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.

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.

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.”

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

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

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.

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.

Greenwood in USA Today: Gene Patents Promote Innovation

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

Opposing view: Patents promote innovation

Jun 16, 2009 USA TODAY
By Jim Greenwood

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

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

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

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

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

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

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

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