entrepreneurship alumni, several of whom went through our Venture Initiation Program (VIP)! If that’s not a demonstration of Knowledge in Action, then I don’t know what is.

Let’s Celebrate How Baltimore Is Innovating.

The people and organizations represented below are advancing the city in new and inspiring ways, by growing businesses, increasing regional economic activity, publishing high-quality works of media, creating new gateways to the technology community and much, much more. They’re the best of the best in this community. This is the Baltimore region’s only people’s choice award for technology, entrepreneurship and new thinking.

Winners will be determined by online voting counts. Voting closes on Friday, September 13th. Awards will be announced at the Baltimore Innovation Week week closing party on Fri. Sept. 27.

Due to the global shortage of donor hearts, patients on the waiting list for a heart transplant can wait several months to several years for a match to be found. But for 36-year-old Frédéric Thiollet, who surpassed two years of support with the SynCardia temporary Total Artificial Heart on Aug. 5, he’s enjoying each and every day.

“I feel well and I am confident, having been implanted now for over two years,” said Frédéric Thiollet. “I have recuperated all my physical functions, even my sexual activity, which I had believed was gone forever. In my own words, I have enjoyed an effective resurrection, a new birth. Physically I have no limit. I am as strong and powerful as before, even more so than before.”

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-OD-13-098: Grant and Contract Submission Requirements Regarding the AVMA Guidelines for the Euthanasia of Animals: 2013 Edition 
• NOT-HG-13-014: Request for Information (RFI): Input on Development of Analysis Methods and Software for Big Data 
• NOT-HL-13-185: Notice of Intent to Publish a Funding Opportunity Announcement for a Coordination Core for Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE II) - (R25)
• NOT-HL-13-189: Notice of Availability of Specimens and Data for Hemochromatosis and Iron-Related Research 
• NOT-HL-13-190: Notice of Expiration of PAR-11-090 NHLBI Investigator-Initiated Resource-Related Research Projects (R24)

Request for Applications (RFA):

• RFA-RM-13-006: 2014 NIH Pioneer Award Program (DP1) 
• RFA-RM-13-007: 2014 NIH Director's New Innovator Award Program (DP2) 
• RFA-RM-13-012: NIH Health Care Systems Research Collaboratory - Demonstration Projects for Pragmatic Clinical Trials Focusing on Multiple Chronic Conditions (UH2/UH3)
• RFA-RM-13-018: DNA Sequencing Core for an Undiagnosed Diseases Network (UDN) (U01)

Program Announcement (PA):

• PAR-13-316: NHLBI Program Project Applications (P01)

The University of Maryland College Park, which likes to tout itself as a leading public research institution, has added a little more green to its laurels.

Sierra Magazine ranks the state's flagship campus as the 13th greenest university in its latest national rating of "Cool Schools."

UM trailed the University of Connecticut, Dickinson College, Stanford and American universities, among others, while besting the likes of Harvard, Yale and the University of California, Berkeley.

XLerate Health, a Louisville-based accelerator for early-stage, health-related companies, has selected six companies to participate in its inaugural class. The accelerator’s 10-week intensive immersion program began Monday and runs until “Demo Day” on Oct. 25.

The FDA has stamped an OK on GlaxoSmithKline's HIV drug dolutegravir--to be sold as Tivicay. The approval marks another key advance for Glaxo ($GSK) on the regulatory front this year, providing a blockbuster candidate that analysts believe should do very well in competing against Gilead's ($GILD) rival therapies.

"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a release. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."

This conference brings together small businesses, angel investors, venture capitalists, strategic partners, and business leaders from the biotech and pharmaceutical industries. It will feature presentations by top NHLBI SBIR- funded companies with innovative technologies on the brink of commercialization, an expert panel of investors, and opportunities for partnering and networking. Information about the NHLBI Office of Translational Alliances and Coordination, changes in the SBIR/STTR program re-authorization, and other funding opportunities and resources will be presented. NHLBI staff will be available to provide advice to applicants and awardees.

The NHLBI provides global leadership for research, training, and education to promote the prevention and treatment of heart, lung, blood, and sleep diseases and disorders and to enhance the health of all individuals so that they can live longer and more fulfilling lives.

While scientists have struggled for decades to produce an effective malaria vaccine, Rockville-based biotech company Sanaria is encouraged enough by clinical trials that it hopes to have its malaria vaccine on the market in three to five years, The Gazette reports.

The results of a Phase I clinical trial of the vaccine—published Thursday in the online issue of Science magazine—show that the vaccine provided complete protection against malaria in subjects who were exposed to malaria parasites, according to a news release from Sanaria.

BioBoost, a consortium of OrbiMed Advisors LLC, Johnson and Johnson (NYSE: JNJ) and Takeda Pharmaceutical Co. Ltd. (TSE: 4502) has won the tender to establish the life sciences incubator as part of the Office of the Chief Scientist's incubator program.

The franchise for the biotech tender, like the franchise for all incubators since the reform, is for eight years. The consortium members will receive NIS 6.9 million in financing over three years, more than franchisees of incubators in other fields, as part of the government's wish to provide special support for the life sciences. Most of the incubator's companies will develop drugs, and a few will develop medical devices.

University of Maryland researchers announced last week they have been able to successfully turn a fish known for eating anything, the cobia, into a vegetarian.

While altering any animal’s diet may seem unnatural or even wrong, the biologists said the development could mean big bucks for the seafood industry.

“Aquaculture isn’t sustainable because it takes more fish to feed fish than are being produced,” said Aaron Watson, a graduate assistant at the university’s Center for Environmental Science. “But a new vegetarian diet might change everything.”

A week after Cleveland's nascent biotech accelerator BioMotiv bumped its financial reserves to $46 million, Torrey Pines Investment has stepped in to offer a $20 million commitment and close ties to the Russian drug development industry to back a joint effort to spawn new translational drug efforts around the globe.

In the pact, Torrey Pines Investment will work with its connections in the Russian and the Ukrainian pharma industry to facilitate the R&D networks that BioMotiv is developing. Far from the mainstream of the biotech industry's global hubs, BioMotiv has been piecing together an effort to get new biomedical advances in academia into the clinic, positioning the programs for an out-licensing deal with a biotech or pharma company that can take them the remaining distance to a potential regulatory approval. Nationwide Mutual Insurance Company and several individual investors have now bumped its capital reserves as BioMotiv scouts for additional capital to complete its fundraising effort.

HHS is working to attract entrepreneurial talent to create a culture that supports risk-taking and accelerates innovation.

HHSentrepreneurs is based on the HHS Innovation Fellows Program launched in 2012. HHSentrepreneurs builds on lessons learned during the pilot HHS Innovation Fellows Program, and will:

• Identify HHS staff who are working on some of the Department’s toughest challenges and
• Match these talented individuals with External Entrepreneurs for a period of 6-12 months.

HHSentrepreneurs provides a novel framework to attract outside talent in areas including open innovation, agile development, and lean methodologies to accelerate innovation within HHS. Startup organizations have demonstrated that rapid iteration between various versions or features of a product can yield successful results, and HHS would like to promote these methods internally to address high-priority projects.

No factor defines success and failure for a drug company more than this: Companies that invent more, better drugs at a lower cost do better than those that hemorrhage cash but never get an important product to market. Yet 19 in 20 medicines in experimental development fail, meaning a great many companies fail too.

For years, researchers, including one team from Tufts University and another at Eli Lilly, have estimated the cost of inventing and developing a drug at $1 billion or more. These estimates try to exclude costs not directly related to a drug’s approval and also don’t allow for any comparisons between companies. Last year, for the first time, I did something far cruder: I took the 15-year research spending of a group of big pharmaceutical companies and divided it by the number of new drugs (technically new molecular entities, the Food and Drug Administration’s term for drug molecules that have not been approved in any form for any use previously).

Some hospitals are turning to technology entrepreneurs to reduce readmission rates and avoid penalties imposed under the Affordable Care Act, the Wall Street Journal reports. 

Background

Last year, an ACA provision went into effect that allows CMS to penalize hospitals for excess readmissions of Medicare patients.

The penalties are based on the number of heart failure, heart attack or pneumonia patients above the national average who are readmitted within 30 days to an acute-care hospital.

by Joseph P. Allen and Diane Palmintera

The Final ReportOn May 20, 2013, the White House Lab-To-Market Inter-Agency Summit was held in Washington, D.C. The Summit was organized by the White House Office of Science and Technology Policy and the National Institutes of Health's Heart, Lung, and Blood Institute. The purpose of the meeting was extraordinary: asking national experts outside of the federal agency system to recommend ways to increase the return-on-investment for the $140 billion annual taxpayer expenditure on federally-funded research and development.

The format for the meeting also was unusual. Research agencies nominated 20 national experts experienced in various phases of technology commercialization to participate in the Summit. The Administration placed no preconditions or limitations on the expert Panel and asked it to focus on "transformative" ideas. We were privileged to be asked to serve as the Summit's co-chairs.

The Administration requested that the Panel address several overarching questions:

• How can agencies better align themselves to more effectively promote the commercial development of their research;
• How can effective metrics for various stages of these efforts be developed; and
• How can we better leverage multi-agency resources to enhance the public's return-on-investment through the commercialization of more federally-funded technologies?
  

Kleiner Perkins, the investor behind Google and Amazon, and Accel Partners, best known for its investment in Facebook, are putting $18 million into MyFitnessPal, a little-known digital-health startup that has helped its 40 million-plus users shed a collective 100 million pounds.

Despite those accomplishments, this is the first time MyFitnessPal has raised money from professional investors, which raises the question: Do venture capitalists have any idea what they're doing in the networked fitness market?

For most of us, the blister packs our medicines come in are just temporary barriers to be scratched open with our fingernails or popped open like Chiclets. We usually don’t even pay attention to the tiny, vaguely printed expiration dates tattooed on the silver skin of our aspirin or cough medicine’s packaging; we take for granted that it’s in date.

Yet around the world, billions of people can’t take the expiration dates of their medication for granted. Doing so can, and often is, fatal. A new concept could put an end to that by encapsulating our medicines in strips that change color as they expire, transforming the packaging of dangerously out-of-date medication into a chromatic warning. But will big pharma bring it to market?

The University of Maryland announced Monday that long-time finance professor Alexander J. Triantis has been appointed dean of the Robert H. Smith School of Business.

Triantis, 49, succeeds G. "Anand" Anandalingam, who left the post at the end of June to take a position in London as dean of the Imperial College Business School. Triantis will assume the position Sept. 1.

Money may not make the world go round, but it does keep companies innovating. The Small Business & Technology Development Center has made formal a longstanding relationship with BBCetc., an Ann Arbor-based development consulting company with a specialty in helping businesses secure federal grant funding for commercialization and growth.

The partnership will utilize BBCetc.’s extensive background in federal research grant proposals with the SBTDC’s statewide organization and presence to assist companies with writing proposals specifically for the Small Business Innovation Research and Small Business Technology Transfer federal research grants.

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

NOT-OD-13-095): Using ASSIST to Prepare and Submit Multi-Project Applications to NIH: Webinar - August 13, 2013

NIH will require electronic submission for all P01, P20, P50 and U19 applications intended for due dates on or after September 25, 2013.

NOT-OD-13-097: Extension of eRA Commons User IDs to Individuals in Graduate and Undergraduate Student Project Roles with Measurable Effort on an NIH Annual Progress Report (PHS2590 & RPPR)

Over the next year the NIH will start requiring an eRA Commons ID for all individuals in graduate and undergraduate student roles who participate in NIH-funded projects for at least one person month or more.

NOT-HL-13-187: Notice of Intent to Publish a Funding Opportunity Announcement for Low-Cost Pragmatic Patient-Centered Randomized Controlled Intervention Trials (UH2/UH3)

The NHLBI, along with other NIH Institutes and Centers, intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications to plan and conduct low cost, pragmatic, randomized clinical trials that are integrated into existing clinical practice settings and/or leverage existing electronic patient care resources.

Program Announcement (PA):

PA-13-302: Research Project Grant (Parent R01) (expires September 8, 2016)

The Research Project Grant (R01) supports a discrete, specified, circumscribed project to be performed by the named investigator(s) in areas representing the specific interests and competencies of the investigator(s). The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on descriptions of their programs.

PA-13-292: Behavioral and Social Science Research on Understanding and Reducing Health Disparities (R01) (expires September 8, 2016)

The purpose of this FOA is to encourage behavioral and social science research on the causes and solutions to health and disabilities disparities in the U. S. population.