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.

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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.

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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.

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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.

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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.