6th Edition – May 21, 2012

National Heart, Lung and Blood Institute to Establish NHLBI Centers for Accelerated Innovations

The National Heart, Lung, and Blood Institute (NHLBI) intends to publish a Funding Opportunity Announcement (FOA) in the Spring 2012 NIH Guide for Grants and Contracts to establish Centers for Accelerated Innovations (CAI). The CAI will address the problems that hinder the critical early steps necessary to translate novel scientific advances and discoveries into commercially viable diagnostics, devices, therapeutics, and tools that improve patient care and advance public health.

The Need for Accelerated Innovation

Despite the remarkable success of NHLBI in enabling the development of interventions that have greatly reduced the health burdens due to cardiovascular, lung, blood and sleep disorders, much remains to be done. Cardiovascular and lung diseases still account for 3 of the 4 leading causes of death; 4 of the 10 leading causes of infant death; $392 billion in health care dollars, and 22% of the total economic costs of illness, injuries, and death.

Unfortunately, the pace of translating discoveries from NHLBI-supported research into medical products that can further reduce the public health burden of heart, lung, and blood (HLB) diseases appears to have slowed. Major pharmaceutical firms have announced their intention to abandon drug development efforts for cardiovascular diseases and venture capital and angel investors have shown a decreased interest in the healthcare and biotechnology sectors.

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Human Genome Sciences Board of Directors Unanimously Determines GlaxoSmithKline Unsolicited Tender Offer is Inadequate and Not in the Best Interests of Stockholders – MarketWatch

Human Genome Sciences, Inc.oday announced that its Board of Directors, after careful review and consideration with the assistance of the Company’s management and financial and legal advisors, has unanimously determined that the unsolicited tender offer from GlaxoSmithKline ("GSK") to acquire all outstanding common shares of HGS for $13.00 per share in cash (the "Offer") is inadequate, undervalues the Company and is not in the best interests of HGS and its stockholders.

Accordingly, the Board recommends that stockholders reject GSK’s tender offer and not tender any of their shares to GSK. The basis for the Board’s decision is set forth in the Schedule 14D-9 being filed by HGS today with the Securities and Exchange Commission ("SEC"), which will also be mailed shortly to stockholders.

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Human Genome Sciences adopts stockholder rights plan – Baltimore Business Journal

Human Genome Sciences Inc, which has rejected a hostile $13-per-share offer from GlaxoSmithKline, has adopted a short-term stockholder rights plan to fend off such unwanted attention.

Rockville-based Human Genome (NASDAQ: HGSI) said in a statement announcing the plan that it had declared a dividend of one share purchase right for each share of the company’s common stock held of record at the close of business on May 29.

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Emergent gets FDA approval for modified vaccine dosing – Washington Business Journal

Rockville-based Emergent BioSolutions Inc. , which makes the only vaccine licensed by the Food and Drug Administration to protect against anthrax infection, has received FDA approval for a new, shorter-dosing schedule.

The new, supplemental biologics license application, follows trials to determine if the company’s BioThrax vaccine would be effective with as few as three doses over six months.

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United Therapeutics to Own Even More of Downtown Silver Spring

United Therapeutics, which has has greatly expanded their downtown Silver Spring presence as of late, is reportedly set to purchase from the county the parcel located at the corner of Colesville Rd. and Spring Street. The parking garage that current occupies this space abuts an existing UT building, and has been closed for some time due to safety issues. (Surprisingly, it has its own Yelp page. Who uses their limited time on Earth to rate a public parking garage?)

I’m a big fan of the existing United Therapeutics buildings, what with their skybridge and giant external TV’s and all. I also like the touch of the ground lights representing individual elements from the periodic table. The planning and construction of the new building could take five years (or more, because construction delays tend to happen around here), so we won’t be seeing it anytime soon. Hopefully they will choose to incorporate some street-level retail into their design.

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Osiris becomes first company to market stem-cell therapy – Baltimore Business Journal

Osiris Therapeutics Inc. in Columbia has become the world’s first company to receive market approval for a manufactured stem cell product.

Health Canada, the country’s department responsible for overseeing pharmaceuticals, approved for commercial sale Osiris’ Prochymal, which uses stem cells from healthy donors to treat a fatal children’s disease.

“While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last,” Osiris CEO C. Randal Mills said.

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Global Perspective on Regional Collaboration

On any given weekend, there are countless community events throughout the Greater Washington region, many in ethnically diverse immigrant communities.  A Korean church service, an Indian American business conference, a Chinese choral concert and an Iranian Nowruz celebration, whether held in Maryland or Virginia, all draw crowds from the Region’s many counties and cities on both sides of the Potomac River.  These “new communities,” as we are often called, frequently travel across county and state lines to be connected with our own communities to worship, to learn, and to have a good time.  These activities and events add much vitality to local living.

The Washington Metropolitan area is one of the most transient metropolises in the country, with transplants and migrants defining and redefining much of the local demographic landscape.  In fact, in Montgomery County, where I live and work, one in three residents are from other countries and three out of four are from other states. What attracted many of us from other states or countries to this region was economic and career opportunities and a good quality of life afforded by a metropolitan area.  Immigrants like me have no roots in this country and will pursue opportunities wherever they are.

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Two INNoVATE Students Take First Place in Maryland Business Plan Competition ‹ Hopkins Happenings

When Adam Steele worked at the National Institute of Standards and Technology (NIST), he and two other colleagues invented a technology that Steele believed had commercial potential. But Steele, a physicist, didn’t have a business background. He said he had no idea how to take the technology out of the lab and build a company around it. His colleagues recommend he apply for the JHU Carey Business School INNoVATE program. He did so, and was soon accepted into the program’s Class of 2011.

Now he and fellow INNoVATE student Brenton Knuffman, who is one of the technology’s inventors, are quickly becoming a success story for the program. The duo, who both currently work for the University of Maryland NanoCenter, recently won first-place – and $10,000 – in the Maryland Technology Enterprise Institute’s 2012 Business Plan Competition in the Graduate Student, Faculty and Researchers Category.

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University of Maryland Hosts First UM Ventures Symposium on Entrepreneurship

The first symposium on "the notion of entrepreneurship" by the newly formed University of Maryland (UM) Ventures was a breakthrough event for technology collaboration between the Baltimore and College Park campuses, said Jay A. Perman, MD, president of the University of Maryland, Baltimore (UMB).

UM Ventures is a joint effort among the technology transfer offices at the two campuses and the entrepreneurial business services programs at College Park, and is a core initiative of the new collaboration called MPowering the State.

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Baltimore Fishbowl » Johns Hopkins’ Carey Business School Announces Major Shift

The Carey Business School, an offshoot of Johns Hopkins, has tended to be the institution’s least glamorous sister. Founded in 2007 (but with origins dating back a century before that) thanks to a $50 million donation from William Polk Carey, the freestanding school is too new to have established itself as an MBA powerhouse; instead of banking on a storied history, the program has opted to make its name through innovative programs. And now they’re revamping that system yet again.

The reorganization, announced this week, will shift the school’s focus to business as it relates to health care and the life sciences. The move seems like a smart one, both because Hopkins is such a medical powerhouse and because more and more business is happening in the health care arena.  “Health care is approaching 20 percent of the national gross domestic product, and it’s a key factor in the costs of any economic model, whether in manufacturing or services,” said the school’s interim Dean Phillip Phan. “Understanding the complexities of the modern health care industry is a crucial skill for any business manager. For those who manage in the health care sector, Johns Hopkins is the place to learn.”

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Q1 2012 DC Venture Capital Risk Tolerance – Forward Thinking

If you raised seed capital from a DC VC last quarter you are part of an exclusive club.  Only 3 firms raised seed capital from DC firms last quarter from VCs headquartered in our region and 2 of those companies got money from Virginia’s CIT. CIT is a state-sponsored fund chartered to make early stage investments and doesn’t represent the standard risk profile of a traditional VC.

John Backus and the New Atlantic Venture team were the only greed-based, non-state-sponsored fund laying down startup seed-stage bets last quarter with two investments of $3.2M each in American Honors College and Quad Learning Inc.

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Johns Hopkins secures $15M NIH grant for AIDs research center

The National Institutes of Health announced Friday it has awarded Johns Hopkins University $15 million to help establish the school’s new Center for AIDS research.

The Center will tap researchers from Hopkins’ Bloomberg School of Public Health, the school of medicine and school of nursing to address HIV in Baltimore. It will also be supported financially by Johns Hopkins Provost Lloyd Minor and the deans of the Bloomberg School, the School of Medicine and the School of Nursing.

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Federal Telemedicine News: Moving Research Forward

TATRC within the Army’s Medical Research and Materiel Command is taking steps to move research forward according to the article “TATRC: Translating Research into New Medical Products” published in the May 2012 issue of “Mercury”.

Ron Marchessault, Director of Technology Transfer and Commercialization for TATRC, is busy developing a comprehensive commercialization program for more than 1,800 research projects funded since 2000. So far, 2.3 percent have resulted in commercial products, generating $209 million in sales from a total federal investment of $74 million. TATRC manages these projects at universities, government laboratories, and high-tech start-up companies.

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We Can’t Wait: HHS announces first 26 Health Care Innovation awards

Health and Human Services (HHS) Secretary Kathleen Sebelius today announced the first batch of organizations for Health Care Innovation awards. Made possible by the health care law – the Affordable Care Act – the awards will support 26 innovative projects nationwide that will save money, deliver high quality medical care and enhance the health care workforce.  The preliminary awardees announced today expect to reduce health spending by $254 million over the next 3 years. 

“We can’t wait to support innovative projects that will save money and make our health care system stronger,” said Secretary Sebelius. “It’s yet another way we are supporting local communities now in their efforts to provide better care and lower cost.”

The new projects include collaborations of leading hospitals, doctors, nurses, pharmacists, technology innovators, community-based organizations, and patients’ advocacy groups, among others, located in urban and rural areas that will begin work this year to address health care issues in local communities.  This initiative allows applicants to come up with their best ideas to test how we can quickly and efficiently improve the quality and affordability of health care.

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Supernus moves from IPO to FDA – Washington Business Journal

Supernus Pharmaceuticals Inc. capped off its first week on the Nasdaq up nearly $1 from its initial public offering price. With its IPO in the bag, the Rockville biotech now turns to a bigger gamble: seeing two drugs through Food and Drug Administration approval and onto the commercial market.

The modestly successful May 1 offering marks the first time a Washington-area biotech has gone public since 2007 and leaves Supernus with a pile of cash to shovel into its lead product candidates — epilepsy drugs SPN-538 and SPN-804.

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State biotech firms hoping Congress will act – baltimoresun.com

A proposal to speed the approval of new prescription drugs has patient advocates and biotech firms — including many based in Maryland — hoping that Congress will deliver a rare dose of bipartisanship this year.

Lawmakers are proposing a 6 percent increase in the fees that pharmaceutical firms pay the Food and Drug Administration to offset the cost of approving new drugs. If the measure is not signed into law by the end of September, the FDA would lose the ability to charge any fees and be forced to lay off 2,000 workers, significantly slowing review times.

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Should the FDA Approve More Drugs after Phase II? A Response to Matthew Herper – Forbes

Last Friday, Forbes health care editor Matt Herper and I sat down to talk about my proposal, which I detailed in a paper for the Manhattan Institute, to encourage the FDA to approve more drugs after mid-stage phase II testing, using a process called “conditional approval.” (You can read my proposal, in three parts, here.) Matt put forth some very perceptive critiques of the idea, which I respond to in today’s dispatch.

As a refresher, my proposal builds on an existing FDA procedure called accelerated approval in which the FDA approves drugs that show great promise in phase II, with the caveat that the drug sponsor must still perform confirmatory phase III studies. If the phase III studies ultimately show that the drug doesn’t work as advertised, or has previously unknown safety issues, the FDA can revoke its approval. This is exactly what happened when the FDA revoked the approval of Avastin in breast cancer, after phase III tests did not reproduce the early signal of benefit that the drug had shown in phase II studies.

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Biotech Venture Funding Drops 43% in First Quarter | McDonnell Boehnen Hulbert & Berghoff LLP – JDSupra

Last month, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the first quarter of 2012.  The report, which is prepared by NVCA and PriceWaterhouseCoopers LLP using data from Thomson Reuters, indicates that venture capitalists invested $5.8 billion in 758 deals in the first quarter, which constituted a 19% decrease in dollars and a 15% decrease in deals as compared with the fourth quarter of 2011, when $7.1 billion was invested in 889 deals.

The report notes that the Life Sciences sector (biotechnology and medical device industries) and the Clean Technology sector saw marked decreases in both dollars and deals in the first quarter, with the drop in Life Sciences funding mostly due to decreased funding for the biotech industry.  While the biotechnology industry still managed to place second among the industries tracked by the NVCA in terms of dollars invested in the first quarter, with $780 million invested in 99 deals, this constituted a 43% drop in dollars and a 14% drop in deals over the fourth quarter.  The medical device industry picked up some of the slack for the Life Sciences sector, with $687 million invested in 72 deals, which constituted a 33% increase in dollars and a 6% drop in deals.  The number of deals in the Life Sciences sector dipped to its lowest point since the first quarter of 2009.  Overall, eleven of the seventeen sectors tracked by the NVCA saw decreases in dollars invested in the first quarter.

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The top 5 complications of FDA medical device trials

“You do a really good job with complex trials.”

We’re lucky to say that we’ve heard this from several clients over the years. But, while we’re glad for the recognition, it made us ask ourselves a key question. What is it that makes a trial complex?

For pharmaceuticals, trials can be relatively simple. A company makes the drug, the drug is administered to the trial patients and the effects are monitored. There are very few moving parts involved. Medical devices, which can be complex machines in and of themselves, will require training and retraining of all parties that are involved with implementation and monitoring of the device– there are numerous moving parts and numerous opportunities to fall out of FDA compliance.

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Ablitech Hires Director for Research Advisory Board

Ablitech, Inc., a biotechnology company developing delivery systems for gene silencing and cancer-fighting treatments, today announced that Dr. Daniel Bednarik has been named the Director of the Research Advisory Board.  

In his part-time role, Bednarik will assemble and manage a committee of scientists who will provide guidance to the corporation’s research efforts, enhance funding, and create partnering opportunities.  

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3 Start-Ups Join Loyola Business Accelerator – North Baltimore, MD Patch

The first three start-ups have been selected to participate in a new business accelerator program started by Loyola University Maryland.

CodePupil, PointClickSwitch.com and Vidstructor were selected by the university and its partner Wasabi Ventures to participate in the accelerator located in Govans, according to the Baltimore Business Journal.

In March Loyola announced it was creating the business accelerator to partner with local entrepreneurs to help create new businesses.

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RHT Consulting to Come Up with Steps to Spur Research at NIH

Right now there are probably thousands of late-stage cancer patients waiting for drugs that could prolong their lives. Where do they look? Research labs all across the country. In a process called technology transfer, drugs go from the lab to the market, with a few steps in between, and the push is on to speed up the process, without leaving any loose ends.

Recent technology transfers have resulted in treatments for fibromyalgia, a joint and muscle pain illness, called Lyrica; a form of fatal breast cancer, now leaving the disease undetectable, Herceptin, and new chemotherapy agents.

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Public Policy Institute releases new report on New York’s bioscience sector

The Public Policy Institute (PPI), the research arm of The Business Council of New York State, today released an in-depth study on the challenges in attracting and retaining private-sector jobs and companies in New York’s lucrative bioscience sector.

Based on interviews with 30 industry experts as well as existing research, Cultivating the Next Generation of Discoveries and Development in New York Bioscience explores the opportunities and barriers facing companies in various stages of development and offers three public policy recommendations to foster public-private partnerships and make New York more competitive with other states:

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2012 BIO International Convention to Highlight the FDA and Regulatory Environment

The U.S. regulatory environment strongly impacts innovation and the development of new drugs and biologics. With this in mind, the Achieving Regulatory Approval and Compliance educational track at the 2012 BIO International Convention will tackle the most pressing regulatory issues facing the industry, specifically the reauthorization of the Prescription Drug User Fee Act (PDUFA V), implementation of the new biosimilars pathway, and efforts to modernize and expedite drug development. Hosted by the Biotechnology Industry Organization (BIO), this year’s global event for biotechnology will take place June 18-21, 2012 at the Boston Convention and Exhibition Center in Boston, MA.

"Attendees can expect to hear from a distinguished group of speakers from the Food and Drug Administration (FDA), as well as major biotechnology and pharmaceutical companies," said BIO CEO and President Jim Greenwood. "Sessions will address the steps involved in research and development of healthcare products and how to successfully bring these products to market, all while maintaining rigorous standards for safety, effectiveness, and compliance."

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Breaking the Genome Bottleneck – Technology Review

The genomic data generated from next-generation sequencing machines doesn’t amount to much more than alphabet soup if it’s not subjected to significant computational processing and statistical analysis. For the data to be useful, the trick is to turn those As, Ts, Gs, and Cs into a manageable description of disease risks and other genetic predispositions. That requires a lot of computational power and time—already a significant bottleneck for some genomic analysis companies.

Several companies are looking to the cloud as a way to help them analyze all the data. The idea is that researchers can send their data to a Web-hosted analysis service that will process raw data into a genetic profile. However, the data files generated by sequencing machines are so massive that the mundane issue of uploading large files to the cloud becomes its own issue. The strategy of a Redwood City, California-based startup called Bina Technologies is to divide and conquer: give customers an in-house data-crunching machine that will turn a mountain of raw sequence into easily shared genetic profiles. Those profiles can then be quickly uploaded to Bina Technologies’ cloud-hosted site for data management, sharing, and aggregation.

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