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As advances in genomics, molecular analysis, and data processing have propelled disease research forward, scientists and drug developers still face a formidable challenge: recruiting patients for their studies.

Genetic Alliance, a nonprofit that advocates for people with rare genetic disorders, is launching a new site called Reg4All that aims to entice more patients into clinical trials and disease research by giving them unprecedented privacy controls and greater say in how their data is used for research.

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People looking to start a small business in Montgomery County can have some of their questions answered at a series of seminars focusing on small business in Germantown.

Three seminars will be held between March, April and May by Score DC, a chapter of the U.S. Service Corps and Retired Executives, and will have mentors on hand to discuss successful business practices.

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

Request for Applications (RFAs): 

  • RFA-OD-13-004: Lasker Clinical Research Scholars Program (Si2)
    This FOA solicits applications for the Lasker Clinical Research Scholars Program for the purpose of supporting the research activities during the early stage careers of independent clinical researchers. 
  • RFA-RM-12-022: NIH Director's Biomedical Research Workforce Innovation Award: Broadening Experiences
    The purpose of this FOA is to seek, identify and support bold and innovative approaches to broaden graduate and postdoctoral training, such that training programs reflect the range of career options that trainees (regardless of funding source) ultimately may pursue and that are required for a robust biomedical, behavioral, social and clinical research enterprise. Collaborations with non-academic partners are encouraged to ensure that experts from a broad spectrum of research and research-related careers contribute to coursework, rotations, internships or other forms of exposure. This program will establish a new paradigm for graduate and postdoctoral training; awardee institutions will work together to define needs and share best practices.
  • RFA-RM-13-001: Planning Grants for the NIH Building Infrastructure Leading to Diversity (BUILD) Initiative (P20)
    The purpose of this Funding Opportunity Announcement (FOA) is to encourage institutions with expertise and innovative strategies for developing research and mentoring opportunities for undergraduate students from backgrounds underrepresented in biomedical research to submit applications for 6 month planning grants for the NIH Building Infrastructure Leading to Diversity (BUILD) initiative. The BUILD initiative aims to increase the diversity of the NIH-funded workforce by supporting collaborative programs that include novel approaches for enhancing undergraduate education, training, and mentorship, as well as infrastructure support and faculty development to facilitate those approaches.
  • RFA-RM-13-002: Planning Grants for the NIH National Research Mentoring Network (NRMN) (P20)
    The purpose of this Funding Opportunity Announcement (FOA) is to encourage organizations with experience in the mentorship of individuals underrepresented in the biomedical research workforce to submit planning grant applications for the NIH National Research Mentoring Network (NRMN). The NRMN will establish a nationwide consortium to provide networking and mentorship experiences for individuals from backgrounds underrepresented in biomedical research from the undergraduate to junior faculty level.

Program Announcement (PA): 

  • PAR-13-137: Bioengineering Research Grants (BRG) (R01)
    The purpose of this funding opportunity announcement is to encourage collaborations between the life and physical sciences that: 1) apply a multidisciplinary bioengineering approach to the solution of a biomedical problem; and 2) integrate, optimize, validate, translate or otherwise accelerate the adoption of promising tools, methods and techniques for a specific research or clinical problem in basic, translational, or clinical science and practice. An application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research and is appropriate for small teams applying an integrative approach that can increase our understanding of and solve problems in biological, clinical or translational science.

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.

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As our April 5, 2013 receipt date approaches and you prepare your grant submission, please remember to work to register in all the required systems (DUNS, SAM, grants.gov, eRA Commons) in advance. These must all be complete before you can submit your grant application.

Company registration at SBA’s SBIR.gov is NOT required for submissions at this time. Solicitations issued after 1/28/2013 (not due dates for solicitations already on street prior to that date) will have instructions on how to register at SBA.

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After McKesson, Cerner, Allscripts, Greenway and athenahealth made news at HIMSS13 this past week with the launch of the CommonWell Health Alliance – putting aside their competitive instincts, for a moment, to pledge their common commitment to interoperability and data liquidity – Healthcare IT News spoke with McKesson CEO John Hammergren about the road ahead.

Joining Hammergren in the discussion were David McCallie, vice president, medical informatics at Cerner, and Arien Malec, vice president, data platform solutions for McKesson's connectivity business, RelayHealth (and, in his former role at the Office of the National Coordinator for Health IT, the driving force behind the development of the Direct Project).

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Join us on March 20 at Growlers for another BioBuzz Happy Hour

Join our sponsors, BioHealth Innovation, Inc. (BHI) and the Johns Hopkins University Center for Biotechnology Education, along with many others from our local biotech industry at another exciting BioBuzz event on March 20 from 4:30 - 7 p.m. in Gaithersburg. This month, we're having our event a week early to accommodate BioBuzzers with kids in Montgomery County Public School system who will be on spring break the next week. We're also holding the March BioBuzz event at a new location, Growlers in Old Towne Gaithersburg. We're excited to see all of you soon, so please register today!

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She sent her first tweet just after noon, and already Kathleen Sebelius (@Sebelius) has 2,000-plus followers.

The secretary of U.S. Health and Human Services is the latest federal health official to join Twitter and follows in the footsteps of colleagues Dr. Tom Frieden (@DrFriedenCDC), the director of the U.S. Centers for Disease Control and Prevention, and Dr. Francis Collins (@NIHDirector), director of the National Institutes of Health.

Johns Hopkins University

Johns Hopkins University generally does well on U.S. rankings of the top colleges. 

But how does it stack up against institutions of higher learning from around the world?  Not bad. It ranks No. 19 in the Times Higher Education World Reputation Rankings of the top 100 universities from around the globe. The University of Maryland, College Park also comes up on the list, at 95.

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Montgomery County-based Novavax is a biopharmaceutical company creating nanoparticle vaccines targeting a wide array of infectious diseases. In this new video, CEO Stanley Erck speaks about the different processes Novavax scientists are working on, and the overall momentum of the company. Mr. Erck also highlights the company's partnerships with Path, LG Life Sciences, GE Healthcare, and Cadila Pharmaceuticals. Novavax is excited by the promising new data from clinical trials with its RSV vaccine candidate and pandemic influenza vaccine candidate, and by the potential of its technology platform. From discovery to commercialization, Novavax is positioned to develop the vaccines for tomorrow.

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A tax measure that would create a new, more lenient capital gains rate for tech investors and entrepreneurs cashing out their stock in the District is "going to be a focal point" for the Gray administration's policy efforts this year, Mayor Vincent Gray told me in an interview Friday.

Gray, discussing his upcoming trip to the South by Southwest technology competition in Texas and his broader efforts to expand the District's tech startup scene, acknowledged that resistance to the tax cut persists in the D.C. Council, which tabled the tax break last summer:

"I don't get the sense that they're any further along," he said.

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Nevro Corp., a medical device company focused on improving pain relief in patients suffering from debilitating chronic pain, today announced it has completed a $48 million Series C financing round. The round was led by new investor Novo Ventures, joined by New Enterprise Associates (NEA) and Covidien Ventures. Existing investors participating in this financing round included Accuitive Medical Ventures (AMV), Bay City Capital, Johnson & Johnson Development Corporation (JJDC), Mayo Clinic, MPM Capital, and Three Arch Partners.

“We are excited to welcome premier investors Novo Ventures, NEA, and Covidien Ventures who share Nevro’s vision to be a leader in neuromodulation through continuous innovation”

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Personal Genome Diagnostics Inc. (PGDx), a pioneer in conducting patient-specific analyses aimed at identifying genomic alterations in tumors, today announced a number of developments that will support its expanding business.  The company licensed exclusive rights to Digital Karyotyping (DK), an important genome-mapping technology developed by the company's founders at Johns Hopkins University.  PGDx also announced that it is expanding into new facilities and has made a number of key hires, including Genzyme Oncology executive Antony Newton as Chief Commercial Officer.

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GlaxoSmithKline (GSK) has submitted its albiglutide once-weekly injection for type 2 diabetes to European regulators.

If approved the biologic treatment, which was submitted for US approval in January, will be marketed as Eperzan.

Albiglutide is, along with lupus treatment Benlysta and heart disease drug darapladib, one of a trio of drugs GSK has developed with Human Genome Sciences.

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Personalized medicine -- the ability to tailor therapies to patients' individual genetic characteristics -- has long been the holy grail of the life sciences industry. The effort has produced a string of recent successes, including a host of drugs targeted to people with specific genetic profiles, the European approval of the world's first gene therapy treatment, and a much-heralded leukemia treatment pioneered at Children's Hospital of Philadelphia (CHOP) that uses tweaked versions of patients' own cells to eliminate their cancer. While these advances are certainly exciting for patients, they raise a host of ethical, legal and financial challenges that people working in the field will need to address before personalized medicine can become a thriving business.

The challenges are so great, contends Wharton health care management professor Ezekiel J. Emanuel, that claims of a renaissance in medicine brought on by individualized approaches often seem hyperbolic. "Before we buy into this, we need to remember that almost every evaluation of what drives health care costs up points to new technologies," says Emanuel, who is also a professor of medical ethics and health policy at Penn's Perelman School of Medicine. "We need to be skeptical. We need to see the data before people buy into the idea that personalized medicine is going to produce cost savings and be so much better for the system."

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The University of Maryland, College Park has cracked the top 100 global reputation ranking by a publication based in the United Kingdom, The Washington Post reported.

Times Higher Education shows that UMd. is in a group ranked 91-100, in a class with Monash University in Australia, Lund in Sweden, Bristol in the U.K., the Free University of Berlin and Texas A&M. The rankings were based on surveys of academics around the world. Johns Hopkins, in Baltimore, ranked No. 19, the highest from the local region. Harvard University was ranked No. 1.

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NANOMEDICINES: CHARTING A ROADMAP TO COMMERCIALIZATION

On 6-7 March 2013, the Nanomedicines Alliance will be holding a Industry Symposium: Charting a Road to Commercialization. The Symposium will address:

  • desigining nanomedicines
  • preclinical pharmacology
  • chemistry, manufacturing & controls
  • toxicology/ADME and
  • clinical studies

through podium presentations, breakouts sessions and poster sessions.

Six HIT heavy-hitters announce interoperability organization | Healthcare IT News

Big news was made at HIMSS13 on Monday when, in an unprecedented collaboration, some health IT heavy-hitters joined forces in an effort to push the needle on interoperability. 

In announcing the launch of the CommonWell Health Alliance, executives from Cerner, McKesson, Allscripts, athenahealth, Greenway and RelayHealth touted what they say is a first-of-its-kind organization: a collaboration of rival vendors, uniting to enable care integration and data liquidity. 

NCET2


NOW IN ITS 7th YEAR!

University Startups Showcase and Conference 2013

March 20-22, 2013

Washington Convention Center, Washington, D.C.

"Corporate Venture Capital and University Startups: An Open Innovation Paradigm"

GETTING YOUR UNIVERSITY STARTUP FUNDED

2 WEEKS LEFT

REGISTRATION CLOSES: Friday March 15, 2013

(no onsite registrations)

Click here to register

[or go to http://www.ncet2.org/index.php?option=com_content&view=article&id=543]

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Venture investment in health care cratered in 2012. While others cut back, SR One charged ahead.

The venture arm of GlaxoSmithKline formed in 1985 and has steadily invested $30 million to $50 million annually. Seeing strong prospects at a time when many conventional venture firms had to sit it out, SR One invested more than $50 million last year, making eight new deals and eight follow-on investments, said Jens Eckstein, its president.

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The Tech Council of Maryland (TCM), Maryland's largest technology trade association with more than 400 life science and technology members employing more than 200,000 in the region, will honor Dr. James Barrett, a general partner in venture capital firm New Enterprise Associates (NEA), with its third annual Lifetime Achievement Award. Barrett will be presented the award at TCM's Lifetime Achievement Gala, which is taking place March 6 at the Bethesda North Marriott Hotel and Conference Center.

The TCM Lifetime Achievement Award is given each year to a local individual who has gone above and beyond to serve the community at large over the course of his or her career. Recipients display commitment and leadership both in the field and within their company, fostering new ideas and encouraging creativity. The recipient also demonstrates generosity and compassion, making sure their work benefits others.

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A little more than a year ago the American Heart Association launched an accelerator to fund biotechnolgy and medical device startups to fill a crucial gap in research funding caused by the increasing hesitance of investors to risk support on early-stage innovation. Now, it’s getting ready for a $2 million fundraising round to invest in two companies by the end of the year. It’s also working with sister organizations and mission-driven investment organizations to identify areas of common interest.

In a phone interview with MedCity News, Ross Tonkens, the director of the Science & Technology Accelerator, and Major Gifts Officer Mark Germano said they’re forming a group of donors who can provide expertise to screen applications. These donors have investment backgrounds steeped in biotechnology, drug development and medical devices. They also have expertise in legal issues, commercialization, IP, regulatory, clinical trial design and conduct issues. In a lot of cases, these are people who have had personal or close contact with people who have had cardiovascular disease or a stroke and want to see things move from the [lab] bench to bedside.

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The InvestMaryland Challenge has whittled down the 259 start-up companies that applied to the business competition to 33 semifinalists.

Only nine of those companies will move on to be finalists in the contest; three will win grand prizes of $100,000.

On March 5 the semifinalists will pitch their ideas to a panel of judges and complete a product demonstration. Grand prizes will be announced April 15.

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If you need an effective drug today for age-related macular degeneration, the leading cause of blindness in the elderly, you need to get an injection at the back of the eye.

Waltham, MA-based Kala Pharmaceuticals believes it may be able to get the drug where it needs to go, without sticking a needle in your eye.

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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-HL-13-167: Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Centers (CC)
    The National Heart, Lung, and Blood Institute intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for institutions to participate as Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network, a new multi-center clinical trials network that will develop and test prevention or early treatment strategies for Acute Lung Injury. Read more.
  • NOT-HL-13-168: Notice of Intent to Publish a Funding Opportunity Announcement for a Clinical Coordinating Center (CCC) 
    The National Heart, Lung, and Blood Institute intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for institutions to serve as the Clinical Coordinating Center (CCC) for a new multi-center clinical trials network that will develop and test prevention or early treatment strategies for Acute Lung Injury. Read more.
  • NOT-OD-13-043: NIH Operation Plan in the Event of a Sequestration
    The NIH continues to operate under a Continuing Resolution as described in NOT-OD-13-002, and therefore all non-competing continuation awards are currently being funded at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Final levels of FY 2013 funding may be reduced by a sequestration. Despite the potential for reduced funding, the NIH remains committed to our mission to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. Read more.

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.

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In 2009, President Barack Obama selected the Republic of Turkey as a pivotal port of call in his first trip abroad as the new President of the United States. That symbolic visit led to the launch of an initiative to boost trade and investment ties between the two strategic allies under what was called a “model partnership,” culminating in a $ 17 billion mutual trade volume. Following in the footsteps of the President, US Senator John Kerry will also visit Turkey in his first international tour as the new American Secretary of State. These visits further underline the significance of American-Turkish relations for this administration. As the 16th strongest economy in the world, Turkey is not only an important geopolitical ally, but also an increasingly valuable commercial partner.

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Government contractors across the U.S. have found themselves in a holding pattern over the past few years, adapting to constant delays and waiting for economic uncertainty to be resolved.  Between continuing resolutions, the debt ceiling crisis, and the threat of sequestration, government contracting companies have struggled to find new ways to be successful in the face of change.

According to a recent white paper by the Professional Services Council, “between fiscal years 2011 and 2012, federal spending on service contracts dropped more than $5 billion, which translates directly into the elimination of tens of thousands of contractor positions across the nation.”  This, combined with a rise in the award of lowest-priced technically acceptable contracts, the delay in the award of new contacts and shorter term task orders under existing contract vehicles are all signs that a storm is brewing.  Increased audits and investigations into contracting fraud waste and abuse, the increase in more regulations and compliance issues, and the Federal Strategic Sourcing initiative are clear evidence of this prevailing wind.

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GlaxoSmithKline encountered some stiff industry headwinds when it pledged to open up its data vault to outside investigators. But as of today it has a high-profile convert on its side. The biopharma giant Roche ($RHHBY) has agreed to follow in GSK's ($GSK) footsteps, saying that it will work with an independent group which will be charged with sorting out and approving requests for access to anonymized clinical trial data for all approved products. If regulators can't provide the data, says Roche, then the company will make it available.

"We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine," said Daniel O'Day, chief operating officer of Roche Pharma. "At the same time, we firmly believe that health authorities need to remain the gatekeeper for drug assessment and approval. We believe we have found a way in which patient data can be provided to third party researchers in a legitimate environment that ensures patient confidentiality and avoids the risk of publishing misleading results or giving rise to public health scares and consequences."

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Johns Hopkins’ John Wong, Ph.D., has won a BioMaryland LIFE Award, and Ronald Berger, M.D., Ph.D., and Hien Nguyen, M.D., were awarded funds from the Abell Foundation, the researchers learned last week. Each of the winners will receive $50,000 to help develop their discoveries for clinical use.

The prizes were awarded as part of the annual Joint Meeting of the Johns Hopkins Alliance for Science and Technology Development and the University of Maryland, Baltimore Commercial Advisory Board on Feb. 19. The meeting was attended by more than 150 venture capitalists, seasoned biotech entrepreneurs and business development executives from the biopharma industry. Judging committees evaluated presentations from two dozen university researchers before selecting the winners. The aim of the awards is to speed the translation of promising research into commercial application.

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New technology from the University of Maryland (UM) could potentially provide a five-minute diagnostic test and a vaccine for tough-to-treat Staphylococcus aureus infections, including the antibiotic-resistant MRSA, often called a "super bug," says inventor Mark Shirtliff, PhD, an associate professor at the UM School of Dentistry in Baltimore.

Shirtliff is the winner of the 2013 BioMaryland LIFE (Leading Innovative Faculty Entrepreneurs) Prize for the most promising technology from the University as awarded by a judging panel at the annual joint meeting of the UM Baltimore Commercial Advisory Board and the Johns Hopkins University (JHU) Alliance for Science and Technology Development.

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The Tech Council of Maryland (TCM), Maryland's largest technology trade association with more than 400 life science and technology members employing more than 200,000 in the region, will honor Dr. James Barrett, a general partner in venture capital firm New Enterprise Associates (NEA), with its third annual Lifetime Achievement Award. Barrett will be presented the award at TCM's Lifetime Achievement Gala, which is taking place March 6 at the Bethesda North Marriott Hotel and Conference Center.

The TCM Lifetime Achievement Award is given each year to a local individual who has gone above and beyond to serve the community at large over the course of his or her career. Recipients display commitment and leadership both in the field and within their company, fostering new ideas and encouraging creativity. The recipient also demonstrates generosity and compassion, making sure their work benefits others.

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University of Maryland, College Park and two other East Coast schools will share $3.75 million from the National Science Foundation to develop a regional hub for turning university research into marketable products and services.

University of Maryland will be working with George Washington University and Virginia Tech to create an Innovation Corps for the mid-Atlantic region. The initiative will aim to draw out the best research ideas from students and faculty members and bring them to the commercial market.

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This chart shows the pharmaceutical drugs with the most patents still in force.

The drugs with the most active patents are COMBIVENT RESPIMAT, KALETRA, ADVAIR HFA,FLOVENT HFA, VIVITROL, THALOMID, VYVANSE, REVLIMID, VENTOLIN HFA, andCHILDREN’S ALLEGRA ALLERGY.