Greenwood in USA Today: Gene Patents Promote Innovation

BIO CEO Jim Greenwood provides the "opposing view" editorial in today's USA Today.

Opposing view: Patents promote innovation

Jun 16, 2009 USA TODAY
By Jim Greenwood

Can a gene be patented? The easy answer is this: Genes as they exist in nature cannot be patented. No one can patent a naturally occurring gene or protein as it exists in the body.

Here's where it becomes more complicated: Researchers can isolate a protein or DNA sequence that can help treat or potentially cure a disease, like cancer or heart disease, and they can patent this discovery. Many, if not most, human diseases have their roots in our genes. More than 4,000 diseases are suspected to stem from mutated genes inherited from one or both of our parents.

Armed with this knowledge, scientists have developed more than 200 innovative new therapies and vaccines that have helped extend and improve the quality of life for hundreds of millions of patients. Researchers, for example, located the gene responsible for cystic fibrosis, then used that knowledge to create therapies that have extended the average lifespan of a person who has CF from 12 years to more than 40.

Like all other patents, gene-based patents protect the intellectual property of a scientist, researcher or biotech company, spurring investment in research and development. The Patent and Trademark Office has strict guidelines on patents, including the patenting of DNA molecules or genetic material.

Two recent studies, from the American Association for the Advancement of Science and a Department of Health and Human Services advisory committee, both confirm what a prior National Academy of Sciences report concluded: Patents do not hinder biomedical innovation. The HHS panel's study also found that patents are not the cause of access-related issues regarding genetic diagnostic tests, in particular.

Public debate over access to, and use of, genetic technology is a good thing. It requires the consideration of many factors, including coverage and cost, concerns over genetic discrimination and myriad regulatory issues.

Even so, banning patents on gene-related breakthroughs would slow biomedical innovation to a halt — taking away the hope biotechnology offers to patients suffering from debilitating diseases such as cancer, Parkinson's and HIV/AIDS — while doing nothing to address what is really a much more complicated set of issues.

Former representative Jim Greenwood, R-Pa., is president and CEO of the Biotechnology Industry Organization.

A Bridge To Cross The Chasm

An innovative funding program at the National Cancer Institute could prove a model for other National Institutes of Health divisions to follow.

By Daniel S. Levine

The National Cancer Institute is known for funding innovative research, but one of the Bethesda, Maryland center’s most recent breakthroughs isn’t a drug or new imaging agent. Instead, the latest burst of creative thinking has led to a new financing strategy to enable a host of new treatments. The initiative involves providing funding to help companies avoid the so-called valley of death. That’s the a gap in between the early-stage financing that the National Institutes of Health divisions such as the NCI typically provide for basic research, and the later-stage capital that investors supply when promising technologies are sufficiently developed.

Nearly two and a half years ago, then acting NIH Director Elias Zerhouni asked NCI Director John Niederhuber to consider enhancing the Small Business Innovative Research program. NIH was wrestling with concerns that the roughly $650 million invested each year into research through the SBIR program and the Small Business Technology Transfer Program weren’t getting the expected bang for the buck when it came to commercialized technology down the road.

The task of seeking new approaches fell in part on the NCI’s Michael Weingarten and Andy Kurtz. One of the most significant ideas to emerge from the effort was the establishment of a new grant program that could bridge the point at which the SBIR grants end and private investors are prepared to provide funding. At any given time, the NCI funds about $100 million worth of projects with some 350 companies through its SBIR program. That program allows companies to apply for funding through an initial funding to test the technical feasibility of a concept for grants that average around $150,000. If successful, a follow-up grant, which averages about $1 million, funds research and development of a technology.

“If we looked across our portfolio of grants, many of our Phase II awardees nearing the end of their Phase II awards—which in the SBIR model is the end of the line—hadn’t advanced enough to attract investment from downstream investors,” says Kurtz, program manager for the NCI’s Small Business Innovation Research Development Center. “A lot of projects die on the vine when they exhaust the usual funding through the SBIR program. The idea with the Bridge Awards was to provide additional funding for the most promising projects.”

The NCI’s new SBIR Phase II Bridge Award has just issued its first set of grants and is now reviewing a second set. Already, the program has generated enough interest that the NIH is expected to broaden the program throughout its other institutes to help commercialize more of the basic discoveries it funds.

The NCI Bridge awards are for $1 million a year for three years, for a total of $3 million. That’s more than triple the amount available to applicants through the NCI’s SBIR program. The funds are used for such things as pre-clinical research and development needed for regulatory filings to begin human clinical trials, or conduct the trials themselves. The NCI expects to award up to $10 million in fiscal 2009 under the program. The Bridge grants are open to current and recently expired NIH SBIR Phase II projects in the area of cancer therapies or cancer imaging.

One catch is that applicants must provide at least a dollar-for-dollar match from an outside source of funding. For the NCI, this provides not only validation of the commercial potential of a technology, but serves also as an important means of leveraging its own investment. And, for companies, having such a grant is a tool that can help raise money. It not only shows investors that government experts think enough of the technology to help fund the development, but it also reduces investor risk by providing non-dilutive capital.

“It’s money that buys you some runway or buys you time to a next milestone where you can get traditional venture capital,” says Glen Giovannetti, global biotechnology leader for Ernst & Young. “With NIH, there’s a process by which you have to qualify, so there is a scientific review and validation that comes from that.”

For Lpath, a San Diego-based developer of Asonep, an anti-angiogenic monoclonal antibody that targets S1P, a lipid that fuels the growth and spread of cancer, the funding will help it satisfy its financial obligations under an alliance with Merck Serona and provide it with a little independence. Lpath has entered into a worldwide agreement with Merck Serono to develop and commercialize Asonep. Under the agreement, Merck Serono will pay up to $23 million in upfront payments and R&D funding to support Lpath’s completion of the Phase 1 clinical trial.

“Every licensing deal acts in effect like an option,” says Gary Atkinson, Lpath’s vice president and chief financial officer. “The big company that licenses in a product can put a halt on the program at anytime. We have a critical juncture coming up with Merck Serono. We feel this award will be validating, help in their decision making, and give us a little more leverage.”

The Bridge Awards are perhaps the most significant part of a broader set of changes put into place by the NCI to address the challenges of translating discoveries into commercialized products. In addition to establishing the Bridge Awards, the NCI has centralized the management of grants through a newly created center, rather than rely on scientists throughout the institute to manage grants among their other responsibilities. The institute has also brought in people with industry experience and knowledge of how to commercialize technology to staff the center and manage the grant programs. Among other things, the center is helping advise companies on everything from how to improve failed grant applications to what preclinical preparations need to be done to win regulatory approval to begin clinical trials.

“Before we set up the center, it was a much more hands-off process for both managing and interacting with the companies that were being funded under the SBIR program,” says Weingarten, director of the NCI’s Small Business Innovation Research Development Center. “We have a much closer working relationship with the companies we are funding now and we are helping mentor them along the way and helping them be successful.”

From BIO Enews with Burrill Insights

Iambiotech Interview with Governor Kaine

While at BIO 2009 in Atlanta Governor Tim Kaine was interviewed by iambiotech.org. Check out yesterday's post on from their website with Kaine's video.

Today is the Democratic Primary in the Virginia Governor’s race. It’s been a contentious campaign season so far, with some heated debate over which candidate is the best choice to continue the legacy of the current Governor, Tim Kaine. On the day that the next Democratic nominee is chosen, we wanted to bring you a recent, exclusive interview with Governor Kaine about how he has helped grow the biotech sector in his state. This year, with the economic crisis front and center in the campaign, the role of biotech in building a robust innovation economy will no doubt be a hot topic. Here’s what Governor Kaine had to say:

We asked Mark Herzog, the executive director of the Virginia Biotechnology Association, about Governor Kaine’s record of supporting biotechnology in the state:

“While other states have cut back on their bioscience economic development investments during the global downturn, the Virginia General Assembly passed legislation this year that enhances tax credits and incentives for bioscience-related start-ups. Governor Kaine signed that legislation into law and has, along with state legislators, received the thanks of the industry for the support.”

Watch the video.

Kappametrics Inc. Appoints Healthcare Industry Veteran Jay D. Miller CEO

Company Pioneering Imaging Technology for Diagnosis of Chronic Brain Disorders

Taps Executive with 25 years of Imaging-Related Experience

CHANTILLY, Va.--(BUSINESS WIRE)--Kappametrics Inc., a medical technology company pioneering technology to enable the real-time collection of EEG data during fMRI scans of the brain, has named Jay D. Miller president and chief executive officer, effective immediately.

Kappametrics’ flagship product, fEEG™, employs patent-pending technology to capture electroencephalography (EEG) data concurrently with functional magnetic resonance images (fMRI) to provide more detailed mapping of brain activity. fMRI scans capture spatial images of the brain while EEGs record electrical activity of brain cells. The availability of combined EEG and fMRI data would provide physicians with valuable information to improve the understanding and diagnosis of chronic neurological disorders. Each year, more than 10 million Americans are evaluated for various brain disorders. Kappametrics’ initial market for fEEG™, pending FDA marketing clearance, is academic and clinical research.

“I’m thrilled to be part of a company with such great technology and growth potential,” Miller said. “Our mission is to bring Kappametrics technology to the marketplace as soon as we can to help address serious neurological conditions, such as epilepsy, brain tumors, Alzheimer’s disease and chronic pain. John Zett, chief operating officer, has done a terrific job leading Kappametrics to where it is today, and I’m excited about working with him to advance this much-needed technology.”

Mark Muth, Kappametrics board chair, noted Miller is well suited for this new role with his background as a medical imaging executive. “Jay is a proven leader who builds strong customer relations, fosters collaboration and has an ability to raise funds to drive Kappametrics’ growth.”

Zett added, “I’m delighted to team with Jay to move the company forward. Kappametrics will benefit from his background in medical imaging, experience with emerging companies and contacts in the investment community.”

Miller brings 25 years of medical technology experience to Kappametrics. Most recently, he was an independent healthcare consultant for approximately 10 healthcare companies. Previously, he was chief executive officer of Minneapolis-based Vital Images (Nasdaq: VTAL), a leading provider of advanced visualization software solutions. After joining Vital Images in 1997 as vice president of marketing and business development, Miller was named CEO in 2002. During his tenure, Miller presided over the company’s growth to $70 million in revenue in 2007 from $15 million in 2001, and workforce growth to more than 300 employees from fewer than 25 employees. Prior to Vital Images, Miller served in a range of strategic and marketing positions for General Electric Medical Systems from 1989 to 1997 and Siemens Medical Systems from 1986 to 1988.

In addition, Miller currently serves on the board of directors of publicly held Streamline Health Solutions (Nasdaq: STRM), as well as on the boards of the Midwest Division of the American Cancer Society and the Coulter Foundation at the University of Virginia. Miller received a bachelor’s degree in chemistry from Dartmouth College, a master’s in biomedical engineering from the University of Virginia and an MBA from the Kellogg School of Management at Northwestern University. He has also garnered several awards, including medical imaging “CEO of the Year” from Frost & Sullivan in 2004 and Ernst & Young “Entrepreneur of the Year” for the Minnesota and Dakotas region in 2005.

About fEEG™
Kappametrics’ breakthrough fEEG™ technology employs innovative noise cancellation techniques to eliminate the large radio frequency, electrostatic and magnetic noise induced on the EEG signals by the fMRI scanner, thereby enabling the real-time collection of physiologic EEG data during fMRI scans. The system will help ensure the integrity of the EEG signal by dramatically improving the signal to noise ratio of the data at the source prior to digitization, while also removing ballistocardiogram and other artifacts, to provide concurrent acquisition of EEG data during fMRI imaging. The fEEG™ system’s user-friendly design and simultaneous imaging capabilities are expected to offer cost and efficiency benefits for academic researchers and clinicians.

About Kappametrics
Kappametrics Inc., a private medical technology company based in Chantilly, Va., was established in 2004 after its spin-out from Unilever, with a vision to develop innovative solutions to address the problems of data acquisition in functional MRI environments. After nine years of research and development, Kappametrics is finalizing the development of its fEEG™ noise cancellation technology, and plans to submit an application to the FDA for 510k marketing clearance in the near future. For further information, please visit the company’s Web site at http://www.kappametrics.com.

Alliance Engineering Celebrates 20 Years in Business: with Social Responsibility

Richmond-based engineering firm turns 20 and gives back to the community through three pro-bono projects.

RICHMOND, Va., June 2 /PRNewswire/ -- Richmond-based Alliance Engineering marks its 20th Anniversary by reinvesting in the communities that are home to its regional offices. Through its offices in Richmond, VA, Baltimore, MD, and Newport News, VA, Alliance has partnered with community organizations to donate design and engineering services aimed at improving the local area. It also marks the beginning of an annual plan by Alliance to champion social responsibility - a plan devised by the firm's employees.

Founder Kevin Kokal, commented, "This anniversary belongs to the employees that have fueled the growth of our company. We couldn't think of a better way to show our appreciation then by giving back to the communities they call home." Kokal credits Alliance employees' strong community connections and spirit of charity for giving rise to the firm's generosity. "We are reflecting the character of our people through these projects and we are saying thank you."

The Richmond office's community project is the most ambitious. Working with the John J. Maddox River Conservation, Alliance committed to building a 550 foot boardwalk along the riverside trail. "This will truly be a structure that the entire Richmond community can enjoy," says Michael Golden, Director of the Chesterfield County, Virginia Department of Parks and Recreation. "Alliance is a special company with strong Richmond ties. It says a lot about who they are that they would commit their time and resources to this." The boardwalk is set to be unveiled to the public on June 6th.

In Baltimore, the Alliance team came together to support a charity near and dear to everyone's heart - Habitat for Humanity. Founder Jim Burnette noted that "Habitat has such a good thing going that there's no reason to reinvent the wheel. We believe in what they do and, as engineers, we figured we could lend a hand and build a home in the Baltimore area." The Alliance Engineering team, in partnership with Habitat for Humanity volunteers, completed the home's construction on May 30th.

It's the kids that won the attention of the Alliance Newport News office and who were the recipients of their act of social kindness. Alliance employees selected the Boys & Girls Club of the Virginia Peninsula as its partner for this year's inaugural social responsibility project. On April 25th, Alliance completed a park beautification project installing picnic tables, sand boxes, tetherball poles, basketball hoops, and dinosaur fossils in a recreational area. Mike Mullins of the Boys & Girls Club of the Virginia Peninsula commended Alliance on their contribution saying, "This is not something that the Boys and Girls Club would have been able to do without the help of Alliance Engineering. I can't say enough about the job that they did for our kids."

Kokal reflects, "Social responsibility is nothing new but it's needed more than ever today. At Alliance Engineering, we have a lot to be thankful for - talented employees, a growing business, and strong relationships in three communities. This is our way of showing our gratitude for 20 successful years." Plans are already in the works for next year's community giving projects. "It's a part of who we are," says Kokal.

About Alliance Engineering, Inc.

Founded in 1989, Alliance Engineering, Inc. is a multi-disciplinary engineering and construction management firm with expertise in industrial, manufacturing, power, pharmaceutical and biosciences environments. Alliance has provided services to over 700 industrial clients in the U.S. alone and boasts a 95% client retention rate which is credited to the firm's core values of integrity and quality.

Commonwealth Biotech Buys Chinese Peptide Company

Commonwealth Biotechnologies, Inc. (“CBI”) (NASDAQ Capital Market:CBTE) is pleased to announce that it has executed an agreement to acquire all of the outstanding shares of GL Biochem (Shanghai) Ltd (“GL Biochem”), a privately owned Shanghai-based chemical company and the largest supplier of research-grade peptide products and peptide reagents globally. Over the past 5 years, GL Biochem and related businesses have demonstrated compound annual revenue growth of over 40%. Based on the results of an independent financial due diligence report, they reported 2008 revenues of over $13 million and net income after tax of approximately $2 million. The proposed transaction would be a transformative deal for CBI, providing it with a strong balance sheet, significant free cash flows and propelling it into a position of dominance in the research-grade custom peptide market.

This transaction is subject to the completion of PCAOB-qualified audits of GL Biochem and the approval of CBI shareholders and lenders. The transaction will involve the issuance 6.56 million fully paid ordinary CBI shares to the shareholders of GL Biochem, representing 51% of CBI’s outstanding share capital. As part of the transaction, GL Biochem will grant CBI an unencumbered option to purchase all the issued capital of three related businesses, namely GL Biochem (Danyang) Ltd, GL Peptide (Shanghai) Ltd and GL Peptide (Binhai) Ltd (collectively, the “Associated Companies”) within twelve months of the closing of the transaction (the “Option”). The purchase price of the Option will range between 8.14 million shares and 18.64 million CBI shares, based on the forthcoming 2008 audited after-tax profit results of GL Biochem and Associated Companies.

According to Dr. Bill Guo, Chairman and CEO of CBI, “The transaction has the potential to generate enormous value for CBI shareholders. GL Biochem has demonstrated outstanding revenue and income growth over the last ten years and is now the clear global leader in the research-grade peptide market.” Dr. Guo added that, “GL Biochem brings to CBI an outstanding debt-free balance sheet, significant free cash flows, clear synergies with CBI’s existing peptide business unit (Mimotopes) and its existing Chinese operations through Venturepharm (Asia), and provides for significant continued growth opportunities in the rapidly expanding peptide outsourcing market.”

Dr. Paul D’Sylva, Director of CBI and Chairman of Mimotopes said that “Peptides make up only a small proportion of the pharmaceutical products on the market today but represent one of the fastest growing classes of new drugs because of their high activity and specificity, low toxicity and high degree of potential chemical diversity. The market for peptide drugs is now growing at a compound annual rate of 7.5% and is estimated to be worth in excess of US$13.4b by 2010. The increased interest in peptides as therapeutics has triggered a boom in the outsourcing of peptide reagents and custom peptide synthesis, core business areas for both GL Biochem and Mimotopes. The proposed transaction with GL Biochem would make CBI the largest global player in the non-GMP segment of this market and provide it with a strong foothold and significant growth potential in the complementary segments of GMP peptides, custom antibodies and specialty amino acids.”

Dr. Hongyan Xu, CEO and President of GL Biochem said, “We are very excited about the potential of combining GL Biochem and CBI, particularly because it strengthens an already significant ongoing relationship between Mimotopes and our company. We believe that the addition of talented new staff, our complimentary commercial relationships and our respective global sales and marketing strategies will mean that the CBI group’s position as leader in the research-grade custom peptide market is assured.”

Dr. Richard Freer, CBI’s COO said that, “This transaction delivers three significant benefits to CBI and its shareholders: it is earnings accretive upon completion, which will add significant value to the Company; it strengthens CBI’s China-strategy by combining it with the largest peptide contract research business in China; and it propels CBI to a globally dominant position in the peptide market with three leading peptide assets and partnerships through Mimotopes Pty Ltd, GL Biochem (Shanghai) and Genzyme Pharmaceuticals.”

About CBI

CBI offers cutting-edge research and development products and services to the global life sciences industry. CBI now operates through: (1) CBI Services, a discovery phase contract research organization; (2) Fairfax Identity Laboratories, a DNA reference business; (3) Mimotopes Pty Ltd, Melbourne, Australia, a peptide and discovery chemistry business; and (4) Venturepharm (Asia), a contract research consortium specializing in drug discovery and development, process scale-up, formulation development, cGMP manufacturing and clinical trial management. For more information, visit CBI on the web at www.cbi-biotech.com.

MD To Open Two Biotech Centers and Increase Venture Funding

Thursday, May 21, 2009, 9:30am
O’Malley: Maryland’s biotech strategy to get funding boost
Baltimore Business Journal - by Julekha Dash Staff

Maryland plans to increase funding for the Maryland Venture Fund and a biotechnology tax credit to boost the state’s $29 billion life sciences industry.

Gov. Martin O’Malley unveiled a more detailed version of the state’s 10-year, $1.3 billion strategy Wednesday afternoon at the BIO 2009 Convention in Atlanta. The convention attracted more than 400 attendees from Maryland, including a delegation of 30 Maryland bioscience companies. State officials and biotech executives made the trip with the hopes of landing new biotech companies for Baltimore and getting investors that have been scarce since the downturn.

Offering access to capital is a key piece of the state’s Bio 2020 plan.

The roadmap includes increasing the Maryland Venture Fund from $2 million to $24 million by 2020 and raising the biotech tax credit from $6 million to $24 million by 2020.

On Monday, O’Malley said the state will open two biotechnology centers in Rockville and Baltimore in the next 30 days. Other features of the Bio 2020 plan include:

• Establishing a bioscience commercialization institute that can help speed up drug discoveries;

• Creating a venture capital trust with $10 million in seed capital;

• Branding Maryland as a leader in the biotech industry;

• Providing loans of up to $5 million to bioscience companies that are in the later stages of product development;

• Increasing funding for technology transfer initiatives at research universities.

The proposals were made at the recommendation of a 15-member life sciences advisory board, which solicited input from more than 100 industry experts to devise the plan.

Insmed's Drug Focus of Moving ALS Story in NYT

Very moving story about a mother's fight to get the right to use Iplex in the care of her son suffering from Lou Gehrig's disease.

May 17, 2009
Months to Live
Fighting for a Last Chance at Life
By AMY HARMON

VIRGINIA BEACH — As Lou Gehrig’s disease sapped Joshua Thompson of his ability to move and speak last fall, he consistently summoned one question from within the prison of his own body. “Iplex,” he asked, in a whisper that pierced his mother’s heart. “When?”

Iplex had never been tested in people with amyotrophic lateral sclerosis, the formal name for the fatal disease that had struck Joshua, 34, in late 2006. Developed for a different condition and banished from the market by a patent dispute, it was not for sale to the public anywhere in the world.

But Kathy Thompson had vowed to get it for her son. On the Internet, she had found enthusiastic reviews from A.L.S. patients who had finagled a prescription for Iplex when it was available, along with speculation by leading researchers as to why it might slow the progressive paralysis that marks the disease. And for months, as she begged and bullied biotechnology companies, members of Congress, Italian doctors and federal drug regulators, she answered Joshua the same way:

“Soon,” she said. “Soon.”

At a time when terminally ill patients have more access to medical research than ever before, and perhaps a deeper conviction in its ability to cure them, many are campaigning for the chance to be treated with drugs whose safety and effectiveness is not yet known.

But even as advances in areas like stem cells and genetics generate greater hope for experimental therapies, there is little consensus on how and when to provide them to dying patients whose lives could be prolonged, or shortened, by trying them.

Insurance companies typically do not pay for drugs that are part of a not-quite-finished scientific process. But even affluent families like the Thompsons find themselves pleading simply for the right to buy a drug, with institutions and individuals that often seem to them to have no logic — and sometimes no heart.

Doctors worry about instilling false hope and doing unnecessary harm. Companies fear damaging a drug’s chance of winning approval from the Food and Drug Administration if a patient suffers a bad reaction. The F.D.A. itself does not want patients to bypass clinical trials, which require that some participants receive a placebo to determine reliably whether a drug works.

Some patient advocates are lobbying for laws and policies that would sanction what has become known as the “compassionate use” of experimental drugs by seriously ill patients who have run out of other options. But for now, each appeal to the guardians of untested drugs is an improvisation, in which success relies on connections, determination, mercy and luck, and the hope of prevailing can sometimes eclipse the hope held out for the drug itself.

The Search for a Treatment

Kathy discovered Iplex deep in the pages of her first Google search for “A.L.S. and treatment” late one night in spring 2007, shortly after Joshua’s diagnosis.

In the daylight, she still had trouble believing that her athletic, magnetic son had the devastating disease with an unknown cause, named for the 1930s New York Yankees star whose career was cut short by it. When Joshua’s racquetball racket flew out of his hand because he could not grip it, his mother’s diagnosis was tennis elbow. When the first neurologist mentioned A.L.S., she scheduled more tests, rooting for Lyme’s disease, multiple sclerosis or even cancer.

But an A.L.S. specialist at Johns Hopkins University, Dr. Jeffrey D. Rothstein, had confirmed it. Like the 5,600 other people given the diagnosis each year in the United States, Dr. Rothstein said, Joshua would almost certainly die of the disease in two to five years.

The doctor prescribed the only drug approved for A.L.S., Rilutek, which typically prolongs life by a few months. Joshua, he said, would be eligible to participate in a clinical trial for another drug, Arimoclomol, that would start as soon as the F.D.A. gave the go-ahead. There was nothing else.

Except, maybe, Iplex.

To read the rest of the story, please visit the New York Times.

Nanotechnology for PED/HGH Detection

From Steroid Nation posted by GRG51

Interesting concept: use of nanotechnology to monitor doping, even those compounds difficult to assay.

A Virginia-based biotechnology company, Ceres uses its patented Nanotrap™ -- a spherical, carbon-based nanoparticle designed to collect, concentrate, isolate and preserve the smallest and scarcest of molecules found in body fluids -- to pursue a range of applications in the diagnosis and treatment of diseases, as well as uses in sports doping screening, homeland security and environmental remediation.

Ceres and the U.S. Anti-Doping Agency have partnered to study the potential for a viable urine-based test for the detection of human growth hormone (HGH). Laboratory findings recently published in NanoLetters and Nano Research strongly suggest that development of this screening tool is highly probable, a move that would revolutionize the way college and professional sports organizations monitor potential drug use by athletes.

The Nanotrap technology also is being reviewed by SAIC-Frederick Inc., a wholly owned subsidiary of Science Applications International Corp., to determine the feasibility of developing diagnostic tools that detect cancer at the earliest possible stage when treatment is most effective.

Lab testing for a peptide (protein) hormone like HGH is always vexing. Whereas the anabolic steroids either show a long half-life, or slowly seep out of muscle, HGH exits the body relatively quickly. A sensitive way of trapping the molecule would be a boon for dope testing.

Former Qimonda workers line up at VCU/VCATS job fair

EMILY C. DOOLEY TIMES-DISPATCH STAFF WRITERPublished: May 20, 2009

Randall "Randy" Pak stood in a long line yesterday waiting for those precious moments when he could sell himself.

Out of work since February, Pak and more than 500 other former Qimonda employees gathered at a career fair at Virginia Commonwealth University yesterday to network and talk with prospective employers about their job offerings.

"I'm looking at all opportunities right now," said Pak, who moved here from Texas two years ago to work at the now-closed memory-chip plant in eastern Henrico County.

"I think the semiconductor industry in the U.S. is really dying," Pak said. "You go through a roller coaster ride emotionally, but you just have to be optimistic."

His goal: getting some face time with the Naval Surface Warfare Center, which recently has been hiring a number of former Qimonda employees.

The lines were long to speak with one of the 18 employers attending the fair. The lines to see representatives from the Naval Surface Warfare Center ran nearly out a door.

"It was very well-attended," said Nan Stewart, district manager for Virginia for the staffing firm Kelly Scientific Resources. "The caliber of candidate was very professional among all of the levels."

Seminars on a variety of subjects were offered, including on managing finances while in career transition, crafting a résumé and applying for federal jobs.

The five-hour fair, held at VCU's School of Business and School of Engineering, was open only to former Qimonda employees.

"What I'm really after is to find someone in the logistics industry who will sit down and talk to me," said Kristian Cauffman, an engineer with a degree in geology, as he sat in the school's atrium named after Qimonda.

"I want to get away from manufacturing," he said.

The event was sponsored by VCU, the Greater Richmond Partnership and the Virginia Council on Advanced Technology Skills.

The semiconductor company had a close relationship with VCU's engineering school. The company has an endowed chair and professorship there and had been the single largest employer of engineering school graduates.

Qimonda has "done a lot for VCU," said Mike Eisenman, director of the career center for the business and engineering schools. "It's done a lot for central Virginia. We thought it was the right thing to do."

In addition to the 18 employers, 10 others that work with entrepreneurs or offer educational training attended the fair.

"There's going to be a lot of competition," said Melba Rainey-Sayed, who left Qimonda in March after nine years there. "It's like 500 people for one job. A lot of us are thinking it's time to go back to school."

Qimonda idled its two production lines at its plant in eastern Henrico this year, putting about 2,500 people out of work. The company filed for bankruptcy in February.

"To see the birth of a company and then to see it go away . . . it was important to me to help put something together," said Don Owen, the former human resources director at the Sandston plant who helped organize the fair.

"We committed to the employees that we would do something for them, and this is kind of the fulfillment of that promise."

Report Finds States Lagging in Science Education

Virginia ranks in second tier.

Link to the Virginia Data: http://www.bio.org/local/battelle2009/VA_bio_09.pdf

States across America are failing to prepare students for pursuing biosciences in higher education—a key pipeline for developing the bioscience workforce of the future. A new report funded and researched by BIO, Battelle, and the Biotechnology Institute provides the first ever comprehensive study of middle and high school bioscience education in the 50 states, Puerto Rico, and the District of Columbia. The report also finds a wide disparity across measures of student achievement in overall science and biosciences, an uneven record across states in incorporating the biosciences in state science standards, supporting focused bioscience education programs and higher level bioscience courses, and ensuring science and bioscience teachers are well qualified.

The findings, which came to light at BIO’s annual convention, indicate a clear need for improved science education that incorporates the biosciences at the middle and high school levels if the United States bioscience industry sector is to remain globally competitive.

“The biosciences are a dynamic economic driver with a sizable footprint in nearly every state,” explains James Greenwood, President of BIO and member of the Board of the Biotechnology Institute. “The bioscience industry is a knowledge-based sector dependent upon the skills of its workers. Bioscience workers are needed to conduct research, translate innovation into product development and improved health care techniques, and ultimately to manufacture biomedical and other bioscience-related products. The prospect of the United States losing its competitive edge in student achievement and the subsequent skills of our future workforce is a matter of significant concern.”

This is not to say that bioscience education is non-existent in the United States because there are many examples of programs that work. However, the report does say that these programs should be replicated across the country and that states need to commit resources to them.

“The biosciences are the great adventure of our time, and states that aspire to play a part, either as supporters or leaders, must nurture their life science education programs," says Paul A. Hanle, president of the Biotechnology Institute. "This report rates the states' performance in life science education according to certain indicators of achievement. It also identifies best practices and programs throughout the nation. Both will be vital tools to help states wanting to strengthen their life-science education efforts."

This review of state activities in bioscience education suggests a number of actions that should be taken. For example, individual states:

Should incorporate biotechnology as they revise their science standards and should involve research scientists with expertise in the biosciences in their development.
Must commit to improving student achievement in biology and the life sciences and ensuring that their high school graduates are ready to pursue college-level bioscience courses.
Should improve the collection and dissemination of data, tracking student participation and performance in the biosciences and the broader sciences and if they do not participate in the National Assessment of Educational Progress (NAEP) science exam should be encouraged to do so.
Should take a more systematic approach to teacher professional development, experiential learning, and career awareness.
“The study recognizes the important link that high schools and middle schools have as the primary feeders to post-secondary institutions and in shaping career preparation,” explains Mitch Horowitz, Vice President and Managing Director of the Battelle Technology Partnership Practice. “The vast majority of bioscience jobs require some level of post-secondary education to ensure quality control and good manufacturing practices, conduct clinical research, design and engineer new products, or conduct research and development.”

The report provides the following evidence that states are not measuring up:

On average, only 28% of the high school students taking the ACT , which is a national standardized test for college admission, reached a score indicating college readiness for biology and no state reached even 50%.
Only 52% of 12th graders are at or above a basic level of achievement in the sciences, and for 8th graders only 57% are at a basic level of achievement.
Average scores for 12th graders in the sciences have actually declined from 1996 to 2005 and shown no improvement for 8th graders both overall and on the life science component.
A significant gap exists in science achievement for low-income middle-school students, although the gap is slowly narrowing.
Some states fared much better than others with respect to student achievement in the biosciences. While it is difficult to give a single grade across states because of the limited quality and comparability of the student achievement data, the patterns of student performance suggest the states fall into several broad categories.

Leaders of the Pack: Connecticut, Massachusetts, Minnesota, New Hampshire, New Jersey, Ohio, Vermont, Wisconsin

Second Tier: Colorado, Delaware, Illinois, Maryland, Missouri, North Carolina, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Utah, Virginia, Washington

Middling Performance: Alabama, Arizona, California, Hawaii, Indiana, Kentucky, Maine, Michigan, Montana, South Carolina, Wyoming

Lagging Performance: Arkansas, Florida, Georgia, Louisiana, Mississippi, Nevada, New Mexico, Oklahoma, Texas, West Virginia

Not Rated: States that do not participate in the NAEP science assessment were not rated.

The report also finds an uneven record across states in incorporating the biosciences in state science standards, supporting focused bioscience education programs and advanced bioscience courses, and ensuring well-qualified science and bioscience teachers.

Only thirty-one states reported that their science standards explicitly mention or define standards or applied laboratory or other instruction tools specifically for biotechnology or the biosciences.

At least half the states have at least one school with a bioscience focus, and all of the states have schools with a focus on broader STEM education. But states do not seem to be succeeding in encouraging high school students to take upper-level science courses. Although data on this subject are very limited, the share of students taking the AP biology exam averages 4.6% of high school graduates.

The report also notes that nearly one in eight U.S. high-school biology teachers was not certified to teach biology. The average share of biology teachers who are certified in a given state ranged from 50% to 100% in data collected by the Council of Chief State School Officers (CCSSO), although 88% of biology teachers are certified nationally on average.

The study and individual state profiles are available at: http://bio.org/battelle2009

Persistence pays off for biotech firm Insmed

JOHN REID BLACKWELL TIMES-DISPATCH STAFF WRITER
Published: May 15, 2009

At a time when many small biotechnology firms are struggling to stay afloat, Richmond-based Insmed Inc. is in the enviable position of being a newly cash-rich company.

Thanks to the sale of some of its biotech drug candidates in March, the biopharmaceutical company has received a cash infusion of $125 million. That's a huge turnaround from the $2.4 million in cash the company had on hand in late December, when it was burning through about $1.2 million per month.

Insmed executives say the deal, which came after two years of work and struggles for the company, gives it a war chest to hunt for new growth opportunities, possibly by acquiring drug candidates from other biotech companies that are facing financial distress in the economic downturn.

"It's a tribute to the tenaciousness with which we've run our business over the years," said Geoffrey Allan, the company's president and chief executive officer. "Two years ago, we could have folded the tent. We didn't do that."

The money also gives Insmed a cash buffer while it continues to test one of its key drugs, Iplex, for treatment of myotonic muscular dystrophy, a genetic, muscle-wasting disease that affects about 30,000 Americans.

The timing of the deal also was important, coming just as the financial crisis has made it more difficult for biotechnology firms to raise money. About 30 percent of publicly traded biotech companies have less than six months' worth of cash on hand, while 45 percent have less than one year, according to a recent report by the Biotechnology Industry Organization, a national trade group.

"I would definitely say that Insmed is in a unique position of having significant resources on hand," said Mark Herzog, executive director of the Virginia Biotechnology Association.

"The vast majority of companies I speak to are really struggling with only having enough cash on hand to last three to six months," Herzog said. "Insmed is very well-placed to be able to continue their research and development efforts."

The deal is the latest in a series of twists and turns for Insmed, which was founded in Charlottesville in 1988 to develop diabetes drugs.

In 1995, the company became one of the first tenants of the Virginia BioTechnology Research Park in downtown Richmond. It has since moved its corporate office to Stony Point Parkway in South Richmond.

The company has taken its share of lumps in recent years, most notably in 2007, when Insmed settled a patent-infringement lawsuit filed by a competitor, which forced it to remove Iplex from the market for treatment of a rare growth disorder in children.

The settlement allowed Insmed to continue developing and marketing Iplex for other illnesses such as muscular dystrophy and Lou Gehrig's disease, but the lawsuit "had a fairly devastating effect on our business," Allan said.

In the past couple of years, the company suffered from cash-flow issues and fought to keep its shares listed on the Nasdaq stock exchange.

Setbacks come with the territory in biotech, where the outcome of product research is uncertain and financial backing is often difficult to obtain.

"I think we are pretty battle-hardened here in terms of what we have gone through," said Kevin Tully, the company's executive vice president and chief financial officer. "You are always in the situation where you are having to finish a clinical trial, manufacture a drug, and look for cash to support it. You are constantly having to adjust. As a small company, we have been able to do that. We don't have a lot of bureaucracy."

After the lawsuit settlement, Allan said, "we essentially circled the wagons and figured out what we were good at, and how to deploy the resources we had available to survive that particular blow."

Insmed's strategic solution in 2007 was to move into follow-on biologics, an area of research in developing and making generic versions of drugs produced through biological processes. The company was successful at developing several experimental versions of drugs used in therapies for cancer patients.

The strategy paid off in February when pharmaceutical company Merck & Co Inc. agreed to buy Insmed's follow-on biologics platform for $130 million. Insmed said it will have about $125 million from the deal after fees and taxes.

On Wednesday, Insmed reported a first-quarter profit of $117.8 million, compared with a loss of $4.9 million in the same period of 2008. The turnaround was largely because of the sale of its follow-on biologics business to Merck.

The deal also makes Insmed a much leaner company, with just 20 employees at its Richmond office. Its Boulder, Colo., facility, which employs 70 people, was sold as part of the Merck deal.

The company's next step is to complete testing on its Iplex drug for muscular dystrophy, which has no other drug treatment.

"We are, in many ways, pioneering development in that area," said Glen L. Kelley, the company's vice president for regulatory affairs. Though the outcome is still uncertain, "it is a great place for a company like Insmed to spend time developing drugs, because it is a niche opportunity."

Insmed executives said they are also going to carefully evaluate other opportunities such as acquisitions of potential drugs that are in the late stage of development that would help the company become profitable for the long term.

"Can we repeat the exercise and in two years have a very positive outcome?" Allan said. "I can't guarantee it, but we will all work towards it."

Biotech Jobs And Training In Virginia

WhatCanBiotechDoForYou Question of the Day on May 13

I am a Chemical Engineer with 30+ yrs. experience in a variety of materials processing industries. Now I’m preparing to go to school to gain stronger technical background for a position in biotech. Can you refer me to any contacts for advice on specific school programs that would be most useful?May 13th, 2009

Hi Terry. Given the state of the economy, it probably shouldn’t be too surprising that our sister site http://www.iambiotech.org/ receives a lot of similar requests every week. It turns out that a good number of folks are now looking to the biotech industry when exploring their career options.
The Virginia Biotechnology Association for example has received so many queries that they’ve launched a career center website for local biotech jobs in Virginia. Now while that’s all good and interesting, it doesn’t really address your question. What does is another project that the Virginia Biotechnology Association has established called VCATS.

VCATS is co-led by the Virginia Biotechnology Association, Virginia Manufacturers Association, and Training & Development Corporation. What these co-sponsors (and other states!) have realized is that there must be a program that solves the critical and growing skill shortage locally. With more than 100,000 retirements among manufacturing workers anticipated over the next ten years, including 45,000 technically skilled workers, Virginia is currently failing to qualify their replacements.

What VCATS does is provide an easily accessible solution to this problem. They are developing a three-tier certification system for work in biotechnology laboratories. This system will be recognized (at the very least) statewide, and may provide an innovative model for those regions not already considering programs like this. By setting basic standards, employers can hire with greater confidence, and more biotech businesses will know that Virginia is an attractive destination for them.

And speaking of employers… in Virginia alone, the local employers partnering and co-investing in VCATS include: Alcoa, Boehringer Ingelheim Chemicals, Merck, Micron Technologies, Novozymes Biologicals, Philip Morris, and Wyeth Pharmaceuticals. Other principal partners include the Maryland Biotechnology Association, Virginia Community College System, Virginia Career Education Foundation, Virginia Department of Business Assistance, and the Capital Area, Northern Virginia, and Richmond Workforce Investment Boards.

So I would encourage you to look up your local state or regional biotech organization (assuming you don’t live in Virginia) and ask if they too are starting a biotech certification program. It sounds like a perfect match for what you’re looking for.

Scientist arrested for smuggling Ebola research into US

Scientist arrested for smuggling vials used in Ebola research into US
A Canadian scientist has been arrested for smuggling 22 vials stolen from Canada's National Microbiology Lab, used in Ebola and HIV research, into the United States, Canadian and US officials said Wednesday.

Konan Michel Yao, 42, "was taken into custody" while crossing the border from Manitoba province into the western US state of North Dakota on May 5, said a spokeswoman for the Public Health Agency of Canada, which operates the lab.

According to US prosecutor Lynn Jordheim, Yao was detained for carrying unidentified biological materials in vials wrapped in aluminium foil inside a glove and packaged in a plastic bag, along with electrical wires, in the trunk of his car.

Yao said in an affidavit he stole the vials, described as research vectors, from the Winnipeg lab on his last day of work there on January 21.

He told US border guards he was taking them to his new job with the National Institutes of Health at the Biodefense Research Laboratory in Bethesda, Maryland.

US authorities feared their contents could pose a terrorist threat. But tests later showed "they are not hazardous," said Jordheim.

"This turned out not to be a terrorism-related case," he said by telephone from North Dakota. "It appears to be exactly as he (Yao) said. However, he still faces possible charges for smuggling the vials into the United States."

Yao, meanwhile, remains in US custody after waiving his right to bail and preliminary hearings, as he awaits a possible grand jury indictment for smuggling, he said.

A Public Health Agency of Canada spokeswoman told AFP Yao "was working on vaccines for the Ebola virus and HIV, among other things."

"But he only had access to harmless and non-infectious materials, similar to what you'd find in a hospital or university lab. He did not have access to dangerous materials."

The Ivory Coast-born scientist is said to have studied at Laval University in Quebec and briefly worked at the University of Manitoba's plant sciences department.

Charlottesville Biotech Ships "SpermCheck" Product

This is great news for Ed Leary's company, ContraVac. Several new products on the way.


Charlottesville company sends out its home male sterility tests

A Charlottesville biotech company has begun shipping out samples of its cutting-edge home tests for male sterility. ContraVac, located off Preston Avenue, is dispatching its SpermCheck Vasectomy test to urologists across the country.

The test, which is based on a protein discovered at the University of Virginia, aims to measure a man’s sperm count following a vasectomy.

According to the World Health Organization, a fertile male has a sperm count of 20 million sperm per milliliter. The SpermCheck Vasectomy tests if a vasectomy recipient has a sperm count of above or below 250,000 sperm per milliliter, essentially a trace level of sperm. ContraVac President and CEO Ed Leary said the home test can replace a follow-up appointment after a vasectomy operation. Often, he said, patients skip the follow-up appointment, during which they must provide a sperm sample.

“For the patient, it’s inconvenient and embarrassing,” he said.

A study that appeared recently in the British Journal of Medicine found that 35 percent of vasectomy patients do not return for their first sperm-level test following a vasectomy. More than 70 percent do not return for their second.
While the success rate of vasectomy operations is fairly high, one of every 238 vasectomies results in at least a partial failure, Leary said. The SpermCheck Vasectomy test ensures the procedure worked.

“There is an overall cost saving,” Leary said. “It saves the patient time and it saves the physician time.”

The test kit, which will soon be available at many urology practices and vasectomy clinics, carries a price tag of $39.99. Some 1.5 million men have vasectomies each year worldwide. In the United States, there are an estimated 500,000 such procedures each year. The Charlottesville company’s technology is based on inventions by the firm’s founder, John C. Herr, a UVa professor of cell biology and director of UVa’s Center for Research in Contraceptive and Reproductive Health.

ContraVac has another product, called Sperm-Check Fertility, which is targeted at couples trying to conceive. SpermCheck Fertility measures if a male’s sperm count is above or below 20 million sperm per milliliter, essentially showing if he is fertile or subfertile. ContraVac has filed for Food and Drug Administration approval of SpermCheck Fertility. The company expects the product will be approved by the end of July. SpermCheck Fertility will be sold at pharmacies across the country, Leary said, ideally alongside home pregnancy tests. The company is also working on a third product, a new contraceptive drug for men. The drug, called SpermCheck Contraception, is being tested in a multi-center National Institutes of Health-funded study.

“The SpermCheck family of products is intended for use by men on both sides of the fertility equation — those who don’t want to father children and those who do,” Herr said in a statement.

In an interview, Herr said it is exciting to see products finally come to market that are based on his scientific breakthroughs.
“It’s all coming together,” he said.

AP: Insmed swings to 1Q profit on Merck deal

AP story on Insmed's financial success since selling the FOB business to Merck...

Insmed swings to 1Q profit on Merck deal
RICHMOND, Va. (AP) - Insmed Inc. reported a first-quarter profit Wednesday, bolstered by Merck & Co. buying several of the biopharmaceutical company's drug candidates.

In February, Merck said it would pay $130 million to buy a slate of biotech drug candidates and a manufacturing facility from Insmed.

The company earned $117.8 million, or 96 cents per share, compared with a loss of $4.9 million, or 4 cents per share, during the period a year prior. Revenue remained flat at $2.4 million.

The swing to a profit came from the Merck deal, which included Insmed's biosimilar assets. Biosimilars are copies of biotech-based drugs. There is currently no approval process in place in the U.S., though Congress is debating several bills on the issue.

Insmed recorded a pretax gain of $127.8 million in the quarter from sale of assets.

The company, meanwhile, continues developing the muscular dystrophy treatment candidate Iplex.

Shares of Insmed fell 10 cents, or 7.3 percent, to $1.28 in afternoon trading. The stock has traded between 32 cents and $1.52 over the past 52 weeks.

Big Turnout for BIO Town Hall in Virginia

 
More than 80 bioscience industry guests attended a special "Biotech town hall" meeting organized by the Virginia Biotechnology Association (VaBIO) and the Biotechnology Industry Organization (BIO). Speakers included BIO CEO Jim Greenwood, Joe Trippi, Howard Dean's 2004 campaign manager and Ray Cypess, CEO of ATCC, the host venue for the event.

The event promoted social media avenues for advocates of the bioscience industry:

What Can Biotech Do for You? http://whatcanbiotechdoforyou.com/

I am Biotech: http://iambiotech.org/

VaBIO on Twitter: http://twitter.com/vabio

VaBIO on Facebook.

Biotech Leaders Raise Funds for Science Education Foundation

  More than eighty people turned out April 29th to support the Chesapeake Bioscience Education Foundation (C-BEF) at a special fundraiser at Indoor Biotechnologies in Charlottesville, Virginia. The event, “Biotech and Art After Hours,” was organized by the Virginia Biotechnology Association, and featured more than twenty works of art, Moroccan food, lab tours and networking with the crowd heavy with bioscience leaders from across the Piedmont region of the state.

“We couldn’t have been more pleased with the strong support we received for the Foundation,” said Mark A. Herzog, executive director of the Virginia Biotechnology Association (VaBIO). “The event was like nothing we had ever done before in terms of mixing works of art in a wet-lab environment. The patrons who attended really enjoyed the experience.”

Chesapeake Bioscience Education Foundation is a non-profit charitable organization that develops and promotes programs designed to encourage young students before they choose specific careers, to appreciate and participate in the challenging work of math and science so that they do not preclude subsequent career choices in the biosciences. Among other initiatives, C-BEF funds internships at eligible biotech companies through matching grants.

Photos of the event are available here:

In addition to VaBIO, the event was sponsored by the Charlottesville Business Innovation Council, the University of Virginia, Indoor Biotechnologies, Woods Rogers PLC, Birch Studio Graphics, Diffusion Pharmaceuticals, Afton Scientific, Garris and Company, PGxHealth and Klann Plastics.

OSTP Launches New Blog on Science Policy

President Obama's Office of Science & Technology Policy (OSTP) launched a blog to serve as a place where the public can have input into the policy-making process as it relates to science and technology. http://blog.ostp.gov/

NAS Posts Video of Obama Speech on US Research Funding

From the National Academy of Sciences: President Obama addressed members of the National Academy of Sciences on April 27, announcing a renewed commitment to science, technology, engineering, and medicine. Topics included America's energy future, revitalizing our health care system, science and math education, and allocating funding and implementing policies to ensure that America reclaims a position of world leadership in scientific innovation.

Click here for the video: http://www.nap.edu/obama/obama_nasvideo.html