Carilion Biomedical Institute is creating dividends

Here is an op-ed from the Roanoke Times...

Carilion Biomedical Institute is creating dividends
Daniel Barchi

Barchi is president of the Carilion Biomedical Institute and chief information officer of Carilion.

The Carilion Biomedical Institute has achieved many exciting milestones since its creation in 1999. Some are visible, such as the activity at the Riverside Center on Reserve Avenue. Some are less visible, but just as important to the development of the region. The CBI board of directors has asked me to share our progress report with the community.

The Carilion Biomedical Institute was established to stimulate regional economic development through medical technology advancement, business creation and research collaboration.

We have delivered on these goals with more than $33 million in economic impact, 10 new companies and 60 new jobs in the Roanoke and New River valleys since 2003. Another milestone will be reached when CBI moves into its new building on Riverside Center next month.

More important than these accomplishments, however, are the relationships and institutions that have sprung from CBI that are now creating growth even beyond CBI's long-term targets.

CBI's goal is to stimulate research by investing in partnerships among Carilion, Virginia Tech and the University of Virginia. By the end of 2006, these three institutions had collaborated to conduct $17 million in laboratory research which has resulted in 100 discoveries, 68 inventions and 22 patents.

While those numbers are significant, the longer-term outcome of this work has been the full-blown partnership between Carilion and Virginia Tech that now includes the recently announced joint medical school and a Carilion/Virginia Tech research institute, which will have the expertise to continue advancing the research mission and spawn research that far exceeds CBI's early lofty goals.

CBI's medical technology advancement goal has been built around our ability to create new companies from university research and attract other growing companies to this area to join a growing bioscience enterprise.

One of the companies that CBI created from laboratory research is OcuCure, Inc., which used CBI-sponsored technology and investment to create an eye-drop formula to stop macular degeneration, blood vessel growth at the back of the eye that blinds 200,000 Americans annually.

OcuCure, headquartered in Roanoke, has now raised more than $2 million in investment and is working to develop the compound into an FDA-approved drug.

CBI used a small seed investment to start OcuCure and several other companies, which are young but growing. CBI's incubation work for small companies led Carilion and Virginia Tech to discuss the need for more investment capital in the region to relocate or fund larger companies and facilitate faster growth.

The result of that conversation is NewVa Capital Partners, a $14 million investment pool funded by Virginia Tech, Carilion and Third Security of Radford, which now invests in promising companies that operate in the Roanoke and New River valleys.

With its move into the new building, CBI is helping to achieve the goal of developing Riverside Center from a brownfield into a business park.

With the partnership of the Roanoke Redevelopment and Housing Authority and the city of Roanoke, Carilion has developed the first biomedical building ahead of schedule, secured a hotel that is now under construction, made plans for a 200,000-square-foot Carilion Clinic building and identified the site for the Carilion/Virginia Tech joint medical school.

By developing new research, companies and jobs, CBI has already created more economic impact than the capital invested in it at its inception. CBI could continue to grow itself and its staff to achieve its goals independently.

Instead, we will focus on our primary business of assisting physician researchers and facilitating medical technology transfer. More important, by facilitating the partnerships and collaborations outlined above, CBI has helped create for this region independent research, business development and education organizations that will help the Roanoke and New River valleys achieve even greater economic success.

Generic Biologics Debated in Congressional Hearing

Representatives from the biotechnology industry squared off this week on opposing sides of the debate on generic biologics. Biologics comprise one of the fastest growing and most expensive categories of drugs. By 2009, sales are estimated to reach $90 billion. Many biopharmaceutical drugs are already off patent or will come off-patent, allowing for a generic pathway to create biologics. According to published reports, an estimated $10 billion worth of biopharmaceutical drugs are expected to come off patent by 2010.

Geoffrey Allan, Ph. D., president and CEO of Richmond-based Insmed, Inc., testified this week at a congressional hearing in support of the bill (H.R. 1038) sponsored by Rep. Henry A. Waxman (D-CA) that would authorize the FDA to grant approval of generic biologics.

Dr. Allan was a witness before the House of Representatives Oversight and Government Reform Committee Majority Staff hearing. In his testimony, Dr. Allan stated, "Insmed has developed significant intellectual capital focused towards protein characterization and purification. We have invested in building the facilities required to manufacture quality proteins...The combination of our proprietary protein platform with a biogeneric protein platform meets our goal to sustain innovation along with the ability to provide safe and affordable drugs to address a growing economic issue."

In contrast, Jim Greenwood, President of the Biotechnology Industry Organization, strongly opposes the legislation. "Any legislative discussion of creating a pathway for follow-on biologics must ensure patient safety and preserve incentives for biomedical research and innovation," said Mr. Greenwood. "We strongly oppose H.R. 1038 as it fails to do either. H.R. 1038 would permit the approval of follow-on biologics that do not meet the same rigorous standards of safety, purity, and potency that innovator products must meet; would restrict the ability of the FDA to require whatever clinical testing it believes appropriate to determine the safety and efficacy of such products; would prohibit the FDA from requesting post-marketing safety studies; and would improperly dictate scientific conclusions that the FDA should reach about the comparability or similarity of such products. The legislation also eviscerates incentives to develop new therapies through its one-sided alteration of long-standing patent law in ways that favor follow-on biologics' manufacturers, who would be able to restrict and infringe the intellectual property rights of various parties including universities and innovative biotechnology companies."

At the same hearing, FDA Deputy Commissioner Janet Woodcock told lawmakers it could be a decade or more before the science is available to safely approve generic versions of biotech drugs in the way the FDA approves generics of traditional drugs derived from chemical synthesis.

Dr. Allen told the committee that his company would be well positioned to produce generic biologics, opening up a new level of competition in the industry. "The science has reached a level of sophistication to make this endeavor entirely possible, all we need now is the regulatory go ahead."

Bob Eaton Resigns As President & CEO of MdBio, Inc.

After more than ten years as president and chief executive officer of MdBio, Inc., C. Robert Eaton announced his resignation effective Friday, March 30. According to the Tech Council of Maryland (TCM), Mr. Eaton resigned to pursue opportunities in the private sector.

"Leading MdBio has been rewarding and challenging," said Mr. Eaton. "I am proud of the programs MdBio has developed over the last 10 years that support the growth of bioscience companies in Maryland."

Under Mr. Eaton's leadership, MdBio was instrumental in forging close ties to regional trade associations sharing a common interest in promoting the mid-Atlantic region's bioscience assets. "Bob's commitment to regionalism made the Mid-Atlantic Bio events possible," said Mark A. Herzog, executive director of the Virginia Biotechnology Association. "The political and economic divide between the two states can be pretty wide, but Bob was one of the first to recognize that the industry would benefit by bridging those gaps."

"The respect that MdBio enjoys not only in the state but also nationally is due in large part to Bob's tremendous commitment and hard work over the years," said Jim Leslie, Chair of the MdBio Foundation board of directors. "Through Bob's creativity and leadership, MdBio has been a significant contributor to the growth of Maryland's bioscience industry and also planted the seeds for future generations of industry employees through the organization's early education efforts like MdBioLab. Bob's work ethic and respect from both government and industry leaders is evidenced by his appointment to the Board of Visitors at the University of Maryland Biotechnology Institute and the Board of Advisors at the Sloan Biotechnology Industry Center," added Leslie.

"Bob's efforts were instrumental in supporting the growth of our company and so many others across the state," said Dr. Lawrence Tamarkin, President and CEO of CytImmune Sciences, Inc. "His leadership will be missed."

According to the Baltimore Sun, there has been speculation that the merger and a loss of autonomy led to Mr. Eaton's resignation. When asked to comment by the newspaper, Mr. Eaton declined to comment.

MdBio and MdBio Foundation will conduct a national search for the next president. Until a replacement is named, Julie Coons, CEO of the Tech Council, will serve as interim president of MdBio and the MdBio Foundation.

New BioLife Fund Set to Invest in Life Sciences Sector

New BioLife Fund Set to Invest in Life Sciences Sector

By Kim Hart
Washington Post Staff Writer
Thursday, March 15, 2007; VA12

The Center for Innovative Technology this week started a venture fund that will invest in the life sciences sector. The new BioLife Fund is an outgrowth of CIT's growth acceleration program, a three-year-old fund that finances early-stage technology companies in Virginia.

Johnson & Johnson provided the initial investment of $250,000, which will be matched by CIT. The BioLife Fund will finance start-ups in the pharmaceutical, medical devices and health services fields, said Peter Jobse, CIT president and chief executive.

About a third of the companies that looked for financing through the original venture fund came from the biotechnology industry, Jobse said. CIT makes an investment of up to $100,000 and helps to trigger the interest of other angel investors or venture capitalists. CIT's growth acceleration program has invested in 17 firms since it opened in December 2004.

A large concentration of life sciences start-ups has come out of the Charlottesville area, in connection with the University of Virginia, as well as Richmond and Virginia Commonwealth University. About a third of the companies are setting up shop in Northern Virginia, with some scientists coming out of George Mason University.

"The fund is not specific to firms coming out of universities," Jobse said. "We would like this fund to address the needs of the community as a whole, not just one aspect. Technology doesn't necessarily roll out of the [university] labs."

Some venture capitalists are wary of financing life sciences companies because they take much longer to generate a profit or a return on the investment. Jobse said the "social mission" of the fund helps balance out the risk of a long-term investment.

"If it takes nine years and $100 million to produce a great drug, there may not be an immediate payback," he said. "There isn't necessarily a great return on the financial side, but there will be on the social side."

The new fund is looking to provide cash to first-time entrepreneurs with advanced intellectual property, he said.

European Official Urges Caution on Generic Biologics

Caution urged on biologic drugs

By Diedtra Henderson, Globe Staff | March 8, 2007

WASHINGTON -- European regulators told a Congressional panel today that some biological drugs -- such as insulin and human growth hormones -- are simple enough to produce in generic versions, but others are too complex to be safely duplicated.

Generic versions of certain biologics have been allowed in Europe for the last four years, but approval came only after manufacturers conducted rigorous human clinical trials. European regulators recommended today that the United States adopt the same standards.

The testimony came during a Senate Health, Education, Labor and Pensions committee that is considering a bill to permit United States regulators to approve generic versions of biologics, drugs based on living organisms and cells.

Too much flexibility for generic manufacturers in Europe would have “spread suspicion” that the generic biologic products were unsafe, said Nicolas Rossignol, who is responsible for implementing the European Commission’s legislation governing generic biologics. Rossignol testified from Brussels.

Senator Edward M. Kennedy, who chairs the committee, called biologic drugs “miracle medicines” that can come at a steep price to the healthcare system tens to hundreds of thousands of dollars annually per patient. Americans spent an estimated $60 billion on such products last year, according to IMS Health, a healthcare information company, compared with $53 billion in 2005.

Generics that are chemical equivalents to conventional drugs save Americans at least $10 billion per year. The Food and Drug Administration, however, lacks the legal ability to approve generic versions of biologics.

Kennedy, Democrat of Massachusetts, said such legislation should be “led by the science,” while protecting patient safety and valuing the investments made by innovator companies.

Opponents of the current measure, including Senator Orrin Hatch, Republican of Utah, say it lowers safety standards and could imperil patients. Hatch cosponsored legislation that speeds to market generic versions of conventional drugs. He favors requiring that prospective generic biologic manufacturers test their drugs in humans before approval. Hatch also supports establishing patient registries to track side effects that may not occur until years after patients start using a product.

“What we need to do is keep working to get the best legislation,” Hatch said.

VaBIO Podcast Noted in RTD Article

Podcasting a tool for firms
Experts say shows can be helpful in getting message out to public
BY JEFFREY KELLEY
TIMES-DISPATCH STAFF WRITER
Saturday, March 3, 2007

Since its early days circa 2004, podcasting has touched on such subjects as gardening, video games, cooking and sports.

But the online audio or video shows have also become a tool for businesses that want to share a message with their clients, investors or the general public.

Podcasting's audience? Largely male, folks who work out and commuters and business travelers who want something other than music or the newspaper to pass the time.

Lasting about a half hour, podcasts made by Ironworks Consulting revolve around corporate information-technology topics the average person would find perplexing "open source" software, anyone? But such content has an audience: folks who know and work in information-technology, and understand all of its jargon.

"It's kind of a marketing thing because we're showing our perspective on technologies we help clients implement," said Will Loving, the Henrico County firm's chief operating officer. "If someone listens to it, they can actually learn something from it and use it in their day-to-day work."

That's precisely how podcasts should be done, experts say. If made correctly, a corporate podcast can become a marketing and public-relations tool, but it shouldn't look or sound that way.

Steven Hearn, a former Richmonder and president of podcastGO.com, said the programs should be considered "infotainment" -- in other words, listeners should learn something, yet stay amused.

A little more than one in 10 Web users in the U.S. have downloaded a podcast, the Pew Internet & American Life Project said in November. Few consumers appear to download podcasts with great frequency, perhaps a sign the technology is still young. Forrester Research says the adoption of broadband and spread of MP3 players will push podcasting's popularity in the future.

Still, Forrester said last month, Internet videos, blogs and networking sites such as MySpace are still much more trendy with consumers than podcasts.

"My caution is that companies shouldn't be dashing out to create expensive original content for a small audience -- unless they gain value from being seen as innovative," Charlene Li, a Forrester analyst, wrote last year in her blog.

As people who use podcasts know, listeners can subscribe to the programming as they would a magazine, through services such as Apple's iTunes. When a new show is published, it is sent to software on the user's computer or hand-held device such as the Palm Treo.

Chesterfield County-based PrecisionIR Group converts corporate earnings calls and shareholder meetings into podcasts for some clients. It handles investor-relations services for thousands of public and private companies.

"If you're a Wall Street analyst you can download all the earnings calls and listen to them on the treadmills while you work out, or on the train back [home], and listen to what the CEOs have to say," said J. Patrick Galleher, PrecisionIR's chief executive, a frequent flier who, on his iPod, has everything from Guns N' Roses tunes to corporate podcasts from paper and packaging firm Stora Enso.

PrecisionIR began its podcasting service in June 2005, and that year turned 116 corporate events into podcasts. Last year, the firm offered 1,286 podcasts, which were downloaded 64,692 times.

Galleher projects his company will have thousands of podcasts available this year.

Virginia Biotechnology Association Executive Director Mark Herzog has hosted seven podcasts since September. He's interviewed state life-sciences entrepreneurs, government officials, and others involved in the creation of a biotechnology industry in Virginia.

The programs, running anywhere from 10 to 15 minutes, are as much an advertisement for the association as they are informative to those who are engrossed in science.

"Some [listeners] are interested in policy aspects, some are concerned about new trends in science. . . . The podcasts are a way that we can [cover] different topics and people can download those topics to meet their needs," Herzog said.

The association has tracked about 200 downloads of the podcast each month since December. People can subscribe to the podcast for free on the association's Web site, VaBio.org, or through iTunes.

The Federal Reserve Bank of Richmond has been podcasting the speeches of its president, Jeffrey M. Lacker, since December 2005. "It's one of the most popular features on our Web site," Fed spokeswoman Lisa Oliva said, although she did not provide figures.

"It just gives you a greater dissemination of information. Our audience is broader because of podcasting."

Contact staff writer Jeffrey Kelley at jkelley@timesdispatch.com or (804) 649-6348.

This story can be found at: http://www.timesdispatch.com/servlet/Satellite?pagename=RTD/MGArticle/RTD_BasicArticle&c=MGArticle&cid=1149193496236

More on Generic Biologics

This was in the Washington Post:

Generic Biotech Drugs Could Save $71B

By THERESA AGOVINO
The Associated Press
Thursday, February 15, 2007; 12:06 AM

NEW YORK -- Patients and health insurance providers could save at least $71 billion over 10 years if there was a regulatory mechanism that allowed for the marketing of generic biotech medicines, according to a study being released Thursday.

Currently there is no legal pathway that allows generic drug makers to produce biotech medicines, so the pricey treatments, which are derived from a living source such as proteins, have never had to compete with copycat products that drive pharmaceutical costs lower.

Controlling the cost of biotech medicines has become a top priority for those providing health insurance because the cost of such treatments is dramatically increasing. Biotech treatments now account for 25 percent to 30 percent of a company's overall drug costs, according to pharmacy benefit manager Express Scripts Inc., which conducted the study.

Express Scripts said that the average biotech drug costs $71,600 a year, compared with the annual average for a traditional drug of $1,200. It said that escalating biotech drug costs, which reached $40 billion in 2005, are expected to more than double in four years to a total of $90 billion in 2009, a rate three times faster than traditional drug costs.

But on Wednesday, a bill was introduced by a group of bipartisan lawmakers in Washington, D.C., that would give the U.S. Food and Drug Administration the authority to approve copies of biotech drugs. Similar legislation was introduced last year.

Express Scripts conducted the study by taking a 25 percent discount off brand name medicines in four classes of drugs that would already have generic competition because of patent expirations if copycat biologics were allowed. Express Scripts decided on that discount because it said that the generic version of human growth hormone sells at a 25 percent discount to its brand name counterparts in Europe.

The four categories of drugs were: insulin for diabetes, erythropoietins for anemia, growth hormones and treatments for multiple sclerosis.

Dr. Steve Miller, chief medical officer at Express Scripts, said its estimates were conservative because it didn't include other drugs that would lose patent protection over the next 10 years.

Express Scripts said a generic drug typically costs 60 percent less than its brand name counterpart. However, some experts have said that generic biologics may not be that much cheaper than their branded counterparts because it is likely the FDA will require more testing on generic biologics than chemical drug copycats. Biotech drugs are also more expensive to produce.

Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Association, said her trade group supports the new legislation and that numerous companies within the organization had expressed interest in entering the biotech arena, even though the process might be more expensive and complicated than producing generic chemical drugs.

Jaeger said that even if generic biologics were only 25 percent less than their brand name counterparts, it would be a huge savings for consumers.

"If it (the legislation) gets passed it will be a great win for consumers," she said.

Jim Greenwood, president and CEO of the Biotechnology Industry Organization, cautioned against forecasting any savings from generic biotech drugs without knowing how much testing regulators would require. BIO maintains the drugs won't be true generics because a product made from a living source can never be exactly copied.

"We would be happy to support follow-on biologics legislation as long as that legislation is consistent with some very critical principles: first and foremost of course is safety," Greenwood said.

FDA spokesman Kathleen Quinn said the agency hadn't seen the newly introduced legislation but that it plans to provide technical assistance on the bill. She added that as science has evolved, the agency may be able to eventually approve generic biologic drugs.

Democrats in Congress Press for Generic Biologics

Legislation Would Allow Generic Biotech Drugs in U.S. (Update1)

By Justin Blum

Feb. 14 (Bloomberg) -- Lawmakers in the U.S. House and Senate introduced legislation that would for the first time routinely allow copies of medicines made using biotechnology.

The measures offered today would permit generic drugmakers, such as Barr Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd., to produce medications that are now off limits to competition.

``Without action, the manufacturers of these biotech drugs can continue to charge monopoly prices indefinitely,'' Senator Hillary Clinton, a Democrat from New York, said at a news conference in Washington. ``Biotech drugs hold great promise, but we break that promise when the costs push treatments out of reach.''

Generic biotech drugs may reduce prices by almost a third and cut into the profits of brand-name biotech companies including Amgen Inc. and Genentech Inc., analysts say. Opponents of the legislation say attempts to copy complex gene-based medications could pose health risks.

Sponsors of the legislation in the House include Henry Waxman, a Democrat from California, and Jo Ann Emerson, a Republican from Missouri. Backers of a matching Senate version include Clinton and Charles Schumer, Democrats from New York.

Lawmakers introduced similar measures last year that didn't advance in the Republican-controlled Congress. Supporters say prospects have improved with Democrats in control.

Opposition is being led by the Biotechnology Industry Organization, a Washington-based group that represents makers of brand-name biotech drugs.

Passage of the legislation ``may mean that these drugs come onto the market without the testing necessary to make sure they are safe and effective,'' said Paul Winters, a spokesman for the Biotechnology Industry Organization.

FDA's Authority

U.S. law allows the Food and Drug Administration to approve generic versions of conventional drugs, made mostly through chemical synthesis, after patents expire. There is no similar process for most biotech medicines, genetically engineered versions of human proteins such as insulin or growth hormone.

Biotech drugs generated revenue of about $32.8 billion, 13 percent of the $251.8 billion in prescription sales to U.S. pharmacies in 2005, according to IMS Health Inc., a research company in Fairfield, Connecticut.

Many biotech medicines carry high price tags, and generic versions could lower prices by 20 percent to 30 percent, Elise Wang, an analyst with Citigroup Inc. in New York, said in an interview. One of the most expensive biotech medicines is Genzyme Corp.'s Cerezyme, a treatment for a rare enzyme disorder that can cost $200,000 a year.

Expiring Patents

Barr of Woodcliff Lake, New Jersey, says in lobbying literature that patents have already expired for some top- selling biotech medications, making them vulnerable to competition if lawmakers act. Among the products listed is an anemia treatment sold in the U.S. by Amgen as Epogen and by Johnson & Johnson as Procrit. U.S. sales of the drugs, sold by both companies under a marketing agreement, totaled $4.71 billion in 2005.

A report from Citigroup says that one of Amgen's patents lapsed in 2004 and others expire in 2012 through 2015.

Conventional drugs are small molecules that generic makers can reproduce in versions that are almost identical to the original product and change little from batch to batch.

Biotech medications use bacterial cells to produce human proteins, and the final composition can vary, depending on the techniques used.

The legislation would permit the FDA to decide whether generic makers can skip or abbreviate human clinical trials, and supporters say that would give the agency full authority to guarantee the copies are safe. Such studies aren't required for copies of conventional drugs.

Proponents of the legislation use the term ``generics'' for the biotech drugs they want to reproduce. Some brand-name makers say the drugs should be called ``follow-on biologics'' because the new versions aren't identical. European regulators call them ``biosimilars.''

MdBio & VaBIO Launch Mid-Atlantic Bio Encyclopedia

As part of the ongoing efforts to meet the industry's long-term workforce needs, as well as to help the Mid-Atlantic community understand what the bioscience industry brings to our region and the world, the Virginia Biotechnology Association (VaBIO) is pleased to announce a new partnership with MdBIO and the National Institute of Science Media (NISM). NISM is a non-profit organization that is publishing a series of illustrated biotech encyclopedias, titled Working to Improve Lives. This is a nationally distributed series of books, published in a permanent, high quality, hardcover format. NISM recently published the first book in the series, the San Diego Life Science story, and is currently developing books covering the Mid-Atlantic region, the Bay Area, Massachusetts and Pennsylvania.

We encourage everyone to consider this opportunity to document their unique contribution to the bioscience industry. VaBIO & MdBio have worked to ensure that various levels of participation are available to meet each company's time and budget constraints. Please review each option and help us to create an amazing book showing the world the uniqueness of the Mid-Atlantic bioscience community.


Please direct any inquiries you have regarding this project to:
Joel Ball, Director, NISM
8639-B 16th St. , Silver Spring, MD 20910
1.866.NISM-123 Ext. 701/ Fax 1.866.647.6123
jb@nism.org

DNA Discoverer Francis Crick High on LSD?

Nobel Prize genius Crick was high on LSD
when he discovered the secret of life

Copyright 2004 Associated Newspapers Ltd. Mail on Sunday (London)

August 8, 2004

BY ALUN REES


FRANCIS CRICK, the Nobel Prize-winning father of modern genetics, was under the influence of LSD when he first deduced the double-helix structure of DNA nearly 50 years ago.

The abrasive and unorthodox Crick and his brilliant American co-researcher James Watson famously celebrated their eureka moment in March 1953 by running from the now legendary Cavendish Laboratory in
Cambridge to the nearby Eagle pub, where they announced over pints of bitter that they had discovered the secret of life.

Crick, who died ten days ago, aged 88, later told a fellow scientist that he often used small doses of LSD then an experimental drug used in psychotherapy to boost his powers of thought. He said it was LSD, not
the Eagle's warm beer, that helped him to unravel the structure of DNA, the discovery that won him the Nobel Prize.

Despite his Establishment image, Crick was a devotee of novelist Aldous Huxley, whose accounts of his experiments with LSD and another hallucinogen, mescaline, in the short stories The Doors Of Perception and Heaven And Hell became cult texts for the hippies of the Sixties and Seventies. In the late Sixties, Crick was a founder member of Soma, a legalise-cannabis group named after the drug in Huxley's novel Brave New World. He even put his name to a famous letter to The Times in 1967 calling for a reform in the drugs laws.

It was through his membership of Soma that Crick inadvertently became the inspiration for the biggest LSD manufacturing conspiracy-the world has ever seen the multimillion-pound drug factory in a remote
farmhouse in Wales that was smashed by the Operation Julie raids of the late Seventies.

Crick's involvement with the gang was fleeting but crucial. The revered scientist had been invited to the Cambridge home of freewheeling American writer David Solomon a friend of hippie LSD guru Timothy
Leary who had come to Britain in 1967 on a quest to discover a method for manufacturing pure THC, the active ingredient of cannabis.

It was Crick's presence in Solomon's social circle that attracted a brilliant young biochemist, Richard Kemp, who soon became a convert to the attractions of both cannabis and LSD. Kemp was recruited to the THC project in 1968, but soon afterwards devised the world's first foolproof method of producing cheap, pure LSD. Solomon and Kemp went into business, manufacturing acid in a succession of rented houses before setting up their laboratory in a cottage on a hillside near Tregaron, Carmarthenshire, in 1973. It is estimated that Kemp manufactured drugs worth Pounds 2.5 million an astonishing amount in the Seventies before police stormed the building in 1977 and seized enough pure LSD and its constituent chemicals to make two million LSD 'tabs'.

The arrest and conviction of Solomon, Kemp and a string of co-conspirators dominated the headlines for months. I was covering the case as a reporter at the time and it was then that I met Kemp's close friend, Garrod Harker, whose home had been raided by police but who had not been arrest ed. Harker told me that
Kemp and his girlfriend Christine Bott by then in jail were hippie idealists who were completely uninterested in the money they were making.

They gave away thousands to pet causes such as the Glastonbury pop festival and the drugs charity Release.

'They have a philosophy,' Harker told me at the time. 'They believe industrial society will collapse when the oil runs out and that the answer is to change people's mindsets using acid. They believe LSD can help people to see that a return to a natural society based on self-sufficiency is the only way to save themselves.

'Dick Kemp told me he met Francis Crick at Cambridge. Crick had told him that some Cambridge academics used LSD in tiny amounts as a thinking tool, to liberate them from preconceptions and let their genius wander freely to new ideas. Crick told him he had perceived the double-helix shape while on LSD.

'It was clear that Dick Kemp was highly impressed and probably bowled over by what Crick had told him. He told me that if a man like Crick, who had gone to the heart of human existence, had used LSD, then it was worth using. Crick was certainly Dick Kemp's inspiration.' Shortly afterwards I visited Crick at his home, Golden Helix, in Cambridge.

He listened with rapt, amused attention to what I told him about the role of LSD in his Nobel Prize-winning discovery. He gave no intimation of surprise. When I had finished, he said: 'Print a word of it and I'll sue.'

http://en.wikipedia.org/wiki/Francis_Crick

NC Biotech Center Looking for New CEO

Dr. Leslie Alexandre to Leave N.C. Biotechnology Center
Monday January 22, 2:00 pm ET

RESEARCH TRIANGLE PARK, N.C., Jan. 22 /PRNewswire/ -- The North Carolina Biotechnology Center today announced that President and CEO Leslie Alexandre, Dr. P.H., has resigned to pursue new opportunities. To facilitate a smooth transition, Dr. Alexandre will continue working with the Biotechnology Center as needed until March 31.

"Leslie Alexandre has led the Biotechnology Center through a notable period of growth," said Sue Cole, chairman of the Biotechnology Center's board of directors. "She has helped enhance North Carolina's reputation as a 'biotech-friendly' state. Citizens will benefit in the coming years from the groundwork she has laid."

"Leading the Biotechnology Center since 2002 has been exciting and rewarding," said Dr. Alexandre. "I leave having accomplished what I set out to do when I arrived: strengthen the Biotechnology Center's programs, services and infrastructure and expand its reach to all corners of the state through the establishment of regional offices; secure greater State funding to support additional innovative research projects and company startups; increase life science company expansions and attractions by building high-impact partnerships with the N.C. Department of Commerce and other economic developers; and broaden global recognition of North Carolina as a leading place to conduct biotechnology research, development and commercialization."

Dr. Alexandre also led the creation of New Jobs Across North Carolina: a Strategic Plan for Growing the Economy Statewide through Biotechnology on behalf of Governor Mike Easley. "Our strategic plan has already had a very positive impact on our state, and I believe that its continued implementation will ensure a bright future for North Carolina biotechnology," she said. "The Biotechnology Center is well positioned to lead that future for years to come.

"I will miss my wonderful staff and the energy of the Biotechnology Center, but I will watch with pride as they continue to accomplish great things for the people of North Carolina," concluded Dr. Alexandre.

The Board of Directors of the Biotechnology Center will conduct a national search for the President and CEO position.

The Biotechnology Center, headquartered in Research Triangle Park with five regional offices throughout the state, is a private, non-profit corporation supported by the N.C. General Assembly. Its mission is to provide long-term economic and societal benefits to North Carolina by supporting biotechnology research, business and education statewide.

Wanted: Project Director

The Virginia Bio/Advanced Manufacturing Skills Initiative, a two-year national demonstration project that is funded jointly by the U.S. Department of Labor and a group of bio/advanced manufacturing companies in Virginia, is seeking a project director to lead and manage this significant economic development and workforce development initiative.

The project will establish certification and assessment standards for advanced manufacturing technicians; develop and operate an outreach, recruitment and pre-screening program; and design, build and operate an innovative training program to qualify advanced manufacturing technicians at an entry threshold of employability. The Project Director’s primary responsibilities will be to work with the project partners to create, develop and execute the project’s ambitious goals and schedule of activities. The Project Director will oversee the management and administration of the project activities and provide timely, accurate and informative reports and other required documentation. Requirements: a bachelors degree in business administration, project management or related field, a minimum of two to five years of previous work experience in advanced manufacturing, experience in private-sector supervision and project fiscal and performance management, and excellent interpersonal, speaking, presenting and writing skills. Preferred skills/experience: training and certification in Lean Six-Sigma, and experience in grants management and fund-raising. Competitive salary and benefits.

The project is being jointly led by the Virginia Biotechnology Association, the Virginia Manufacturers Association, and Training & Development Corporation, and will be managed out of offices in Richmond. Qualified candidates are invited to submit a cover letter with resume and references to ATTN: Search Committee/Project Director, Virginia Biotechnology Association, at hr@vabio.org. For additional information about the project and the position please visit click here.

Italian Health Ministry Taps Insmed Drug for ALS

Insmed Incorporated, based in Richmond, Virginia, has been requested by the Italian Ministry of Health, to make its drug, IPLEXTM (rhIGFI/rhIGFBP-3), available to physicians in Italy to treat patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease.

The request comes as a result of several Italian Court rulings ordering the Italian National Health System to provide the drug to specific ALS patients who have petitioned the Court. Through an agreement with Cephalon, which holds European patent rights to IGF-1 pertaining to the treatment of ALS, Insmed will be able to provide IPLEX to physicians in Italy. IPLEX will be distributed through an expanded access program, with Insmed receiving payment for drug from the Italian Health
Authorities.

ALS is a neurodegenerative disorder that causes progressive muscle weakness and loss of motor neurons. IGF-1 is a neurotrophic factor essential for normal development of the nervous system. In animal models and cell culture systems IGF-1 protects motor neurons and promotes muscle and nerve regeneration.

“We are very pleased that the Italian ministry has approached us to help in treating this devastating disease,” said Geoffrey Allan, President and CEO of Insmed. “We greatly appreciate the fact that Cephalon has collaborated with us in this effort. We hope that data collected from this expanded access program will be useful for the further clinical development of IPLEX for this indication,” he added.

In Italy, there are an estimated 1000 new cases of ALS per year. The Ministry of Health has tried for several years to provide IGF-1 to these patients and in doing so has contacted several pharmaceutical companies worldwide.

“We are very pleased that Insmed responded to our request and are willing to provide IPLEX,” said Carlo Tomino of the Italian Ministry of Health/AIFA.

Former FDA Comissioner Agrees to Plea Deal

http://www.businessweek.com/ap/financialnews/D8MOJSVO0.htm


Former FDA Commissioner Lester Crawford would face a $50,000 fine and probation but no jail time as punishment for lying about ownership of illegally held stocks, according to a deal worked out between his attorney and federal prosecutors.

Crawford and the government both have agreed to the fine and some form of probation, though his ultimate sentence will be at the discretion of Magistrate Judge Deborah A. Robinson, according to sentencing memoranda filed with the U.S. District Court in Washington.

His sentencing is set for Tuesday.

Crawford pleaded guilty in October to charges of having a conflict of interest and false reporting of information about stocks he and his wife owned in food, beverage and medical device companies he regulated while head of the Food and Drug Administration.

The U.S. Attorney's office recommended the $50,000 fine, saying it would exceed the roughly $39,000 Crawford and his wife, Cathy, made from exercising options and in dividends from the forbidden stocks they held in the FDA-regulated companies.

The government also recommended Crawford be sentenced to probation and community service but skip any jail time, according to its sentencing memo filed with the court. Crawford could face up to six months in jail under sentencing guidelines.

"Given his early acceptance of responsibility, the defendant's actions merit the stigma of criminal convictions, a fine, and probation, but not incarceration," according to the government memo, signed by assistant U.S. attorneys Howard R. Sklamberg and Timothy G. Lynch. Sklamberg declined to comment Friday.

Crawford's attorney, Barbara Van Gelder, said her client agreed to pay the fine, according to her memo to the court. However, Van Gelder specifically requested unsupervised probation, which would allow Crawford to travel overseas for work. Van Gelder did not mention community service in her memo. She did not immediately return a message seeking comment.

In October, Crawford admitted to falsely reporting that he had sold or did not own stock when he continued holding shares in the firms governed by rules of the FDA, which is illegal. Beginning in 2002, Crawford filed seven incorrect financial reports with a government ethics office and Congress, leading to the misdemeanor charges.

Although Crawford lied about ownership of the stocks -- including under oath before the Senate -- government attorneys acknowledged there is no evidence he was "engaged in a concerted scheme to use his high office for personal gain."

Van Gelder, meanwhile, suggested Crawford's wife, secretary and financial adviser prepared and handled the inaccurate financial statements Crawford filed with the government. She acknowledged, however, that Crawford remained ultimately responsible for their accuracy.

Crawford, a veterinarian and food-safety expert, abruptly resigned from the FDA in September 2005 but gave no reason for leaving. He had held the job for two months, following his confirmation by the Senate.

More on the Eli Lilly Decision

Here is an article from the Washington Examiner...

Loss of Lilly’s name recognition a setback for region’s biotech industry
Katie Wilmeth, The Examiner
Jan 15, 2007 3:00 AM

WASHINGTON - The cancellation of the $325 million insulin manufacturing plant being built by pharmaceutical giant Eli Lilly in Prince William County is a clear blow to the Washington area’s growing biotechnology industry, but economic development officials said it shouldn’t hurt the region in the long run.

“Certainly it’s a setback,” said Jason Grant, a spokesman for the Prince William County Department of Economic Development. “The setback is you lose that internationally recognizable name. From a marketing standpoint, Lilly was very successful for us.”

The Washington region has been an up-and-comer in the biotech industry for a number of years, but it has struggled to make the transition from a research and development center to one with commercially viable products. The success of the industry hinges on securing more publicly traded companies and bringing in more drug manufacturing companies, said Tim Priest, executive director of the Greater Washington Initiative, the organization charged with promoting the region to potential business.

Lilly would have brought both. The Indianapolis-based corporation is one of the most high-profile pharmaceutical companies in the world and would have boosted the credibility of a region that has depended largely on start-up companies for its industry’s growth. But homegrown success stories like Gaithersburg-based MedImmune are few and far between.

Economic development officials were quick to point out that despite the loss of Lilly, the region — and Northern Virginia in particular — has grown significantly in the last few years. Northern Virginia has made a big push and invested hundreds of millions of dollars to build its biotech industry and catch up with Montgomery County, which is well-known outside the region as a hub for bioscience. George Mason University’s Prince William County campus is dedicated solely to life sciences, and the county’s Innovation Technology Park has attracted several new biotech firms. In Loudoun County, the opening of the Howard Hughes Medical Institute’s $500 million research campus, Janelia Farm, has brought international recognition to the region.

Lilly’s decision “is a really unfortunate development for the region,” said Mark Herzog, executive director of the Virginia Biotechnology Association. “It’s regrettable that they would choose not to fulfill the plans for the project in Prince William ... but certainly Prince Williams’ Innovation Park was not just about Eli Lilly. There’s quite a few major bioscience facilities that are either there right now or being developed.”

Lilly selected Prince William County for its manufacturing plant over 300 other possible sites in the U.S., said Priest, and the region has only matured since that 2002 selection.

“The reasons [Lilly] picked it are as solid today just as when they did in 2002,” Priest said. “This is a step back but they’re still growing.”

Virginia Bioscience Podcast: Virginia General Assembly

VaBIO has posted their latest Podcast. The guests are members of the state legislature. In addition to biotech issues, Senator Stosch talks about taxes and transportation.



This edition of the Virginia Bioscience Podcast features several elected officials from the Virginia General Assembly discussing the role of state government in the development of the biotechnology industry.

This panel discussion was recorded on December 14, 2006 at the Virginia Biotechnology Association’s policy conference on effective state economic development policies for the bioscience industry. The panelists include three members of the Senate of Virginia: Walter Stosch of Henrico County, Ryan McDougle of Hanover County and Benjamin Lambert of the City of Richmond. Also speaking on the panel is Dr. John O’Bannon, a member of the House of Delegates representing a suburban district in Henrico County and Patrick Gottschalk, Virginia’s Secretary of Commerce and Trade. The moderator of the session is Hugh Keogh, the president of the Virginia Chamber of Commerce.



The program starts with remarks by Delegate O’Bannon, followed by Senators Stosch and McDougle, then concludes with a question from the audience.

The focus of the program is what the state should specifically do to help expand Virginia’s biotechnology industry. The panelists also address major issues facing the legislature such as the transportation impasse and tax increases.

The program lasts approximately twenty minutes. The host of the program is Mark Herzog, executive director of the Virginia Biotechnology Association.

Eli Lilly Cancels Virginia Insulin Plant

Eli Lilly and Co. said on Thursday it would stop construction of an insulin manufacturing plant in Virginia because it can meet expected capacity needs with existing sites.

In addition, Lilly said it would offer a voluntary exit package to up to 250 employees of 1,000 workers at the manufacturing site in Lafayette, Indiana.

The Indianapolis-based drug maker also said it would make "significant" new investments at a site in Kinsale, Ireland, where the company does manufacturing for biotechnology products.

Lilly said it would take estimated restructuring and asset impairment charges of about $155 million to $185 million. The company will take a fourth-quarter charge of 5 cents against earnings per share, it said.

Stem Cell Battle Looming at the General Assembly

Controversial bills will start session
Democrats want law to prevent ban on stem cell research
BY A.J. HOSTETLER
TIMES-DISPATCH STAFF WRITER
Saturday, January 6, 2007

Virginia Democrats will propose a package in the coming legislative session to specifically authorize embryonic stem cell research at state universities.

The package is an attempt to prevent a possible ban on studying embryonic stem cells, said a spokesman for Del. Brian J. Moran of Alexandria, the House Democratic Caucus chairman. It would lay the groundwork for Virginia legislators to someday authorize significant state spending to support the research, such as in California and Maryland.

Embryonic stem cells are master cells that grow into any type of body tissue. Scientists want to use them to develop new treatments for Alzheimer's, diabetes, spinal-cord injuries and numerous other diseases.

"The hope and opportunity that embryonic stem cell research provides should never be closed to thousands of Virginians suffering in silence," Moran said. "Now we have a real chance to cure the incurable, and it's morally wrong to close the door."

Scientists at Virginia Commonwealth University already study embryonic stem cells. The proposed package would specifically authorize embryonic stem cell research within the Code of Virginia, said Moran's spokesman, Jesse Ferguson.

"So that there's no question, no ambiguity, no question that we can stick something in a budget bill to prohibit it," Ferguson said.

During last year's session, Republicans attempted to prohibit the research in Virginia by eliminating any state funding for any institution conducting embryonic stem cell research.

Moran's bill will be joined by a similar one from Del. Mark D. Sickles, D-Fairfax. Another from the Senate would allow the state to put money aside in the Christopher Reeve Stem Cell Research Fund to pay for such research.

"We need to make sure the commonwealth of Virginia leads the way on this cutting-edge research that will save lives," said Sen. Janet D. Howell, D-Fairfax, who will co-sponsor the Senate bill along with Sen. Creigh R. Deeds, D-Bath.

The package would provide safeguards to ensure that the stem cells were donated with informed consent without any inducement and provisions ensuring review of projects through an oversight committee.

The Senate bill would also ban "therapeutic" cloning of stem cells, Deeds said. The Code of Virginia, which bars cloning for reproductive purposes, doesn't ban therapeutic cloning.

Given that the General Assembly cannot add new money to the budget in this session and that all seats are up for election this fall, "This is all about politics," said political analyst Bob Denton of Virginia Tech. The proposal is more about posturing and partisanship than science, he said.

Del. Robert G. Marshall, R-Prince William, agreed. "They're keeping the door open for a quick, dirty, ill-informed attack ad in November. That's all that does. It doesn't do anything for advancing science," said Marshall, who opposes embryonic stem cell research and leads the joint legislative subcommittee on medical, ethical and scientific issues relating to stem cell research.

Virginia's stem cell scientists, however, welcome the proposal.

"Clearly, this legislative effort will demonstrate that the state is taking the potential of regenerative medicine for curing debilitating diseases seriously," said Raj Rao, a VCU scientist studying embryonic stem cells as part of the school's focus on regenerative medicine.

University of Virginia stem cell scientist Roy Ogle said: "This should speed up progress and put [Virginia] scientists on more even footing with those in other states."

He added that even if therapeutic cloning, used to create self-perpetuating lines of stem cells from a cloned embryo, were banned, there are several major areas of research that Virginia scientists could pursue to better understand the cells, which were first isolated in 1998.

"I applaud the leaders in Virginia who are seeking to make the state a safe place to pursue the exciting area of stem cell research," said Sean Tipton, president of the advocacy group Coalition for the Advancement of Medical Research. "Virginia was the birth place of in-vitro fertilization in the United States, and it's nice to see its leaders again stepping up to protect research that might alleviate human suffering."

Contact staff writer A.J. Hostetler at ahostetler@timesdispatch.com or (804) 649-6355.

This story can be found at: http://www.timesdispatch.com/servlet/Satellite?pagename=RTD/MGArticle/RTD_BasicArticle&%09s=1045855935264&c=MGArticle&cid=1149192517676&path=%21news%21politics

VaBIO Policy Video on "YouTube"

Here is the link to the "Virginia Biotech: Vision 2010" video on YouTube.

http://www.youtube.com/watch?v=Bia1MjhUAtY

Comedian Will Farrell on Government Investment in Biotechnology

Will Ferrell giving his speech from the film "Old School" on "government investment in the field of biotechnology." James Carville also appears.


http://www.youtube.com/watch?v=fgsJjy359i0

Recap of 2006 Biotech in Maryland and Virginia

Another recap from the DC Examiner-- This highlights biotech in Virginia and Maryland.


Biotech industry makes significant strides in 2006
Katie Wilmeth, The Examiner
Dec 28, 2006 3:00 AM (3 days ago)
Current rank: Not ranked

WASHINGTON - The region’s biotechnology industry took center stage in 2006 as several high-profile successes showcased Washington’s growth in the highly competitive sector.

The October opening of Janelia Farm — a $500 million, 689-acre state-of-the-art research campus dedicated to basic biological research in Ashburn, Va. — demonstrated the region’s ability to attract world-renowned scientists and drew the attention of even more investors to the region.

“It’s the single largest science investment of the decade and it will probably have the most impact for [Virginia], maybe for decades to come,” said Larry Rosenstrauch, director of economic development for Loudoun County, in a September interview. “We have to recognize this is a global asset that has landed in our region and we have to try and use it.”

October also saw a successful biotech fair that attracted hundreds of venture capitalists and numerous local biotech firms in search of capital. Though the event was only the second bio-focused venture capital fair for the region, it was a sign that biotechnology was on the same path as the region’s other highly successful industry: information technology.

“We wanted to create a platform where private equity and venture investors felt they could do business around the growing industry of life sciences,” said Julia Spicer, president of sponsoring organization Mid-Atlantic Venture Association, in a September interview.

MAVA launched a similar fair, Capital Connection, 20 years ago when the region’s technology industry was finding its footing and today the conference is one of the most respected in the industry.

Several individual biotech firms had notable successes in 2006. MedImmune, the region’s most successful biotech company by revenue, broke ground on a $250 million plant in Frederick, Md., that will allow it to manufacture vaccines in the state. While there are many biotech firms in the region, there is limited manufacturing capability. MedImmune’s plant points to a maturing of the industry, said economic development officials.

MedImmune’s expansion “is important. All of this is evolutionary,” said Aris Melissaratos, Maryland’s secretary of business and economic development, in September. “For every drug in the pipeline, you want to get [to the manufacturing stage].”

Several companies, including Vanda Pharmaceuticals, also went public, each one an important step in turning Washington’s research-focused industry into a commercial one.

“I really think [success] is when you have more publicly traded companies,” said Tim Priest, executive director of the Greater Washington Initiative, a regional organization that markets the Washington area to potential biotech companies looking for a home. “We have a handful of companies that are forces in their industry ... but there’s a deficiency in this region. We don’t commercialize as much as we should.”

As more investors look to Washington as a biotech region, local industry leaders expect to see the industry gain ground on competitors. There were also signs in 2006, that the industry was beginning to catch up to the region’s robust the IT industry. In the second quarter, for example, venture capital investments in local biotech firms overtook both software and telecommunications.

Examiner

Recap on DC Area VC Activity for 2006

Here is an article that gives a recap on the DC area's VC activity for 2006. Mid-Atlantic Bio is mentioned at the end.

Venture capital: Strong year for software, telecom

Katie Wilmeth, The Examiner
Dec 27, 2006 3:00 AM (6 hrs ago)
Current rank: # 1 of 13,170 articles
Washington, D.C. - Despite several high-profile biotechnology deals in 2006, software and telecommunications remained the dominant industries among venture capitalists looking to invest in the Washington region.

“We have a strong legacy sector in telecommunications and technology in this region,” said Julia Spicer, executive director of the Mid-Atlantic Venture Association. “That will continue to be opportunistically a great investment space, and we have lots of investors across the board who understand that space.”

Funding for local software companies was approaching the $200 million mark at the end of the third quarter with $192 million invested in 51 deals. While numbers aren’t out yet for the fourth quarter, those figures put the category on track to outpace 2005 investments. During the third quarter of 2005, investments had reached only about $140 million.

Telecom also had a strong year. With more than $270 million invested in 17 deals in the first three quarters of 2006, the industry sector jockeyed with software and biotechnology for the top spot among investors.

But while software and telecom quietly remained on top, it was the biotech industry that made headlines in 2006 with several multimillion dollar deals. Investments in local biotech companies surged ahead in the second quarter with $145 million in funding and 13 deals. Much of that money went to Rockville-based CoGenesys. The biotech firm received nearly $55 million in Series A financing in June, a number often unheard of in the software industry.

Biotechnology remains a growth area for the region, said Spicer, with few venture firms focused on the sector and more money needed to fund fewer companies.

“[Software] is more predictable in some ways,” said Bill Gust, managing general partner of Anthem Capital in a July interview. “It’s more predictable. You can sell the company or software to somebody else and recoup your investment. Whereas the life sciences … you’re talking about tremendous amounts of money needed to carry a company into commercialization.”

The opening of Janelia Farm — a bioscience research campus in Loudon County — and a successful venture capital fair sponsored by MAVA, as well as the Virginia Biotechnology Association and MdBio, also put the industry in the spotlight in 2006.

Top five venture capital deals of 2006:

» CURRENT Communications Group — $129,999,700 (Germantown)

» CoGenesys Inc. — $54,999,9000 (Rockville)

» MacroGenics Inc. — $45,000,000 (Rockville)

» SunRocket Inc. — $33,000,200 (Vienna)

» Kajeet Inc. — $27,000,000 (Bethesda)

Examiner

Re Building on Virginia's Biotechnology Foundation

The 2006 Virginia Biz/Bio Conference (December 14, Virginia BioTechnology Park, Richmond) was an important, perhaps seminal event for the Commonwealth. Robert Skunda, Mark Herzog, Aneesh Chopra and all the organizers deserve congratulations for an excellent, eye-opening Conference. Dr. Charles Hamner, William Conklin and other speakers graphically illustrated what works to develop and grow a world-class biotechnology and life sciences cluster, and thereby provided keys to what we need to do now. The speakers and panelists illuminated many dimensions of Virginia's opportunities and challenges.

It is clear that Virginia has a solid foundation, and exciting new developments, thanks to proactive State action, important biopharma industry investments and public-private-academic partnerships. We are ready to jumpstart Virginia's leadership position.

We need to work hard, and together, to develop and strengthen the critical mass, infrastructure and identity to support Virginia's emergence as a global leader in the biotechnology and life sciences sector. Let us make 2007, the Jamestown QuadriCentennial, a year of leadership, action and progress for Virginia-based biotechnology and life sciences.

Virginia Bioscience Podcast: Dr. Charles Hamner

This edition of the Virginia Bioscience Podcast features Dr. Charles E. Hamner, DVM and PhD, the former president and CEO of the North Carolina Biotechnology Center. When Hamner joined the Center in February 1988, the state had a fledgling biotechnology industry. Today, North Carolina is among the nation’s top five biotechnology states with several hundred thriving bioscience, contract research, device, and other supporting companies throughout the state.

Under his leadership, the Center strengthened the state’s biotechnology infrastructure by investing more than $50 million in the state’s universities, seed-funding 62 startup companies, creating a $26 million venture capital fund for new companies, building a permanent headquarters building and conference facility, providing biotechnology workshops for more than 1,000 high school teachers, and helping recruit more than a dozen biotechnology companies to North Carolina.

Dr. Hamner’s presentation, “Key Factors of Attracting the Biotechnology Industry to a State,” was given on December 14, 2006 at the Virginia Biotechnology Association’s conference on economic development strategies for the bioscience industry. The host is Mark Herzog, executive director of the Virginia Biotechnology Association.

Dr. Francis Collins Featured in Va Biotech Podcast

Virginia Biotech Podcast: Dr. Francis Collins

This special edition of the Virginia Bioscience Podcast features Dr. Francis Collins, the director of the National Human Genome Research Institute (NHGRI) at the National Institutes of Health.

Dr. Collins was the guest speaker at the 2003 Virginia Biotechnology Summit, held at the McLean Hilton in Tyson’s Corner, Virginia. Following his remarks about his work on the Human Genome Project, Dr. Collins thrilled the crowd by pulling out a guitar and singing some pop songs—though with new lyrics that take a light-hearted view of genetics and the commercial side of biology.

Dr. Collins sings “Amazing DNA” and “We Really Got The Code On You.” The recording quality is poor but well worth the download!

The host of the Virginia Bioscience Podcast is Mark Herzog, executive director of the Virginia Biotechnology Association.

Bioscience Economic Development Focus of State Conference: December 14 in Richmond

Nearly thirty national and state organizations have joined forces to present a half-day policy conference on how to develop and enhance Virginia's bioscience industry. The event, "The Virginia BizBio Conference," will be held from noon to 7 p.m. on Thursday, December 14, at the Virginia Biotechnology Research Park in Richmond.

This interactive half-day conference will address how government, business, academia, investors and entrepreneurs can work together to create a positive climate to maximize the growth of the biotechnology and biopharmaceutical industry in the Commonwealth.

Here is a link to the "Virginia Biotech: Vision 2010" Report:
http://www.vabio.org/documents/VaBio-2010.pdf

Here is a link to a video that helps frame the issues:
http://www.vabio.org/documents/Vision2010Final.wmv

Here is a new report from the Biotech Industry Organization that outlines important legislation passed by state legislatures across the United States: Click here.

Here is the link to the 2006 Batelle State Biotech Report that outlines all of the known state initiatives and some basic statistics about each state:
http://www.bio.org/local/battelle2006/


Featured speakers include William Conklin, biotech business unit director for Merck & Co.; Charles Hamner, founder and former CEO of the North Carolina Biotechnology Center; Tony Corso, CEO of B.I. Chemicals; Cheryl Moore, COO of the Janelia Farm Research Campus of the Howard Hughes Medical Institute; the Honorable Brian Feldman, Maryland House of Delegates; Hugh Keogh, president of the Virginia Chamber; the Honorable Walter Stosch, majority leader of the Virginia Senate and member of the Finance Committee; the Honorable Patrick Gottschalk, Virginia Secretary of Commerce and Trade and the Honorable Aneesh Chopra, Virginia Secretary of Technology.

Bioscience research and development represents a major source of capital to Virginia and local communities. Throughout the discussions during the event, the speakers will illustrate the potential economic growth that the industry can bring to Virginia if resources are accessible.

The event is open to all interested attendees but requires advanced registration. Lunch and a closing reception are included. Limited seating is available. For more details and registration information, please visit www.vabizbio.org.

West Virginia's Biotech Vision 2015

An article about WV's plans for tech-based economic development...

West Virginia enters biotech race
Deven Swartz
Posted: 11/16/06
As states across the United States are beginning to bank their futures on the potentially unlimited possibilities of biotechnology, West Virginia feels it has no other choice but to enter the competition.

The state government has invested $4 million in Technology-Based Economic Development to date. TBED is a program that calls for postsecondary research institutions to stimulate a region's economy by creating state-of-the-art inventions, mainly in the biotechnology field.

The state's TBED proposal, Vision 2015, calls for a state investment of $250 million by 2015. Governor Joe Manchin has publicly spoken in support of the proposal and TBED in general, and proponents are currently touring the state to try to build enough legislative support to pass the proposal.

The state received $60 million from the federal government for TBED activities as of 2005, which proposal literature considers below the national average. However, the state received its largest grant, $9 million, from the National Science Foundation in July. All the money from the grant was earmarked for Marshall University research.

The goal would increase the amount of federal funding to more than $120 million by 2010 and $220 million by 2015.

Proponents of Vision 2015 point out that every federal dollar invested in TBED will yield $7 in revenue. However, a Web site at the University of Louisville, a member of Kentucky's TBED program, states that each federal dollar invested has yielded $3 in revenue.

The proposal also includes recruiting 89 new scientists and engineers to the state. West Virginia University would get 63 of the scientists, and Marshall University would receive 26.

Start-up costs for the new scientists and engineers would be close to $40 million, and the universities would be collectively paying out more than $8 million per year in salaries and fringe benefits. The universities' base budgets would need to be increased beginning in 2008 in order to compensate for possible salary increases, according to the proposal.

Vision 2015 also calls for the construction of two minimum 100,000 square-foot facilities-one at Marshall and the other at West Virginia University-by 2010. More than $120 million must be raised in order to pay for both buildings, and the proposal sets a December 2007 deadline to obtain the funding.

Marshall would be getting a science and engineering building meant to complement the $48 million Robert C. Byrd Biotechnology Science Center, which was dedicated in August. The biotech center had been in the planning stages since the late 1990s and was initiated by former Marshall President J. Wade Gilley, Dr. Howard Aulick, Marshall vice president for research, said.

Two other major items in the proposal include increasing the production of scientists and engineers already in the state, as well as developing new tech-based businesses.

If Vision 2015 is completed as proposed, it will create 33,000 jobs and have a total economic impact of more than $3 billion, according to proposal literature.

"If we don't do this now, Ohio will recruit our best researchers or Kentucky will," Aulick said.

Looking at TBED investments made in neighboring states, West Virginia is years behind. Kentucky, through the Bucks for Brains project, has invested $300 million in state funding into TBED since 1997. Ohio's TBED project, Third Frontier, has received $300 million from the state to date as well, but it started funding the project only three years ago. The state will invest a total of $1.1 billion in the project by 2013.

Because neighboring states have already made large-scale investments into TBED, some wonder if West Virginia has entered the marketplace too late to compete effectively.

"Every university in the nation is making the same bet, and many are better equipped and located to succeed in (biotechnology)," one person said in a message on the open comment section of the Marshall Strategic Vision Web site.

Aulick said he has heard this argument before. However, because West Virginia's TBED projects and investments will focus on health problems of major importance in Appalachia, the state will have its own competitive advantage, Aulick said.

Virginia's Goodlatte Blasts EU on Biotech Trade

Go get 'em Bob Goodlatte! Here is an article from the WP:

U.S. lawmakers: EU dragging heels on biotech trade

By Missy Ryan
Reuters
Wednesday, November 15, 2006; 1:46 PM

WASHINGTON (Reuters) - The United States must pressure the European Union to stop dragging its feet on approving new imports of bioengineered food, senior U.S. lawmakers said in a letter released on Wednesday.

"The EU has avoided for too long its WTO obligations ... The illegal discrimination against biotech products on nonscientific grounds must cease," a group of lawmakers said in a letter to U.S. Trade Representative Susan Schwab.

Bioengineered foods are made from crops altered by biotechnology, boosting the vitamin content of a strain of rice, for example, by inserting genes from daffodils and from soil bacterium.

The EU has insisted on careful regulation of bioengineered food to screen for any risk to human health or to the environment.

The U.S. lawmakers, including the incoming chairs of the House and Senate Agriculture committees, want European officials to act quickly on the heels of a September 29 ruling by the World Trade Organization's dispute settlement body.

A main finding of that ruling was that a ban on approving new biotech products, which the EU had in place for four years until 2003, led to "undue delays."

"Winning the WTO case without achieving any positive changes in the approval process would greatly erode the credibility of the WTO in the eyes of U.S. agriculture," the lawmakers wrote in the letter, which was delivered to Schwab's office late on Tuesday.

It was signed by Iowa Sen. Tom Harkin and Minnesota Rep. Collin Peterson, who are poised to lead the Senate and House Agriculture committees once Democrats take control of Congress in January.

The committees' outgoing chairs, Republicans Saxby Chambliss of Georgia and Bob Goodlatte of Virginia, also signed the letter, along with the current heads of the powerful Senate Finance Committee and House Ways and Means Committee.

The European Union says its current regime for approving bioengineered products -- including a food safety authority based in Italy -- complies with WTO rules.

"The new system is science-based. We've set up a centralized procedure ... that's responsible for doing risk assessment" of bioengineered food, said Canice Nolan, who directs food safety, health and consumer affairs for the EU's delegation in Washington.

Keith Williams, a Chambliss spokesman, said the European Union had sidestepped WTO rulings in the past, and pointed to a case involving beef hormones.

Nolan said the European Union had not decided if it would appeal the WTO's ruling. It has until late November to do so.

A representative for Schwab, who is traveling in Asia, was not immediately available for comment.

Bacon's Rebellion: Virginia's Chronic Budget Surplus: An Update

Bacon's Rebellion: Virginia's Chronic Budget Surplus: An Update

Dem Victories in Md & Va Mean More Stem Cell Action?

More coverage of stem cells and the elections...

New Dems in Md., Va. won’t bring stem cell research funding right away
Katie Wilmeth, The Examiner
Nov 14, 2006 5:00 AM (3 hrs ago)
Current rank: # 9 of 5,967 articles


WASHINGTON - Despite victories for Democrats who support stem cell research in the Maryland governor’s race and the U.S. Senate race in Virginia, local biotechnology industry officials aren’t expecting a huge shift in policy anytime soon.

Virginia Democrat Jim Webb’s win in the U.S. Senate that captured the Senate majority for the party and Gov.-elect Martin O’Malley’s win in Maryland may eventually make some waves, but “it’s way too soon to tell,” said C. Robert Eaton, president of MdBio, an organization that represents the interests of the biotech industry in Maryland.

Eaton said the organization has no plans to meet with Governor-elect Martin O’Malley, but “I’d love to hear what their plans are and hope they get up to speed on [the industry].”

Maryland garnered national attention under outgoing Gov. Robert Ehrlich with the establishment of the Maryland Stem Cell Commission and a $15 million stem cell research fund. The commission is currently accepting grant proposals from Maryland-based researchers.

Funding for stem cell research has been a hot topic in the Washington region, and particularly in Maryland, recently. But it comes down to those in the scientific community — not in the political arena — who are largely shaping the progress, said stem cell research watchers.

Funding for stem cell research “primarily depends on whether the universities or hospitals think they have something to add.

Once they take up the issue of stem cells, then the politics comes in,” said Gail Pressberg, author of “The Promise of Politics of Stem Cell Research.”

Johns Hopkins University in Maryland is a leader in stem cell research, which helped secure funding from the state, Pressburg said. But in Virginia, where state universities haven’t focused on the issue, a Webb win isn’t likely to turn the tide locally.

However, the fact that Webb tipped the scales on the national level may eventually lead to new legislation, she said.

“It makes a difference when the party in favor of stem cell research controls the agenda by chairing the committees,” Pressberg said. “But it’s no guarantee ... they have to first deal with Iraq. I’ve talked to a bunch of lobbyists and nobody has a clue as to when this might come out.”

kwilmeth@dcexaminer.com
Examiner

Stem Cells and the new Congress

Stem Cells and the new Congress:

Stem cells a priority for new Congress
By KRISTYN ECOCHARD
UPI Correspondent

Click here for the article.

WASHINGTON, Nov. 9 (UPI) -- Stem cell issues emerged as an important platform during the midterm elections, and despite some moral concerns the new Congressional leadership is poised to bring the issue to the table.

Presumptive Speaker of the House Nancy Pelosi, D-Calif., has already listed funding for stem cell research as one of the top priorities of the new House.

"Bringing this issue up in the first 100 hours of Congress indicates the importance it had on the electorate," Daniel Perry, executive director of the Alliance for Aging Research, told United Press International.

Stem cell research focuses mostly on embryonic stem cells and how they might be used to create other kinds of tissue cells. A bill providing federal funding was passed by Congress earlier in Bush's presidency, but he vetoed it due to a religious outcry about the sanctity of life.

The support of stem cell research is promising but not a complete turn-around, said Jonathan Moreno, senior fellow at the Center for American Progress and professor at the University of Virginia in Charlottesville.

"On the surface, it doesn't appear there's a veto-proof majority in the House or the Senate," he told UPI. "But people may be more open now to hearing what the scientific evidence says."

One of the biggest challenges to supportive policy and funding other than from the private sector is the use of human embryos as the source of the stem cells, Henry Greely, professor at Stanford University, said during a public stem cell symposium at the National Academy of Sciences Tuesday.

Since the beginning of the debate, progress has been stalled by religious objections to endangering or destroying human embryos.

"The greatest religious concern has been the moral status of the embryo," said Suzanne Holland, associate professor of ethics and chair of the department of religion at the University of Puget Sound in Tacoma, Wash. "The greatest ethical concern surely is sensible oversight -- the just use of healthcare resources and research for the common good."

The Catholic Church's stance is that life begins at the moment of conception. However, survey results from a 2005 Johns Hopkins University study show that among U.S. Catholics, 69 percent dissent from the view of the church and approve embryonic stem cell research. Perhaps more surprisingly, the poll showed 49.5 percent of fundamental evangelical Christians approve of stem cell research, Holland said.

In the scientific community there is still some debate as to when a child's life has begun, although most believe an embryo is a developing human life. It's still debatable, however, whether the fetus is developed enough at five days or 14 days of life. At 14 days, it's highly unlikely the embryo will divide into twins, which begins its individual identity, Holland said.

Researchers can also do stem cell research on tissue or adult stem cells instead of embryos, which is more acceptable to religious leaders. The answer, Holland suggested, lies in respecting developing human life at the appropriate time and allowing research that has the potential to cure disease in people.

Using the existing method types -- destroying potential viable human embryos, the "dead" embryo method and non-embryonic cell harvesting -- a variety of cell types can be produced.

Nerve, liver, cardiac muscle, skeletal, blood and insulin-creating cells can all be derived from embryonic stem cells, said Alan Colman, chief executive officer of Embryonic Stem Cell International and senior scientist for A*STAR Centre for Molecular Medicine in Singapore.

The tissue cells that are created, however, only simulate the activity of an original cell and aren't as effective as the original, he said.

In recent research, cardiac muscle cells have been transplanted to pigs, rats and mice in Holland and California.

While the animal transplants were successful, the 97 trials transplanting skeletal cells into humans have had some problems, Colman said. One of the patients died of irregular heartbeat, and the rest of the patients have since been hooked up to defibrillators.

Another challenge, Greely pointed out, is that while embryonic stem cells are able to turn into any kind of cell, and they can be used to replace large quantities of different tissue types, safety regulations are difficult to define and enforce.

Whether the research is funded, banned, permitted or supported could be decided by the language used, he added.

"It matters what we call these entities," Greely said. "It may affect whether funding is admissible under President Bush's policy."

To make the best of the available funding, Greely suggested the scientific community should rank the types of research methods and invest in the ones that are most promising.

But for now, it's clear the new Congress will be in favor of stem cell research, said Sean Tipton, president of the Coalition for the Advancement of Medical Research.

He also said this issue is likely to be a major factor in the 2008 elections.

Tissue Technologies receives NIH grant

Virginia Biotechnology Research Park tenant, Tissue Technologies, was recently awarded a $100K Phase I SBIR grant from the National Institutes of Health for the development of a bedside diagnostic strip which will lead the care giver to treat chronic wounds more effectively.

“Some of the treatments that are currently on the market for chronic wounds can be extremely expensive and unfortunately are often used on wounds that simply won’t benefit from them,” commented Kel Cohen, MD, president and CEO of Tissue Technologies. “Our diagnostic strip will help medical professionals evaluate the best treatment options for their patient’s wonds.”

According to Cohen, the diagnostic strip can test the level of proteases in the wound. These are the enzymes found at high concentrations in chronic wounds. While these enzymes play an important role in tissue synthesis and degradation in normal wounds, chronic wounds produce too much proteases, resulting in substantial healing problems. Specifically, high protease levels in chronic wound fluid delays the wound healing process by degrading newly formed tissue and growth factors.

By using these “litmus” type testing strips, the doctor or nurse can determine protease levels to better evaluate what treatments will be most effective. It can also be used to monitor protease levels during and after treatment to ensure healing is occurring as expected.

“We are very excited about the results of our preliminary studies and the potential applications of this product,” commented Cohen.

In addition to the diagnostic strip, Tissue Technologies recently announced the FDA approval of a new product for dressing chronic wounds, which could potentially promote healing by eliminating the elevated levels of protease in chronic wound fluid.

Richmond Bioscience Companies Participate in Virginia Capital Day

Tissue Technologies LLC and Living Microsystems participated in Virginia Capital Day on November 2, 2006 at the Jefferson Hotel in Richmond. Living Microsytems Chairman Michael Grisham joined Wayne Hunter , Harbert Venture Partners, David Kauffman, Envest and Samuel Bemiss, III, Ewing Memiss & Co. in a panel discussion on investment strategies. The panel offered insightful comments on today's investment marketplace and shared the views of both investors and comapny executives on the current investment environment.

Tissue Technologies LLC was part of a select group of "Companies to Meet" who are currently seeking financing and looking to establish relationships with sources of capital. Dr. Kelman Cohen, founder and CEO of TT reprresented the company at this event.

Both Tissue Technologies and Living Microsystems are tenants in the bioscienes incubation program at theVirginia Biotechnology Research Park in Richmond.

Medgenics Scores $3M from Angels

Good news for a new Virginia biotech company...

Va. biotech secures $3M from angels
Washington Business Journal - October 27, 2006
by Vandana Sinha
Staff Reporter

A Virginia biotech is close to securing a $3 million first round of funding before hitting the road in search of more money.

Medgenics, which moved to Vienna from California in March after a struggle to survive, expects to close on nearly $2 million in mostly angel financing in the next month, adding to the $1 million it's already raised.

The company shares an office with one of its investors, venture capital firm Windy City.

After the first round closes, Medgenics will jump back on the circuit hoping to drum up $15 million more to fund Phase I and Phase II trials of its protein injection treatments, one for anemia slated to begin at the end of next year and another for hepatitis C expected to follow in the first quarter of 2008.

This is the second time around for the company, which had shut down for a year.

Medgenics raised $17 million in four rounds of funding during the company's first three years of operation. CEO Andy Pearlman founded the company in Palo Alto, Calif., in 2000 with technology he licensed from Hebrew University in Israel.
After failing to raise an additional

$25 million in a tough climate for biotechs, Pearlman was asked by a divided board to leave in 2003. He was replaced by Menachem Nassi, a CEO from the cardiac-imaging industry who sported an IPO track record and, the board thought, could round up that cash.

The company foundered without funding and closed up in 2004, leaving 32 people in California and Israel to find other jobs.

"Even though the technology succeeded, the CEO was unable to sell it or get people to invest in it," says Pearlman, who had remained on the board. "It just died for all the wrong reasons."

Last year, Windy City spent about $250,000 to buy out two investors, and Pearlman picked up the investment road map again. He's hired eight people, almost all former employees in Israel from Medgenics' previous incarnation, and is already talking up a potential IPO.

The staff has revived its tests on the technology, which turns a patient's toothpick-size tissue sample into its own production plant for disease-fighting proteins within 10 days. Doctors can inject that sample back into the patient's skin to pump those proteins through the body for months, dispelling the need for regular shots.

Once Medgenics is well funded, and well on its way through trials, it will hunt for a new headquarters, perhaps remaining in the Washington area.

"Washington has two great assets going for it. One is that the FDA is located here," says Joel Kanter, president of Windy City, a family-owned investment firm, and also "there is an extensive network of life sciences companies and, therefore, life sciences executives."

E-maiL: Vsinha@bizjournals.coM Phone: 703/258-0838

Diffusion Pharma Closes Deal; To Start Human Trials

Diffusion Pharmaceuticals LLC, a drug discovery and development company pioneering a revolutionary mechanism of action to treat life-threatening diseases, today announced that it has completed all animal toxicology studies required by the U.S. Food and Drug Administration (FDA) to file an investigational new drug (IND) application for its lead compound trans sodium crocetinate (TSC). The company also announced that it has completed a private financing round of $1.5 million, the proceeds of which will be used to support the company’s overall growth and move TSC into Phase I clinical trials in early 2007.

The recently completed toxicology tests were conducted at independent research laboratories, and were funded in part by a grant from the Office of Naval Research. The no adverse effect level (NOAEL) was about 500 times the efficacious dose in those animals, which is substantially higher than the proposed dose to be examined in humans.

“These studies show no appreciable toxicity of TSC, even at doses much greater than the proposed human dose,” said David G. Kalergis, Diffusion’s Chief Executive Officer. “Reaching this critical milestone has positioned us to prepare and file our IND application, which is currently being assembled by a team of Diffusion staff members and expert consultants,” he continued.

Assuming no significant FDA objections after filing, the company can proceed with its plans to initiate testing in healthy human volunteers. These studies are expected to begin in early 2007. Completion of these Phase I clinical trials will provide the foundation for further testing of TSC in populations suffering from such life-threatening conditions as hemorrhagic shock, stroke, respiratory disorders and cancer.

Additionally, Diffusion announced that it has closed a financing round in which it raised its target of $1.5 million in private equity, primarily from existing shareholders.

“These funds help move TSC into human testing, where we will have the opportunity to demonstrate the drug’s safety in humans and show proof of principal for the company’s novel technology,” said Kalergis. “Over the past 18 months, the company has also solved complex technical formulation issues, manufactured TSC to GMP (human) quality standards, and enhanced its intellectual property portfolio, all of which add value to the company and its platform technology.”