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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.

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.  

mont-county-ded

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.

murray-dominick-md

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.