Monday, December 21, 2009

VA Biotech Park CEO Bob Skunda on State Biotech Policy

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

Tuesday, November 10, 2009

Howard Dean on Biotech & Healthcare Reform

Wednesday, November 04, 2009

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!

Friday, October 30, 2009

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!

Thursday, October 29, 2009

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

Tuesday, October 20, 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.

Monday, October 05, 2009

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.”

Friday, September 18, 2009

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.

By Allan Maurer From: TechJournal South

Tuesday, September 08, 2009

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

Friday, September 04, 2009

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.

Wednesday, September 02, 2009

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.

Thursday, August 20, 2009

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."

Wednesday, August 19, 2009

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.


Monday, August 03, 2009

Blacksburg's Intrexon: Branching out in biotech

Five years ago, a small biotechnology company relocated to Southwest Virginia from Ohio.

Intrexon Corp., then called Genomatix, had five employees.

Now, after a period focused primarily on research and development, the private company is reporting a wave of hiring, expansion and scientific progress. The company has received clearance to test an experimental treatment for melanoma in human beings.

"This is a young company that's emerging out," said Robert Beech, vice president of business development at Intrexon.

Started as a contract manufacturer of genetic materials, Intrexon now strives to develop products. Its says its modular DNA control systems can improve medical therapeutics, human protein production, industrial enzymes and agro-biotechnology.

Intrexon has received outside investments of $66.5 million, including $10 million in June. Its revenue, from licensing activities, is "on the margin," Beech said.

Beech said that Intrexon plans to open an office in the Maryland biotech corridor to support clinical development activities and one in San Francisco related to a push into human protein production.

He said the firm intends to fill 50 new jobs by the end of the year, mostly outside Blacksburg. Beech declined to give the current employment, saying some secrecy helps preserve the company's competitive edge. (It's been as high as 140 between Blacksburg and an office in Pennsylvania, according to past company statements, but the company has also confirmed a number of dismissals.)

Many in the health care and patient communities want the kind of therapy Intrexon is trying to create.

The target of Intrexon's experimental therapy, melanoma, is a serious form of skin cancer that doctors find difficult to effectively treat in its advanced stages with surgery chemotherapy, radiation or immune system stimulation, said Dr. Fred Lupton, a Greensboro, N.C., dermatologist.

Melanoma causes an average of 8,650 deaths annually in the United States and 68,720 new cases are diagnosed each year, according to the National Cancer Institute.

"If we can cut it out early and get rid of it when it's still on the skin or in the skin, we can have a great chance of success," Lupton said.

Untreated, the abnormal cells may spread to adjacent skin or migrate through the lymphatic system or bloodstream to even distant tissue or organs. When that happens, survival is difficult, Lupton said.

"We're just kind of beating our heads against the wall on this disease," Lupton said.

On May 11, Intrexon announced that its therapeutics division had administered an experimental therapy for melanoma to the first of up to 16 patients in a clinical trial.

The University of Pittsburgh Cancer Institute recruited or is recruiting advanced melanoma patients to be injected with their own cells reprogrammed in a way that company officials believe will stimulate the immune system to fight the cancer. Intrexon spent four years developing the experimental therapy.

In an interview, Beech couched his description of the therapy in terms of possibilities, not certainties. As he knows, nothing is a sure thing, at least until after the Food and Drug Administration gives approval to provide a drug or therapy to the public. (And even then, FDA-approved drugs have been pulled from markets.)

"It is our belief," Beech said, that the therapy can train the immune system to attack and kill solid tumor cancers.

The intent, he said, is not only to treat tumors effectively but to combat cancer at a lower cost than some other therapies that produce serious side effects requiring separate, additional treatment.

Intrexon "has a great mission," Beech said. "If it is as successful as we think it can be, it will have very significant positive socioeconomic consequences."

Getting started

Five years ago, the company left Cincinnati, where it was founded in 1998, and relocated to Southwest Virginia at the urging of the Virginia Tech Corporate Research Center and Carilion Biomedical Institute.

Creating jobs and investment in Southwest Virginia was a major objective for the courtship, which was followed by construction of a laboratory for the company in the Warehouse Row business center in downtown Roanoke. Carilion, the Virginia Tech Foundation and individual investors put $850,000 in the company in return for ownership shares. Company executives invested $75,000.

Intrexon later established its headquarters and laboratories for DNA vector production and cell testing at the corporate research center. An acquired company is located near Valley Forge, Pa.

Cory Donovan, who directs the NewVa Corridor Technology Council, said Intrexon stands out in the high-tech business world locally for several things.

It is relatively large as council members and research center tenants go and is one of a small number of NewVa region firms to receive investments from Third Security LLC, a Radford venture capital firm.

Sunil Chada, Intrexon's senior vice president of clinical research and development, said in a news release the firm is "very encouraged" by recent events.

Rob Patzig, chief investment officer at Third Security, said the melanoma therapy is "on track to significantly enhance the safety and efficacy of cancer treatments while also maintaining centralized production and distribution efficiencies."

Dr. John Kirkwood, the physician leading the study, could not be reached for comment.

Dr. Martin Weinstock, a Brown University professor of dermatology who directs a skin cancer committee at the American Cancer Society, said Kirkwood has a national reputation for his melanoma research.

"He's obviously doing this because he thinks this could work," Weinstock said.

For now, researchers are determining only the treatment's safety and tolerability -- to see that it doesn't harm patients or make them sicker. Results are due early next year.

Next, the company would be in a position to test it against cancer.

Planning future endeavors

Looking ahead, there is some evidence the company could go the way of another home-grown biotech corporation, Radford-based New River Pharmaceuticals, which is no longer in business locally.

New River Pharmaceuticals -- led by Third Security CEO R.J. Kirk -- won FDA approval for a stimulant for attention-deficit hyperactivity disorder in partnership with drugmaker Shire plc of England.

In 2007, Shire bought shareholder-owned New River Pharmaceuticals for $2.6 billion. Local operations closed down. Some of the money is still circulating in the local business community.

Beech said that, given what he called the mature state of the company's DNA technology, Intrexon is ready to form a partnership or partnerships. For one, partners bring needed cash. Typically, as a life sciences technology moves toward commercialization, spending rises from tens of millions of dollars to hundreds of millions of dollars, Beech said.

"For these types of endeavors, what one would typically see next are partnering arrangements, which is certainly a key focus area for me right now," said Beech, whose title recently changed from chief executive officer to head of business development.

Kirk is Intrexon's CEO.

Connecting with a partner means getting out and telling the company's story. In that vein, Beech said he was encouraged that Intrexon was invited to describe its latest developments at the J.P. Morgan Annual Healthcare Conference, held in January in San Francisco.

The experimental melanoma therapy is not the company's only shot a commercial success and a sustained revenue stream, however. Company executives strategically chose to develop it now because of its potential to impact human health and earn large financial returns to sustain the company, Beech said.

But the company's DNA control systems, which reprogram cells with DNA that has been engineered outside the body, are building blocks for a host of opportunities elsewhere in health care and in industry and agriculture, he said.

The power of gene manipulation is summed up in this explanation on the site of the Union of Concerned Scientists: "Genes are the chemical blueprints that determine an organism's traits. Moving genes from one organism to another transfers those traits."

Beech compares the still-untapped potential of DNA manipulation to the present-day benefits of the microchip. Such firms as Hewlett Packard, Honeywell International, Lockheed Martin, Oracle Corp. and Microsoft adapted integrated circuit technology for commercial use and revolutionized the electronics industry, he noted.

Intrexon, Beech said, has a platform to tap the power of genetic engineering and commercialize its high-impact potential.

"The way to think of Intrexon right now -- you know, we're DNA.com -- we're sitting here at the dawn of this era," Beech said.

From The Roanoake Times by Jeff Sturgeon

Wednesday, July 29, 2009

High-Tech Firms at Risk in Down Economy

Just like companies in many other industries, tech firms face heightened financial risks during an economic downturn. Failure to follow good risk management practices and sidestepping prudent business procedures can leave a tech company with greater exposure to a professional liability lawsuit.

Financially stressed customers often drive these types of shortcuts as they become dependent upon technology solutions to improve operations, increase revenue, and/or reduce expenses. As margins shrink for these customers, the successful implementation of technology solutions becomes critical to their survival and the costs associated with such solutions are more heavily scrutinized. This not only raises the stakes for a tech firm to ensure the technology meets expectations but also to deliver the technology on time and within budget.

The additional pressure caused by financial conditions can lead customers and tech firms to rush projects through the process and make modifications on the run. This tends to compromise the normal quality and documentation practices that are established to ensure the successful implementation of deployed technology solutions. Elizabeth Feil Matthews, tech insurance specialist at Hanckel-Citizens Insurance in Charlottesville, VA. states, “Unfortunately, these pressures to implement technology solutions as quickly as possible often lead to escalating project costs and more importantly, failing to meet the customer’s expectations. While the customer may drive the decision to hasten the development and implementation process, it is frequently the tech firm that becomes responsible for the problems that result. Especially during economically stressful times, these problems can reduce or possibly eliminate the benefit of the project to the customer and as a result, the customer pursues legal action against the tech firm for lost revenues, cost savings, as well as, a long laundry list of other incurred expenses.”

To protect against these types of lawsuits “Good project management and documentation is essential,” says Matthews. Unless best practices are in place and followed, a software client and the developer can have a general idea about a project, what it should accomplish and what it should cost. But often, this general idea is not adequately documented and the client’s expectations for the project are not aligned with what the tech firm is attempting to deliver. This divergence in expectations creates a lack of understanding of the project’s functionality, time and cost. The result? Delays, customer disappointment with project capabilities, and/or disputed bills that can lead to a legal action against the tech firm.

This is just one of many risks faced by tech firms in today’s challenging business environment. The good news for techs firms Matthews adds is “while financial institutions face double digit rate hikes, rates for the technology sector remain flat. Additionally many insurers are creating custom professional liability products to cater to this niche.”

Thursday, July 23, 2009

Two days left to apply for the SEBIO Investor Forum - Deadline July 24th

Companies have only two days left to apply for the Southeast's premier biotechnology investor event, being held on December 3-4, 2009 at the Charleston Place Hotel in Charleston, South Carolina.

Since 1996, companies that have participated in the SEBIO Investor Forum have gone on to raise over $2.5 billion in venture capital funding, making it the region's most successful venue for linking industry investors with the Southeast's top life sciences companies.

CLICK HERE TO APPLY NOW

Companies Apply To:

• Meet, talk with and introduce their company to target investor groups
• Network with peers, potential investors and partners
• Hear presentations focused on industry trends and emerging company issues
• Be recognized among the Southeast's top emerging life science companies

Two Application Opportunities:

The SEBIO Early-Stage Event is for life sciences companies seeking their first round of venture capital and/or angel investment. Company representatives will meet privately with an advisory panel to present their opportunity and receive feedback from the panel. Each advisory panel will select one company to make a presentation to the full conference audience and be judged by an elite group of venture capitalists.

The SEBIO Main Stage Event is for companies that generally have completed at least one round of institutional financing. Main stage company presentations are typically 12 minutes in length and are made publicly to the full conference audience. A single-track format is normally followed so that all conference attendees have the opportunity to view all presentations.

Thursday, July 09, 2009

Transforming Science Education in America: A Stakeholder Conversation

Leading stakeholders in the future of science education in the U.S. will gather to discuss two recently released reports that are sure to impact this nation's science education agenda for years to come.

The basis of the conversation will be The Carnegie Corporation's new report, "The Opportunity Equation," which calls for a national mobilization to achieve higher levels of math and science learning, and "Taking the Pulse of Bioscience Education in America," a report that finds that the U.S. is failing to prepare students for pursuing biosciences in higher education.

Speakers to date include:
• Bruce Alberts, Editor-in-Chief, Science, AAAS, and former president of the National Academy of Sciences
• The Honorable Jim Greenwood, President and CEO, Biotechnology Industry Organization, and former Congressional representative from Pennsylvania
• Joan Ferrini-Mundy, Executive Officer (Acting), Education and Human Resources; Director, Division of Research on Learning in Formal and Informal Settings, National Science Foundation
• Susan Sclafani, Director, State Services, National Center on Education and the Economy

When:
Tuesday, July 14, 2-4:30pm

Where:
AAAS Auditorium, 1200 New York Avenue NW, Washington, DC
Registration deadline:
Email name and affiliation by July 10 to registration@biotechinstitute.org.

More information:
Visit http://www.biotechinstitute.org/programs/educationreport.html

Howard Dean on Biosimilars: At Least 12 Years Exclusivity

Legislation on innovative drugs is key to health reform

July 8, 2009
The Hill, Opinion
Howard Dean

More than 60 years after President Harry Truman called on Congress to provide Americans the “opportunity to achieve and enjoy good health” and “protection or security against the economic effects of sickness,” we are still fighting for healthcare reform.

Since Truman’s time, the health landscape in this country has changed dramatically. Diseases such as polio and tuberculosis are no longer the scourges they were. Advancements in biomedical research have led to treatments that have helped people with cancer, cystic fibrosis and a host of other diseases. In the 1950s, the cure rate for cancers was 33 percent, whereas today nearly two-thirds of people diagnosed with cancer live five years or more after their diagnosis.

As we move toward a universal healthcare system, most of the debate centers on big-picture issues such as how to craft and finance a public health insurance option. There is much less focus on smaller, but equally essential issues. One of these is patent reform. Another is maintaining America’s leading edge in research and innovation.

The Congress is now developing a regulatory pathway for the approval of biosimilars — medicines that are similar to, but not the same as, breakthrough biologics. Some inaccurately suggest that biosimilars are essentially generic versions of traditional pharmaceutical drugs. Biologics are actually much more complex than traditional drugs and cannot be copied using existing science. By expanding market competition, biosimilars can expand access to and reduce the cost of these cutting-edge drugs. But if the initial breakthroughs are not supported by adequate patent protection, innovation in America will die. And given the complexity of biologics, a properly constructed biosimilars pathway must provide necessary protections to ensure patient safety.

A commonsense and fair approach, similar to the process and timeline currently in place for generic versions of chemical-based medicines, would allow the original developer of the biologic to protect the proprietary data used to develop the medicine for at least 12 years. A shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cures. Most firms would be unable to recoup their investments in new medicines, which ordinarily top $1 billion and involve 15 years of research and development. If we discourage investment, we jeopardize the development of the next generation of breakthrough medicines and cures.

These principles are incorporated in biosimilars legislation sponsored by Reps. Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.) and Joe Barton (R-Texas) in the House (H.R. 1548) and in The Biologics Price Competition and Innovation Act introduced by Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) in the last Congress. Both bills include a balanced approach that protects patient safety and encourages research that helps bring new, more advanced treatments — and even cures — to patients around the world. To encourage market competition, this should be combined with provisions that allow the patent life to begin running at the time of FDA approval, not at the time of application. Frivolous lawsuits over patents also should be eliminated at the end of patent life.

Today, too many diseases and disorders remain with no treatment or treatment with limited therapeutic benefit. With the right balance, we can set a path for biosimilars that maintains the highest standards for patient safety, lowers costs and increases access today while providing the necessary incentives for new therapies and cures tomorrow.

Tuesday, July 07, 2009

WaPo: Biotechs React to No SBIR Set-Aside in Stimulus

Start-Ups Say Innovation Doesn't Grow on Trees

By Kim Hart
Monday, July 6, 2009

Biotechnology start-ups have long relied on grants from the National Institutes of Health to fund the research-and-development process for new drugs, medical devices and disease treatments. Every year, the agency is required by law to set aside 2.8 percent of its research budget -- $650 million in 2009 -- for small businesses and the commercialization of technologies developed at universities.

But when nearly $10 billion in stimulus funds went to the NIH, a last-minute change in the legislation exempted the agency from the requirement. That means the NIH does not have an obligation to reserve a portion of the money to small businesses.

This has created a stir in the area's biotech community. The companies say that without the requirement to set aside money for the Small Business Innovation Research program, they have a tougher time securing funding that could help them develop new products and survive the recession.

"It has just been a slap in the face to small businesses, especially because it's been a lifeline to biotech," said Aprile Pilon of Clarassance, a Rockville-based biopharmaceutical company that develops treatments for respiratory diseases. "We don't have access to institutional investors. We're going to lose a lot."

The SBIR program has been a key part of the grant-giving process for many agencies that support research and development, including the Energy Department and the Agriculture Department. For biotech companies, the NIH grants typically help companies pay for clinical trials or move their products through the regulatory process. Universities and other academic institutions also receive a large number of grants for scientific research.

In February, executives from 20 companies sent a letter to Maryland's senators, Democrats Barbara A. Mikulski and Benjamin L Cardin, asking for help in applying the small-business set-aside to the stimulus funds. Two weeks ago, Cardin, Rep. Chris Van Hollen (D-Md.) and Rep. Donna F. Edwards (D-Md.) held a hearing in Rockville on the issue. Jonathan Cohen, chief executive of 20/20 Gene Systems, Joe Hernandez, chief executive of Innovative Biosensors, and Pilon testified before the panel. Raynard Kington, acting NIH director, did not attend the hearing. Instead, Sally J. Rockey, director of extramural research, sent written testimony outlining alternative funding programs that did not reach the members of Congress until after the hearing.

Cardin, Van Hollen and Edwards sent a pointed letter to Kington after the hearing, saying that his "absence sent a message of indifference."

In an interview Friday, Rockey said no one was available to appear at the hearing. She also said that, although the NIH is not required to provide a set amount of funds for small businesses, the agency has encouraged them to apply for several other funding opportunities supported by stimulus money. These programs, she said, have received a lot of interest from biotech firms.

"When the Recovery Act was first being discussed, we were concerned, because the number of [small-business] applications had dropped dramatically," she said. "And we were concerned we wouldn't have enough applications to distribute funds expeditiously."

Pilon argues that small-business applications get tougher scrutiny than those from academic institutions, and she claims that the board reviewing the applications is largely made up of university representatives.

"Small businesses are at a disadvantage in terms of preparing grants," she said. "We don't have the resources that universities do. We have to think hard if we have the time and money to write a grant, and if we don't get grant funding, the penalty is much greater than if a university doesn't get funding."

Cha-Mei Tang, chief executive of Potomac-based Creatv MicroTech, said she submitted a grant application last week to help hire more employees to gather patient samples and statistics in the development of a tool to detect chronic lymphocytic leukemia. She said past efforts to compete for funds that are not reserved for small businesses have been unsuccessful, so she is concerned that companies will not have much of a shot at stimulus money.

"Everything we sell is based on SBIR funding," Tang said. She said she plans to visit lawmakers on Capitol Hill this week. The House is scheduled this week to take action to reauthorize the SBIR program, which expires at the end of July. The biggest issue in question is whether venture-backed firms should have access to SBIR grants.

Allen Cunningham, chief executive of Charlottesville-based Gencia, said his company received an NIH grant that is not tied to stimulus funding for the pre-clinical development of a therapy for Alzheimer's disease, so his company is not in dire need of additional money at the moment.

But he said he agrees that setting aside some portion of the stimulus funding would be invaluable for small firms.

"There's no doubt that if the exemption wasn't there, that more money would be available for applicants and in line with the goals of the stimulus," he said.

Thursday, July 02, 2009

Danville, VA Highlighted in Bioscience Dev Piece

Life Science Leader magazine Danville, Virginia highlighted in article about bioscience economic development!


Survey Identifies Widely Varying Pharma/Bio Site-Selection Drivers
Regional and local economies provide financial incentives to attract life sciences companies, but financial incentives don’t always trump business opportunities and quality-of-life issues.

Life Science Leader, July 2009
Written by: Ann Roberts Brice

At one time or another, most life sciences companies add facilities, spawn new units, or simply seek greener pastures. Site-selection managers and executive leadership teams need to stay on top of their games to find optimal environments. Companies often begin with a review of key regions around the country for life sciences, but the overall relocation experience is also an important consideration. Financial incentives, business opportunities, and quality-of-life issues all become persuaders in relocation decisions.

To provide an edge, Life Science Leader (LSL) informally surveyed several U.S. areas known for growth and innovation in the life sciences industry. The survey was completed by state economic development officials and, in some cases, private sector partner groups at state and regional levels.

Tax breaks, grants and loans, and workforce training topped the list in response to our question: Identify the five key incentives used to entice biotechnology and pharmaceutical companies to locate in your state or region. The states polled said that incentive programs typically revolve around tax credits for R&D, job creation, and investment capital, as well as a variety of conditional grants, assistance loans, loan guarantees, and state-assisted workforce training programs (often held at local two-year community colleges).

Many officials said the basic structure of most states’ incentive programs is similar, while the magnitude of the funds may differ along with conditions for eligibility and the lifespan of specific incentives.

Among the several states that have funded recent initiatives for technology and life sciences-based development are: Ohio, which allocated $1.6 billion; Maryland, $1.3 billion; and Massachusetts, $1 billion. All of these programs extend for 10 years.

Massachusetts’ new program is designed to create jobs, drive innovation, and support good science, commented Susan Windham-Bannister, president & CEO of the Massachusetts Life Sciences Center (MLSC). The MLSC is a quasi-public entity authorized to be the “stewards” of the state’s investment. Windham-Bannister disagrees with “the broad brush generalization” that incentive programs are basically the same. “The way Massachusetts’ specific initiatives are structured is quite different,” she claims, citing one that encourages fund matching from private investors. Also, the MLSC is “broadly welcoming” a range of life sciences companies, including pharmaceuticals, diagnostics, bioinformatics, biotechnology, and devices, which is “the strength of our cluster,” she says. The MLSC has a scientific advisory board and reports to a board of directors.

A FOCUS ON BIO
In contrast, Maryland is more focused on biomedical R&D, with nearly $15 billion of research conducted by federal agencies, academia, and some 400 private companies. “Opportunities abound for biotechnology and pharmaceutical companies to in-license, codevelop or outsource within the state,” notes Dr. Larry Mahan, head of the new Maryland Biotechnology Center.

In June 2009, the Maryland Biotechnology Center will officially open as a “one-stop” resource for the bioscience community, grouping together existing programs. It was designed by the state’s Life Sciences Advisory Board to focus on entrepreneurial development and foster relationships between industry, academic research centers, and federal institutes.

Mahan says Maryland receives more National Institutes of Health (NIH) R&D contract awards than any other state and has nearly the highest number of doctoral scientists and engineers as a percentage of total employment. Like Boston and North Carolina, it has grown to become a “classic biotech” cluster over the past 20 years.

Other states such as New Jersey and Pennsylvania are associated with “classic pharma.” Continuing its growth, New Jersey has 238 biotechnology firms in addition to 15 of the world’s 25 largest pharmaceutical companies. Its critical mass in biopharmaceuticals, which attracts others in the industry for partnering, has led it to be called the “Medicine Cabinet of the World.”

Ohio’s $1.6 billion “Third Frontier” program includes a competitive grants initiative under which 45% of funding has been awarded to biomedical and bioscience firms, noted Ohio’s Lieutenant Governor Lee Fisher, a former director of development. Ohio’s tax reform measures, giving it the lowest business taxes in the Midwest, have also been extremely helpful in attracting companies, he added.

Fisher, who was involved with San Diego-based Amylin Pharmaceuticals opening a new facility near Cincinnati, worked closely with county, city, and regional agencies so the company didn’t have to “knock on multiple doors.” However, the real “game changer,” he added, was the customized workforce development package that his group put together.

A VERY COMPETITIVE ENVIRONMENT
While every state possesses unique strengths and distinctive characteristics, competition has heated up among states to attract life sciences companies. This was evident when one of our survey participants expressed reservations about providing details about areawide programs for fear of having them imitated.

Studies show that life sciences bring to an area skilled workers, high-paying jobs, and lots of profits that boost state economies over the long term. In 2006, the average annual wage for a bioscience worker was $71,000 compared with $42,000 for all private sector workers, according to Battelle Research.

The biotechnology sector outpaced the private sector in job growth, increasing 5.7% as compared with 3.1% overall between 2001 and 2006, says Battelle. Indirect and induced employment generated millions of other jobs in the economy besides the 1.3 million in the biosciences. Even in the current recession, one regional official observed that the number of relocation leads has not declined, although companies are taking longer to make decisions.

Nonfinancial incentives also play a role, according to survey responses, including a willingness to tailor packages to individual company needs. The personal touch never hurts, with some officials using a proactive approach in reaching out to potential residents. Shire Pharmaceuticals USA is a case in point, having consolidated its operations in Wayne, PA in 2004 from two other states and expanding its workforce by 400 employees in 2007.

Shire’s relocation experience was included in Greater Philadelphia officials’ response to another LSL survey question: Identify a few companies that have moved to your state or region, and describe which specific incentives convinced them to do so. David Reese, VP of Shire’s Global Facilities, recalls how Governor Edward Rendell made a personal phone call to Shire’s Matt Emmens, who was CEO at the time. The Governor made it “crystal clear” that he wanted our company in his state, says Reese. “Other states didn’t reach out with the same type of passionate involvement.” The state also put together a nice package of incentives that made it difficult for Shire to decline, he continued.

Raindance Technologies also valued nonfinancial decision drivers. Its President & CEO, Chris McNary, pointed out that Massachusetts’ $1 billion initiative demonstrated the state’s “position of support” for the industry long term.

Raindance moved from Connecticut to Lexington, MA in mid-2008 after its directors became confident it would grow to become a “sizeable” company. Its technology, when applied in biopharmaceuticals and molecular diagnostics, could find a new way to discover drugs to break the existing paradigm, claims McNary. “We wanted to make sure the area was recognized as being a biotech and also an innovation center,” he said. Emerging companies tend to thrive near hubs of innovation (i.e. research institutes, medical centers, universities). While a West Coast biotech cluster was also considered, McNary noted that, “The distance from Connecticut to Massachusetts made it easier to move for us,” thus illustrating the practical aspect of decision making. In addition, the company is involved in a joint project with Harvard.

FINANCIAL+NONFINANCIAL INCENTIVES MAKE THE DIFFERENCE
For Octapharma USA, a unit of a growing Swiss-based company, financial and nonfinancial incentives played a role in its decision making, according to Louis DiCriscio, VP, finance & operations. The unit moved to the Hoboken, NJ new Waterfront Corporate Center in February, 2008 from Virginia, with the help of a $517,500 Business Employment Incentive Program (BEIP) grant from the state. Octapharma was attracted by a number of things, including New Jersey’s strong pharmaceutical talent pool. From its new location, it has easy access to three international airports with direct overseas flights, DiCriscio noted. It is currently partnering on a project with Hackensack Hospital in Hackensack, NJ.

Octapharma develops and markets products from human blood plasma for people with bleeding or immune deficiency disorders. Hoboken’s accessibility to New York City was important, as it has stakeholders there including a large patient organization partner and group purchasing organizations with which it contracts. As to quality of life, Hoboken and Jersey City, both on New Jersey’s waterfront, have tremendous views of New York City, good transportation, and are in a state of “tremendous revitalization” with beautiful parks for employees on piers jutting out into the Hudson River, commented DiCriscio.

Incentives are sometimes built on the strategic advantages provided by the resources of a geographic area. Danville, VA, at the heart of the old tobacco industry where agricultural farmlands are plentiful, is developing a new economic base around this asset.
It has created, with the state and county, the Institute for Advance Learning and Research (IALR) in Cyber Park, a partnership that provides academic support on-site from Virginia Tech. Since its 2004 founding, the Institute has attracted three high-tech firms and some 6,000 jobs in Pittsylvania County and the city of Danville.

Danville had just the environment that Michael Duncan, general manager of Donnachaidh LLC, sought for his biofuel start-up, he said. Duncan was attracted not only by the land needed for research on the hybrid poplar tree, the resource for his biofuel, but also the available workforce with experience around agriculture, Duncan said. The real “kicker” in the deal was the IALR and its sustainable and renewable resources arm, which will facilitate the research underway, noted Duncan. In addition, his firm received a $105,000 cash grant from the Tobacco Commission for the building project, which will help create 25 jobs and have a capital investment of $7 million.

To sum up, companies are often looking for proximity to innovation, a qualified workforce, a favorable tax environment, and availability of working capital. The decision is usually based on a combination of these factors, with financial incentives being important but not primary, believes Tom Morr, president & CEO of Select Greater Philadelphia, which covers parts of three states (Pennsylvania, Delaware, and New Jersey) and several counties. “When we talk to companies, the first question is: What’s my business opportunity? The second is: Can I find the people I need to do what I want to do? Third can be a variety of things that relate to environmental factors such as quality of life, good schools, cost of living, housing, and state taxes,” stated Morr. “Companies ask for the financial breaks because they have a fiduciary responsibility to shareholders. Few companies decide to go someplace because someone offers them money. If they did, they’re probably making their decisions for the wrong reason.”

Wednesday, July 01, 2009

Loudoun County Technical Center Adds Biotechnology Program

Charles S. Monroe Technology Center was established in 1977 to provide technology and vocational education to students in Loudoun County.

Last Spring, Education Reporter Julia Stewart and the Loudoun Independent Video Crew were provided with a tour of Monroe Tech, where they spoke with teachers and students from several different programs.

While some might assume that vocational education in public schools deals with older technology, nothing could be further from the truth. Monroe Tech has entered into a partnership with Virginia Tech to implement the new biotechnology program—available next year along with the new Veterinary Tech program.

Even traditional vocational classes like Automotive Science Technology takes a different approach in the modern work—often using computer diagnostic and training tools as often as a wrench.

Unlike many high school classes, many vocational education programs also enable students to obtain college credit or even obtain certification or a license in chosen field.

Programs at Monroe Technology Center include: Cosmetology, Environmental Plant Science, Computer Digital Design, Robotics and Computer Design, Automotive Science Technology, Culinary Arts, Television Production/ Digital Moviemaking, Health & Medical Sciences, Radiology Technology, Firefighter/ Emergency Medical Technicians.

Click here to take the video tour of the opportunities available at C.S. Monore Technology Center.

From the Loudon Independent

Monday, June 29, 2009

Biotech Start-Ups Line Up Again for Tax Credits

By Kim Hart, The Washington Post
Monday, June 29, 2009

Last year, Scott Allocco spent 12 hours sitting on a downtown Baltimore sidewalk, waiting to turn in his application to get a tax credit for the angel investors who'd promised to give money to his cancer diagnostics company, BioMarker Strategies. He was the third company in line.

This year, he was the first. He showed up at the University of Maryland's BioPark facility Friday at 10 a.m., armed with a borrowed air mattress and sleeping bag. He and other company executives will wait in the building's auditorium, which is available to them for the first time this year, for five days. They can't formally turn in their application until 9 a.m. Wednesday, and the tax credits are given on a first-come, first-served basis. Since 2006, 38 firms have received the credits. By the end of the day Friday, when his chief executive, Karen Olson, relieved him of waiting duty, representatives of 10 other companies had already lined up behind him.

"This shows how important this program is to biotech start-up companies and how important it is for Maryland to increase funding for the program," Allocco said, adding how relieved he was that companies could wait inside the building, where there is a gym, a shower and carpeted floors, rather than on the side of Redwood Street. "I was concerned that in this economy there would be great demand for these credits."

The popular program encourages investment in Maryland biotechnology start-ups by letting investors receive a tax credit for 50 percent of the money they put into eligible companies. The state provides $6 million a year for the tax credits. The funding for the program was in danger of getting slashed this year due to tightened budgets, despite Gov. Martin O'Malley's efforts to increase it. The credit cannot exceed $50,000 for individual investors and $250,000 for corporations and venture capital firms.
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"I had worked hard to attract investors and I felt I had an obligation to protect their tax credits," Allocco said.

Word that the line was forming spread quickly through the biotech community. By 10:45, Marty Zug, chief executive of Sequella in Rockville, which develops treatments for infectious diseases, arrived in the third slot in line. A scientist relieved him later in the afternoon. Zug planned to return today.

Alternative fuel-producing firm Zymetis of College Park was second in line. Gliknik, a Baltimore firm that develops drugs for autoimmune diseases, was fourth.

"Everyone's scrambling right now to figure out how to cover five days' worth of line-waiting," Zug said. "Every year it seems to get more and more competitive. We've got people willing to give up their weekend and are going to stay there for the duration."

WBJ Interviews Early Stage Biotech VC on Economy

Excellent interview by Vandana Sinha with HIG Bioventures' Bruce Robertson.

Friday, June 26, 2009
Bruce Robertson: Why he's still bullish on biotech VC
Washington Business Journal - by Vandana Sinha Staff Reporter

Bruce Robertson, managing director of HIG BioVentures, has been working the venture capital circuit long enough to see the ups and downs in biotech investment — and observant enough to learn from them. He talks about the lessons of the worst period he has seen.

What do biotechs need to be considered for venture capital money? A pipeline of good drugs and experienced management teams are getting funded. Good data around the compounds. Certainly, it’s not like a company can decide to do this overnight.

What’s the craziest pitch you’ve received? It was basically a baseball hat with an ultrasonic music oscillation device in it to slow the progression of Alzheimer’s disease. Part of the baseball cap played music, and the other part was vibrating. We didn’t do that deal.

What’s something that will always get noticed by you? Really good preclinical or clinical data in a big unmet medical need where we believe we can build a company in a very capital-efficient manner.

What will always turn you off? Capital inefficiency. Big burn rate.

What’s going on with venture capital now? In 2000, people had been doing so well. VCs had gotten sloppy at how they reserved cash [for future financing rounds for their existing portfolio companies]. That behavior continued even when the bubble started to burst. High-priced deals continued to happen and reserves continued to be short. By 2001, VCs couldn’t invest because they didn’t have the money, and good companies went under. So, when Lehman Brothers went down last September where the venture market was slow to react in 2000, the venture market was fast to react in 2008. Lehman closed on a Monday, and the venture markets closed on Wednesday to make sure they had reserves to support their existing companies.

So there’s money in the system? There’s less than there was in September, but there is capital. It just became incredibly conservative overnight.

What else are VCs dealing with?
It’s a really tough time for VCs to raise money. So you’re going to be really conservative on how you deploy those last three, four deals. For the first three to six months nothing happened because we were all internally focused on our portfolio companies. Now VCs are starting to look at new deals again, but the bar is a lot higher. I think you’ll see some deals opening up in the next six months assuming no major disruption in the market.

What are you seeing in the life sciences market? When VCs perceive the risk to be high, they tend to migrate to later-stage companies. I don’t agree with that, but it does tend to be where things go. Early-stage companies suffer pretty disproportionately. Meanwhile, valuations have come down, so you end up seeing later-stage companies at much more favorable prices.

What do you mean prices are more favorable?
In late 2007 to the middle of 2008, there was a little mini bubble. We did zero new deals between the middle of 2007 and the end of 2008, because virtually everything we saw was overpriced.

And you said you don’t agree with automatically migrating away from early-stage companies? Three to four years from now, we’ll be in a pretty decent economy. So the early-stage company you’re investing in now is likely to be thinking about exits — an IPO, an acquisition — in a better environment.

What do you see in the local life sciences market?
Our region tends to be an earlier-stage region, which means it’s on the slower end of things to react. I don’t know how to gauge it, though, as it was slow during the uptick. It’s related to the thin pool of experienced entrepreneurial management. We haven’t recycled a lot of experienced people back into the market.

What happens to biotechs that don’t get money? The ones in the worst shape are public biotechs. A certain percent of biotechs have less than one year’s cash. Those guys are in real trouble. They have to report their financing options. It’s harder to be creative because they are public and have public shareholders. For the really early-stage companies, if you can hunker down and survive on grants for a year or two, that’s not a bad place to be. For the mid-stage companies that can’t survive on grant money and need more capital, that’s a tougher place to be. Sadly some will go out of business.

When will things turn around? I think this should probably all shake out in the next 12 months.

How much might we see here in terms of mergers and acquisitions?
I’m long term really bullish on the M&A market, but this is also a tough time because Big Pharma is extraordinarily busy. I heard from someone in Big Pharma that they’re getting three new deals per day. Many of them want to do deals, but it’s a tough triage process. And I think they have been emboldened to feel they have a lot of leverage in every deal, even with well-financed companies. So if you’re a biotech that needs to get bought, it’s tough.

What will the local sector look like long term?
There’s a lot of good stuff coming. The local governments are very supportive. I’m very encouraged by what’s going on in the local universities, particularly Johns Hopkins. There is money around. I know entrepreneurs fret that there isn’t. But in the three- to five-years time frame, I’m pretty bullish.

Biovista Inc. Announces Positive Results in a Pre-Clinical Trial of Epilepsy Drug

Biovista Inc. announced on June 23, that BVA-601, its small-molecule drug targeting epilepsy, has shown positive results in the Kainic acid murine model of temporal lobe epilepsy. BVA-601, an existing drug that Biovista repositioned in epilepsy, exhibits both anti-epileptic and neuroprotective activity. In this pre-clinical trial, BVA-601 induced a statistically significant decrease of epileptic activity in mice pre-treated with Kainic acid.

"We are pleased with these initial results that confirm the predicted efficacy of BVA-601 and encourage us to further test and develop this compound in a disease area where there is a need for new, patient-friendly therapies," said Aris Persidis, Ph.D., President of Biovista. "This successful repositioning builds on our previously reported success with BVA-101 in multiple sclerosis, expanding our CNS portfolio. At the present time we are exploring all options available to us, including the further co-development with a pharmaceutical company and the licensing of the IP to a generics company," added Dr. Persidis.

For a non-confidential information pack on BVA-601, contact Biovista at info@biovista.com.

In the animal proof of concept trial, BVA-601 was compared to diazepam, a potent anti-epileptic drug that is efficient in reducing epileptic activity but has troubling adverse events. BVA-601 induced a statistically significant reduction in the number of animals showing epileptic activity and delayed the onset of epileptic seizures.

From PharmaLive

Wednesday, June 24, 2009

MdBio Offers Support for State Life Sciences Plan

ROCKVILLE, Md. -- As the association representing the biotech industry in the State of Maryland, the MdBio Division of the Tech Council of Maryland is pleased to wholeheartedly support "BioMaryland 2020: A Strategic Plan for the Life Sciences Industry in Maryland." Last month, at the BIO 2009 International Convention in Atlanta, Georgia, Governor Martin O'Malley unveiled the Strategic Plan developed by the Maryland Life Sciences Advisory Board, a 15-member panel formed by the Governor and Maryland General Assembly in 2007. The Board's purpose is to advise the State on setting priorities for the biotech industry. BioMaryland 2020 lays out a 17-point program whose "one-stop shop" centerpiece, the Maryland Biotechnology Center, has already been launched, and whose recommendations include more spending on some existing programs as well as the creation of new initiatives.

The four priorities of the plan, innovation, competitiveness, talent, and capital, are areas of critical interest to biotech companies in the State. Many of the programs and initiatives of the MdBio Division and its companion organization, The MdBio Foundation, have been dedicated to addressing these specific issues. A number of the plan recommendations reflect long-standing Tech Council of Maryland priorities. These priorities include increasing funding for the Biotech Tax Credit, increasing funding for Maryland Venture Fund, expanding Maryland's R&D Tax Credit, supporting stem cell research, and encouraging nanobiotechnology.

"It is our intention to work closely with the Maryland Biotechnology Center and the Maryland Life Sciences Advisory Board in a synergistic manner to advance implementation of these recommendations for the good of our member companies and for the life sciences industry in Maryland as a whole," said Dr. Richard Zakour, Executive Director of the MdBio organizations. "Many of our member companies have played a role in shaping the Plan. Its success is critical to the future growth and success of the biotech industry in our State."

The BioMaryland 2020 initiative and recommendations of the Maryland Life Sciences Advisory Board pro vide a clear road map to maintain Maryland's prominence and realize its potential leadership role for the future of biotechnology industry globally. MdBio will enthusiastically continue to support of the Maryland Life Sciences Advisory Board and the Maryland Biotechnology Center in achieving these goals.

Tuesday, June 16, 2009

Geoff Allan Resigns from Insmed

Insmed Inc. (NASDAQ: INSM) , a biopharmaceutical company, today announced that Geoffrey Allan, Ph.D. has resigned as Insmed's President, Chief Executive Officer and Chairman of the Board of Directors, effective immediately, due to a health condition. Dr. Allan has served as Insmed's President, Chief Executive Officer and Chairman of the Board since its inception in November 1999.

Insmed's Board of Directors has chosen Melvin Sharoky, M.D. to assume the role of Chairman of the Board, formerly held by Dr. Allan. Dr. Sharoky has been a member of Insmed's Board of Directors since 2001 and has extensive executive experience in the biopharmaceutical industry, including serving as President and CEO of Somerset Pharmaceuticals from January 2002 until March 2007. In addition, he was President of Watson Pharmaceuticals, Inc. from July 1995 through January 1998.

Mr. Kevin P Tully C.G.A., Executive Vice President and Chief Financial Officer, Mr. Steve Glover, Chief Business Officer, and Mr. Glen Kelley, Vice President, Regulatory Affairs, will continue in their roles managing the day-to-day business and report directly to Dr. Sharoky.

Insmed's previously announced process of evaluating various alternatives for the use of the proceeds from the March 2009 asset sale to Merck will move forward uninterrupted with the continued assistance of Insmed's financial advisor, RBC Capital Markets.

"Geoff Allan has played a critical role in the evolution of Insmed from its inception, navigating the Company through the various challenges and uncertainties frequently encountered within the biotech sector, and putting Insmed in an envied position of financial strength in these times of market instability," said Dr. Sharoky. "His drive, commitment and counsel will be greatly missed and all of us at Insmed wish Geoff and his family the best as he confronts his health condition."

"Among Geoff's most substantial accomplishments as CEO was the assembly of a strong management team in Kevin, Steve and Glen," continued Dr. Sharoky. "As this core team will remain in place following Geoff's departure, I expect no change in the day-to-day operations of the Company, nor any delay in pursuing potential strategic initiatives. I look forward to working closely with the entire Insmed team to continue advancing the Company's drug development mission and enhancing shareholder value."

BizWeek: FOBs-- Cure or Quagmire?

Generic Biotech Drugs: Cure or Quagmire?
Jun 16, 2009 Business Week

By Arlene Weintraub

When President Barack Obama spoke to the American Medical Assn. on June 15, he tossed out some pretty impressive numbers for savings that would be achieved by implementing various health reform ideas. Limiting tax deductions for the wealthiest Americans would save $300 billion over 10 years, he said, and allowing competitive pricing in Medicare Advantage programs would save $177 billion. But when it came to the idea of allowing generic biotech drugs onto the market, Obama couldn't quite quantify the impact.

"These drugs are used to treat illnesses like anemia," the President said, taking a direct shot at Amgen's (AMGN) blockbuster drugs Aranesp and Epogen, and Johnson & Johnson's (JNJ) Procrit. "But right now, there is no pathway at the FDA for approving generic versions of these drugs. Creating such a pathway will save us billions of dollars."

How many billions? And how fast would those savings be achieved? The answers provided by the drug industry and the government differ vastly. Several government agencies are calling for legislation that would allow the Food & Drug Administration to speed generics, or "follow-on biologics," to market. Creating FOBs is a delicate task, however: Unlike standard drugs, which are made of simple chemicals, biologics are complex proteins that are cloned and then grown in expensive cellular systems.

An Alarmed Biotech Industry

Taking the simplest view of the generic landscape has produced some very rosy scenarios for FOBs. A June report by the Medicare Payment Advisory Commission (MedPAC) said biotech drugs cost Medicare $13 billion a year and that the expenditures would drop dramatically if the FDA could approve cheaper versions of those drugs. And on June 10, the Federal Trade Commission issued a report suggesting that the government make it easier for companies to market FOBs by abbreviating the FDA approval process. Furthermore, the report concluded, there would be no need for special procedures to resolve patent disputes between the drug's inventor and the generic drugmaker prior to the FDA's approval. On June 11, members of the House Energy and Commerce subcommittee debated the issue, with some suggesting companies that pioneer biotech drugs should not continue to reap huge profits for years on end at the expense of needy patients.

The $60-billion-a-year biotechnology industry—fearing an end to the unlimited pricing freedom it has enjoyed throughout its three-decade history—has emerged as the biggest opponent of Obama's generic plan. The Biotechnology Industry Organization dashed out a hostile response to the FTC's suggestions, issuing a statement that faulted the agency for "an exceedingly narrow policy perspective."

The industry fears that limiting patent protections and market exclusivity would crush profits, which would in turn make it difficult for companies to invent new drugs. The average innovation takes $1.2 billion to bring to fruition, the industry group says. The FTC, it adds, "appears to minimize greatly the impact on innovation that would occur under a new paradigm in which biosimilar competitors would be able to take a free ride off the massive [research and development] investment made by the initial innovators."

Herceptin vs. Tykerb? "Nobody knows"

Industry experts predict that technical challenges involved in making biotech drugs will be a hurdle for generic manufacturers. Dr. Lee Newcomer, senior vice-president for oncology at UnitedHealthcare (UNH), uses the examples of cancer drugs Herceptin and Tykerb to illustrate just how little is understood about biotech drugs—even after they're introduced to the market. Herceptin, made by Roche's Genentech unit, and Tykerb, from GlaxoSmithKline (GSK), are essentially the same drug except for a small difference in the way the molecules are built. Some patients respond well to Tykerb, but not to Herceptin.

"Why is that? Nobody knows," Newcomer said in an interview earlier this year. "If this is the active part of the molecule, why does changing this other part make a difference? I think it will be a long time before we see follow-on biologics, because we just don't know enough."

Amgen executives have been speaking out against the idea of a streamlined FDA approval process for follow-on biologics. Roger Perlmutter, executive vice-president for research and development, believes the only way to guarantee patient safety is to scrutinize each FOB as if it's a brand-new invention. "What you have to demand of any follow-on biological is that you do the kinds of studies that establish it has the same benefit/risk profile associated with it as did the pioneer molecule," he says. "A certain amount of clinical experience will be required."

Amgen has more to lose in this fight than any other company: Its biotech drugs to treat anemia, rheumatoid arthritis, and other diseases brought the company $4.2 billion in profits last year, on $15 billion in sales. While the President was making his case for generic biotech drugs before the AMA, Amgen's stock dropped nearly 2%, to 49.45, before recovering.

Weintraub is a senior writer for BusinessWeek's Science & Technology department.