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American innovation, badly damaged last year by federal budget tightening and the across-the-board cuts known as sequestration, appears to be getting partial relief with the bipartisan budget deals struck last month and Monday night. The progress is praiseworthy, but it will not counteract the decades-long decline in federal funding for research and development that is so essential to our economic future and critical to accelerating treatments for today’s major health care challenges, including Alzheimer’s, diabetes, heart disease and cancer.

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First there was a blizzard of new drug deals. Now comes the forecast for sunnier financial weather ahead.

AstraZeneca CEO Pascal Soriot arrived at JPMorgan with a message: The pharma giant ($AZN) has beefed up its late-stage pipeline and is now ready to prove it can start to grow again in the near future as it pushes through one of the industry's most radical R&D reorganizations. As of today, AstraZeneca counts 11 drugs in late stages of development--just about double what Soriot inherited when he was named CEO a year ago--with another 27 coming up behind it. And it's mapped out a combo strategy for immunotherapies designed to get the company in the race to gain approvals and start growing oncology revenue.

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The approaching March deadline for individuals to enroll in a health insurance plan is a useful reminder that provisions of Obamacare will continue to roll out this year. The Affordable Care Act and related legislation are putting a huge demand on the health system, from accelerating the shift to electronic medical records to creating a need for more efficient communication tools between physician offices, patients and insurers. A handful of industry insiders offers a glimpse of the kind of targets that will shift into focus in 2014 and the groups that will be looking to buy them.

University System of Maryland

A Maryland Industrial Partnerships (MIPS) and I-Corps presentation, “Linking Innovative Technology with University System of Maryland Resources,” with Mr. Joe Naft, Director, MIPS will take place on Thursday, February 6, 11:15 am – 12:30 pm in Wyle Building 1 North conference room, 22309 Exploration Dr., Lexington Park, MD 20653. This program, sponsored by The Patuxent Partnership, is free and open to the public. Check-in begins at 11:00 am; attendees are welcome to bring their lunch.

Maryland Technology Enterprise Institute’s (Mtech) MIPS program accelerates the commercialization of technology in Maryland by jointly funding collaborative R&D projects between companies and the faculty of Maryland’s public universities. With more than 500 Maryland companies participating in project awards since 1987, MIPS-supported products have generated over $25.2 billion in sales, added jobs to the region, and infused state-of-the-art technology into the global marketplace. To be sponsored by MIPS, projects must show strong potential for commercialization and economic impact. These projects cover the gamut of state-of-the-art technologies in fields such as biotechnology, nanotechnology, clean energy, robotics, information technology and all types of engineering.

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After a successful launch of the Academy in September, we are excited to be offering another run of our career-oriented courses. We saw that our web development courses were incredibly popular so we have decided to focus on these two courses for our Winter semester.

A handful of students that took our Academy last year have been placed in either full-time positions or paid internships. Some came to learn the skills needed to build their own websites, while others were sent for professional development. Whatever your reason is for wanting to learn more, the Academy is the most intense digital education program in the region.

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ATCC is featuring specific cell-based solutions for screening at SLAS2014, the 3rd Annual Conference and Exhibition of the Society for Laboratory Automation and Screening. Meeting attendees visiting ATCC at booth #1348 will find helpful information on hTERT immortalized cell lines, human stem cells, cancer cell panels, and reagents that are particularly suited for screening and drug discovery research. ATCC, the premier global biological materials resource and standards organization, maintains the largest collection of cells lines characterized and authenticated for use by the research community.

Cell-based screening programs, especially when automated, require a stable supply of cells for extended studies. To aid in this endeavor, ATCC currently maintains over 20 human telomerase reverse transcriptase (hTERT) immortalized cell lines of different types, including epithelial cells derived from various human tissues. These cell lines represent a breakthrough in cell biology research that combines the in vivo characteristics of primary cells with the ability to survive continuously in vitro.

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Biomātrica®, Inc., a world leader in ambient temperature biological stabilization technologies, and ATCC, the premier global biological materials resource and standards organization, today announce the completion of a licensing agreement. According to the agreement terms, Biomātrica will supply ATCC with DNAstable® and RNAstable® reagents for the stabilization of DNA and RNA standards.

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A JOLT of caffeine can boost memory, according to a study that provides a scientific motive for students slurping coffee, tea or energy drinks when cramming for exams.

A team at Johns Hopkins University in Baltimore, Maryland, found that caffeine enhances certain memories for at least a day after they were formed.

Evidence for caffeine as a memory booster has been anecdotal until now.

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Our community relies on the current crop of PhD researchers to develop the insights, theories and tools to shape the future of innovation management thinking and action. The ISPIM Innovation Management Dissertation Award, sponsored by John Wiley & Sons and Innovation Leaders will reward this endeavour. Authors of the best three PhD dissertations that are completed in 2013 will be able to attend the ISPIM 2014 Conference in Dublin for free. Additionally, the winner will receive a prize of EUR 4000, and the runners-up EUR 2000 each, courtesy of Innovation Leaders, John Wiley and Sons and ISPIM.

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Who are the entrepreneurs pushing hardest for technology advances that will connect patients with better healthcare? They’re people like Sean Duffy, who’s using the Web to help people make behavioral changes that could head off Type 2 diabetes at his startup Omada Health, and Joanne Rohde, whose company Axial Exchange is building systems that help patients stay in touch with their doctors before and after office visits.

That’s according to Rock Health, the San Francisco-based accelerator and seed fund for Health IT entrepreneurs, which named its 2013 “Top 50 in Digital Health” honorees at a downtown ceremony last night. The event helped to kick off the week-long J.P. Morgan Healthcare Conference and was co-hosted by Goldman Sachs, Silicon Valley Bank, and Fenwick & West.

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Who knew elephant sharks held potential answers for health problems such as osteoporosis and poor immune systems?

An international team of researchers at the Max Planck Institute of Immunobiology and Epigenetics in Germany discovered new insights into human health by sequencing the elephant-shark genome.

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MIMETAS and Galapagos will collaborate to develop miniaturized 3D cell culture models that mimic specific aspects of human diseases. These models will be applied to the identification and improvement of novel compounds. Dr. Richard Janssen, Senior Director of Target Discovery at Galapagos, states: “The MIMETAS platform is the first to combine organ-on-a-chip technology with our high throughput screening of primary human cells. As we see it, OrganoPlates™ make 3D culture as straightforward as traditional cell culture.”

Dr. Jos Joore, MIMETAS’ CBO underscores this notion: “This agreement is a crucial step forward for MIMETAS and for the organ-on-a-chip field in general. Galapagos sets an example as one of the first drug discovery companies worldwide to implement innovative organ-on-a-chip technologies. This collaboration helps us to further validate our technology, by enabling development of unique novel compounds with unique human disease models.”

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Nationally, startups seeking venture capital at an early stage saw another great year in 2013 with an abundance of active seed investments being made. And according to data released by CB Insights last week, of the seed investors making deals with young companies in 2013, three D.C.-based VCs were some of the most active. Among the likes of West Coast seed powerhouses 500 Startups and Andreessen Horowitz, Washington-area CIT GAP Funds, New Enterprise Associates and Fortify.vc were ranked in the top 60 venture capital funds for most active nationally.

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One way pharma giant Johnson and Johnson stays ahead of the competition is via its network of Innovation Centers where researchers are working on new approaches to cardiovascular issues, infectious diseases, neuroscience, and more.

The centers are located in San Francisco, Boston, London, and Shanghai – and this week the company announced that Israel was joining the family, in the form of an incubator J&J will be opening in Rehovot, near the Weizmann Institute. Working together with several other partners, the company said, the new incubator “is the latest in a series of recently announced collaborations to fuel entrepreneurship in the world’s scientific hot spots.”

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Entrepreneur Office Hours for University of Maryland Students, Faculty and Staff, and Regional Entrepreneurs with Tech-Based Startups or Ideas

Get answers now from experienced entrepreneurs and legal/business professionals on how to build a successful startup company. Receive free and impartial advice, brainstorm business strategies, investigate funding opportunities and learn about the vast resources available to entrepreneurs.

DATE:   Tuesday, January 14, 2014

PLACE:  Room 1103, Technology Advancement Program building (directions)

REGISTER:  Schedule an appointment here to guarantee your time slot. Walk-in appointments are also available.

Montgomery County ED

Happy New Year! Thanks to two recent, major life sciences announcements spotlighted in Site Selection magazine, Montgomery County shows that our biotech sector is well-poised for accelerated growth in 2014!

The December 2013 Site Selection web exclusive features details on the attraction of Brazilian-based Brace Pharmaceuticals' new U.S. headquarters to the County's Rockville Innovation Center and its plans to invest $200 million.  Brace is focused on the late stage clinical development of pharmaceutical products with the potential for near-term commercialization.

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Six months into its fiscal year, the Maryland Technology Development Corp. has received almost as many applications from state startups looking for funding as it got in all of the previous year.

As a result of the spike in demand, Tedco is asking the Maryland General Assembly for what Tedco President Robert Rosenbaum called “a substantial increase” in funding for fiscal 2015. The General Assembly convened for its annual session in Annapolis on Jan. 8.

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Kauffman FastTrac® has just joined with Montgomery College to support future and current business owners before, during, and after the startup process. Entrepreneurs will receive the information, resources, and networks necessary to start and grow successful businesses.

Classes:
SMB957: FastTrac NewVenture for the Veteran Entrepreneur (2/13-4/24)
SMB956: FastTrac TechVenture (2/26-5/7)

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After vanquishing humans on Jeopardy!, IBM says its Watson computer is ready to help save human lives. The company on Thursday announced it has created a new business unit specifically to advance Watson and deliver its artificially intelligent wisdom to research organizations, medical institutions and businesses so that they can process “big data” for detailed answers to complex questions. They won’t actually own a Watson computer—instead its services will rendered via a network connection (the “cloud computing” model).

IBM doesn’t launch new business units every day—or even every decade—chief executive Ginni Rometty noted during the Watson Group announcement. Indeed, the company is making a calculated bet—to the tune of more than $1 billion—on cognitive computing and the role it will play in making big data useful.

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Kaiser Permanente will put its longtime IT expertise to work in building a clinical data network aimed at improving patient outcomes in cancer, heart disease and obesity.

Funded with a $7 million grant from the Patient-Centered Outcomes Research Institute, the network is one of 29 projects approved for a total of $93.5 million to form PCORnet: the National Patient-Centered Clinical Research Network, which seeks to improve the efficiency of health research.

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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:


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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The National SBIR Conference and the 3rd annual National Innovation Summit and Showcase will be held in parallel with the 17th annual TechConnect World Conference, at the Gaylord Convention Center, June 15-19, 2014.

National SBIR Conference

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs are highly competitive, encouraging small businesses to engage in Federal Research/Research and Development (R/R&D) work with potential for commercialization.

National Innovation Summit

In support of the White House and Congressional call for innovation commercialization initiatives, the National Innovation Summit and Showcase delivers the world's largest showcase of industry-vetted emerging-technologies ready for commercialization. Don't miss as TechConnect presents the Nation's top innovations emerging from our federal technology funding programs. All showcasing innovations are vetted by our industry and investment review committees, and all will participate the TechConnect Corporate Acceleration and Matchmaking Programs with our participating Corporate and Investment Partners.

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Last Sept. 22, the chief executive of a startup called CoFoundersLab Inc., Shahab Kaviani, sat up at the moment the clock chimed midnight, ready to tweet.

At that time, a ban on what’s known as “general solicitation” was officially lifted by the Securities and Exchange Commission, which meant startups like his could tell the general public, and not just accredited investors, that they were raising money.

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Intellectual property featured prominently in 2013’s public discourse. Gene patents, patent trolls, India’s anti-patent actions, and other developments around the world captured headlines. Here are Patently Biotech’s top blog posts written in 2013 by number of views.

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GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) has approved Mekinist (trametinib) for use in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.  

The approval of the combination is based on the demonstration of response rate and median duration of response in a Phase 1/2 study. Improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar. The combination was approved through the FDA's Accelerated Approval program and reviewed under a Priority Review designation. This accelerated approval is contingent on the results of the ongoing Phase 3 trial (referred to as MEK115306 or Combi-D), which is designed to evaluate the clinical benefit of the combination in this patient population.

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WellDoc®, developers of the first FDA cleared mobile prescription therapy, BlueStarTM, announced today that it received funding from its first institutional investors, Merck Global Health Innovation Fund and Windham Venture Partners, as part of a $20M round of financing that now broadens its capitalization beyond its initial group of angel investors. For a limited time, WellDoc and its investors will also explore the possibility of adding co-investors that bring strategic value to the company.

“Our new investors share WellDoc’s vision of fundamentally changing how people manage their chronic diseases to improve outcomes and reduce costs,” said Ryan Sysko, co-founder and CEO of WellDoc. “This investment will help WellDoc launch and commercialize BlueStar, the world’s first Mobile Prescription Therapy for type 2 diabetes, on a nationwide basis.”

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Johnson & Johnson Innovation has announced that it is expanding its global incubator presence through a novel collaboration with the Office of the Chief Scientist in Israel and other industry partners to establish a new biotechnology incubator near Israel’s Weizmann Science Park.

This is the latest in a series of recently announced collaborations to fuel entrepreneurship in the world's scientific hotspots. In addition, Johnson & Johnson Innovation announced several new collaborations with academia and biotech that focus on multiple disease areas and consumer healthcare challenges.

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AstraZeneca today announced that Granta Park-based MedImmune, its global biologics research and development arm, has entered into a cancer research collaboration and licensing agreement with Immunocore, an Oxford biotech company.

The approach will be to use the power of the body’s own immune system to find and kill diseased cells, avoiding damage to healthy cells.

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Intrexon Corporation (NYSE: XON), a leader in synthetic biology, announced today that it has entered into a research and development collaboration with Johnson & Johnson Innovation and its affiliate Johnson & Johnson Consumer & Personal Products Worldwide, a division of Johnson & Johnson Consumer Companies, Inc., to advance new skin and hair care products.

"We look forward to advancing new skin and hair beauty products that have measurable impact for consumers," said Randal J. Kirk, Chairman and Chief Executive Officer, Intrexon.  "By combining Intrexon's synthetic biology approaches with the capabilities at Johnson & Johnson Innovation and Johnson & Johnson Consumer & Personal Products Worldwide, we believe that there are multiple areas for new product exploration."

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Neuralstem, Inc. (NYSE MKT: CUR) announced today that it has entered into agreements with leading institutional investors for a registered direct placement (the "Offering") of 6,752,744 shares of common stock at a price of $2.91 per share, resulting in aggregate gross proceeds of approximately $19.65 million.

In addition, the Company will issue to each investor a warrant to purchase a number of shares of common stock equal to one-half of the number of shares purchased by the investor in the Offering. The warrants have an exercise price of $3.64 per share, and are exercisable from the issuance date, for a period of five years.

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Elliott Sigal has opened the next chapter of his career. The former R&D chief at Bristol-Myers Squibb ($BMY), who helped squire a number of blockbuster programs through the clinic, is joining David Mott as a venture partner at New Enterprise Associates.

Bristol-Myers' R&D group had its setbacks, particularly in 2012, but during Sigal's tenure at the top of the research arm he guided an amazing 14 drugs to an approval, including Abilify, Erbitux and Onglyza. Those were all part of Bristol-Myers' "string of pearls," which earned the company a rep as one of the leaders in innovation in the field. Few other R&D chiefs--including a number who had much larger budgets to work with--even came close.

glaxosmithkline

GlaxoSmithKline plc [LSE/NYSE: GSK ] announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test.1 Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.2

The approval of the combination is based on the demonstration of response rate and median duration of response in a Phase I/II study. Improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar.1 The combination was approved through the FDA's Accelerated Approval programme and reviewed under a Priority Review designation.3 This accelerated approval is contingent on the results of the ongoing Phase III trial (referred to as MEK115306 or Combi-D), which is designed to evaluate the clinical benefit of the combination in this patient population.

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The International CES expo in Las Vegas, which kicks off Tuesday, has long been the site of new technology announcements and gadget demonstrations. This year, about 55 Washington area companies plan to exhibit at the show, up slightly from last year’s 53.

The group represents one of the most diverse that the region has sent to Las Vegas, said Jeff Joseph, senior vice president for communications with the Consumer Electronics Association, which puts on the show.

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The healthcare industry will continue to command the spotlight in 2014, and healthcare executive search consultants from Witt/Kieffer have some advice for making 2014 a stellar year on the work front, including a recommendation to broaden the role of the CIO.

The recommendations:

Prepare for unplanned CEO turnover – Paul Bohne, managing partner, says, “Technological advancements, physician alignment, market consolidation and government policy changes have all increased the complexities of how large, diverse healthcare organizations operate.” These mounting responsibilities have exacerbated the turnover issue.