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.

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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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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.

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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.

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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.

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.