West Virginia's Biotech Vision 2015

An article about WV's plans for tech-based economic development...

West Virginia enters biotech race
Deven Swartz
Posted: 11/16/06
As states across the United States are beginning to bank their futures on the potentially unlimited possibilities of biotechnology, West Virginia feels it has no other choice but to enter the competition.

The state government has invested $4 million in Technology-Based Economic Development to date. TBED is a program that calls for postsecondary research institutions to stimulate a region's economy by creating state-of-the-art inventions, mainly in the biotechnology field.

The state's TBED proposal, Vision 2015, calls for a state investment of $250 million by 2015. Governor Joe Manchin has publicly spoken in support of the proposal and TBED in general, and proponents are currently touring the state to try to build enough legislative support to pass the proposal.

The state received $60 million from the federal government for TBED activities as of 2005, which proposal literature considers below the national average. However, the state received its largest grant, $9 million, from the National Science Foundation in July. All the money from the grant was earmarked for Marshall University research.

The goal would increase the amount of federal funding to more than $120 million by 2010 and $220 million by 2015.

Proponents of Vision 2015 point out that every federal dollar invested in TBED will yield $7 in revenue. However, a Web site at the University of Louisville, a member of Kentucky's TBED program, states that each federal dollar invested has yielded $3 in revenue.

The proposal also includes recruiting 89 new scientists and engineers to the state. West Virginia University would get 63 of the scientists, and Marshall University would receive 26.

Start-up costs for the new scientists and engineers would be close to $40 million, and the universities would be collectively paying out more than $8 million per year in salaries and fringe benefits. The universities' base budgets would need to be increased beginning in 2008 in order to compensate for possible salary increases, according to the proposal.

Vision 2015 also calls for the construction of two minimum 100,000 square-foot facilities-one at Marshall and the other at West Virginia University-by 2010. More than $120 million must be raised in order to pay for both buildings, and the proposal sets a December 2007 deadline to obtain the funding.

Marshall would be getting a science and engineering building meant to complement the $48 million Robert C. Byrd Biotechnology Science Center, which was dedicated in August. The biotech center had been in the planning stages since the late 1990s and was initiated by former Marshall President J. Wade Gilley, Dr. Howard Aulick, Marshall vice president for research, said.

Two other major items in the proposal include increasing the production of scientists and engineers already in the state, as well as developing new tech-based businesses.

If Vision 2015 is completed as proposed, it will create 33,000 jobs and have a total economic impact of more than $3 billion, according to proposal literature.

"If we don't do this now, Ohio will recruit our best researchers or Kentucky will," Aulick said.

Looking at TBED investments made in neighboring states, West Virginia is years behind. Kentucky, through the Bucks for Brains project, has invested $300 million in state funding into TBED since 1997. Ohio's TBED project, Third Frontier, has received $300 million from the state to date as well, but it started funding the project only three years ago. The state will invest a total of $1.1 billion in the project by 2013.

Because neighboring states have already made large-scale investments into TBED, some wonder if West Virginia has entered the marketplace too late to compete effectively.

"Every university in the nation is making the same bet, and many are better equipped and located to succeed in (biotechnology)," one person said in a message on the open comment section of the Marshall Strategic Vision Web site.

Aulick said he has heard this argument before. However, because West Virginia's TBED projects and investments will focus on health problems of major importance in Appalachia, the state will have its own competitive advantage, Aulick said.

Virginia's Goodlatte Blasts EU on Biotech Trade

Go get 'em Bob Goodlatte! Here is an article from the WP:

U.S. lawmakers: EU dragging heels on biotech trade

By Missy Ryan
Reuters
Wednesday, November 15, 2006; 1:46 PM

WASHINGTON (Reuters) - The United States must pressure the European Union to stop dragging its feet on approving new imports of bioengineered food, senior U.S. lawmakers said in a letter released on Wednesday.

"The EU has avoided for too long its WTO obligations ... The illegal discrimination against biotech products on nonscientific grounds must cease," a group of lawmakers said in a letter to U.S. Trade Representative Susan Schwab.

Bioengineered foods are made from crops altered by biotechnology, boosting the vitamin content of a strain of rice, for example, by inserting genes from daffodils and from soil bacterium.

The EU has insisted on careful regulation of bioengineered food to screen for any risk to human health or to the environment.

The U.S. lawmakers, including the incoming chairs of the House and Senate Agriculture committees, want European officials to act quickly on the heels of a September 29 ruling by the World Trade Organization's dispute settlement body.

A main finding of that ruling was that a ban on approving new biotech products, which the EU had in place for four years until 2003, led to "undue delays."

"Winning the WTO case without achieving any positive changes in the approval process would greatly erode the credibility of the WTO in the eyes of U.S. agriculture," the lawmakers wrote in the letter, which was delivered to Schwab's office late on Tuesday.

It was signed by Iowa Sen. Tom Harkin and Minnesota Rep. Collin Peterson, who are poised to lead the Senate and House Agriculture committees once Democrats take control of Congress in January.

The committees' outgoing chairs, Republicans Saxby Chambliss of Georgia and Bob Goodlatte of Virginia, also signed the letter, along with the current heads of the powerful Senate Finance Committee and House Ways and Means Committee.

The European Union says its current regime for approving bioengineered products -- including a food safety authority based in Italy -- complies with WTO rules.

"The new system is science-based. We've set up a centralized procedure ... that's responsible for doing risk assessment" of bioengineered food, said Canice Nolan, who directs food safety, health and consumer affairs for the EU's delegation in Washington.

Keith Williams, a Chambliss spokesman, said the European Union had sidestepped WTO rulings in the past, and pointed to a case involving beef hormones.

Nolan said the European Union had not decided if it would appeal the WTO's ruling. It has until late November to do so.

A representative for Schwab, who is traveling in Asia, was not immediately available for comment.

Bacon's Rebellion: Virginia's Chronic Budget Surplus: An Update

Bacon's Rebellion: Virginia's Chronic Budget Surplus: An Update

Dem Victories in Md & Va Mean More Stem Cell Action?

More coverage of stem cells and the elections...

New Dems in Md., Va. won’t bring stem cell research funding right away
Katie Wilmeth, The Examiner
Nov 14, 2006 5:00 AM (3 hrs ago)
Current rank: # 9 of 5,967 articles


WASHINGTON - Despite victories for Democrats who support stem cell research in the Maryland governor’s race and the U.S. Senate race in Virginia, local biotechnology industry officials aren’t expecting a huge shift in policy anytime soon.

Virginia Democrat Jim Webb’s win in the U.S. Senate that captured the Senate majority for the party and Gov.-elect Martin O’Malley’s win in Maryland may eventually make some waves, but “it’s way too soon to tell,” said C. Robert Eaton, president of MdBio, an organization that represents the interests of the biotech industry in Maryland.

Eaton said the organization has no plans to meet with Governor-elect Martin O’Malley, but “I’d love to hear what their plans are and hope they get up to speed on [the industry].”

Maryland garnered national attention under outgoing Gov. Robert Ehrlich with the establishment of the Maryland Stem Cell Commission and a $15 million stem cell research fund. The commission is currently accepting grant proposals from Maryland-based researchers.

Funding for stem cell research has been a hot topic in the Washington region, and particularly in Maryland, recently. But it comes down to those in the scientific community — not in the political arena — who are largely shaping the progress, said stem cell research watchers.

Funding for stem cell research “primarily depends on whether the universities or hospitals think they have something to add.

Once they take up the issue of stem cells, then the politics comes in,” said Gail Pressberg, author of “The Promise of Politics of Stem Cell Research.”

Johns Hopkins University in Maryland is a leader in stem cell research, which helped secure funding from the state, Pressburg said. But in Virginia, where state universities haven’t focused on the issue, a Webb win isn’t likely to turn the tide locally.

However, the fact that Webb tipped the scales on the national level may eventually lead to new legislation, she said.

“It makes a difference when the party in favor of stem cell research controls the agenda by chairing the committees,” Pressberg said. “But it’s no guarantee ... they have to first deal with Iraq. I’ve talked to a bunch of lobbyists and nobody has a clue as to when this might come out.”

kwilmeth@dcexaminer.com
Examiner

Stem Cells and the new Congress

Stem Cells and the new Congress:

Stem cells a priority for new Congress
By KRISTYN ECOCHARD
UPI Correspondent

Click here for the article.

WASHINGTON, Nov. 9 (UPI) -- Stem cell issues emerged as an important platform during the midterm elections, and despite some moral concerns the new Congressional leadership is poised to bring the issue to the table.

Presumptive Speaker of the House Nancy Pelosi, D-Calif., has already listed funding for stem cell research as one of the top priorities of the new House.

"Bringing this issue up in the first 100 hours of Congress indicates the importance it had on the electorate," Daniel Perry, executive director of the Alliance for Aging Research, told United Press International.

Stem cell research focuses mostly on embryonic stem cells and how they might be used to create other kinds of tissue cells. A bill providing federal funding was passed by Congress earlier in Bush's presidency, but he vetoed it due to a religious outcry about the sanctity of life.

The support of stem cell research is promising but not a complete turn-around, said Jonathan Moreno, senior fellow at the Center for American Progress and professor at the University of Virginia in Charlottesville.

"On the surface, it doesn't appear there's a veto-proof majority in the House or the Senate," he told UPI. "But people may be more open now to hearing what the scientific evidence says."

One of the biggest challenges to supportive policy and funding other than from the private sector is the use of human embryos as the source of the stem cells, Henry Greely, professor at Stanford University, said during a public stem cell symposium at the National Academy of Sciences Tuesday.

Since the beginning of the debate, progress has been stalled by religious objections to endangering or destroying human embryos.

"The greatest religious concern has been the moral status of the embryo," said Suzanne Holland, associate professor of ethics and chair of the department of religion at the University of Puget Sound in Tacoma, Wash. "The greatest ethical concern surely is sensible oversight -- the just use of healthcare resources and research for the common good."

The Catholic Church's stance is that life begins at the moment of conception. However, survey results from a 2005 Johns Hopkins University study show that among U.S. Catholics, 69 percent dissent from the view of the church and approve embryonic stem cell research. Perhaps more surprisingly, the poll showed 49.5 percent of fundamental evangelical Christians approve of stem cell research, Holland said.

In the scientific community there is still some debate as to when a child's life has begun, although most believe an embryo is a developing human life. It's still debatable, however, whether the fetus is developed enough at five days or 14 days of life. At 14 days, it's highly unlikely the embryo will divide into twins, which begins its individual identity, Holland said.

Researchers can also do stem cell research on tissue or adult stem cells instead of embryos, which is more acceptable to religious leaders. The answer, Holland suggested, lies in respecting developing human life at the appropriate time and allowing research that has the potential to cure disease in people.

Using the existing method types -- destroying potential viable human embryos, the "dead" embryo method and non-embryonic cell harvesting -- a variety of cell types can be produced.

Nerve, liver, cardiac muscle, skeletal, blood and insulin-creating cells can all be derived from embryonic stem cells, said Alan Colman, chief executive officer of Embryonic Stem Cell International and senior scientist for A*STAR Centre for Molecular Medicine in Singapore.

The tissue cells that are created, however, only simulate the activity of an original cell and aren't as effective as the original, he said.

In recent research, cardiac muscle cells have been transplanted to pigs, rats and mice in Holland and California.

While the animal transplants were successful, the 97 trials transplanting skeletal cells into humans have had some problems, Colman said. One of the patients died of irregular heartbeat, and the rest of the patients have since been hooked up to defibrillators.

Another challenge, Greely pointed out, is that while embryonic stem cells are able to turn into any kind of cell, and they can be used to replace large quantities of different tissue types, safety regulations are difficult to define and enforce.

Whether the research is funded, banned, permitted or supported could be decided by the language used, he added.

"It matters what we call these entities," Greely said. "It may affect whether funding is admissible under President Bush's policy."

To make the best of the available funding, Greely suggested the scientific community should rank the types of research methods and invest in the ones that are most promising.

But for now, it's clear the new Congress will be in favor of stem cell research, said Sean Tipton, president of the Coalition for the Advancement of Medical Research.

He also said this issue is likely to be a major factor in the 2008 elections.

Tissue Technologies receives NIH grant

Virginia Biotechnology Research Park tenant, Tissue Technologies, was recently awarded a $100K Phase I SBIR grant from the National Institutes of Health for the development of a bedside diagnostic strip which will lead the care giver to treat chronic wounds more effectively.

“Some of the treatments that are currently on the market for chronic wounds can be extremely expensive and unfortunately are often used on wounds that simply won’t benefit from them,” commented Kel Cohen, MD, president and CEO of Tissue Technologies. “Our diagnostic strip will help medical professionals evaluate the best treatment options for their patient’s wonds.”

According to Cohen, the diagnostic strip can test the level of proteases in the wound. These are the enzymes found at high concentrations in chronic wounds. While these enzymes play an important role in tissue synthesis and degradation in normal wounds, chronic wounds produce too much proteases, resulting in substantial healing problems. Specifically, high protease levels in chronic wound fluid delays the wound healing process by degrading newly formed tissue and growth factors.

By using these “litmus” type testing strips, the doctor or nurse can determine protease levels to better evaluate what treatments will be most effective. It can also be used to monitor protease levels during and after treatment to ensure healing is occurring as expected.

“We are very excited about the results of our preliminary studies and the potential applications of this product,” commented Cohen.

In addition to the diagnostic strip, Tissue Technologies recently announced the FDA approval of a new product for dressing chronic wounds, which could potentially promote healing by eliminating the elevated levels of protease in chronic wound fluid.

Richmond Bioscience Companies Participate in Virginia Capital Day

Tissue Technologies LLC and Living Microsystems participated in Virginia Capital Day on November 2, 2006 at the Jefferson Hotel in Richmond. Living Microsytems Chairman Michael Grisham joined Wayne Hunter , Harbert Venture Partners, David Kauffman, Envest and Samuel Bemiss, III, Ewing Memiss & Co. in a panel discussion on investment strategies. The panel offered insightful comments on today's investment marketplace and shared the views of both investors and comapny executives on the current investment environment.

Tissue Technologies LLC was part of a select group of "Companies to Meet" who are currently seeking financing and looking to establish relationships with sources of capital. Dr. Kelman Cohen, founder and CEO of TT reprresented the company at this event.

Both Tissue Technologies and Living Microsystems are tenants in the bioscienes incubation program at theVirginia Biotechnology Research Park in Richmond.

Medgenics Scores $3M from Angels

Good news for a new Virginia biotech company...

Va. biotech secures $3M from angels
Washington Business Journal - October 27, 2006
by Vandana Sinha
Staff Reporter

A Virginia biotech is close to securing a $3 million first round of funding before hitting the road in search of more money.

Medgenics, which moved to Vienna from California in March after a struggle to survive, expects to close on nearly $2 million in mostly angel financing in the next month, adding to the $1 million it's already raised.

The company shares an office with one of its investors, venture capital firm Windy City.

After the first round closes, Medgenics will jump back on the circuit hoping to drum up $15 million more to fund Phase I and Phase II trials of its protein injection treatments, one for anemia slated to begin at the end of next year and another for hepatitis C expected to follow in the first quarter of 2008.

This is the second time around for the company, which had shut down for a year.

Medgenics raised $17 million in four rounds of funding during the company's first three years of operation. CEO Andy Pearlman founded the company in Palo Alto, Calif., in 2000 with technology he licensed from Hebrew University in Israel.
After failing to raise an additional

$25 million in a tough climate for biotechs, Pearlman was asked by a divided board to leave in 2003. He was replaced by Menachem Nassi, a CEO from the cardiac-imaging industry who sported an IPO track record and, the board thought, could round up that cash.

The company foundered without funding and closed up in 2004, leaving 32 people in California and Israel to find other jobs.

"Even though the technology succeeded, the CEO was unable to sell it or get people to invest in it," says Pearlman, who had remained on the board. "It just died for all the wrong reasons."

Last year, Windy City spent about $250,000 to buy out two investors, and Pearlman picked up the investment road map again. He's hired eight people, almost all former employees in Israel from Medgenics' previous incarnation, and is already talking up a potential IPO.

The staff has revived its tests on the technology, which turns a patient's toothpick-size tissue sample into its own production plant for disease-fighting proteins within 10 days. Doctors can inject that sample back into the patient's skin to pump those proteins through the body for months, dispelling the need for regular shots.

Once Medgenics is well funded, and well on its way through trials, it will hunt for a new headquarters, perhaps remaining in the Washington area.

"Washington has two great assets going for it. One is that the FDA is located here," says Joel Kanter, president of Windy City, a family-owned investment firm, and also "there is an extensive network of life sciences companies and, therefore, life sciences executives."

E-maiL: Vsinha@bizjournals.coM Phone: 703/258-0838

Diffusion Pharma Closes Deal; To Start Human Trials

Diffusion Pharmaceuticals LLC, a drug discovery and development company pioneering a revolutionary mechanism of action to treat life-threatening diseases, today announced that it has completed all animal toxicology studies required by the U.S. Food and Drug Administration (FDA) to file an investigational new drug (IND) application for its lead compound trans sodium crocetinate (TSC). The company also announced that it has completed a private financing round of $1.5 million, the proceeds of which will be used to support the company’s overall growth and move TSC into Phase I clinical trials in early 2007.

The recently completed toxicology tests were conducted at independent research laboratories, and were funded in part by a grant from the Office of Naval Research. The no adverse effect level (NOAEL) was about 500 times the efficacious dose in those animals, which is substantially higher than the proposed dose to be examined in humans.

“These studies show no appreciable toxicity of TSC, even at doses much greater than the proposed human dose,” said David G. Kalergis, Diffusion’s Chief Executive Officer. “Reaching this critical milestone has positioned us to prepare and file our IND application, which is currently being assembled by a team of Diffusion staff members and expert consultants,” he continued.

Assuming no significant FDA objections after filing, the company can proceed with its plans to initiate testing in healthy human volunteers. These studies are expected to begin in early 2007. Completion of these Phase I clinical trials will provide the foundation for further testing of TSC in populations suffering from such life-threatening conditions as hemorrhagic shock, stroke, respiratory disorders and cancer.

Additionally, Diffusion announced that it has closed a financing round in which it raised its target of $1.5 million in private equity, primarily from existing shareholders.

“These funds help move TSC into human testing, where we will have the opportunity to demonstrate the drug’s safety in humans and show proof of principal for the company’s novel technology,” said Kalergis. “Over the past 18 months, the company has also solved complex technical formulation issues, manufactured TSC to GMP (human) quality standards, and enhanced its intellectual property portfolio, all of which add value to the company and its platform technology.”