"A Tale of Two Biotech Cities"

"A Tale of Two Biotech Cities"

By Michael Rosen, Senior Vice President, New Business Development Forest City Enterprises.

CHICAGO – As my readers have seen from past columns, I like to juxtapose bioscience regions to better understand what’s happening in one part of the world that might be shared in another. Within the span of two days last week, I had the opportunity to sit through two regional bioscience events.

The first – a Maryland event held on Feb. 19 in Annapolis entitled “Maryland Bioscience in the 21st Century” – was put on by the Tech Council of Maryland, which includes the Maryland Biotech Association. The second – an Illinois event held in Chicago by iBIO – was entitled “Capitalizing on Progress”. Amazingly, the underlying themes of both were remarkably similar:

1. A review of the major milestones achieved in the region to show development versus the prior year,
2. Showcasing of some of the key biotech movers and shakers in the region, and
3. A yearning to be ranked in the top ranks of biotech clusters in the world with comparisons to the California clusters, Boston and North Carolina.

While I can understand the first two regions, it’s surprising how North Carolina came up in both meetings. Maryland and Illinois are both part of larger bioscience clusters. Maryland participates in a region including Virginia and Washington, D.C. while Illinois is at the hub of the eight-state Midwest.

To be fair, the meetings were very different. While the Maryland meeting did represent an annual meeting, it was a half-day event. Maryland has opted to participate in a larger annual regional 1.5-day event called the Mid-Atlantic Biotech Conference, which usually draws more than 1,000 people.

On the other hand, iBIO has cut back its 1.3-day event to a one-day event focused on Illinois. Given that the BIO annual international conference is coming back to Illinois in 2010, Illinois would be well-served to try to do a regional type of event. Though this kind of event might be difficult to assemble with eight states, perhaps with neighbors Wisconsin, Indiana, Iowa and Missouri it might be possible and important.

As each state has its own issues with biotechnology, I can understand the need to try and focus on a state approach (particularly key state incentives necessary to attract companies). The reality is this is an industry that has globalized. Competition doesn’t come from a neighboring state but from India, China, Australia, Israel, Brazil, Singapore, Korea, etc.

Both regions have hosted the annual BIO international conference in the past. BIO 2006 was held in Chicago as will BIO 2010. BIO 2005 was held in Washington, D.C. (a stone’s throw from Baltimore. Let’s take look at how both of these states compare in terms of biotech characteristics:

The above story obviously doesn’t give a complete picture. We would need to add a number of other categories. At first blush, Maryland has more government research spend and institutions than Illinois and much more bioscience companies. Maryland is probably more focused on drug development with a sprinkling of diagnostic and medical device companies.

On the other hand, Illinois has a much larger chunk of big life sciences companies (much more than Maryland).

Though it doesn’t have the university research concentration that Maryland has, Illinois does have a number of key universities with sizeable government research funding. Illinois has a large drug business and also an equally large medical device and diagnostics business along with agricultural biotech, clean tech, nanotech and renewable fuels research.

The Illinois annual meeting did a very good job showing this diversity of biotech as well as highlighting the state’s excellent university research and key foreign life sciences company. The Astellas U.S. president articulated clearly why Astellas was here and explained their growth plans.

On the other hand, Maryland’s life sciences meeting emphasized legislation.

A number of state representatives were there to talk about how they saw the importance of the local industry. Additionally, Maryland has just formed a Bioscience Advisory Committee to advise the governor on strategy and policy. This newly formed committee is composed of representatives from the leading university, FDA, NIH, leading biotech companies, the U.S. Army and more.

Interestingly enough, the group is chaired by the CEO of Human Genome Sciences. Tom Watson is a former senior and longtime executive from Abbott Labs. Also of interest was that another up-and-coming biotech company CEO on a panel came out of Eli Lilly, which means that once again the Midwest is a good source for managerial talent.

So what does this all mean? A really great meeting might have included key aspects from both state’s biotech agenda. Both states would be well-served to sit down with each other and share notes as both have some great programs going on and could learn from each other.

Meanwhile, Boston and San Francisco are hardly standing still and have already initiated state efforts to maintain their world leadership in this vital industry. This means that both Maryland and Illinois need to dial up the state government involvement in their own industries. It was an interesting couple days. See you soon!

Michael Rosen Michael S. Rosen is Senior Vice President, New Business Development for the Science + Technology Group at Forest City Enterprises, a NYSE-traded real estate development company which develops and builds bioscience parks across the U.S. Rosen is also a founder and board member of the Illinois Biotechnology Industry Organization. He can be reached at rosenmichaels@aol.com.

NC Legislators Increase Biotech Funding

There they go again...

Posted on Sat, Feb. 23, 2008
State increases bet that biotech can grow jobs
SABINE VOLLMER
Oliver Smithies, who joined UNC Chapel Hill in 1988, is one of the N.C. Biotechnology Center's biggest success stories.

The biotech center, funded largely with state tax dollars, spent $899,875 to help UNC Chapel Hill recruit Smithies and six other researchers in 1988, when the state's fledgling biotech industry needed more research power.

Two decades later, the investment paid off: He won the 2007 Nobel Prize in Medicine.

Now the third-largest U.S. biotech hub by number of companies, North Carolina is again counting on the biotech center to attract the next generation of researchers, companies and discoveries.

Legislators have more than doubled state funding for the biotech center since Gov. Mike Easley called on the biotech industry to help revitalize the state economy four years ago.

For the current fiscal year, funding is about $15.6 million. The legislature approved an additional $83 million to boost research, worker training and manufacturing initiatives that the biotech center supports.

"We invest in other people's ideas, but our ultimate goal is to create more jobs," said Norris Tolson, a former state secretary of revenue who became chief executive of the center in July.

The goal is to replace about 100,000 textile, tobacco and furniture manufacturing jobs that the state has lost by 2023. That's about double the existing statewide biotech work force of 54,000.

To build on the state's regional strengths, the biotech center has opened five satellite offices since 2003, including one at UNC Charlotte. The broader reach of the center has led to plans to expand its Research Triangle Park headquarters.

Competition for jobs is fierce. Massachusetts, the second-largest U.S. biotech hub, plans to spend $1 billion to boost research and job development and create a first-in-the-nation state stem cell bank.

Top-ranked California committed $400 million to help establish the California Institutes for Science and Innovation. Up-and-comer Florida has pledged $310 million for the Scripps Research Institute, and Ohio will spend $60 million on a center for innovation at the Cleveland Clinic.

Meanwhile, lower-cost countries are drawing companies and investors.

GlaxoSmithKline, the British drugmaker with a U.S. headquarters in the Triangle, is cutting jobs in the U.S. and planning a 1,000-employee research laboratory in China.

Contract drug research companies are expanding in the United States -- the largest of them, Quintiles Transnational Corp., is doubling its work force to 2,000 at its Durham headquarters -- but also in Asia and Eastern Europe.

North Carolina's response has been not only to spend more but also to promote diversification beyond drug development, which has long been the strength of the state's biotech industry. It is throwing money into biofuels, natural remedies, nanotechnology and medical devices.

Indeed, environmentally friendly biotech is particularly dear to Tolson and several lawmakers overseeing the biotech center's budget. At stake are the state's forestry and fishing industries and farm production as the climate changes, Tolson said.

Research money handed out last year is indicative of the trend. The center awarded $6.4 million in fiscal year 2007 to companies, researchers and teachers.

Funding for drug research figured prominently in that amount. Ashutosh Chilkoti, a Duke University professor overseeing efforts to make chemotherapy safer and more effective for cancer patients, received a $100,000 grant.

One of the biotech center's largest research grants last year, $249,988, was awarded to Jay Cheng, an assistant professor of biological and agricultural engineering at N.C. State University. Cheng is trying to determine whether coastal Bermuda grass can be used to make ethanol.

Last year, an initiative to support research on natural remedies started at the N.C. Arboretum in Asheville. That research, which received $3 million from the legislature, is being done under the auspices of the biotech center.

Biotech center officials also successfully lobbied to establish the Biofuels Center of North Carolina. Legislators approved $5 million to establish the nonprofit organization, which opened last month in Oxford.

Biofuels and development of novel feedstocks to make them are of particular interest to David Weinstein, a Democrat and chairman of the state's Senate Appropriations on Natural and Economic Resources Committee. Construction of the state's first ethanol production plant is under way in Hoke County, which Weinstein represents.

Weinstein supports funding other segments of the industry. "Any money we put in biotech," he said, "is money well-spent."

Join VaBIO at "Bio-Europe" Meeting, April 7-9 in Madrid

The BIO-Europe Spring™ event, located at the Palacio Municipal de Congresos, Campo de las Naciones, in Madrid, Spain, brings together international decision-makers from all sectors of the biotechnology industry, and features the successful combination of one-to-one meetings, company presentations and a lively exhibition.

The event, April 7-9, 2008, enables biotechnology companies to identify, meet and network with companies across the biotechnology value chain from large biotech and pharma companies to financiers and innovative start-ups.
BIO-Europe Spring 2007, held at the International Congress Center Milan, Italy, drew over 1,200 delegates representing more than 700 companies from around the world.

Organizers include the EBD Group and the Biotechnology Industry Organization (BIO). The event is also sponsored by VaBIO and members can receive a discount on registration fees. Please contact the VaBIO office for details.

Website: http://www.bioeuropespring.com

VaBIO is on Facebook and YouTube

For those of you who have accounts on FaceBook and YouTube, you can sign up to our groups and keep up with others who share your interests.

Just search for "Virginia Bio" or "Virginia Biotechnology" on either and you should find us.

DC Region: Plenty of Research, Not Enough Capital...

Another good article by Vandana Sinha of the WBJ...

Friday, February 8, 2008
Region rich with biotech research fares poorly with investors
Washington Business Journal - by Vandana Sinha Staff Reporter

The Washington area boasts some of the highest public-dollar figures for biotechnology research in the country. If only the private investors were nearly that interested.

Venture capital for the region's biotech community plummeted by 45 percent last year, compared with 2006, even as biotech investments reached record highs nationally and the industry became the most venture-backed sector last year, according to a new report by PricewaterhouseCoopers and the National Venture Capital Association.

For 2007, nearly $1 of every $3 in venture capital nationally went to a life sciences company. In this region -- which includes Maryland, Virginia, D.C. and West Virginia -- the ratio dropped to a little more than

$1 of every $10 for biotech companies.

Even though the Washington area is considered one of the country's top five biotech markets it slipped into 10th place among 17 regions in biotech venture financing.

Without funding, startups can rarely attract experienced managers and push their products forward in one of the most expensive industries in the world. And yet without tested entrepreneurs and later-stage clinical trials, venture capitalists aren't as apt to take notice. The local market got only 3 percent of last year's national biotech deal flow.

Some biotech experts speculate that part of the problem is the high proportion of early stage companies here.

They also mention two other difficulties: attracting seasoned, serial entrepreneurs who catch the attention of venture capitalists and moving research from federal labs and academia into the marketplace.

"There's a disconnect between the amount of research in the region and startups," said Bill Gust, managing partner of Baltimore-based Anthem Capital Management.

That's partly because the National Institutes of Health discourages commercializing its research, and The Johns Hopkins University has a "puny, puny flow of commercialization," he said.

The startups that do emerge in the Washington area today must confront the effects of a Wall Street that is sour on biotechs.

As the stock market continues to batter publicly traded biotechs and drag down their valuations, venture capitalists realize they must invest more dollars and wait longer for that money to pay off in an IPO or sale.

"If that's the world you're dealing with, then there's a tendency to look only at later-stage deals," said Jim Barrett, general partner at New Enterprise Associates, a venture capital firm in Chevy Chase. "So the question becomes who is bringing these companies along to the point of late-stage deals? That's what everyone is grappling with."

Venture capitalists say a crucial element sometimes missing in local biotechs is tested management.

Some of the biggest deals of 2006 flowed to Cogenesys, founded by Human Genome Sciences Inc. executives, MacroGenics, founded by MedImmune Inc. executives, and Supernus Pharmaceuticals Inc., founded by Shire Laboratories Inc. executives.

Those deals illustrate the importance of developing a "critical mass" of biotech companies that can spin off new businesses, said Steve Mayer, a former HGS finance chief who spun out Cogenesys in 2005. The company announced last month it would be sold to an Israeli pharmaceutical for $400 million.

San Francisco and Silicon Valley, where biotech spinoffs are common, got $1.2 billion in biotech financing in 2007, more than a fifth of the country's biotech money.

New England rung up $897 million and San Diego raked in $973 million.

In comparison, the Washington area raised only $158 million last year in biotech venture capital. The region has stuck to an average, and slender, 4.5 percent slice of the national biotech VC pie in the last decade.

With more biotech buyout activity anticipated in the area and more companies reaching maturity, many hope those numbers will start rising this year.

"With where we were in 2007, it wouldn't take a lot to make 2008 a pretty interesting year," said Bruce Robertson, a managing director who heads the Rockville office of Atlanta-based HIG Ventures, which is eyeing two area biotech companies.

BizBio in Maryland Sparks Good Discussion

From the Gazette regarding Maryland's BizBio event this week. I attended and was very impressed by the frankness of the speakers. Only a few seemed to focus on "boosterism" and the rest highlighted the good and what could be improved. Congrats to TCM and the planners of the BizBio event for a good platform for discussion.

Friday, Feb. 22, 2008
Maryland bioscience poised to bloom, FDA chief says
State’s industry can exploit developments in medicine
by Steve Berberich | Staff Writer

ANNAPOLIS — Maryland is well-positioned for exponential growth in biosciences because of a ‘‘profound transformation in the history of medicine” now under way, according to Andrew C. von Eschenbach.

The commissioner of the U.S. Food and Drug Administration told a Biz⁄Bio conference of about 300 biotech and government leaders this week in Annapolis that ‘‘what you are doing today in Maryland is very important to the future of this country.”

A radical change ‘‘in how we deal with disease is changing the model of health care to one more personal, pre-emptive and much more participatory,” Eschenbach said. The old way of microscopically observing the manifestations of disease has given way to a new molecular perspective to actually understand the mechanisms of disease.

Maryland’s strength in biotech and medical research infrastructure potentially puts the state at the forefront of that change, and now is the time to catch that chance for growth, said Eschenbach and other speakers.

The Baltimore-Washington, D.C., bioscience cluster is one of nine such areas nationwide that get three-fifths of all National Institutes of Health funding, said Blake M. Paterson, CEO and co-founder of Alba Therapeutics in Baltimore. He said the local cluster ranks first in its number of researchers and scientists with 45,000, third in bioscience companies, fifth in total bioscience employees and sixth in venture capital deals.

Maryland’s biotech efforts can make it a leader in cutting health care costs, said James C. Greenwood, president and CEO of the Biotechnology Industry Organization: ‘‘There is an innovation-friendly environment in this state.”

The conference was the latest in many powwows of state bioscience leaders to share strategies on how to better market the state’s resources.

With few exceptions, discussions mirrored a similar gathering three years ago by many of the same participants.

This time, speakers congratulated each other for taking initiatives to enhance biotech and business incubators, advisory committees and tax credits. This week’s conference also took up an initiative to invest the state employees pension funds in local biotechs and related companies, which Indiana, Michigan and Florida already do.

Paterson suggested that the state take a page from the Indiana bioscience game plan. Indiana has invested in six local and national funds, which in turn invest in Indiana life sciences businesses. Paterson said the fund perhaps is having ‘‘some success” because it will be going to the same venture capital groups more than once.

But Maryland’s government is far behind some other states in funding the industry, he said. He cited California which is spending $300 million a year on stem cell research; Florida, with $1 billion of its employee pension fund invested in bioscience; Massachusetts’ recent commitment to provide $1 billion for biotech development; and North Carolina’s investment of $14 million portion of its tobacco settlement funds in biotech.

Paterson said the fundamentals for the Maryland region to become the nation’s most vibrant cluster are in place. Baltimore has greatest potential because the cost of doing business there is lower than in Montgomery County’s technology corridor, he said.

Biotech entrepreneur Paul Silber outlined a paradox. Maryland is a ‘‘hot bed” of bioservice companies and contract research organizations surrounded by a strong infrastructure of research facilities and research parks.

But what is lacking, Silber said, is a pool of capable CEOs to run those bioscience companies. The region also lacks coordination among the different life science organizations in the state, he said.

Silber recommended that Maryland expand its $6 million biotech tax credit and establish an institution that coordinates the life sciences organizations in the state.

Another speaker, H. Thomas Watkins, president and CEO of Human Genome Sciences Inc. in Rockville, is also chairman of the state life sciences advisory committee charged with writing a strategic advancement plan.

He said Boston and California biotech clusters are located near universities with easier access to technology, and Maryland lacks a large pharmaceutical company nearby. But he said the state’s major obstacle is lack of funding.

‘‘We are in a race with a number of other states,” Watkins said, and the state needs to step forward or languish.

Insmed Commissions FOB Study

Here is another report on FOB that was commissioned by Insmed! Boy, have they been busy!

Insmed Posting Videos Promoting Generic Biologics

Insmed is getting more engaged in the lobbying for generic biologics...

http://youtube.com/user/insmedinc

Jeffrey Sachs on Biotech Seeds

Cville Hook: Stupid Legislative Tricks...

This summary is not available. Please click here to view the post.

Secreatry of Technology's Podcast on Sponsored Research

Check out Secretary of Technology Aneesh Chopra's podcast on industry-sponsored research at universities:



http://www.technology.virginia.gov/media/audio/podcast/020608.mp3

Governor: Shortfall is $1.4 Billion

Governor Kaine Announces Revised Budget Revenue Forecast
– Proposes strategy for addressing anticipated budget shortfall –

RICHMOND – Governor Timothy M. Kaine today announced the revised revenue forecast for fiscal years 2008 through 2010, as well as a budget reduction plan designed to deal with the shortfall in state revenue brought on by the national downturn in the economy. The shortfall for the remainder of fiscal year 2008 and fiscal years 2009 and 2010 totals nearly $1.4 billion.

The Governor’s proposed strategy to meet the shortfall includes increased utilization of the Revenue Stabilization Fund; targeted reductions to the Governor’s initiatives and other programs; percentage cuts to executive agencies; and bonding of capital projects. While the plan does include some targeted reductions in K-12 education and percentage cuts to some local aid, it does not reduce funding for the constitutionally required Standards of Quality program in K-12 education. The Governor’s plan does not include tax increases.

“Since the November 2007 revenue forecast, the national economy has dramatically slowed,” Governor Kaine said. “While Virginia can weather economic downturns better than most states, we are not immune. In the past week, we have gathered the most recent data and met with our leading economists, representatives of the private sector, and state legislators. The revised consensus revenue forecast indicates that we are now facing an additional shortfall of nearly $1.4 billion over the remainder of fiscal year 2008 and the 2009-2010 biennium.”

The revenue shortfall for the remainder of this fiscal year is projected to be $339 million. It is expected to be $520 million in fiscal 2009 and $532 million in fiscal 2010.

“My recommended revisions include an additional withdrawal from the Revenue Stabilization Fund, targeted reductions in spending, and percentage cuts to executive branch agencies,” Governor Kaine said. “We sought to minimize the impact of the cuts on services and balance the burden of the cuts, keeping in mind that some agencies made bigger reductions in the first round of cuts we made in October.”

Governor Kaine’s plan to address the shortfall in fiscal year 2008 includes utilization of an additional $162 million from the Revenue Stabilization Fund, as well as bonding for existing capital projects, and a mixture of targeted and percentage cuts to executive agencies. This plan brings the total proposed withdrawal from the Revenue Stabilization Fund to $423.5 million. The withdrawal will leave the account balance at about $800 million

For fiscal year 2008, the Governor is making 0.5% reductions across all executive branch agencies, excluding higher education institutions, which made significant cuts for fiscal year 2008 in October. The Governor had already instructed agencies to take preemptive actions to address the shortfall, including a freeze on discretionary training, travel, and purchases and a requirement of an additional level of approval for hiring and entering consulting contracts.

For the 2009-2010 biennium, the Governor is recommending continued percentage cuts to executive branch agencies at 2% for higher education and 3% for all other agencies. The Governor’s plan also makes targeted cuts to budget initiatives, including his proposals to fund the expansion of existing pre-kindergarten education, the increase in foster care rates and foster care worker training, and the creation of the Virginia Share health insurance program. His proposal also includes a 1% reduction in proposed salary increases for state employees and teachers – the full proposed 3% for state employees and 3.5% for teachers will be included in the budget in 2010, if the revenues are available.

In addition, the Governor is recommending 5.4% cuts in certain state aid to localities’ programs, excluding K-12 education and car tax relief. Under the Governor’s plan, localities may allocate the 5.4% cuts across state-funded local programs as they deem appropriate. The Governor’s plan makes no reductions in funding for the Standards of Quality program in K-12 education. The Governor’s plan does, however, recommend a $55 million reduction in K-12 school construction funding over the biennium, and shifts $165 million of lottery proceeds from school construction to basic aid for K-12 operations.

The Governor’s Recommended Budget Reductions plan is available at: http://www.governor.virginia.gov/Initiatives/Legislation2008/CombinedPlan02-12-08.pdf.

DiaKine Lands Islet Cell Pioneer

Pioneer in Successful Islet Cell Transplants Named to DiaKine Therapeutics’ Scientific Advisory Board

DiaKine Therapeutics, Inc., a developer of drugs designed to treat diabetes and other immune-related diseases by modulating inflammation, today announced the appointment of Dr. Jonathan Lakey to its Scientific Advisory Board.

Dr. Lakey’s research career is centered on cell and tissue preservation and isolation, with a focus on insulin producing cells from the pancreas for patients with insulin dependent diabetes. His contributions and partnership with surgeon Dr. James Shapiro led towards the improvement of islet isolation techniques and the development of the "Edmonton Protocol" for patients with type 1 diabetes. The Edmonton Protocol is recognized as a major advancement in the treatment of diabetes and a significant step towards curing diabetes.

“I am very enthusiastic about working with Dr. Jerry Nadler and his team at DiaKine as they develop new and exciting treatments for diabetes,” said Dr. Lakey. “I believe that the demonstrated restorative properties of DiaKine’s drugs have the potential to dramatically alter the way diabetes is treated.”

“Dr. Lakey’s superior knowledge of islet cell preservation will serve well as we develop our islet cell protecting and rejuvenating drugs, and I look forward to his contribution to our success,” said Dr. Nadler, DiaKine’s Chief Scientific Officer.

“I am pleased to welcome Dr. Lakey to our Scientific Advisory Board, and believe that his unique understanding of insulin-producing cells and their preservation will be invaluable as we work to bring our therapies to market,” said Keith Ignotz, President, and CEO of DiaKine.

Dr. Lakey is widely published with over 250 referred papers and 22 book chapters and submitted over 450 scientific abstracts, and has recently published a book on islet isolation. Together with his team, Dr. Lakey has assisted and collaborated with more than 40 clinical islet transplant programs worldwide. Dr. Lakey graduated from the University of Alberta (BSc, MSc, PhD) and received post secondary training in Indianapolis and Seattle before returning to establish his research laboratory at the University of Alberta.

Dr. Lakey joins Dr. Alexander “Zan” Fleming, a well recognized authority in the metabolic and endocrine fields, Dr. Mark Atkinson, an internationally recognized authority on multiple aspects pertaining to type 1 diabetes, and Dr. Raghu Mirmira, a leading authority on beta cell development and function and the study of the regulation of insulin gene expression, on the DiaKine Scientific Advisory Board.

Drugs being developed by Diakine modulate cytokines, part of the body’s immune system, which sometimes mistakenly attack normal organs and tissue and cause diseases such as diabetes and multiple sclerosis. Research by Dr. Nadler and his collaborators published in 2006 showed that controlling certain cytokines can arrest the progression of, or reverse, type 1 diabetes in an animal model.

About DiaKine --

DiaKine Therapeutics, Inc. is a development-stage company commercializing novel immune modulators initially targeting the treatment of autoimmune and inflammatory diseases such as diabetes and related complications. These new drugs regulate cytokines, part of the body’s immune system, which mistakenly attack tissue and cause inflammation. The Company designed its first product, IsletLife-LSF Media 1, to improve the viability and insulin producing capabilities of harvested islet cells prior to transplant. IsletLife-LSF Media thus can potentially improve the success rate of the procedure. Additional therapeutics under development by DiaKine include: adjunct therapy to islet cell transplants, halting the progression of type 1 diabetes in newly diagnosed adults, treatment and prevention of Latent Autoimmune Diabetes of Adults (LADA), treatment and prevention of insulin requiring type 2 diabetic, treatment and prevention of diabetes complications. For more information, visit www.diakine.com.

Biotech Commission Bill Altered on House Floor

HJ 248, Delegate Sickles' (D-Fairfax) resolution to create a joint subcommission dedicated to studying proposals to advance the biosciences in Virginia, had passed the House Rules committee and was on its way to full passage by the House of Delegates on Friday. However, in a last minute surprise move, Delegate Joe May (R-Loudoun) proposed an amendment in the nature of a substitute on the floor of the House. The revised language, transferring the work of the proposed commission to JCOTS, passed and the measure is now on its way to the Senate. The end result should be the same. The only concern is that in the past, JCOTS had a reputation for being more focused on IT issues. We certainly hope that this is a good opportunity to change that perception in 2008.

Here is the language in the new amended version:


HOUSE JOINT RESOLUTION NO. 248
FLOOR AMENDMENT IN THE NATURE OF A SUBSTITUTE
(Proposed by Delegate May
on February 8, 2008)
(Patron Prior to Substitute--Delegate Sickles)
Directing the Joint Commission on Technology and Science to study and advance the development and enhancement of the biosciences and biotechnology in the Commonwealth. Report.

WHEREAS, the biosciences, broadly defined, are producing advances in human knowledge beyond even our most recent optimistic predictions; and

WHEREAS, neighboring states to the Commonwealth as well as states around the country are investing in bioscientific research and have developed strategic plans for, among other things, higher education-based research, public-private partnerships, and venture capital incentives; and

WHEREAS, the Governor’s Commission on Biotechnology has laid the groundwork for a better understanding of the role of these disciplines in the social and economic welfare of the Commonwealth; and

WHEREAS, future investment in the biosciences and biotechnologies promises to yield improvements in the quality of life for Virginians as well as fellow citizens throughout the nation and the world; now, therefore, be it

RESOLVED by the House of Delegates, the Senate concurring, That Joint Commission on Technology and Science be directed to study and advance the development and enhancement of the biosciences and biotechnology in the Commonwealth.

During the course of its study, the Joint Commission on Technology and Science shall ensure the participation and contribution of representatives of Virginia's public research institutions of higher education, the Center for Innovative Technology, the private biotechnology industry, and the Secretary of Technology. The Joint Commission of Technology and Science shall also ensure the involvement of representatives of agricultural and tobacco interests, federal laboratories in Virginia involved in research and technology transfer in life sciences, and the not-for-profit life science and research institutions and laboratories in the Commonwealth.

In conducting its study, the Joint Commission on Technology and Science shall (i) review and implement appropriate and efficacious recommendations of state and national research investigations in the disciplines of bioscience and biotechnology, including the Governor’s Commission on Biotechnology; (ii) examine, continue, and enlarge the work begun by the Governor’s Commission on Biotechnology, including, but not limited to, determining how Virginia’s research universities, federal and state laboratories, biotechnology incubators, research parks, private industry, and other major resources can be leveraged to help make Virginia a more attractive location for the development and enhancement of the biosciences and biotechnology industry; (iii) determine how these resources may increase the development of the biotechnology industry through technology transfer and commercialization of new ideas and discoveries; (iv) assess how strategic initiatives in bioscience and biotechnology may generate economic development and investment in Virginia, particularly in rural and urban regions of the Commonwealth; (v) examine Virginia’s workforce development status, including education, supply, and training needs relative to supporting viable bioscience research and biotechnology industry in the Commonwealth; (vi) evaluate the capacity of bioscience and biotechnology to protect and preserve Virginia’s natural resources; (vii) investigate innovative directions in bioscience, including informational, technological, infrastructure, funding, and long-term research goals, and regulatory needs in areas such as biomedical research; genetic engineering; disease, growth and metabolism, and development and reproduction in livestock, fish and food animals; agricultural biotechnology; and plant diseases and insect pests; (viii) define and recommend the optimal climate that is conducive to basic bioscientific and biotechnological research in Virginia; (ix) identify the type of bioscience and biotechnology industries that the Commonwealth is positioned to attract, recruit, and support due to the state’s workforce, location, and other advantages; (x) consider the work and recommendations of the Governor’s Commission on Biotechnology, together with other bodies of research on the application of the biosciences and enhancement of the biotechnology industry; and (xi) develop and recommend a strategic and visionary plan that implements certain of the recommendations deemed feasible and appropriate, establishes Virginia as a national and global leader in bioscience and biotechnology research and application by 2018, and enables the Commonwealth to maintain its national and global leadership thereafter.

The Joint Commission on Technology and Science shall complete its meetings by November 30, 2008, and the chairman shall submit to the Division of Legislative Automated Systems an executive summary of its findings and recommendations no later than the first day of the 2009 Regular Session of the General Assembly. The executive summary shall state whether the joint subcommittee intends to submit to the General Assembly and the Governor a report of its findings and recommendations for publication as a House or Senate document. The executive summary and the report shall be submitted as provided in the procedures of the Division of Legislative Automated Systems for the processing of legislative documents and reports and shall be posted on the General Assembly's website.

Virginia Bioscience Legislative Caucus Kick-off a Success

The Virginia Bioscience Legislative Caucus (VBLC) was launched this week at the 2008 Session of the Virginia General Assembly. On Monday, February 4th, 18 members of the state legislature attended one of three bioscience dinners held simultaneously across the city. At each dinner, an equal number of bioscience company leaders joined them to discuss what is going on with this industry in the Commonwealth.

The next morning, Tuesday, February 5th, more than 70 people met for breakfast at 7 am at the Richmond Marriott to formally kick-off the new Bioscience Caucus. 16 members of the state legislature were able to participate there too. Breakfast attendees heard from speakers such as Delegate John O'Bannon and Senator Janet Howell, the House and Senate co-chairs of the new caucus. They also heard from Mark Herzog of VaBIO, Patrick Kelly of BIO, Brett Vassey of the VMA, Bob Skunda of the Virginia Biotech Park and Aneesh Chopra, Virginia's Secretary of Technology. Also speaking were Ted Melnik, the president of Novozymes Biologicals and Eric Edwards, the Chief Science Officer of Intelliject. Here is the list of legislative participants:

Attended Dinner and Breakfast:
Sen. Ralph Northam (D)
Sen. Janet Howell (D)
Del. Donald Merricks (R)
Del. David Nutter (R)
Del. John O’Bannon (R)
Del. Margaret Vanderhye (D)

Breakfast Only:
Sen. Harry Blevins (R)
Sen. Mark Herring (D)
Sen. L. Louise Lucas (D)
Sen. Henry Marsh, III (D)
Del. Anne Crockett-Stark (R)
Del. Albert Eisenberg (D)
Del. Jimmie Massie (R)
Del. Joe Morrissey (D)
Del. Kenneth Plum (D)
Del. David Poisson (D)

Dinner Only:
Sen. John Edwards (D)
Sen. Fred Quayle (R)
Sen. Patsy Ticer (D)
Sen. Toddy Puller (D)
Del. Phil Hamilton (R)
Del. Bob Brink (D)
Del. Steve Shannon (D)
Del. Mark Sickles (D)
Del. Chris Peace (R)
Del. Joe May (R)
Del. Kathy Byron (R)
Del. Jennifer McClellan (D)

Lilly Counsel Not at Fault After All?

http://druganddevicelaw.blogspot.com/

It Wasn't Pepper's Fault! Berenson Confirms.

Since we're pharmaceutical product liability defense lawyers, we keep our ears pretty close to the ground in that sandbox. (Yeah, yeah: We get a lot of sand in our ears.) Anyway, we heard rumors that we had spread false information. We had written that a mis-directed e-mail from Pepper Hamilton to Alex Berenson of The New York Times prompted Berenson's front-page article about Eli Lilly's talks with prosecutors to pay $1 billion to settle charges of impropriety in the marketing of Zyprexa.That story originally appeared at Portfolio.com. We were, we think, the first to repeat the misinformation in the post we published yesterday. But we weren't alone, as the story ricocheted around the web from Starkman to Above the Law to Pharmalot to the Wall Street Journal Law Blog. If this story wasn't true, then none of us should have been spreading the rumor.The story wasn't true.We don't know anything about journalistic propriety, so we picked up the phone and called Alex Berenson at the Times. We asked him whether a misdirected e-mail from Pepper to Sidley & Austin had prompted his front-page story.It did not. Berenson did receive a mis-directed e-mail from Pepper, but that e-mail did not contain a detailed description of the status of the settlement talks. Berenson had known independently about the settlement talks for some time, and he obtained the details he published in the Times from sources other than Pepper.We apologize, Pepper Hamilton. We shouldn't have unfairly accused you, and we hope that this post helps to set the record straight.(But you've gotta admit, it was a heckuva story -- "There but for the grace of God go I" -- while it lasted. If only it had been true.)Sorry about that, folks.

Florida launches their Biotechnology Caucus

BioTech Gets Some BFFs

posted by John Kennedy on Feb 6, 2008 1:27:29 PM

Although it may sound like its members should be outfitted with pocket protectors and nerd glasses, Florida lawmakers forming a new "caucus on biotechnology" met for the first time Wednesday to underscore the state's commitment to the booming research field.

Officials from Scripps Florida, Torrey Pines Institute and Orlando's own Burnham Institute huddled with lawmakers from South and Central Florida, where the industry's Florida research is in its infancy.

Most of the Southern California-based research giants said they were satisfied with their early Florida experience -- and the hundreds of millions of dollars in state incentives that inspired them to launch what promoters once dubbed Silicon Beach.

Dr. Richard Houghton, president of Torrey Pines Institute -- which has a branch in Port St. Lucie, home of Senate President Ken Pruitt -- said he wanted to dispell the notion that bio-tech firms would have trouble recruiting scientists to Florida, which remains an outpost in the research world.

But he suggested that Florida is easier to sell to out-of-state researchers during winter months.

"All this business of trouble trying to recruit in Florida isn't true," Houghton said. "Especially this time of year."

Elizabeth Gianini, a former chief-of-staff to Orange County Mayor Rich Crotty and now a Burnham vice-president, said her facility has taken a major step forward with this week's hiring of Dr. Dan Kelly from St. Louis' Washington University to head a new center on obesity and diabetes.

She noted that about 10 percent of health care dollars are currently spent in some aspect of managing diabetes and that the institute is poised to make major research inroads. "Burnham really wants to cure diabetes," Gianini said.

Dale Brill, director of the state's Office of Tourism, Trade and Economic Development, acknowledged that the state's budget woes will make it difficult to attract public dollars that can be used to woo bio-tech firms.

While climate change technologies, aviation and homeland securities remain potentially lucrative fields for research firms already in Florida, Brill said that he and other advocates may have to work harder this spring to urge lawmakers to take the long view and avoid cutting economic development dollars.

He cited the philosophy of former House Speaker Allan Bense, R-Panama City.

"Speaker Bense used to always say that you can't hunt with your dog tied to the porch," Brill said.

Lawyer for Eli Lilly Leaks Negotiation to NY Times by Accident

From Portfolio.com...

Lilly's $1 Billion E-Mailstrom
by Katherine Eban
Feb 5 2008
A secret memo meant for a colleague lands in a Times reporter's in-box.

When the New York Times broke the story last week that Eli Lilly & Co. was in confidential settlement talks with the government, angry calls flew behind the scenes as the drug giant's executives accused federal officials of leaking the information.

As the company's lawyers began turning over rocks closer to home, however, they discovered what could be called A Nightmare on Email Street, a pharmaceutical consultant told Portfolio.com. One of its outside lawyers at Philadelphia-based Pepper Hamilton had mistakenly emailed confidential information on the talks to Times reporter Alex Berenson instead of Bradford Berenson, her co-counsel at Sidley Austin.

With the negotiations over alleged marketing improprieties reaching a mind-boggling sum of $1 billion, Eli Lilly had every reason to want to keep the talks under wraps. It was paying the two fancy law firms a small fortune to negotiate deftly and quietly.

If and when it did settle the allegations that it had improperly marketed its most profitable drug, Zyprexa, for schizophrenia, it would certainly want to announce the news on terms carefully negotiated with the government.

"We usually try to brace for that [kind of] story," a Lilly staffer said.

So when the Times' Berenson began calling around for comment, and seemed to possess remarkably detailed inside information about the negotiations, Lilly executives were certain the source of the leak was the government.

As it turned out, one of Eli Lilly's lawyers at Pepper Hamilton in Philadelphia wanted to email Sidley Austin's Berenson, about the negotiations. But apparently, the name that popped up from her email correspondents was the wrong Berenson.

Alex Berenson logged on to find an internal "very comprehensive document" about the negotiations, the consultant said, and on January 30, Berenson's article, "Lilly in Settlement Talks With U.S." appeared on the Times' website. A similar article followed the next day on the front page of the New York Times.

Those who knew the real story must have had a chuckle—or shed some tears—over Lilly's statement to the Times that it had "no intention of sharing those discussions [with the government] with the news media and it would be speculative and irresponsible for anyone to do so."

When reached for comment, Alex Berenson told Portfolio.com, "I can't say anything. I just can't."

A spokeswoman for the U.S. Attorney's office in Philadelphia, which is spearheading the Zyprexa investigation, declined to comment, as did a spokeswoman for Eli Lilly.

However, the Lilly spokeswoman called back to add that the drugmaker would continue to retain Pepper Hamilton. Phone calls to Sidley Austin and Pepper Hamilton were not returned.

And sadly, no confidential emails with further scoops were received in error.

2008 General Assembly Update: Biotech Bills Still Alive

The 2008 Session of the Virginia General Assembly is nearing the infamous half way point known as "crossover" where each house of the legislature must finish acting on its own bills and resolutions. Staff and volunteers of the Virginia Biotechnology Association are walking the halls and attending numerous committee meetings for about 30 key bills and resolutions that are of specific interest to the bioscience community. Those bills can be viewed here: http://www.richmondsunlight.com/photosynthesis/3t1bh/

House of Delegates Members Bob Purkey (R-Virginia Beach) and Mark Sickles (D-Fairfax) have joined forces and agreed to roll their similar bills together at a House Finance subcommittee meeting on February 1st. After testimony in favor of the bills from VaBIO Executive Director Mark Herzog and Eric Edwards, the chief science officer of Intelliject, a Richmond-based medical device firm, the subcommittee voted to report the bill favorably to the full committee. The combined bills are now under HB 125.

Delegate Mark Sickles HJ 248 and Senator Mark Herring's (D-Loudoun) SB 787 have both advanced in their respective Rules committees and are likely to make it at least to the floors of both houses. These pieces of legislation establish a commission on bioscience within the legislative branch to review the recommendations from previous gubernatorial commissions and identify specific action items for the 2009 session of the General Assembly.

"Senator Herring and Delegates Purkey and Sickles are really going to the wall for us this year," said VaBIO Executive Director Mark A. Herzog. "While we have had some early successes I am afraid that we still have a long way to go through the legislative process."

Please contact your state legislator to let them know that you support these bills and resolutions that will promote the Bioscience industry in Virginia. Here is a link to find out who represents you in Richmond: http://conview.state.va.us/whosmy.nsf/main?openform

Also starting during this 2008 Session is the new bipartisan legislative caucus dedicated to the advancement of the life sciences industry in Virginia. The "Virginia Bioscience Legislative Caucus" (VBLC) was formed in October by the Virginia Biotechnology Association and two leading members of the state legislature, Delegate John O'Bannon, MD (R-Henrico) and Senator Janet Howell (D-Reston). The VBLC, which now has more than forty members, will serve as a bipartisan forum for lawmakers to coordinate polices being developed in human, plant, and animal biosciences and devices. Such dialogue can lead to better understanding as to how to both grow Virginia's economy and benefit our citizens with new life-saving medicines.

The Caucus has its kick-off breakfast on Tuesday, February 5 at the Richmond Marriott. All VaBIO members are encouraged to attend. Click here for details: http://www.vabio.org/legislative-caucus-events-feb-4-5

For more information about the VaBIO legislative agenda or to volunteer, please call us at 804-643-6360.

Action Alert: US Senate Votes Monday on Stimulus for R&D

On January 30th, the U.S. Senate Finance Committee approved a package of individual and business tax cuts designed to stimulate the U.S. economy. One of the provisions included in this package would allow businesses to more quickly deduct from their taxes the costs of new business investments in capital equipment, commonly known as "bonus depreciation." However, for companies that are not yet profitable and who do not owe federal income tax - such as many small biotech companies - this "bonus depreciation" does not provide any immediate economic benefit. Due to this fact, the Biotechnology Industry Organization (BIO) worked closely with Senators Debbie Stabenow (MI), Orrin Hatch (UT) and Jay Rockefeller (WV) to include an alternative investment incentive for not-yet-profitable companies.

The alternative incentive would allow not-yet-profitable companies to utilize a portion of their R&D or AMT credits. Specifically, the provision would allow a company to elect to use this alternative incentive instead of bonus depreciation. Importantly, this credit would be refundable, meaning that the biotech or device company could get a payment from the IRS even though it owes no federal income tax. This could be incredibly beneficial for a bioscience company that is investing in new business equipment but that does not yet owe federal tax.

Unfortunately, the Finance bill may not have the votes to pass on the Senate floor, where a vote is expected Monday, February 4th. If the Finance package does not garner the 60 votes necessary for adoption, the Senate will likely pass the House economic stimulus bill, which does not include any provision of benefit to not-yet-profitable companies.

As such, BIO and VaBIO are strongly urging that bioscience company representatives call Senator Warner and Senator Webb and ask to speak with the staff who is dealing with the Economic Stimulus Package. Please let them know that any economic stimulus bill should help ALL of America's businesses, not just those that have already achieved profitability.

Senator John Warner: (202) 224-2023. Senator Jim Webb: (202) 224-4024.

Anyone with questions should call Paul Poteet in BIO's Federal Government Relations Department at (202) 312-9268.

Deadline for GMU High School Student Program: March 3

High school or college students interested in exploring the cutting edge of science and medicine, gaining hands-on experience with state-of-the-art technologies in a university research laboratory, and mentoring with high-profile scientists, are encouraged to apply now for the 2008 Aspiring Scientists Summer Internship Program at George Mason University.

Open to rising high school juniors and seniors and college students, 20 aspiring scientists will be accepted into this highly competitive program. Interested students must be 15-years-old as of June 23. The students will work alongside Mason scientists on timely projects related to proteomic and genomic analysis of cancer and other diseases, antimicrobial drug design, developmental neurobiology, nanotechnology and environmental science. Opportunities may exist for their work to be published in scientific journals or presented at professional conferences. In addition, students will learn about the college application process and career preparation, and meet scientists from varying disciplines during career day seminars.

The application deadline is March 3. For additional information visit the web site at http://mason.gmu.edu/~avanmete.

Virginia Biotech Park Signs Deal with Israeli Bio Incubator

The Virginia BioTechnology Research Park, located in Richmond, and its newly formed Virginia Biosciences Commercialization Center announced a strategic alliance with Xenia Venture Capital, one of Israel's top technological incubators that focuses on initiation, investment and business development of Israeli life sciences and information technology.

"This alliance is very important for the state of Virginia, and specifically for the Virginia BioTechnology Research Park," stated Donna Edmonds, executive director of the Virginia Biosciences Commercialization Center. "Israel is well known for its proliferation of intellectual property and new technological advances in the life sciences industry, and the Virginia BioTechnology Research Park has expanded the current infrastructure to help their companies successfully enter U.S. markets."

"Xenia is encouraging companies that wish to do business in the U.S. to approach the VBCC. We also can and want to support later-stage companies that wish to develop a successful track record by operating from one of the main business hubs in the U.S.," stated Anat Segal, CEO of Xenia Venture Capital. "This partnership was formed because the Virginia BioTechnology Research Park has an experienced and very committed executive team, significant industry and clinical connections, and the know-how to launch these companies successfully in the U.S."

Xenia is an investment firm founded in 2003 by a group of experienced entrepreneurs and is traded on the Tel Aviv Stock Exchange. Much like the Park's incubator program, Xenia has gathered experts in various fields to support the growth of high-potential companies. It is focused on the acceleration of development and positioning for commercial success and has the ability to directly fund the first stages of company growth.

In addition to the Park's nationally recognized incubator program, the Virginia Biosciences Development Center, the newly formed VBCC provides considerable expertise in bringing "graduates" of Xenia's, or other incubator programs, to successfully commercialize their products and make them more likely candidates for additional funding sources, business alliances and exit options.

BIO Touts UVA Patent Report

WASHINGTON, D.C. (Thursday, January 31, 2008) - A study by researchers at the University of Virginia, released today by the Biotechnology Industry Organization (BIO), found that the three key reports often cited as justification for a sweeping overhaul of the U.S. patent system lack any empirical data to support the claims that alleged over-patenting and poor quality patents are hampering innovation and successful commercialization of inventions.

“BIO continues to support consensus-oriented approaches to patent reform that would truly improve the U.S. patent system,” stated BIO President and CEO Jim Greenwood. “However, this study demonstrates that draconian measures that would fundamentally weaken patents for the benefit of a handful of industries to the detriment of many others are simply not justified by an objective review of the facts.”

The study, entitled “Proposed Patent Reform Legislation: Limitations of Empirical Data Used to Inform the Public Policy Debate,” analyzed reports on patent reform produced by the Federal Trade Commission, the National Academy of Sciences, and the National Research Council. The new study found that, contrary to the assertions of the industry proponents of the pending patent reform legislation, the evidence contained in these reports actually demonstrates that the current patent system is working well to promote innovation.

The study also determined that the reports relied upon conjecture, anecdotes and individual publicized cases rather than upon empirical data supporting the underlying premise of bad quality patents. For example, the study showed that concerns in the reports about the quality of patents issued are undermined by the consistently low rates of litigation and low rates of erroneously-granted patents. More, the evidence presented in the reports indicates that, to the extent industry participants are experiencing alleged “patent thickets” or other issues associated with poor quality patents, they are finding market-based solutions to effectively address these problems.

The study also examined how several recent court cases have addressed some of the concerns and recommendations contained in the reports, further undermining the need for sweeping legislative changes to the U.S. patent system.

The study authors conclude that there is an utter lack of evidence to justify overhauling the patent system in a way that could disrupt the incentives of industries, such as biotechnology, which rely on patents to encourage and protect innovation.

“While certain reform measures could improve the U.S. patent system, it remains the best in the world at promoting and rewarding innovation,” stated Greenwood. “This study reinforces our continuing request of Congress: when it comes to patent reform, tread carefully and first, do no harm.”

The study is available at http://bio.org/ip/domestic/UVA_Limitations_of_Empirical_Data.pdf.