Human Genome

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.

jhu-award-winners

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.

NewImage

“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.

human-genome-sciences

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.

CapitalConnection

Capital ConnectionTM, one of the nation’s most respected industry conferences, brings together high-growth and innovative technology companies from some of the most noted technology sectors and couples them with top business resources, including one of the largest concentrations of private financing sources of venture and private equity investors in the country.  The event is presented by the Mid-Atlantic Venture Association (MAVA) and will be held on May 23-24 at the Omni Shoreham Hotel in Washington, D.C.

More than 800 attendees from throughout the United States attend each year to connect with other established companies and aspiring entrepreneurs and peers who share a common focus on building, investing, or serving some of the country’s most promising companies. For 25 years, Capital Connection and now TechBUZZ, have brought together a high-powered cross section of the nation’s technology-based, high-growth ecosystem.  Attendees include senior players from across the industry – investors across the continuum of capital, professional advisors, technology product and service firms, and, at the center of it all, innovative entrepreneurs.  

UofMFoundingCampus

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.

Risk

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.

Lily Qi

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.

PPI NY

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:

jhu-carey

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.”

bio-internation-convention

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."

Ablitech logo

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.  

Health datapalooza

Plug into the Ecosystem of Health Innovation. Bring creative ideas, and connect with startups, developers, and designers. Learn how to utilize the exploding market of healthcare data innovation, and network with recognized VCs, funders, policy makers, and potential partners.

The Health Datapalooza will feature keynote addresses, a Data & Apps Expo, demonstrations of cutting-edge apps, hands-on data deep dives, and thought-provoking panel discussions. There will also be plenty of time for networking and one-on-one interaction.

RHT Consulting

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.

Johns Hopkins University

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.

Tatrc logo

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.

human-genome-sciences

GlaxoSmithKline PLC is taking its unsolicited $2.6 billion bid for Rockville-based Human Genome Sciences Inc.    directly to the biotech's shareholders through a tender offer this week, a hostile move that will test GSK's partnership with the smaller firm, The Wall Street Journal reported.

Human Genome Sciences last month rejected GSK's $13-per-share share offer as too low, and said it had hired two banks to advise it on "strategic alternatives," including a possible sale of the company. In a statement Wednesday, Glaxo said it won't participate in Human Genome Sciences' strategic review process, and will instead launch a cash tender offer this week at $13 per share.

National Heard Lunch and Blood Institute

The National Heart, Lung, and Blood Institute (NHLBI) published 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.

Secretary Kathleen Sebelius

From the electric light bulb to the Internet, American innovations have made lives better for people in this country and all over the world.

The kind of work we’ve done to advance technology, communication and so many other aspects of people’s lives is about to get a jump start in health care, thanks to today’s announcement of 26 Health Care Innovation Awards. The awards are part of our We Can’t Wait initiative.

“What America does better than anyone else is spark the creativity and imagination of our people," said President Obama during his 2011 State of the Union address, and that’s exactly what the Health Care Innovation Awards aim to do.  These awards provide our most creative minds—whether they’re health care professionals, technology innovators, community-based organizations, patients’ advocacy groups, or others—with the backing they need to build the strong, effective, affordable health care system of the future.  These are 26 unique projects, tailored to the needs of patients by local doctors, hospitals, and other leaders in their communities.

Health and Human Services (HHS) Secretary Kathleen Sebelius

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.

DNA data: Narges Bani Asadi founded Bina Technologies, a genome-analysis company that aims to speed up the processing of DNA sequence data.

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.

Supernus Pharmaceuticals.png

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.

Steve Gleockler, lab operations supervisor, works in the bioreactor lab at Medimmune. (Amy Davis, Baltimore Sun / May 1, 2012)

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.

US Secretary of Health and Human Services Kathleen Sebelius (R) speaks alongside Food and Drug Administration (FDA) Commissioner Margaret Hamburg during the Daily Press Briefing in the Brady Briefing Room of the White House in Washington, DC, June 21, 2011. (Image credit: AFP/Getty Images via @daylife)

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.

NewImage

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.

pills

Yesterday at the New York Biotechnology Association’s 21st annual meeting, National Institutes of Health director Francis Collins was beamed in by videoconference to a keynote lunch at the Times Square Marriott Marquis. Collins, who was the featured speaker, apologized for his virtual appearance at the event, but he had a good excuse: Just two hours earlier he was at the National Press Club in Washington, D.C., making an announcement about an ambitious new program being undertaken by the NIH and drug giants Pfizer, AstraZeneca, and Eli Lilly. The NIH said it will collaborate with the companies to make existing compounds available to outside scientists who want to find new uses for them.

NewImage

Cambridge’s most prolific life sciences entrepreneur, Andy Richards, says the local cluster is attracting more cash and global kudos than at any time in its history.

Dr Richards says a number of ‘secret’ investments in the UK sector have created a far healthier funding environment than available figures would suggest.

A serial angel investor in Cambridge’s European-leading BiomedTech cluster, Dr Richards is also its most passionate evangelist and believes it has never ridden so high in its quarter-century evolution.

Qaigen Logo

QIAGEN expands Point of Need portfolio with unique AmniSureassay to detect rupture of fetal membranes (ROM) - checked in up to 30% of U.S. pregnancies

Novel FDA-cleared test is highly synergistic with QIAGEN's clinical sales channels

QIAGEN N.V. QGEN -1.92% (frankfurt prime standard:QIA) today announced the acquisition of AmniSure International LLC, a privately owned Boston company that markets the AmniSure assay for determining whether a pregnant woman is suffering rupture of fetal membranes (ROM), a condition in which fluid leaks from the amniotic sac prematurely.

Loyola

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.

nanotechnology

The results of the human trials are startling. Even at a lower-than-usual dose, multiple lung metastases shrank or even disappeared after one patient received only two-hour-long intravenous infusions of an experimental cancer drug. Another patient saw her cervical tumor reduce by nearly 60 percent after six months of treatment. Though the drug trial—by Bind Biosciences in Cambridge, Massachusetts—of an experimental nanotechnology-based technique was designed simply to show whether the technology is safe, the encouraging results revive hopes that nanomedicine could realize its elusive promise.

Maryland

Maryland has the foundation on which it can grow a robust environment of high-tech, innovative start-ups, but needs a stronger angel and venture capital network, more support for entrepreneurs and better programs to nurture young, creative minds, a group of business leaders said Tuesday.

"There's no reason Maryland can't be an entrepreneurial hotbed like Austin or Boston or Silicon Valley," said John M. Wasilisin, executive vice president of the Maryland Technology Development Corporation (TEDCO). "We have our challenges, but our assets are off the charts, our education system and our quality of life, our access to federal facilities."

Loyola

Loyola University Maryland and Wasabi Ventures, a California-based venture capital firm with a presence in Baltimore, named the first three companies participating in the business accelerator program the two organizations operate in the Govans community of North Baltimore. They are:

- CodePupil, an educational technology system that teaches software coding;

- PointClickSwitch.com, an energy choice platform that gives residential customers the ability to compare supplier offers, enroll, and save;

- and Vidstructor, a software company enabling interactive video training platforms for businesses.

Harry Weller

Four New Enterprise Associates (NEA) venture capitalists were named to Forbes Midas List of Tech Investors, which aims to single out the top 100 venture capitalists that provide "the best returns for their investors, while helping create the most valuable and impactful technology and life science companies."

Scott Sandell from the firm's Menlo Park office ranked highest at 14th. He was joined by Chevy Chase, Md. based Harry Weller (17), Peter Barris (23), both stalwarts on the Midas list, and "newcomer" James Barrett.

Weller's and Barris' biggest deal was in Groupon while Barret's was in Pharmion.

WhiteHouse

President Barack Obama’s administration rolled out its National Bioeconomy Blueprint last week, on April 26. It details measures by which Washington intends to apply biological innovations toward national challenges that include health, food, energy, and the environment.

At the top of the Blueprint’s five priorities is supporting “R&D investments that will provide the foundation for the future U.S. bioeconomy.” Also on the list: increasing the focus on translational and regulatory sciences, reforming regulations, updating training programs, and identifying and supporting opportunities for public-private partnerships.

Pfizer

For years, drug companies have known that their days of plenty were numbered, that the moment would arrive when the best-selling drugs that had driven two decades’ worth of profits would lose their patent protection and succumb to competition from generic alternatives. Without new blockbusters to replace them, profits would tumble.

For Pfizer, that day has arrived. Pfizer profited from hits like Lipitor and Viagra, and swallowed up smaller companies from the 1990s onward.

But it has no immediate successor to Lipitor, the best-selling drug in history, which lost patent protection last fall. The problem was punctuated on Tuesday when the company said that profit declined 19 percent last quarter, largely because of declines in Lipitor sales.