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Rockville-based MacroGenics Inc. has struck a drug development deal with Gilead Sciences Inc. that could ultimately be worth $1 billion.

The licensing agreement is for the development and potential commercialization for drugs directed at up to four undisclosed targets.

DHHS

HHS' Health Resources and Services Administration has announced plans to distribute $1.9 million for the creation of six telehealth resource centers, mHIMSS reports (Wicklund, mHIMSS, 1/3).

About the Grants HRSA is administering the grants through the Telehealth Resource Center Grant Program, which provides funding to projects that use telehealth networks to improve health care services (Roney, Becker's Hospital Review, 1/4).

The grants will help launch five regional centers and one national center.

HRSA will administer grants of up to:

  • $325,000 for each regional center; and
  • $300,000 for the national center.

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IBBR (www.ibbr.umd.edu) is a joint research institute, which brings together partner institutions including the University of Maryland, College Park (UMCP); University of Maryland, Baltimore (UMB); and the National Institute of Standards and Technology (NIST). The next Director will have the opportunity to recruit faculty and staff, acquire needed instrumentation for transformational research, develop new and innovative technological solutions, and create partnerships with commercial entities to facilitate translation to clinical practice.

The University of Maryland and the National Institute of Standards and Technology are seeking an outstanding individual to serve as Director of the Institute for Bioscience and Biotechnology Research (IBBR) with the vision of making IBBR a premier biotechnology research institute. A primary role of the new Director will be to lead and significantly expand a joint NIST/UM research effort that combines basic, measurement and translational research for the development, manufacturing and standardization of advanced therapeutics and supporting diagnostics.

For more information: Position Description

glaxosmithkline

GlaxoSmithKline (GSK) has been ranked first among global pharmaceuticals companies assessed for their efforts to improve access to medicine in developing countries, in the 2012 Access to Medicine (ATM) Index released recently by the Access to Medicine Foundation.

An independent initiative, the Access to Medicine Index ranks the world’s 20 largest companies according to their efforts to make their products more available, affordable and accessible in developing countries, highlighting policy and practice that either facilitate or hinder access to medicine.

SBIR STTR

On December 27, 2012, the US Small Business Administration (SBA) published a final rule to amend regulations governing eligibility for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs and to implement provisions of the SBIR/STTR Reauthorization Act of 2011. The Reauthorization was included in the FY12 National Defense Authorization Act (NDAA), which reauthorized the SBIR Program for six years and now allows small firms that are majority-owned by venture capital operating companies (VCOCs), hedge funds, or private equity firms to compete for SBIR grants.

This advisory briefly summarizes the most important changes to the SBIR eligibility rules and discusses how investments in or acquisitions of SBIR-funded companies may be affected.

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Freeman A. Hrabowski III, president of the University of Maryland, Baltimore County, has joined the board of T. Rowe Price Group as an independent director, the Baltimore-based investment firm announced Thursday.

Hrabowski has led the university since 1992, and was recognized last year by Time magazine as one of the 100 most influential people in the world. According to Price, Hrabowski sits on a number of civic boards, including the Alfred P. Sloan Foundation, the Urban Institute, the Marguerite Casey Foundation and the France-Merrick Foundation. He also serves as a director for McCormick & Co. Inc. and the Baltimore Equitable Society.

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"Disease is too complex to just think your way through it," says Raimond Winslow, director of The Institute for Computational Medicine at Johns Hopkins. "We can no longer work with what I call purely mental models of how biological systems function in either health or disease."

Thankfully, we have technology to lend a hand.

The burgeoning and highly complex field of computational medicine is showing promise for the treatment of illnesses such as Alzheimer's, heart disease, cancer and more, as technology and troves of data are harnessed to investigate the underpinnings and map the progression of diseases.

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Emergent Biosolutions Inc. said it has secured exclusive right to manufacture and sell VaxInnate Corp.'s pandemic influenza vaccine candidate in the United States.

Under a license agreement with VaxInnate, Emergent Biosolutions acquired exclusive U.S. commercial rights to next generation pandemic influenza vaccine candidate.

This license enables Emergent to fulfill the requirement to secure a pandemic influenza vaccine candidate under its contract with the Biomedical Advanced Research and Development Authority (BARDA), the company noted.

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Maryland policymakers have taken encouraging steps the past two years to strengthen the state’s technology and life sciences economy.

Two years ago, they expanded access to capital for early-, mid- and late-stage growth companies through the InvestMaryland program.

Last year, they accelerated the transfer of novel technologies from universities into the hands of private companies through the Maryland Innovation Initi

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Every day, inside our body, there is a war going on. Microscopic invaders of one kind or another try to make a meal of us, and our immune system fights back, seeking out the invaders and destroying them. One of our body’s most important foot-soldiers in this war is the T cell, a type of white blood cell with receptors that can recognize foreign substances. Like all white blood cells, T cells originate in the bone marrow, but then they migrate to an organ called the thymus (hence the “T” in “T cell”), where they evolve into specialized immune system warriors. Mature T cells, which leave the thymus and circulate around the body, come in different types. One type, the cytotoxic T cell, specializes in attacking and killing cells of the body that are infected by viruses, bacteria, or cancer.

emergent-logo

Emergent BioSolutions Inc. (NYS: EBS) announced today that it has signed a license agreement with VaxInnate Corporation under which Emergent acquired the exclusive right to manufacture and sell VaxInnate's pandemic influenza vaccine candidate in the United States. The product candidate, a recombinant vaccine, has the potential to be produced quickly, at high yields and in a cost-effective manner. This license enables Emergent to fulfill the requirement to secure a pandemic influenza vaccine candidate under its contract with the Biomedical Advanced Research and Development Authority (BARDA), which established Emergent as a Center for Innovation in Advanced Development and Manufacturing (Center) in June 2012. VaxInnate will continue to develop its pandemic influenza vaccine candidate under its current BARDA contract and Emergent will manufacture the pandemic influenza vaccine candidate using flexible manufacturing technology.

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The U.S. Small Business Association (SBA) published a final rule on Thursday that will implement changes to the Small Business Innovation Research (SBIR) program, such as eligibility criteria that now includes companies that are majority-owned by multiple domestic VCs. The rule is implementing the SBIR/STTR Reauthorization Act, which was signed into law this year and extended the SBIR program through Sept. 30, 2017. The changes take effect on Jan. 28, 2013 (see BioCentury, Oct. 17, 2011).

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The Johns Hopkins Bloomberg School of Public Health was awarded a four-year, $5 million grant from the Bill & Melinda Gates Foundation to promote the effective use of oral cholera vaccine around the world. The Delivering Oral Vaccine Effectively (DOVE) program will provide relief agencies and governments with technical assistance on how to use oral cholera vaccine, evaluate current vaccine-use practices and develop new field surveillance methods for monitoring and controlling outbreaks of the disease.

Cholera is an infectious disease caused by drinking unsanitary water. The disease is estimated to be responsible for between 100,000 to 200,000 deaths worldwide each year and infects as many as 2.5 million people annually. The oral cholera vaccine is over 70 percent effective and costs $1.85 per dose, but is not yet widely used in preventing outbreaks.

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CytImmune and AstraZeneca have entered into an agreement to study the feasibility of a new cancer nanomedicine that will bind an oncology compound from AstraZeneca to CytImmune's CYT-6091 nanomedicine platform.

CYT-6091, which is comprised of gold nanoparticles bound with an immune avoiding molecule (PEG-Thiol) and tumor necrosis factor alpha (TNF), has been successfully tested at the National Cancer Institute, Bethesda, MD in a phase I clinical trial in advanced-stage cancer patients. As seen in that study, the gold nanoparticles trafficked to tumors, not to healthy tissue, resulting in an improvement in the safety of systemically administered TNF formulated as CYT-6091.

astrazeneca-gold-nanoparticles

The pharmaceutical giant AstraZeneca­ is expected to announce this week that its oncology unit in Waltham is collaborating with a Maryland company to develop an innovative cancer therapy. The proposed treatment involves delivering powerful cancer drugs on the backs of gold nanoparticles made by CytImmune, of Rockville, Md., that are so tiny 5,000 of them can fit in the width of a human hair.

At that size, the gold flecks make a particularly good vehicle because they can easily carry other molecules, like cancer drugs. They are also believed safe to use in the body.

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Reston-based New Atlantic Ventures, which invests in technology start-ups, has launched its fourth venture capital fund.

The New Atlantic Venture Fund IV expects to raise $125 million, with its first investors contributing $42.5 million in the fund's initial sale last week.

New Atlantic Ventures currently holds stakes in more than two dozen start-ups, including six in the Washington area. It currently has $230 million in capital under management.

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On December 19th, 2012, BioHealth Innovation, Inc. hosted an appreciation event for the 30+ commercialization consultants that are working closely with BHI's Entrepreneur-in-Residence Todd Chappell at the NIH Office of Technology Transfer to identify novel research and technologies. With the help of these consultants, Todd has been able to identify a multitude of interesting endeavors which BHI will now help push to the next stage of commercialization. We hope that the coming year will bring even more opportunities for post-docs to work closely with BHI in shaping the future of Maryland's biotechnology industry!

medicine

As we anticipate a new year characterized by unprecedented interest in healthcare innovation, pay particular attention to the following three emerging tensions in the space.

Tension 1: Preventive Health vs Excessive Medicalization

A core tenet of medicine is that it’s better to prevent a disease (or at least catch it early) than to treat it after it has firmly taken hold.   This is the rationale for both our interest in screening exams (such as mammography) as well as the focus on risk factor reduction (e.g. treating high blood pressure and high cholesterol to prevent heart attacks).

Johns Hopkins University

A Maryland corporation established to help accelerate the commercialization of new technologies has awarded nearly $300,000 to three Johns Hopkins-related projects that hold promise for ushering new medical devices to the marketplace.

In its first round of investments, the Maryland Innovation Initiative (MII) on Dec. 19 awarded three awards to BOSS Medical LLC, a Johns Hopkins University start-up company, and to two School of Medicine faculty members who are working on other medical devices.

Johns Hopkins University

Clear Guide Medical LLC is readying its first product, a medical device used in minimally invasive ultrasound surgeries that will be for sale in early 2014. Federal and state grants received this year aided the commercialization process for the Johns Hopkins spinoff, which hopes to receive another state grant early next year.   

The Baltimore life sciences company received a total of $550,000 from the federal National Institutes of Health and National Science Foundation, in 2011 and 2012, and $125,000 from the Maryland Technology Development Corp. in 2010 and 2012. It is waiting to hear about another grant from the latter, for $100,000.

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Lonza today announced together with Sartorius Stedim Biotech (SSB), a leading international pharmaceutical and biotech supplier, a long-term global collaboration, supply and distribution agreement in the field of cell culture media. Cell culture media are growth substances and nutrients for cells or microorganisms and are required in every biopharmaceutical manufacturing process.  

In the agreement, SSB will assume global sales and marketing of media and buffers used in the manufacture of protein-based therapeutics and vaccines, while Lonza will continue to carry out development, manufacture and logistics operations for these products. New product development will be mutually performed. The cell culture media, which are usually sold in liquid or powder form to biopharmaceutical customers, are to be successively converted to packaged forms as ready-to-use, pre-filled SSB sterile single-use bags. Furthermore, Lonza and SSB have agreed that these cell culture media will be sold under both brands in a co-branding arrangement. Lonza will maintain commercial responsibility for global sales and marketing of media used for research purposes and in the manufacture of cell-based therapeutics and gene therapy as well as for manufacturing for any of Lonza’s custom manufacturing customers.  

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Join us for the upcoming Tech Transfer Speakers Series event on January 9th, 2013:

"Do You Know the Export Control Regulations Impacting Your Technology Business?"

How well do you know the export control regulations affecting the technology industry? Right now there are dramatic changes to the export control requirements that technology firms need to be aware of to avoid fines. Questions such as: Do I need a license from the government to have a foreign national work on my technology here ? How can I find out if my technology requires a license for its export ? What about fundamental and basic research- is a license required ? Will I need to have an export license for government contracts ? If I have an office overseas working on research, is an export license required ? These questions and more will be addressed.

Presenter:

Stephen Hall
Senior Policy Analyst
Office of Exporter Services, Bureau of Industry and Security
United States Department of Commerce

For more information, and to register: http://techtransferspeakers.eventbrite.com/

healthcare-r-and-d

Investment in research & development in the U.S. life science industry will turn a corner in 2013 after three years of reduced spending, if a new market analysis is correct.

In their 2013 R&D Funding Forecast (PDF), research and development organization Battelle and R&D Magazine propose that U.S. life science companies will bump up their total R&D spending from $181.6 billion in 2012 to $189.3 billion in 2013. Better access to healthcare information, via data analysis, will accelerate and enhance pharmaceutical R&D and adoption of connected health technologies, they say.

mikulski-barbara-appropriations-committee

In an unexpected move that could have significant implications for Maryland, Sen. Barbara A. Mikulski will be named the first female chair of the powerful Senate Appropriations Committee on Thursday.

The Baltimore native and Maryland Democrat, who had been the most senior member of the U.S. Senate without a committee gavel, was suddenly in line to head the influential spending panel following behind-the-scenes maneuvering for chairmanships that played out after the death Monday of its former chairman, Sen. Daniel Inouye of Hawaii.

The Democratic caucus is expected to formally approve her chairmanship Thursday.

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Maryland's second-in-command on economic development matters will step into the top job in January when the current secretary leaves for the private sector, state officials announced Wednesday.

Dominick Murray, who joined the Maryland Department of Business and Economic Development six years ago, will succeed Christian S. Johansson as secretary of the agency. Johansson is heading to Baltimore-based Laureate Education, a company that runs universities worldwide, after nearly four years as agency chief.

Both officials were praised by the Maryland Chamber of Commerce on Wednesday for their work on entrepreneurship and efforts to give businesses more of a voice.

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BHI and Ahead are collaborating to accelerate commercialization of Symcat, Ahead Research’s patient/healthcare provider matchmaking app

ROCKVILLE, MARYLAND, Dec. 19, 2012 - BioHealth Innovation, Inc. (BHI) announced today that its newest client, Ahead Research, Inc. (Ahead), received the first Cigna Innovation Health Challenge award at the 2012 mHealth summit. BHI and Ahead recently signed a Memorandum of Understanding (MOU) to jointly accelerate the commercialization of Symcat, Ahead’s web and mobile application whose module was the basis for the Cigna award.

“Ahead Research – with its Symcat app – is the type of entrepreneurial start-up company that BioHealth Innovation seeks to foster as part of its mission to drive the commercialization of market-relevant biohealth innovations,” said BioHealth Innovation’s President & CEO Richard Bendis.

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MedImmune, the global biologics arm of AstraZeneca, announced that it has signed an in-licensing agreement with Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) for Progenics’ Clostridium difficile late-stage preclinical program.  The agreement was led by MedImmune’s Infectious Diseases & Vaccines Innovative Medicines (iMed) Unit.

Clostridium difficile infections are the leading cause of hospital-acquired bacterial infections in the U.S. and are associated with more than 20,000 deaths and more than $1 billion in healthcare costs annually. The disease causes severe diarrhea in patients and significantly lengthens the time patients stay in the hospital, leading to poorer outcomes. MedImmune’s program for this property will assess the potential efficacy and safety of treatment of the infection with investigational monoclonal antibodies targeting toxins that mediate the disease.

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NHLBI Funding and Research Opportunities

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

Request for Applications (RFAs):

Program Announcement (PA):

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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University of Maryland System’s Diverse Space Offerings Provide Sterilization Technology Company the Ability to Grow Locally

Baltimore, MD, December 18, 2012 – The University of Maryland (UM) BioPark announced today that Noxilizer, Inc., a sterilization technology company, is the latest advancing life sciences company to sign a lease for space within the BioPark. Noxilizer relocates to the UM BioPark from the bwtech@UMBC Research and Technology Park in Baltimore County to accommodate the company’s explansion plans.

Said Jane Shaab, UM Research Park Corporation Senior Vice President, “Noxilizer’s move to the UM BioPark symbolizes the diverse space offerings within the University of Maryland system. This move also adds to our mix of growing technology businesses, research centers, and educational offerings.”

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CONGRATULATIONS to 20 INNoVATE 2012 graduates—celebrating completion of their unique commercialization training program--co-sponsored by UMBC, NSF & JHU-- in Rockville last night. (See class below)

- Gaurav Basu (Skin-S)
- David Beylin (Brain Biosciences Inc.)
- Kostyantyn Bobyk (MyoTherapeutics, LLC)
- Eva Chin (MyoTherapeutics, LLC)
- Gina Devasahayam (GenetikSignal, Inc.)
- Ghadeer Hasan (Relocation Support Services)
- Lawrence Jones (TelaSense)
- Dun Liang (ViDDx)
- Saravana Murthy (Onc-Marcare)
- Oluwadamilola Ogunyankin (Jifad Fuels)
- Ping Qiu (NoInfection Pharmaceutical)
- Zelicia Read (Vital-Sight, Inc.)
- Anthony Saleh (Nitron Therapeutics)
- Colleen Sico (InnoSico, LLC)
- Andrew Stewart (Tolerogenix)
- Raimon Sunyer (TelaSense)
- Rajesh Thangapazham (Skin-S)
- Leonard Wayne (ExTenebris Optics, LLC)
- Christopher van de Wetering (Chesapeake Cellular)
- Mark Ziats (NeuroNetDx)

perman-jay-umd

University of Maryland, Baltimore said Monday it reached its $650 million fundraising goal, a record for the school.

The campaign, launched in fiscal 2005, has supported several campus projects, including construction of a new campus center, improvements at the law school, an endowed scholarship for nursing students and nearly twice as many endowed chairs and professorships at the School of Medicine.

Ueno-Ryuji-Sucampo

Two little-hyped drugs developed by Human Genome Sciences Inc. and Sucampo Inc. (Nasdaq: SCMP) have won Food & Drug Administration nods.

The approval of HGS' Raxibacumab as a treatment and prevention for inhaled anthrax and the supplemental approval of Sucampo's Rescula, for glaucoma and ocular hypertension, both represents wins for Maryland biotech.

invest-maryland-challenge

Startups are coming out of the woodwork to vie for InvestMaryland cash. Under a business plan competition, the state-run investment program is offering prizes of $100,000 to three early-stage companies.

Prizes will go to a company in the life sciences, one in the IT space and one in a general category.

Not surprisingly, a whopping 259 startups applied — a colorful bunch that includes entities such as BodyCount LLC, A.I.R. Lawn Care and Fraud Sniffr, as well as some more traditional tech and biotech companies, according to an official list. About 10 percent of the companies that applied are from out of state.