4-H Targets STEM Education in PSA

Senator Herring Named To State Technology Panel

If Governor-elect Bob McDonnell (R) has a New Year’s resolution, it might have something to do with bipartisanship.

In an interview with the Times-Mirror Dec. 30, Democratic State Sen. Mark Herring (eastern Loudoun) shared the news that McDonnell – who takes office Jan. 16 – has named Herring to the Technology Working Group advisory panel, part of the governor-elect’s transition team.

According to the transition office, the group involves technology leaders in the private sector with state government experience and legislators.

The mission of the panel is to do fact finding from the agencies, offer long-term strategic planning for state government and to turn campaign promises into action. The group will produce a report for the incoming governor and secretary of technology to advise them in the new administration.

Before his election in November, McDonnell had made technology a focus of his campaign.
“Northern Virginia’s technology community powers the economy of our state," he stated. "The men and women who work at [technology] companies are the innovators key to Virginia's, and America’s, future economic prosperity.”

Herring, who is halfway through his first term in the state Senate and is running for re-election in 2011, said he was “very honored” by the appointment. He added that he spoke last week with the head of the governor-elect’s policy unit about technology and the new panel.

“We talked a lot about areas where we could work together on technology, and I look forward to working with the new administration,” Herring said.

Herring represents eastern Loudoun County, an area rich in technology companies and data centers, including Aol., Verizon, Telos, Orbital, M.C. Dean, Ask.com, DuPont Fabros.
No further details were immediately available on the group's other members, or when they will meet in the coming weeks.

The position will not require Herring to give up his state Senate seat.

Herring received the 2009 Legislative Leadership Award from the Virginia Biotechnology Association for his successful efforts to adopt the Science and Technology Research Development and Commercialization Act. The legislation increases Virginia’s existing resources to support new technology and bioscience-related businesses.

Herring and his Loudoun colleague in the state Senate, Jill Holtzman-Vogel (R), both serve on the chamber's General Laws & Technology Committee.

By Nicholas Graham
Source: Loudoun Times-Mirror

Intelliject Twins Profile in RTD

Twins start firm to help allergy sufferers
Richmond Times-Dispatch
Jan 4, 2009

Millions of people at risk of severe allergic reactions to certain foods and bee stings rely on pen-size syringes that contain a life-saving dose of the drug epinephrine administered in an emergency.

As lifelong allergy sufferers, twin brothers Eric S. Edwards and Evan T. Edwards, co-founders of the Richmond-based specialty pharmaceutical firm Intelliject Inc., keep their epinephrine auto-injectors close by.

Accidental ingestion of peanuts, tree nuts and shellfish can cause them to go into anaphylactic shock, a potentially fatal allergic reaction. Tongue and throat tissues swell, making breathing difficult. A person may break out in hives and blood pressure may drop, causing fainting.

Injecting the drug epinephrine into the thigh quickly reverses the symptoms.

As grateful as the brothers are to have the existing injector technology available, from their own experiences they've concluded there has to be a better injector system.

The 29-year-old brothers and their management team have built Intelliject around the goal of creating a more intuitive, compact and safer emergency epinephrine delivery system.

Their result: a credit-card-size device that "talks" users through administering epinephrine.

"It's user-centered design," said Evan Edwards, vice president of product development at Intelliject.

"We really started with the patient and worked our way backwards," he said. "A lot of companies don't really think about how, in the moment of truth, when [people] are actually having to use the injector, what are the scenarios involved."

In the hands of a babysitter or parent who has never used an epinephrine injector, for instance, precious seconds could be lost trying to figure it out, he said.

A month ago, Intelliject moved into the big leagues, announcing a multimillion licensing deal with pharmaceutical giant Sanofi-Aventis U.S., which will manufacture and market Intelliject's novel epinephrine injector.

"Evan and I are just a small part of that" deal coming to fruition, Eric Edwards said. "We really have been blessed with an extraordinary management team."

That team includes President and Chief Executive Officer T. Spencer Williamson IV, who has been with the firm since 2006; Vice Presidents Kristopher D. Ford, Ronald D. Gunn, Neil D. Hughes and Mark J. Licata; and Chief Financial Officer Christopher T. Schools.

Sanofi-Aventis U.S. is an affiliate of Sanofi-Aventis, one of the world's largest pharmaceutical firms, with annual sales worldwide of about $40 billion in 2008. Sanofi-Aventis' U.S. product lineup includes blockbuster medications such as the allergy drug Allegra, the sleep aid Ambien and the clot-buster Plavix.

The agreement with Sanofi-Aventis U.S. calls for $25 million up front to Intelliject. In addition, Intelliject is eligible for up to $205 million more over time as development and commercial milestones are reached, plus royalties on sales associated with the licensure.

In announcing the deal, Sanofi-Aventis' Brent Ragans said: "This agreement complements our strong presence in the U.S. as a leader in the allergy arena and is a great example of our company's transformation into a provider of health-care solutions."

Intelliject retains licensing and marketing rights for their auto-injector delivery system in the rest of the world and is shopping around for other partners.

"The $25 million is being used to invest in our business and to realize the potential of Intelliject's portfolio across a range of therapy areas," Eric Edwards said. "We have over 70 patents pending, issued or granted and have multiple other platforms that can be utilized with a variety of pharmaceuticals across many therapy areas."

. . .

Not bad for two young men raised in Chesterfield County who have spent the past decade balancing school, starting families and building a firm they say is "all about relationships."

"Our faith is of extraordinary importance in everything we do," Eric Edwards said. "Some would say this is a faith-based company."

Explained Evan Edwards: "When you have the management team and everyone in the company that shares a similar culture, when you go through some difficult times, it really tests you, and that's when you have to really rely on faith to get over those hurdles. . . . We have seen that time and time again. This whole idea of us having allergies and living with it all our lives and turning it into an opportunity, we feel is very divinely led. It's not just by chance that all these individuals have come into our lives and helped us make an impact."

The sons of Linda and Gary Edwards went to Monacan High School, but their paths diverged for college -- Evan heading off to the University of Virginia to study engineering and Eric to Virginia Commonwealth University for biology and pre-med.

"We pretty much shaped our education around this idea of creating a better delivery system," Eric Edwards said.

A grant from the National Collegiate Inventors and Innovators Alliance started Intelliject, which in the early days was a family company, Evan Edwards said.

"We had our father be the CEO and our older brothers be a part of it," Evan Edwards said.

The brothers realized that to get to the next stage, they needed expertise they didn't have.

The Virginia BioTechnology Research Park, with its business incubation centers, offered a place to fine-tune their idea.

"We asked them to tell us their story," recalled David R. Lohr, executive director and vice president of business development at the park's Biosciences Development Center. "What are you trying to accomplish? What are you looking for in the way of help? We also shared with them our program, how it works, what it does and perhaps what it doesn't do. . . . We don't invest, but we can help them raise capital."

Lohr said his first impression of the brothers is that they had a unique and revolutionary idea -- they probably didn't realize how revolutionary.

"Not only did I see the potential to put epinephrine in this device, but I saw the potential to put a lot of other drugs into the device," said Lohr, who had run a drug-delivery company before. "Especially the newer biotech drugs that typically have to be injected anyway, they are very expensive, they would be more affordable if they could be self-administered, and the whole compliance issue would be better.

"We helped them to think about this as a drug-delivery company and not just a single-product company," Lohr said.

Over the next three to four years, the incubation center provided mentoring, networking, help with the business plan and financial model development, fundraising and help identifying a chief executive.

"Why are these guys successful? They had a great idea rooted in their personal understanding of an unmet medical need," Lohr said.

"The thing that differentiated them is these guys listened and took the advice they were given from this myriad of advisers. They processed it, integrated it, and they just kept redoing their thinking."

. . .

Now ensconced in Intelliject's modern offices in Shockoe Slip, Eric Edwards and Evan Edwards talked about what's next for them.

Evan Edwards is preparing to move to Indianapolis temporarily. The brothers are limited in what they can say about product development, so he will not say what he will be doing specifically.

"As Spencer [Williamson] likes to say, it's really the end of the beginning," Evan Edwards said. "Because there is so much more work to do."

Success, for them, will be when their auto-injector is in the hands of people, like themselves, at risk of severe allergic reactions, Eric Edwards said. That is at least a year or more down the road.

"With this partnership, Intelliject is responsible for finishing the development of the product through [Food and Drug Administration] approval," Eric Edwards explained. "It's a late-stage product. We will be filing our new drug application with the FDA [in 2010]. . . . Within the next couple of years this product should be on the market."

VA Biotech Park CEO Bob Skunda on State Biotech Policy

VA State Senator Mark Herring (D-Loudoun) on Biotech Development

Howard Dean on Biotech & Healthcare Reform

Building Biotech Bridges Conference

Co-hosted by: Biotechnology Institute and MdBio Foundation, Inc.

November 17, 2009 - 8:30am-4:15pm
Naval Heritage Center - 701 Pennsylvania Avenue, NW - Washington, DC

Early bird rates apply until Nov. 5!
A comprehensive look at how the biotechnology and education communities work together at the local, state, and national level to address science education and workforce development. Attendees will learn how to develop and enhance partnerships between the biotechnology and education communities.

WHO Should Attend? The conference will be a premier professional development and networking opportunity for:
• Biotechnology professionals in community relations, communications, government relations, or human resources who want to develop or enhance their science education support initiatives in order to advance their company's strategic objectives
• Educators and education administrators looking to establish or better leverage partnerships with industry in order to advance their education agenda
• Nonprofit professionals who want to become integral to developing partnerships among the industry and education communities
• 
Keynote speaker: Rep. Vernon J. Ehlers
• Other speakers include: Thomas F. Bumol (Applied Molecular Evolution, 
Eli Lilly and Company), Christy Shaffer (Inspire Pharmaceuticals), Henry Darnell (Genzyme Corp.), Tara Hiltke (Program Manager, National Cancer Institute), Liz Huntley (MedImmune), and Lynn Johnson Langer (Johns Hopkins University)


Register now at http://www.biotechinstitute.org/programs/bridges.html
Early bird rates apply until Nov. 5!

Forbes on Essentials for Attracting Angel Investors

Great article on essentials for raising angel funding.

Forbes.com
Deep Pockets
Ten Ways To Attract Angel Funding
Martin Zwilling, 10.27.09, 6:15 PM ET

The papers are filled with scary statistics. Here are a few more for entrepreneurs on the hunt for capital from angel investors--those loosely banded groups of deep-pocketed individuals looking for the handsome returns that only risky, early stage investing can (sometimes) bring.

According to the latest data from AngelSoft, which pairs entrepreneurs with angel groups in a particular city or ZIP code, only about one out of 100 companies that make a formal request for angel funding manage to secure the capital. Among the axed, three-quarters never make it past the initial screening process; of those that do, more than half are eliminated during live presentations and discussions, and another 10% during the following due-diligence process.

It's a brutal gauntlet.

While there are no guaranteed strategies for success, you can boost your chances of survival. Over the past decade, I have had the opportunity to see how the process works, several times from the start-up side, and more recently from the angel perspective (as a member of the selection committee for the Arizona Angels Investment Network, in Phoenix).

Here is my list of the top 10 action items for those looking to land angel funding. If some of these are familiar, ask yourself: Are you actually doing something about them?

1. Incorporate your business now. If you expect to seek external funding, first incorporate as an S-Corp, C-Corp, or a limited liability company, rather than the more expeditious sole proprietorship or partnership. Corporate entities allow for easy carving up of equity stakes, one reason why unincorporated entities often can't find funding.

2. Line up an experienced team. There's an adage: "Investors fund people, not ideas." Not only is this dead on, poorly assembled teams are probably the biggest stumbling block in the initial angel-screening process. If the founders are not experienced, find a couple of advisers who are experts in your industry to fill the gap.

3. Launch a Web site. I don't care what kind of company you are, in today's world, you need a cleanly designed, easy-to-use Web site. If not, you won't be perceived as a real company. Investors routinely troll sites of companies looking for capital to get a feel for their tone and scope, as well as the nature and maturity of their products and services. Also, protect that virtual real estate by reserving the company name on social-networking sites.

4. If you have real intellectual property, defend it. File patents and trademarks. They may or may not be true barriers to entry (first-mover advantage can be more powerful than any patent), but they are often perceived as such. Start the process early, as it takes a while to pound through. (Note: Patents can run the gamut. For more on this, check out "Ten Of The Zaniest Patents.")

5. Build a prototype product. Many entrepreneurs need capital to build a prototype product, yet most angels expect to see a prototype before they invest. Do what you can to demonstrate progress early.

6. Hit the high notes. At the initial screening, investors expect a one- or two-page summary of the business, including an explanation of how it makes money and how specifically you would invest an angel's capital to boost your prospects--all backed up by a streamlined 10-slide PowerPoint investor presentation. Remember to aim the content at investors, not customers. (Translation: Don't spend too much time gushing over every last product detail.)

7. Prepare an investment-grade business plan. All entrepreneurs need a well-crafted business plan for their own use, whether they intend to seek investor funding or not. As a founder, you may think that everyone understands your vision based on your words and passion, but it doesn't work that way. A good business plan should answer every question an investor or associate might ask. For a breakdown, check out "10 Elements Of A Sound Business Plan."

8. Finalize your financial model. Like the business plan, a financial model is required as much for your own use as to impress angel investors. In most cases, an interactive Microsoft Excel spreadsheet is adequate, with projections (and well-defined and denoted assumptions that drive them) for revenue, expenses and cash flow over the next five years. Best-, expected and worst-case scenarios add credibility.

9. Close at least one customer. This must be someone who is willing to pay real money for your product or service. Free trials don't count. All the conviction and market research in the world are no substitute for real customers paying real money.

10. Network--ahead of time. This last item should be your first: Build relationships with investors and friends of investors before you need their money. Start by taking an active role in relevant technology groups, trade associations and university functions.

I hope the takeaway is clear: Angels can be saviors, but not without plenty of careful preparation. Don't expect anyone to swoop down, gather you up and whisk you to financial freedom. For more on raising angel funding, read "Wooing And Choosing The Right Backer."

Martin Zwilling is the founder and chief executive officer of Startup Professionals, a company that provides products and services to start-up founders and small business owners. He can be reached at marty@startupprofessionals.com.

Biotech Issues Featured in O'Bannon vs. Shields Race for Delegate

Delegate John O'Bannon (R-Henrico), co-chair of the Virginia Bioscience Caucus, is promoting his support of the Virginia biotech industry in his advertising. John also was the chief sponsor of our legislative package last year that enhanced the incentive for investors to support advanced technology companies in Virginia.

Way to go, John!

A New Treatment for Chronic Wounds

Israel could become a leader in the $3 billion chronic wound industry with a new device that heals wounds faster and more cheaply than alternatives.

Millions of Americans, particularly the elderly and diabetics, are afflicted with chronic wounds, which are complicated to treat and can lead to lengthy hospital stays. With life expectancy and the numbers of those suffering from diabetes and obesity increasing worldwide, the global chronic wound industry currently totals around $3 billion.

Israeli company EnzySurge hopes to change the way chronic wounds are treated, with its DermaStream product line. The device is relatively low-cost, has the appearance of a bandage and is disposable, unlike the unwieldy equipment in use today.

Its small size and simplicity make it convenient for use in outpatient facilities or at home, reducing the need for costly hospital stays. It also helps wounds heal faster, saves time for physicians and nurses, and cuts costs. The technology is currently undergoing regulatory procedures and will reach the market next year.

Based on the company's patented Continuous Streaming Therapy technology (CST), the new DermaStream device meets a variety of important needs: It applies negative pressure to a wound, while at the same time providing a continuous stream of healing solutions to the wound bed. DermaStream also drains the wound of exudates - bacteria and other fluids that are released and can hinder the healing process.

Simplify treatment, reduce costs

"DermaStream provides the combined effect of streaming, negative pressure, and the active ingredient in a solution that is determined according to the wound type and stage, for a comprehensive approach to treatment," Amir Shiner, CEO of EnzySurge, tells ISRAEL21c. "The idea is to simplify the means of treatment while simultaneously providing an effective solution for patients that is low-cost, easy to use, and can be used in homecare."

A supplemental technology developed by EnzySurge is SilverStream solution, which topically infuses the wound with a very low concentration of silver ions. This solution is a powerful enemy of bacteria and can enhance the effects of DermaStream. Like DermaStream, it will be available next year.

Given recent US government attempts to reform national healthcare and reduce standard treatment costs, EnzySurge's products are coming to market at just the right time, says Shiner.

"Most of these chronically ill patients are 65 and older and are covered by Medicare or Medicaid. There's a lot of receptiveness now to alternative treatments that are lower-cost and intended for outpatient settings, to be used by the patients themselves," he says.

Getting rid of dead tissue in the wound

The latest technology in development at EnzySurge is an enzymatic Debridement solution, which in conjunction with the DermaStream device removes necrotic (dead) tissue from the wound.

A clinical trial on the new system performed on 48 venous ulcer patients in Israel demonstrated good results. The debridement solution is expected to begin its regulatory approval process in 2010.

EnzySurge's technology is based on research by Prof. Amihay Freeman of Tel Aviv University's Department of Biotechnology. He founded the company, which is headquartered in central Israel in Rosh Ha'ayin, with an additional office in Richmond, Virginia, in 2001.

The company is collaborating with the Virginia Biotech Commercialization Center (a wholly owned subsidiary of Virginia Life Sciences Investments) on business development, reimbursement, marketing and sales. EnzySurge currently employs 10 people and has raised $8 million from private investors in Israel.


Israel 21C
By Ilana Teitelbaum
October 25, 2009

State bioscience group formed

West Virginia's bioscience firms have started a new group in hopes of expanding the biotech industry across the state.

The BioScience Association of West Virginia will be made up of biotech companies and organizations, as well as research groups at Marshall University and West Virginia University. The statewide association will be an affiliate of the National Biotechnology Industry Association.

"This organization will coordinate the exchange of ideas and research, develop new business relationships and expand efforts to attract economic development opportunities for biosciences in our state," said Gov. Joe Manchin in a prepared statement.

About 6,900 people across the state work in bioscience jobs, according to a study by WVU's Bureau of Business and Economic Research. In 2006, the average bioscience worker earned more than $55,000 a year. Bioscience employees made a combined $1 billion in wages. The industry creates about $7.2 billion a year in economic activity across the state, according to the WVU study.

Bioscience employment is largely concentrated in Charleston, Huntington, Morgantown and Tyler County. Monongalia has the most bioscience employees -- 2,269, followed by Kanawha County with 2,033. West Virginia has about 241 firms that work in bioscience fields. Those firms include organic chemical and fertilizer manufacturers, biopharmaceutical companies, and biological research facilities and testing laboratories.

Patrick Kelly, vice president of government relations for the national bio-tech group, said Manchin's "Bucks for Brains" initiative -- a plan to stimulate research jobs at WVU and Marshall -- has given West Virginia's nascent bioscience industry a "tremendous shot in the arm." The state spends about $4 million a year on the "Bucks for Brains" program.

"We look forward to working with [the West Virginia BioScience Association] to help promote the bioscience industry development, champion science education and help attract high-skill, high-wage jobs to the state," Kelly said.

The West Virginia biotech group has started a membership drive. Its Web address is www.biowv.org.

Derek Greg, chief operating officer at Vandalia Research in Huntington, is chairman of the statewide association. Steven Turner, chief executive officer of Protea Biosciences in Morgantown, also will serve on the group's board of directors.

By Eric Eyre

The Charleston Gazette

Two Prominent State Biotech CEOs Resign: Gardner from BayBio and Eaton from AzBio

Two state biotech execs with roots in the Maryland biotech community resigned from their posts last week. Bob Eaton, the former CEO of MdBio, resigned from AZBio. Matt Gardner, the CEO of BayBio, and former executive director of the Tech Council of Maryland's Bioscience Alliance, also resigned his post late last week.

Both were members of the board of directors of the Council of State Bioscience Associations (CSBA), the national group comprised of all 44 state bio trade associations across the USA.

BayBio chief Matt Gardner resigns
Matt Gardner, president of local biotech trade organization BayBio for six years, has resigned.

In an email from Chairman Bill Young to BayBio members, Gardner said he would “pursue other opportunities.” Gardner did not specify what he was considering or when he would officially step down from BayBio.

“I have worked with the BayBio board of directors to effect a smooth transition plan designed to deliver the organization to new heights,” Gardner wrote.

In six years under Gardner’s leadership, BayBio has grown more than 150 percent in membership, he noted, and is nearing 500 members at its 20th anniversary. The organization also has added new programs, including lobbying, advocacy, communications, group purchasing, entrepreneurship and science education.

BayBio serves more than 900 life sciences companies.

Gardner, who bachelor’s and master’s degrees from the University of San Diego, came to BayBio from the Maryland Bioscience Alliance, where he was director, and spent six years as North American business development director for the government of Queensland, Australia.

San Francisco Business Times

And here is the news on Bob Eaton...

Eaton out, Green takes over at Arizona BioIndustry Association
Bob Eaton has quietly left the Arizona BioIndustry Association, and a new president and CEO already has been named.

Eaton is resigning his position under a mutual agreement with the AZBio board.

His replacement, Robert Green, is a longtime Tucson biotechnology entrepreneur who has formed and operated several biotech companies since moving to Tucson in 1989. Late last year, he sold Integrated Biomolecule Corp. to Ventana Medical Systems/Roche Group.

On Sept. 24, AZBio held its annual awards dinner, honoring six companies and individuals who are changing the world through bioscience innovation. Ventana was named Bioscience Company of the Year, while Applied Microarrays Inc. of Tempe received the Fast Start Award.

Martin Shultz, vice president of government affairs at Pinnacle West Capital Corp., received the Jon W. McGarity Leadership Award. Bruce Rittman, director of the Center for Environmental Biotechnology at Arizona State University’s Biodesign Institute, won the Award for Research Excellence.

Arizona Rep. Nancy Barto, R-Phoenix, received the Public Service Award, and the Bioscience Educator of the Year Award went to Barbara Fransway, outreach coordinator and research specialist at the University of Arizona’s Arizona Research Laboratories.

Device Makers Fight to Cut New Fees in Senate Health Bill

This article from the WSJ provides background on the multi-billion dollar battle over new fees (taxes) placed on the makers of medical devices.


Medical-Device Makers Push to Cut New Fees in Health Bill
By ALICIA MUNDY and MARTIN VAUGHAN

WASHINGTON -- Medical-device makers, joining an 11th-hour scramble to influence the shape of health-care legislation in the Senate Finance Committee, have petitioned panel chairman Max Baucus to shave billions of dollars in fees that the industry would face under the measure.

The Advanced Medical Technology Association, or AdvaMed, the trade group for the larger device manufacturers, wants the Montana Democrat to reduce $40 billion in fees over the next decade to $15 billion, according to people close to the negotiations. But industry was told that offer is too low. As of Sunday, the final draft included the higher number.

Wanda Moebius, a spokesman for AdvaMed, declined to comment on the $15 billion counteroffer, calling it "rumors and speculation."

"AdvaMed continues to work with members of Congress to educate them of the onerous nature of this [annual] $4 billion tax -- nearly half of the total of the industry's research and development investment in 2007," Ms. Moebius said.

With the Senate Finance Committee expected to vote on its health bill as early as Tuesday, lawmakers, industry executives and others have been seeking to make final changes. A main challenge in passing a health bill has been finding a way to pay for the overhaul. That is the aim of the proposed fees on medical devices, along with other fees and taxes that would be imposed on the drug industry, hospitals and the insurance industry.

People close to the negotiations said the White House supported a medical-device tax to help pay for the overhaul. A White House spokeswoman said the administration doesn't comment on specific health-care legislative provisions.

Administration officials and Mr. Baucus were troubled that AdvaMed and the $200 billion industry didn't offer any concessions to the White House and Senate Finance Committee early this summer.

AdvaMed's president said in a recent interview that the industry had proposed a way to save billions of dollars that would involve a tax on hospital-supply and device wholesalers, which they could pass on to the device makers. Wholesalers strongly objected to the proposal. It was rejected by the Senate committee, AdvaMed said.

The pharmaceutical industry in June offered concessions that would save the government an estimated $80 billion on health-care costs over the next decade, and the coalition of hospitals proffered $155 billion. Executives from both industries believe some sort of health legislation is likely to pass and would prefer to have a say in shaping it. Administration officials have told them that expanded, government-subsidized health coverage would likely bring them millions of new customers.

Industry and congressional aides said a deal could still emerge with device makers before the Finance Committee votes on the health bill.

A number of lawmakers have voiced support for the device makers. Sens. Amy Klobuchar and Al Franken, both Minnesota Democrats, have publicly objected to the proposed fees, which they describe as a tax, as have Indiana's two senators, Republican Richard Lugar and Democrat Evan Bayh. Medtronic Inc., a major cardiovascular-device maker, is based in Minneapolis, and defibrillator maker Guidant Corp. is based in Indianapolis.

President Barack Obama pushed the health-care overhaul in his Saturday radio address, saying it would drive down the cost of insurance for small businesses, which, in turn, would help them grow and create more jobs.

'Darwinian' Cuts in VC Funds and Biotechs...

Great coverage of David Mott's remarks last week to the MAVA breakfast.

Tuesday, September 29, 2009
Dave Mott: Biotechs face tough road
Baltimore Business Journal - by Vandana Sinha Contributor

Biotech entrepreneur Dave Mott suggested that the worst capital markets he has seen for emerging life sciences companies in a quarter-century has perhaps hit bottom.
But even with an upswing, the next generation of successful companies will confront much stronger barriers to nailing capital than did its predecessors, including Mott himself, the former MedImmune CEO said in a talk to local life sciences leaders hosted Tuesday by the Mid-Atlantic Venture Association.
A year after selling Gaithersburg's MedImmune to London-based AstraZeneca PLC, Mott moved back last year to his investment banking roots to become a general partner at New Enterprise Associates, a Chevy Chase venture capital firm that focuses on health care, technology, energy and biotech companies.
“Three years from now, there will be one-third as many venture capital firms as there were three years ago,” Mott said. “And there will be half as much money.”
But he said that sort of Darwinian selection will be a good thing -- a slimmer funding pot filters out the companies with weaker prospects from the beginning, ensuring only the strongest survive. “The industry is alive if not well,” he said. “Any purging that has been happening and is still ongoing in our ranks is going to be good for our industry. ... [Before], we were starting companies that weren’t going to get bought out.”
Indeed, he said venture capitalists must continue to be more selective, a common criticism from early-stage companies that protest that investors don’t give them a second glance. Mott said he foresees that changing, that earlier-stage companies with pathbreaking science offering a broad range of drug possibilities are likely to start receiving the venture checks and undergoing initial public offerings. Later-stage companies, which have long been the sweet spot among investor circles, may have to prove themselves more able to cross the hurdles that can often pop up among that age group -- things like lukewarm drug results, partnership interference or stock dilution.
“I think there’s going to be a surprising shift to the big idea, science-based companies, sort of where we were 20 years ago,” he said.
But he did render a tough review of the local biotech industry, saying it’s only produced a handful of spinouts that would catch a venture capitalist’s eye. “I go above and beyond looking for local companies” to invest in, he said, “but I can’t make bad investments.”
He added that his job is to opt for the best science and management teams, even if he finds them in La Jolla, Calif., San Francisco Bay or Cambridge, Mass., rather than local counties. “Right now,” he said, “I see a much higher concentration of investable opportunities in those three regions than I see here.”

Venture-backed firms faster at growing jobs, revenue

Venture-backed firms in the United States grew both revenue and jobs faster than non-venture backed companies and accounted for 21 percent of the U.S. GDP in 2008, according to a report by the National Venture Capital Association.

The report, based on IHS Global Insight research, shows that venture-backed companies employed more than 12 million people - 11 percent of the total private sector employment - and generated nearly $3 trillion in revenue in 2008.

"These findings extend trends regarding venture capital’s outsized impact – or “ripple effect” – on the U.S. economy that stretch back to the first edition of this report, published in 2001," the report says.

"Venture-backed companies outperformed the overall economy in terms of creating jobs and growing revenue...and continues to produce some of hte U.S. economy's best performers," it adds.

It points out that the VC industry continues to grow entire new industries from scratch, playing an instrumental role in creating and nurturning the IT, biotech, semiconductor and online retailing industries, while investment data suggests that social media and clean tech will join that list.

The report says that for every dollar of venture capital invested from 1970 to 2008, it generated $6.38 in revenue in 2008, creating one U.S. job for every $37,702 invested.

In the Southeast Georgia came in at number 5 on the top ten list of employment at VC-backed firms in 2008, with Tennessee number 7 and Florida at 11.

In revenue produced by VC-backed companies, Virginia ranked 7, Florida 9, Tennessee 11, and Maryland 14 in 2008.

Maryland had the second highest rate of growing revenue and employment at VC-backed firms from 2006-2008.

For the full report see: http://bit.ly/2iyl0A.

September 17, 2009

By Allan Maurer From: TechJournal South

Sign Letter Now to Support the Federal R&D Tax Credit!

Take action today to support the extension and enhancement of the Federal R&D tax credit that expires on December 31.

The effort is spearheaded by the R&D Credit Coalition. The objectives of the R&D Credit Coalition are: a strong, permanent R&D credit of commensurate rate for all companies; a 20 percent simplified credit; and an extension of the traditional credit.

To add your company to a letter to be sent in late September to all members of Congress, both Senators and Representatives, please click on the link below to 1) read the letter, and 2) electronically authorize your company/organization name EXACTLY as it should appear on the letter. (NOTE: only the Company/Organization name will appear on the letter; the contact name & phone number will Not appear on the letter.)

Company-Organization R&D Credit Letter

Deadline: September 23, 2009

For more information, click here: http://www.investinamericasfuture.org/index.html

VA Biotech Companies Urged to Sign Up for Tax Credits

Another great article by Vandana Sinha.

Virginia biotechs urged to register for tax credits
Washington Business Journal - by Vandana Sinha Staff Reporter

Virginia bioscience leaders are urging companies to register to be eligible for new state investor tax credits targeting their industry for the first time.

Virginia lawmakers narrowed a $3 million pot of tax breaks for angel investors down to those investing in only bioscience and advanced technology companies. The money will be available this calendar year to companies that register by the end of December.

“It was so broad before that in many cases you could be investing in a restaurant and get a tax credit,” said Mark Herzog of the Virginia Biotechnology Association.

With the newly revised tax credits, which both the companies and investors must apply for each year, Virginia joins Maryland by focusing such incentives on an industry where early-stage investments are too crucial to do without, but too risky to attract much attention from established funds. In Maryland, the state allotment is $6 million.

In the Virginia fund, half is reserved for biotech and tech spinoffs from universities. Herzog said all qualified companies would split the available funds equally, unlike the first-come-first-served system in Maryland.

“Going forward, as we reach out to a broader group of investors, that’s something that will be attractive,” said Ross Dunlap, chief operating officer of Ceres Nanosciences LLLP, a Manassas-based George Mason University spinoff that has raised $1.5 million from mostly friends and family in the last year.

The Virginia bill also provides for up to $100,000 in matching federal Small Business Innovation Research grants, though not for firms that work with embryonic stem cells.

RTD Editorial By CEL-SCI CEO: Don't Kill Biotech With Bad Policies

This editorial is in today's Richmond Times Dispatch.

Virginia Economy: Let’s Be Sure Biotech Has a Bright Future
GEERT KERSTEN GUEST COLUMNIST
Published: September 2, 2009

They are the 21st-century's white-coat warriors: biotech researchers determined to create cutting-edge drugs from living organisms. The resulting medicines, called "biologics," typically take over 20 years and $1.2 billion to develop.

Successful drugs can work wonders. There are biologics currently on the market treating cancer, multiple sclerosis, and a host of other illnesses. And with about 600 biologics in the pipeline around the country, more medical miracles might lie just over the horizon.

It's not an exaggeration to say that we safeguard our own health by safeguarding the health of biotechnology research.

But because biologics tend to carry a hefty price tag, they've become a tempting target for cost-cutting among some in Washington. What the politicos fail to appreciate, though, is just how much investment is required to create a biologic in the first place.

While biotech revenues have risen over the three decades since the sector emerged in the mid-1970s, profits have continued to hover near zero.

"Consumers see market prices for drugs far in excess of production costs and it looks like large profits," noted Yale economics professor Fiona Scott Morton in congressional testimony. "Government payors then face the temptation of using their power to force prices below market levels."

Morton warned that if policymakers restrict the financial return on these drugs, the venture capital so critical to funding biologic research will dry up, with investors putting their money where a higher rate of return is more likely.

THE CRUX of the controversy is over intellectual property rights: How long should the government allow biotech companies to sell a new drug competition-free, before allowing outside firms to co-opt the research data on that drug and use it to concoct cheap generic approximations?

Because atom-for-atom replicas of biologics are virtually impossible, these copycat drugs are called "biosimilars" or "follow-on biologics."

Research from Duke University suggests it takes 13 to 16 years of sales for a firm to break even on a biologic drug. Therefore, it's reasonable to grant brand-name producers a 12-year period to keep their research data private, effectively blocking the creation of competing biosimilar products for that time period. A bill recently approved in House and Senate committees does just that.

This robust protection would put U.S. biotech firms on a level playing field with biotech companies in the European Union, which currently grants at least 10 years of data privacy. Unfortunately, some lawmakers have proposed shortening data protection to as low as five years.

If that were the case, firms could churn out biosimilars well before the original manufacturer has had a chance to recoup its investment costs. Developing these medicines would become a money-losing enterprise. At that point, what investors would continue pouring money into this research?

In short, whittling away the data privacy period for biologics will result in fewer investment dollars going into biotech research, which in turn will result in fewer and fewer life-saving biologics.

That would be bad not only for patients in Virginia. The decline of the biotech industry would exact a toll on the state economy, too.

THE BIOSCIENCE sector accounts for more than $2.5 billion in annual economic activity in Virginia. This state is home to 160 biotech-related companies, including 82 biotechnology firms, 29 medical device companies, 28 contract research and support organizations, and 31 businesses that produce sophisticated equipment supporting the bioscience industry.

If data protections aren't strong, investment into these firms will dry up.

Let's use our own company as an example. We have been working with complete dedication for more than 20 years on a cancer immunotherapy that is designed to make the first cancer treatment more successful, and thereby increase the survival of the patients. The treatment has shown excellent results in human studies around the world and is not toxic.

Yet, even with this excellent data, our company has had to survive many "near death" experiences. If there is even the perception among investors that they will not be able to have acceptable returns on such a risky investment, companies such as ours will no longer receive funding and our society will be left with only those advancements that come from the big pharmaceutical companies -- and that's not much. Almost all breakthrough drugs have come from small biotechnology companies and they need the longer protection to recoup the investment costs. If they do not get it, there goes the funding for novel research and with it our hope for new breakthrough drugs.


Geert Kersten is the CEO of CEL-SCI Corp., a biotechnology company headquartered in Vienna. Contact him at (703) 506-9460 or find out more at http://www.cel-sci.com.

Francis Collins Remarks to Reporters on First Day at NIH

Funding Top Goal for New U.S. Research Institute Head
Reuters
By Maggie Fox
August 17, 2009
BETHESDA, Maryland (Reuters) - The new director of the U.S. National Institutes of Health, Dr. Francis Collins, has one main goal for the giant research agency -- getting more money.

On his first day on the job Monday, Collins told reporters he would press Congress for more stable funding of the agency, which has a budget this year of $30.9 billion.

The NIH has complained of "flat" funding in recent years, which Collins says translates to 17 percent less spending power since 2003. As a result, researchers are demoralized, good ideas never see the light of day and the United States is losing its lead in medical research, he said.

Predictable, stable funding "has to be our number one priority," Collins said.

The economic stimulus package approved in March allocates $10.4 billion in extra money to NIH for 2009 and 2010. "What keeps me awake is ... what is going to happen after two years of (stimulus package) funding ends," Collins said.

He said NIH got 22,000 grant proposals for that extra $10 billion. "There is fabulous science there. This tells you there is pent-up demand," he said. But only 3 percent of the ideas will get funding, he said.

He said NIH spending offers all sorts of value, including the potential of helping President Barack Obama's healthcare reform efforts by funding and conducting studies that show which treatments work best.

For example, the NIH-sponsored Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial or ALLHAT found in 2008 that cheap, generic, diuretics protect better against heart disease than newer, more expensive drugs.

'KICKING OURSELVES'

Collins has a pet project that he would like the agency to pursue -- a so-called prospective study of 500,000 people that would look at all aspects of their health over decades to determine the underlying causes of disease.

"I think if we don't start a study of this sort in the next 10 years, we will be kicking ourselves," he said.

Collins also floated the idea of drug companies paying royalties for government research they benefit from. NIH and the 325,000 researchers it funds do much of the basic scientific research that leads to drug development. The most promising work then goes to pharmaceutical companies, which develop and profit from those drugs.

Collins opposes the idea of limiting what companies can charge for drugs, but said the idea of royalties to pay back the taxpayers might work. "You are engineering a system that allows some payback to the public," he said.

He also wants to encourage younger scientists, noting that most U.S. researchers do not get grants to do their own work until age 42. And he wants to do a better job of communicating NIH research to the public.

"Maybe I should start tweeting," he said, referring to the popular Twitter social networking tool. "We have a lot of cool stuff going on, and we don't necessarily tell the world about it," he said.

Collins, an evangelical Christian, also said he had resigned from the BioLogos Foundation he has just founded to address "the harmony of science and faith."

Check out the YouTube Teaser for "District 9 Facts" Website

BIO Just launched a new website called "District 9 Facts" at http://district9facts.com/. It does a great job of looking at the science behind the film in a light-hearted way.