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.

GlaxoSmithKline's new $50 million venture capital fund will be based out of the One Broadway building in Cambridge's Kendall Square, inside an office of SR One, the drug giant's corporate VC arm, a GSK spokesperson said.

The 16-floor One Broadway building also houses the Cambridge Innovation Center startup offices across a number of its floors, as well as venture capital firms Charles River Ventures and Highland Capital Partners.

About one year ago GlaxoSmithKline (NYSE: GSK) set up a division to study the electrical impulses along the peripheral nervous system and develop technologies to read, change, or manipulate these impulses to treat acute and chronic diseases. Now it’s launched a $50 million venture capital fund to invest in companies with pioneering technology in this emerging field of bioelectronics, according to a company statement.

The Action Potential Venture Capital fund, which will be based in Cambridge, Massachusetts, takes its name from the electrical signals that pass along the nerves in the body. Problems with the patterns of these impulses are associated with a broad range of diseases.

Proof of Concept grants are intended to enhance the commercial viability of health-related technologies or concepts developed by non-profit organizations or enhance the competitiveness of early-stage companies for private equity investment. The maximum award is $250,000 in total costs.

Submission and review process:

• Three cycles of pre-proposal review, proposal review, and awards by the LSDF Board of Trustees through August 2014. Up to 32 pre-proposals will be reviewed per cycle. 
• Pre-proposals are reviewed every four months and require a presentation and interview. 
• Invited proposals are due one month after pre-proposal reviews and reviewed the following month. Proposal reviews require a presentation and interview. 
• Awards are made one month after proposal reviews. 
• If a pre-proposal results in an invitation to submit a proposal, that invitation is valid only for the proposal deadline immediately following the pre-proposal review.

When PharmAthene Inc. merges with Seattle-based Theraclone Sciences Inc., it will become part of a company that has the kind of deal with Big Pharma any drug discovery firm would envy.

Theraclone has a multimillion dollar research and development deal with pharmaceutical giant Pfizer Inc. that could be worth as much as $632 million in license, royalty and other payments to the combined company. Theraclone and PharmAthene are entering into an all-stock merger of equals. The combined company will trade publicly.

The Office of Translational Alliances and Coordination (OTAC) in the Division of Extramural Research Activities (DERA), NHLBI is seeking outstanding candidates for the Business Development Specialist (Health Scientist Administrator) position. The OTAC is charged with accelerating the translation of basic discoveries and innovations into new diagnostics, devices, and therapeutics, and facilitating the development of new technologies via Small Business Innovation Research (SBIR) initiatives. The Office facilitates identification of emerging areas of translational opportunities and provides functional integration by developing interdependent teams that leverage resources and intellect across the NHLBI, and with other NIH Institutes, agencies, and organizations. The OTAC enhances communication and coordination between existing programs, develops and coordinates strategic initiatives and Funding Opportunity Announcements (FOAs), and identifies and capitalizes on synergies to meet and enhance program goals. For more information about the OTAC, please visit http://www.nhlbi.nih.gov/about/dera/otac.

The Business Development Specialist will be responsible for the evaluation of the scientific and technological novelty, business opportunity potential and commercialization merits for research projects in the NHLBI SBIR/STTR portfolio as well as other initiatives in the OTAC.  Responsibilities of the position include activities such as portfolio management assistance; drafting solicitations; evaluating the effectiveness of short and long-term SBIR projects, providing advice to the OTAC Director and NHLBI senior-level scientists regarding strategic SBIR technology development; establishing internal and external contacts to foster the development of programs and identification of opportunities for SBIR technology research support and collaboration; facilitating scientific collaborations between NHLBI, NIH, DHHS and other Federal agencies, industry and the private sector; and building public-private partnerships to ensure best practices and exchange information.

Leggett Joins O’Malley/Brown Administration in Announcing $630 Million Investment in County’s Transportation Network; Governor Also Announces Additional $400 Million for Construction of Purple Line for Montgomery and Prince George’s

Montgomery County Executive Ike Leggett today joined Governor Martin O’Malley and Lt. Governor Anthony Brown during their announcement that Montgomery County will be receiving $628 million in transportation investments and an additional $400 million for construction of the Purple Line that will benefit both Montgomery and Prince George’s counties. Brown also announced that the Purple Line will be built as a public-private partnership under HB 560, the law he championed to attract private investment for new infrastructure in Maryland.

It isn’t just the volume of IPOs this summer that makes this window a victory for hibernating private biotechs and their VC backers, it’s the details of the offerings in terms of price, performance, and type of biotech making the leap onto the public stage. For the last five years we have not seen average offering prices land above expectations, but 2013 is breaking that trend. Price performance is also impressive, with a number of IPOs hovering near 2x the offering price. Rounding out these two positives for valuation is the return of the formerly taboo Phase I and Pre-Clinical IPOs – a qualitative signal of strength.

The University of Maryland College Park ranks among the best universities in the nation, but it appears the Terps are known to let their hair down.

College Park also ranks among the top 20 party schools in the country, according to the newly released rankings from the Princeton Review.

You may have a great idea for a new diagnostic, drug, or technology but developing, testing, and commercializing it takes money. One very viable source for a biotech start-ups in the US are SBIR and STTR Small Business Technology Development grants.

These federal grant programs provide essential funds for hundreds of entrepreneurs to get their technology out of the lab into the market. In fact, with awards totaling about $700 million per year, the SBIR/STTR program is one of the leading sources of seed funds for start-ups and small businesses developing new disease and health related technologies.

The Johns Hopkins University’s schools of medicine and public health received a $5.8 million federal government grant for research on frailty among older adults. The five-year grant will allow the university to continue research designed to identify the causes of frailty in older adults and speed the development of interventions to slow or stop it.

The grant renews funding of the Johns Hopkins Claude D. Pepper Older Americans Independence Center (OAIC ), a federally designated center of excellence that is one of only 14 such university sites nationwide supported by the National Institute on Aging (NIA ). The centers are named for a longtime Democratic member of Congress who championed support for older adults.

University of Maryland (UM) Ventures announced today agreements between University of Maryland, Baltimore (UMB) and five different life sciences companies across the Baltimore/Washington metropolitan region. The companies include Montgomery County-based Rexahn Pharmaceuticals, Baltimore County-based Plasmonix, Prince Georges County-based IGI Technologies, Howard County-based A&G Pharmaceuticals, and Frederick County-based BioAssay Works. These deals are part of UM Ventures' continual efforts to accelerate technology commercialization, advance industry collaboration, and support projects with commercial value at both the Baltimore and College Park campuses of the university.

"UMB is very excited to collaborate with these companies, each an innovator in its own right," said Phil Robilotto, Assistant Vice President, Office of Technology Transfer, UMB. "These types of collaborations are at the core of our mission to channel the expertise of our industry partners and highlight our efforts to support the Maryland biotechnology community."

MedCity News writes about all kinds of startups whether their pitch is more at home on CNN or MIT’s Technology Review. We are always so focused on what’s coming next that we forget to reflect on all the companies we have recently discovered. To solve this, we’ve created a monthly report to make sure none of our readers missed any of these posts.

Our new Monthly Startups Index is a free (e-mail registration required) compendium of the early-stage activity across healthcare. It is a piece of business intelligence that includes MedCity’s deeper looks at select early-stage companies, chronicles the investment activity and other news, and even highlights which startups got the most attention from MedCity readers every month.

Digital health accelerator Healthbox and anchor partner Florida Blue had their priorities straight when they chose the seven companies for their inaugural Florida accelerator program: Address the high populations of seniors and youths in the state.

Companies that do that will have more opportunity to scale and build momentum, they reasoned.

Patients like it and so do health organizations, but electronic communications in clinical care will likely not be widely adopted by primary care physicians unless patient workloads are reduced or they are paid for the time they spend phoning and emailing patients, both during and after office hours.

Those are some key conclusions of an in-depth examination by investigators at Weill Cornell Medical College of six diverse medical practices that routinely use electronic communication for clinical purposes. The detailed report, the most comprehensive of its kind, appears in the August issue of the journal Health Affairs.

A person who has suffered from a stroke or spinal-cord injury might need to use crutches or a wheelchair as they gradually regain lost motion through physical therapy.

But these patients could see drastically different effects strapping on a robotic bodysuit or a bionic limb and walking around like Iron Man as they heal. And such digital hardware has the potential to make them recover faster, as well.

Governor Martin O'Malley called attention to state investments in technology during a visit on July 31 to the University of Maryland BioPark, where he spent time in corporate laboratories with chief executive officers and their employees.

Jay A. Perman, MD, president of the University of Maryland, Baltimore (UMB), joined O'Malley on the tour and at a news conference, where the governor spoke about the importance of supporting the life sciences. O'Malley noted that the state has a plan to invest $1.3 billion in life sciences by 2020 and has increased tax incentives to encourage biotechnology and research and development.

The University of Maryland University College announced Wednesday it will be the first in the state’s university system to create a path for students to earn academic credit for learning through “massive open online courses.”

The university is one of the nation’s largest public providers of online higher education with an enrollment of about 93,000 students.