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.

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