Insmed Receives NASDAQ Deficiency Notice Relating to Minimum Bid Price

Insmed Receives NASDAQ Deficiency Notice Relating to Minimum Bid Price

RICHMOND, Va.--(BUSINESS WIRE)--Jun 19, 2007 - Insmed Incorporated (NASDAQ: INSM) announced today that on June 18, 2007 it received a NASDAQ Staff Deficiency Letter from The NASDAQ Stock Market. The NASDAQ Letter states that for the last 30 consecutive business days, the closing bid price per share for the Company's common stock has been below the $1.00 minimum per share requirement for continued inclusion under NASDAQ Marketplace Rule 4450(a)(5).

In accordance with NASDAQ Marketplace Rule 4450(e)(2), Insmed will be provided 180 calendar days, or until December 17, 2007, to regain compliance by maintaining a closing bid price per share of $1.00 or higher for a minimum of 10 consecutive business days. If Insmed is unsuccessful in meeting the minimum bid requirement during this initial compliance period the Company may transfer the listing of its shares of common stock to The NASDAQ Capital Market and receive an additional 180 day compliance period if the Company meets all initial listing criteria, except for the minimum bid requirement, for that market as set forth in Marketplace Rule 4310(c). If Insmed does not demonstrate compliance within the required period the Company will be issued a delisting letter, which may be appealed at that time. The NASDAQ Letter received on June 18, 2007 has no effect on the listing of the Company's common stock at this time. The Company will seek to regain compliance within this cure period and is considering alternatives to address compliance with the continued listing standards of The NASDAQ Stock Market.

HHMI Tax Break Extended

http://www.connectionnewspapers.com/printarticle.asp?article=83103

Supervisors Support Tax Exemption
Staff to review exemption process every three years
By Erika Jacobson
June 13, 2007


The Board of Supervisors reaffirmed the tax exemption status on the land of the Howard Hughes Medical Research Institute (HHMRI) during its Tuesday, June 5, meeting.
While the six Republicans on the board were vocal in their opposition to the research-and-development institute’s exemptions when they first took office in 2004, only three remained opposed during Tuesday’s vote.
"At the end of the day, I felt the resolution of support of the promise that the prior board made to the HHMRI should be honored," Supervisor Bruce E. Tulloch (R-Potomac) who made the motion to reaffirm, said.
As part of the motion, the board also directed staff to detail the process and the requirements for tax exemptions every three years.
"I believe those tax exemptions should be renewed at least once in a term to make sure those exemptions are still in the vein they were given in and are still in the best interests of the citizens," Tulloch said.

SUPERVISORS MICK STATON (R-Sugarland Run), Stephen Snow (R-Dulles) and Eugene Delgaudio (R-Sterling) continued their opposition to HHMRI’s exemption, citing the increasing tax burden on residents and the process the previous board used to grant the exemption.
"What you are asking me to do by the reaffirmation is put my stamp of approval on how this was handled previously," Staton said. "And I can’t do that."
Snow said he could not support giving a tax exemption to a campus where people made hundreds of thousands of dollars a year, when most people in the county were earning much less. He suggested using the money to help the people of HHMRI put it toward workforce housing or other tangible solutions.
"I think we need to make sure we take this money and at least fence it in a way that would benefit that organization and others," he said.
Those supervisors who supported the Howard Hughes institute said they believed in the work researchers were doing and said the organization had been a great benefit to the county.
"They are a community partner with us," Supervisor Lori Waters (R-Broad Run) said. "Picking on this one organization because we may or may not like them is not right."

CURRENTLY THERE IS approximately $4.725 billion worth of property given tax exemptions in the county, both by classification and designation.
County Assessor Todd Kaufman and his staff have been reviewing all of the 4,400 parcels coded as exempt by the county to see if they still meet the requirements. Now only approximately 1,100 parcels remain exempt. Kaufman said, however, that the number of parcels does not necessarily equal the number of exempt sites in the county.
"You could have a 250-acre site that is divided into 250 parcels," he said.
Properties exempt by classification include churches, government property, public schools, state-owned property, public libraries, YMCA properties, missions, hospitals, parks, playgrounds and property used by a nonprofit organization.
Those properties make up a majority of the county’s tax exemptions, including approximately $3.4 billion property value for 635 government parcels and local schools.

HOWARD HUGHES Medical Research Institute’s $3.6 million exemption falls under the designation category, which makes up more than $486 million of the total property receiving exemptions.
Prior to 2003, the Virginia General Assembly had to approve all designation exemptions, but the code changed Jan. 1, 2003, granting authority to the local governments to give designation exemptions.
Kaufman said there are eight questions a government can look at to decide on a property’s eligibility for exemption, including whether it is a nonprofit organization, the revenue impact for the county and whether the services provided are for the common good of the public.
"The answers are not reasons not to make [a property] exempt, it is just something to consider," Kaufman said.
Also given a designation tax exemption in the county are the VFW, the Waterford Foundation and Patrick Henry College in Purcellville.

KAUFMAN SAID he is reviewing each parcel independently in his office’s review of tax exemption, but is not singling out any particular property.
"I just want to make sure that what is in the system is correct," he said.
The portion of the Howard Hughes Medical Research Institute that is tax exempt is also under review, as the exemption was given to the overall value of the property based on construction costs before the campus was finished.

"We’re reviewing that value to make sure it’s still correct," he said.

Tolson Next NC Biotech CEO?

From the Tech Journal South:
http://www.techjournalsouth.com/news/article.html?item_id=3336

NC Revenue Secretary Tolson next Biotech Center President/CEO?
June 19, 2007
By Allan Maurer

EXCLUSIVE RESEARCH TRIANGLE PARK, NC—Sources close to the NC Biotech Center say E. Norris Tolson, Secretary of the North Carolina Department of Revenue, will be the next President and CEO of the Center, replacing Leslie Alexandre, who stepped down in March.

The source close to the Center tells TechJournal South that Tolson was offered the position and has accepted it. The Biotech Center has said it expects to announce its board’s decision in late summer. The board apparently has not yet made a formal decision.

Despite repeated calls to his office Monday and Tuesday, Tolson did not respond to requests for comment.

Biotech Center responds
The Biotech Center issued the following statement in response to TechJournal South’s inquiry:

“Rumors typically swirl around a vacant position, but the Biotechnology Center doesn’t comment on rumors. Our board of directors is responsible for hiring a president, and the board has not yet done so. When the board does hire a president, the Biotechnology Center will share the good news with everyone as quickly as possible.”

When Leslie Alexandre took the helm, however, the news leaked to the “Raleigh News & Observer” prior to being released generally.

Tolson, who would be only the third president/CEO in the Center’s history, is vice chair of its board and was on the steering committee that guided development of the state’s strategic plan for biotechnology. He has wide experience in state government, economic development, and in industry.

Center relies on state support
Gov. Mike Easley appointed Tolson Secretary of Revenue in 2001. He also served as NC Department of Transportation Secretary in 1998 and as NC Commerce Secretary from 1997-98. He was a member of the NC House of Representatives from 1994-97.

The Biotech Center relies on state support for its initiatives, grants, and programs, widely seen as catalysts that helped propel NC into an enviable position as one of the top four biotech hubs in the United States. It's state appropriation for 2006-07 is $13.1 million.

Since 1984, it has invested $187 million in state funds to develop a statewide biotech industry.

The Center has a worldwide reputation and its CEO frequently travels domestically and abroad with state commerce department officials and other economic development specialists.

Tolson has industry experience
According to his NC Revenue site biography, prior to his election to the General Assembly, Tolson worked at E.I. Dupont from 1965 until his retirement in 1993.

He worked in various research, marketing and sales assignments in the company's agricultural products and electronics business for 28 years. He was assigned both domestic and international business responsibilities and lived in Europe for several years.

Tolson graduated from North Carolina State University with a bachelor's degree in crop science and agribusiness in 1962. He also served in the U.S. Army Counter Intelligence Corps from 1963 through 1965.

In an interview with the publication Biotech Catalyst, Tolson said, “Currently, biotechnology generates $3 billion in annual revenues in North Carolina and employs about 18,500 people.

"As a proud member of the North Carolina Biotechnology Center's board of directors, I can assure you that this whole area of scientific development is growing at lightning speed and that, because of our long-term investments in the industry, North Carolina's economy is poised to grow with it.”

Leslie Alexandre led the Biotech Center during a period in which the state climbed to the third ranked in the nation as a biotech hub.

She presided over development of the “Jobs Across North Carolina” strategic plan submitted to Gov. Mike Easley in 2004 and considers it one of her two most important accomplishments.

She also helped establish the Center’s regional satellite offices in the Piedmont Triad, Charlotte, and Eastern and Western NC.

Alexandre followed visionary leader Charles Hamner, who led the Biotech Center for its first two decades.

For more see: www.ncbiotech.org

Vaccines and Autism: Court Convenes in DC

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of Proof
By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007; A06

For more than a decade, families across the country have been warring with the medical establishment over their claims that routine childhood vaccines are responsible for the nation's apparent epidemic of autism. In an extraordinary proceeding that begins tomorrow, the battle will move from the ivory tower to the courts.

Nearly 5,000 families will seek to convince a special "vaccine court" in Washington that the vaccines can cause healthy and outgoing children to withdraw into uncommunicative, autistic shells -- even though a large body of evidence and expert opinion has found no link. The court has never heard a case of such magnitude.

The shift from laboratory to courtroom means the outcome will hinge not on scientific standards of evidence but on a legal standard of plausibility -- what one lawyer for the families called "50 percent and a feather." That may make it easier for the plaintiffs to sway the panel of three "special masters," which is why the decision could not only change the lives of thousands of American families but also have a profound effect on the decisions of parents around the world about whether to vaccinate their children.

A victory by the plaintiffs, public health officials say, could increase the number of children who are not given vaccines and fall sick or die from the diseases they prevent.

Economics and politics intersect in the case with questions of health and the deepening mystery of soaring autism rates. Advocates of the vaccine theory have argued that the increase in cases was triggered by a mercury-based preservative in vaccines that, they say, is toxic to children's brains.

Under pressure from the advocates and to keep the issue from disrupting vaccination programs, U.S. officials began phasing out the additive, thimerosal, in children's vaccines around 1999 while maintaining that there was no hard evidence that it was dangerous. But thimerosal is still used in vaccines across much of the developing world. If the vaccine court decides that the preservative caused autism, parents of children in poor countries are likely to protest its inclusion, but removing it would make vaccines much more expensive and potentially put them out of reach for many.

Gary Golkiewicz, chief special master in the U.S. Court of Federal Claims, where the case is to be heard, said he is aware of the larger ramifications. But the court's job, he said, is only to focus on whether plaintiffs show a plausible link between vaccines and autism.

About 20 experts are expected to testify in the case, which will involve a staggering amount of complicated epidemiology and biochemistry. Golkiewicz said a ruling could be a year off.

Experts for the government will argue that a range of epidemiological studies found no link between vaccines and autism, as the prestigious Institute of Medicine concluded in a 2004 report. The institute, part of the National Academies that was chartered by Congress to advise the government and the public on matters of science, dismissed the vaccine-autism theory, which is mostly based on biochemistry studies on the toxic effects of mercury.

Large international studies -- and preliminary evidence from the United States -- suggest that after thimerosal was removed from children's vaccines, autism rates continued to soar.

If thimerosal was the cause, removing it should have sharply lowered autism rates, scientists say. Although definitive national evidence is not in -- children vaccinated after 1999 are just beginning to enter school, which is the point at which many receive a diagnosis -- data from California suggest that autism rates are continuing to climb steeply.

The cases are rising, experts say, primarily because of better diagnosis and services: Parents and teachers are more attuned to the signs of autism, and doctors are better equipped to spot it than they were two decades ago. Also, the boundaries of the diagnosis have expanded to include a range of problems under an umbrella known as autism spectrum disorders.

The plaintiffs acknowledge that their case is far from airtight scientifically. But Kevin Conway, a Boston attorney representing the family of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was designated the opening test case for more than 4,800 plaintiffs, said that even if the science is equivocal, he has a good legal argument, which is all he needs.

"There is a difference between scientific proof and legal proof," Conway said. "One is 95 percent certainty, and the other is . . . 50 percent and a feather."

Besides, Conway added, those who support the vaccine-autism theory did not put all their eggs in the thimerosal basket. They are also arguing that something else in vaccines might be making children sick.

Like many other advocates of the link, Conway said he believes that vaccines in general are a good thing and have saved many lives. In an age of bioterrorism, moreover, vaccines are not just a health priority but a national security priority. But Congress's efforts to shield vaccine makers from lawsuits over the rare but inevitable side effects of vaccines have given the companies no incentive to make vaccines as safe as possible, Conway said.

Congress set up the vaccine court to provide compensation for individuals harmed by those side effects, because lawsuits were threatening to put vaccine makers out of business.

The law requires people claiming they were harmed by a vaccine to bring the case in the special court first, but if they lose, they can still file suit in civil courts.

Scientific advocates for the vaccine-autism theory, such as the father-and-son team of Mark and David Geier of Silver Spring, say fears about damaging public health programs have prompted scientists and the government to hide evidence of a problem. Many of the families believe that the medical establishment and the U.S. Centers for Disease Control and Prevention have conspired in a massive coverup.

Peter Hotez, president of the Sabin Vaccine Institute and a biology professor at George Washington University, who has a 14-year-old autistic daughter, said the controversy has distracted from the real problem: finding services for rising numbers of autistic children and ramping up research to find a cure.

"We are absolutely confident Rachel's vaccines have nothing to do with her autism," he said. "If we could roll back the clock, we would give her all the vaccines again."

But the family of severely autistic Michelle Cedillo, who arrived in Washington on Friday for the trial, disagrees.

Michelle was a healthy 15-month-old when she was given the measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so words she had been able to speak -- including Mommy, Daddy, baby, kitty and juice -- vanished. She developed a high fever one week after the shot and went rapidly downhill. Today, she does not speak and is totally dependent on caregivers. She suffers from seizures, arthritis and inflammatory bowel disease and is nearly blind.

Cedillo said she is "not anti-vaccine" and not very interested in playing the blame game or weighing in on matters of public policy.

"I am not a scientist. I am not a doctor," she said in an interview. "We want to focus on Michelle and find out what happened and get the help for her that she needs."

Dr. Lee Hood at VaBIO-VCU Systems Biology Event

Dr. Leroy Hood, the famous president of the Institute for Systems Biology was the special guest at the Virginia Biotechnology Association's “Biotech After Hours,” June 4, at the Jefferson Hotel in Richmond. The event was held in conjunction with the opening reception for the “2007 Summit on Systems Biology” sponsored by Virginia Commonwealth University. Hundreds of scientists, students and biotech company representatives from Virginia, North Carolina and other states attended this important scientific meeting.

(Photo: Mark Herzog, executive director of VaBIO; Lee Hood, president of the Institute of Systems Biology; and Maciek Sasinowski, CEO of Incogen and chairman of VaBIO. Photo credit: Mark Licata)

Dr. Hood's research has focused on the study of molecular immunology, biotechnology, and genomics. His professional career began at Caltech where he and his colleagues pioneered four instruments — the DNA gene sequencer and synthesizer, and the protein synthesizer and sequencer — which comprise the technological foundation for contemporary molecular biology. In particular, the DNA sequencer has revolutionized genomics by allowing the rapid automated sequencing of DNA, which played a crucial role in contributing to the successful mapping of the human genome during the 1990s.

In 1992, Dr. Hood moved to the University of Washington as founder and Chairman of the cross-disciplinary Department of Molecular Biotechnology. In 2000, he co-founded the Institute for Systems Biology in Seattle, Washington to pioneer systems approaches to biology and medicine. Most recently, Dr. Hood's lifelong contributions to biotechnology have earned him the prestigious 2004 Association for Molecular Pathology (AMP) Award for Excellence in Molecular Diagnostics. He was also awarded the 2003 Lemelson—MIT Prize for Innovation and Invention, the 2002 Kyoto Prize in Advanced Technology and the 1987 Lasker Prize for his studies on the mechanism of immune diversity.

The event was sponsored by Biogen Idec, Virginia Commonwealth University, AeroTek Scientific, Clearpoint Resources, Inc., and Latimer, Mayberry & Matthews IP Law, LLP.

Inverness Medical Takes 49% of Techlab

Inverness Medical Innovations, Inc. (Amex: IMA) announced that it will acquire 49% of the capital stock of TechLab, Inc., a privately held diagnostics company, in exchange for 303,417 shares of Inverness common stock. TechLab develops, manufactures, and distributes rapid non-invasive intestinal diagnostics tests in the areas of intestinal inflammation, antibiotic associated diarrhea and parasitology.

The transaction provides Inverness, whose Wampole subsidiary already distributes TechLab’s products in the United States, with exclusive global distribution rights to TechLab’s market leading line of enteric disease testing products, as well as future human medical diagnostic products, as Techlab’s existing global distribution relationships lapse. These products include both ELISA and rapid format assays for the detection of C. Difficile Toxins A&B, a rapidily growing world-wide market segment. TechLab works with major universities in the development of new tests for intestinal parasites for use in both industrialized and developing countries.

TechLab has developed and now, with access to Inverness’ intellectual property, expects to commence selling the only US FDA-cleared rapid membrane assay to detect fecal lactoferrin, a test that can help differentiate bacterial enteric infections and inflammatory bowel diseases from maladies such as irritable bowel syndrome and diverticulitis. In the US alone, there are over 3 million cases of Crohn’s Disease, 4 million cases of ulcerative colitis and 10 million cases of irritable bowel syndrome reported anually. Additionally, TechLab has a pipeline of products in development which represent opportunities for Inverness in both the professional and consumer marketplaces.

TechLab will continue to operate with the current executive management team of Tracy Wilkins, Ph.D. as president, David Lyerly, Ph.D. as Vice President of Research and Development and David Wall as VP of Operations.

The agreement includes an option for Inverness to acquire any shares of TechLab offered for sale to third parties by the existing shareholders.

New Leadership at PRA International

RESTON, Va., May 8 PRA International (NASDAQ: PRAI) , a leading clinical research organization, is pleased to announce that, effective May 7, 2007, Terrance J. Bieker (61), who has served as interim chief executive officer (CEO) and a director since December 2006, was appointed as CEO. In addition, effective the same date, Colin Shannon (47) was named president and chief operating officer (COO).

Mr. Bieker Becomes Permanent CEO and Remains a Director

"After a thorough search of highly qualified external candidates, it became increasingly clear that Terry is the ideal person to continue leading our company and we are extremely pleased that he has agreed to become PRA's permanent CEO," said Chairman, Melvin D. Booth. "As previously noted, we were looking for someone with the skill set to manage a complex global enterprise while driving growth and delivering operational excellence. Terry's impressive credentials and outstanding performance as interim CEO solidified our confidence in his ability to drive PRA's business beyond the $1 billion threshold."

Before joining PRA in December 2006, Mr. Bieker served as director, president and CEO of BioSource International, Inc. (now part of Invitrogen Corporation) from November 2003 to November 2005. For the four years prior to this, he was a director and CEO for several medical device corporations, including Axia Medical and Transfusion Technologies Corporation, and was COO for SafeSkin, Inc. Before this, Mr. Bieker was chairman, president and CEO of Sanofi Diagnostics Pasteur, Inc. for nine years. He is a graduate of the University of Minnesota.

"I've spent the last four months visiting many PRA offices around the globe and am genuinely excited about what I see," Mr. Bieker said. "My experience as interim CEO has given me a first-hand look at PRA's prestigious client base, its unique position in the marketplace, its well-established therapeutic expertise, and the caliber and commitment of its entire team. I am more convinced than ever of the untapped potential of PRA and have decided to fully focus my energy on realizing this potential for the company's stockholders."

Shannon Joins Company as President and COO

"As part of strengthening PRA's leadership team, I'm happy to welcome Colin to his new role as president and COO," Mr. Bieker continued. "Colin has demonstrated comprehensive knowledge of the CRO industry and has led the high growth development of global operations -- just the experience we were seeking. He has led the growth of a global Phase II-IV business, creating an international management team, managing organic growth while dealing with emerging markets and setting and exceeding financial goals. More importantly, his management style is a good fit with PRA's culture: encouraging teamwork, sharing best practices and developing close relationships with his clients."

Mr. Shannon said, "I was very impressed with the caliber of the Board and the commitment of their new CEO, Terry Bieker. They have ambitious plans for growth and the culture of the company that is fully compatible with my goals. I am delighted to be part of this exciting phase of the company's development."

Shannon's most recent position for three years was executive vice president, global clinical operations with Pharmaceutical Product Development, Inc. (PPD), one of the largest CROs in the world. For the prior nine years, he served PPD as European COO after being promoted from Chief Financial and Administration Officer for Europe and Pacific Rim. Prior to joining PPD in 1995, Shannon held financial positions with various other companies. Shannon holds a master's degree in business administration from London's City University and is board certified by the Chartered Association of Certified Accountants.

From the FT: Researchers make stem cells from skin

Researchers make stem cells from skin

http://www.ft.com/cms/s/bedffcb2-1479-11dc-88cb-000b5df10621.html

By Clive Cookson in London and Rebecca Knight in Boston

Published: June 6 2007 23:16 | Last updated: June 6 2007 23:16

Three scientific teams published separate studies on Wednesday showing that embryonic stem cells can be made by reprogramming some of the genes in adult skin cells, without having to create an embryo – at least in mice.

Separately, a fourth scientific paper showed that newly fertilised eggs could be used instead of unfertilised eggs to produce cloned mice. If this technique were extended to humans, it might open up a new source of stem cells for therapeutic cloning research: frozen ­early-stage human embryos, which are much more plentiful than human eggs.

The animal research, carried out in the US and Japan and published in the journal Nature, will encourage opponents of human embryo experiments. But the scientists involved in the studies said it was far too early to tell whether the same procedures would work with adult human cells, let alone whet­her it would be safe to use clinically to treat disease.

“These results are preliminary and proof of principle,” said Rudolf Jaenisch, a member of the Whitehead Institute and a professor of biology at MIT, who led one of the studies. “Human embryonic stem cells remain the gold standard . . . and it is a necessity to continue studying embryonic stem cells through traditional means.”

President George W. Bush banned federal funding of human embryo research in 2001 and has since vetoed bipartisan legislation that would have eased restrictions on the study. That has stoked fears among scientists that the US will fall behind in stem cell research – a trend that is already taking place in fields such as technology and engineering.

Several states, such as California, New York and New Jersey, have begun funding such experiments themselves. In addition, privately funded research on embryonic stem cells is under way at many institutions.

Scientists said that these breakthroughs could move this research forward substantially by attracting greater numbers of scientists to the field, as well increasing private investment.

“There’s still a ways to go but at first blush, the results are very encouraging and it’s certainly a boost for the stem cell research business,” said Terry Devitt, a director at the University of Wisconsin’s stem cell research programme. “But we still have a bottleneck in the federal government. We’re hamstrung because the research is inadequately funded.”

Several candidates for president, both Republican and Democrat, have gone on record as supporting human embryo research, which Mr Devitt said is an indication that funding could increase substantially in the next administration. “Right now we’re stuck,” he said.

VaBIO-VMA Grants Project in the News

Plants need skilled labor, and Va. project wants to help
Grant will let alliance train youths, others for manufacturing careers

Sunday, Jun 03, 2007 - 12:06 AM

By JOHN REID BLACKWELL
TIMES-DISPATCH STAFF WRITER
The path to the manufacturing plant was a pretty clear one for Sheryl Alston Bryan.

You might say it was in her blood: Her father worked for Reynolds Metals Co., a Richmond manufacturer, for 40 years; her uncle was a metallurgist for the company.

"In manufacturing, you develop a passion for it, or you don't," she said. "I developed a passion for it."

Now, after a 20-year career in manufacturing at Alcoa Inc., Bryan is trying to help young people find a similar path. It isn't an easy task.

"We don't have a lot of young people coming up who say, 'I want to go into manufacturing,'" Bryan said. "The issue is: How do we develop the new talent?"

Bryan is leading an effort to prepare more Virginians for skilled manufacturing jobs.

In October, the U.S. Department of Labor awarded a $1.49million grant to industry groups in Virginia to support advanced manufacturing training and economic development. The grant was part of a $16.8 million national job-training initiative, but only 11 of 186 groups in the nation that applied were selected to receive funding.

In Virginia, the project is being co-led by the Virginia Biotechnology Association and the Virginia Manufacturers Association, along with Training & Development Corp., a national, nonprofit organization that works on job training and economic development issues.

Bryan was chosen in April as project director for the partnership, known as the Virginia Council on Advanced Technology Skills. She is working with compa- nies with operations in Virginia that also are partnering in the project.

The goal is to develop a training curriculum and certification standards to help young people just entering the job market -- or adults transitioning into new careers -- find work with manufacturing companies that need highly skilled production employees.

The seed money provided by the Department of Labor is helping with outreach and curriculum development. Eventually, the project will involve opening labs, possibly several around the state, for classes in technical skills geared specifically to manufacturing.

One of the goals of the project -- and one of Bryan's personal goals -- is to dispel popular notions that manufacturing is a dead-end career path.

While manufacturing jobs have been declining as a percentage of overall employment in the United States for years, and many lower-skill jobs have migrated overseas, demand is still high for skilled workers, many manufacturing employers say.

"It is not that [manufacturing] is going away. It is changing," Bryan said. "The employee of today is not the same employee as 10 years ago. The manufacturing world today is high-tech, with a lot of problem-solving."

That means people who want to have long, successful and well-paying careers in manufacturing increasingly need to have mechanical, electrical and computer skills, as well as a good understanding of concepts such as lean manufacturing and quality control, said Brett Vassey, president and chief executive officer of the Virginia Manufacturers Association.

"That is the revolution in our industry," Vassey said. "That is what we are trying to keep up with and make sure the state is ahead of the curve."

State officials have estimated that about 100,000 manufacturing workers in Virginia will retire in the next 10 years, including about 45,000 technically skilled workers, which will create a surge of demand for skilled labor.

"Our manufacturers today are having a hard time finding the workers they need to fill positions at their advanced manufacturing companies," said Mark Herzog, executive director of the Virginia Biotechnology Association. "They realize if they are having trouble today filling these jobs, it is going to be almost impossible 10 or 15 years down the road when the baby boomers are retiring."

Private-sector companies that are partnering in the project include Alcoa, Boehringer Ingelheim Chemicals Inc., Micron Technology Inc., Novozymes Biologicals, and Philip Morris USA.

Cathy Martin, human resources and public relations director for the Boehringer Ingelheim Chemicals plant in Petersburg, which makes pharmaceutical ingredients, said her company needs employees who have a good understanding of technology and chemistry.

"Today, we actually spend almost two years in fairly intense training with our new hires before they are really fully capable of being a fully skilled technician for us," she said.

But the training program that Bryan is working to develop could help the company prepare employees six to nine months faster.

David Sutton, a spokesman for Philip Morris USA, said the tobacco company also is concerned about a shortage of skilled labor.

"Given the nature of our business and our operations, we have a need for highly skilled manufacturing employees," he said. "Ultimately, this type of program helps keep these jobs in Virginia."

Bryan was a perfect fit to lead the project, Vassey and Herzog said. "Sheryl epitomizes what we are talking about," Vassey said. "Having run several manufacturing plants, she understands the issue."

When Bryan graduated from Virginia Tech in 1987, she went to work for Alcoa, a global manufacturing company best known for its aluminum products.

Her career with the company took her to plants in Arkansas, Pennsylvania, Detroit and St. Louis, where she worked in a variety of engineering, sales and management roles. Two years after Alcoa acquired Richmond-based Reynolds Metals in 2000, she returned to her hometown to manage the company's local aluminum foil plant, where Reynolds Wrap is made.

She always loved math and physical science and understanding how things are made. When she was in college, she did an internship at Reynolds, in research and development.

"My desire was to go into operations in a plant where products were being made," she said. "I wanted to see the results of my work."

Bryan also has one other key qualification: After leaving Alcoa last year, she spent six months working as a tutor in Henrico County schools, helping students prepare for the state's Standards of Learning tests.

"I love teaching," she said. "It was challenging, but it was fun. It helped me realize what kids are learning today, and how it could relate to what they need to know to be active participants in today's society."

She sees young people who are capable and ambitious, but they often have misconceptions about manufacturing. They might envision it as repetitive, dirty or low-wage work, but Bryan wants to change those views and present manufacturing as a cutting-edge career.

"I've always liked problem-solving," she said. "If we want to keep our jobs here in Virginia, and keep attracting businesses, we have to do something to solve this problem."

Contact staff writer John Reid Blackwell at jblackwell@timesdispatch.com or (804) 775-8123.

GMU Seeking Donations for Tech Transfer

GMU turns to the public to help fund tech innovation
Washington Business Journal - May 25, 2007
by Vandana Sinha
Staff Reporter

George Mason University wants to close the gap between a professor's idea of groundbreaking research and an entrepreneur's idea of a viable startup.

And the Fairfax university is appealing to the public's benevolent side to come up with the cash to do it.

GMU is launching a fundraising campaign in July for its new technology transfer fund -- one that would serve as a source of philanthropic grants rather than of venture capital.

The pot of funding would help the university's tech transfer office do work such as building a prototype or conducting market research to prove a patented idea worthy of formal investing and licensing, ultimately easing the process of spinning out promising young companies.

"We have a lot of things sitting on a shelf, if you will -- things that have been invented, things that have been patented, but need a little bit of work," said Jerry Coughter, GMU's assistant vice president for regional economic development. "This is a pool of money that could be applied to that."

The university is starting out modestly. Its initial goal is $50,000, but university leaders harbor long-term hopes of an annual campaign that rakes in hundreds of thousands of dollars.

The university's tech transfer office, which works with GMU's life sciences and the engineering and information technology colleges, would apply for funding when it comes across discoveries that could set commercial cash registers ringing.

The university envisions starting with grants in light doses, $2,500 to $5,000, to aid academic research that needs only preliminary work -- like market analysis, risk assessment or prototype specifications -- to catch a venture capitalist's eye. Later they would increase the dosage to $25,000 to $50,000 for research that needs a working prototype, detailed business plan or preclinical animal studies.

While the dollar amounts are meek, Jonathan Aberman, the advisory board's chairman, said they are enough to muscle an infant company forward. "You can get a lot done for a small amount of money," said Aberman, co-founder and managing director of Amplifier Venture Partners LP, an early-stage venture fund based in McLean.

University leaders see this program, already dubbed Invention to Innovation, as a significant step up from their current method of foraging for licensers for faculty research: "by hook or by crook." That's how Jennifer Murphy, director of the university's tech transfer office, described it. "It's very hard to find a company willing to develop that technology so early," she said.

The university will approach foundations, companies and individuals to marshal the funds, then will send them updates on the companies they essentially sponsor.

But they are patently clear about the fund's purpose. Entities are giving to it charitably. They are not investing for a piece of the company or a return on their dollars.

VCU Behind New Blood-Clotting Product

VCU develops 'WoundStat'
Independent study by Army found product for troops' blood loss to be highly effective

Tuesday, May 29, 2007 - 12:01 AM

By JEFFREY KELLEY
TIMES-DISPATCH STAFF WRITER

An explosion rips down an Iraqi street, spraying debris through the legs, torsos or arms of military troops.

In such a potentially fatal situation, seconds count when it comes to stopping blood loss. Those seconds and wounds may be filled by a substance created at Virginia Commonwealth University called WoundStat.

Smack a handful of the sandy mineral into a hemorrhaging wound, apply pressure, and the material forms a seal to stop the rapid blood loss. WoundStat has stopped lethal hemorrhaging within two minutes when tested on anesthetized pigs, the Army's model for such studies.

Until recently, methods for stopping heavy bleeding during combat had not changed much since the Civil War. Medics apply gauze and pressure or use a tourniquet to cut blood flow to limbs, which can result in amputations if left tied for too long.

For about a decade, the Army has been researching more high-tech ways to treat hemorrhaging.

"We looked at Vietnam, Korea, World War II. Of all those killed in action . . . about one-third to 40 percent died of bleeding to death," said Ronald R. Blanck, a retired surgeon general of the Army.

And most wounds, he notes, are treatable.

Soldiers overseas now carry the HemCon bandage, made with a blood-clotting agent derived from shrimp shells. A product called QuikClot does to blood what its name implies.

Then there's WoundStat. If it is approved by the U.S. Food and Drug Administration, Bethesda, Md.-based TraumaCure Inc. plans to sell the product to military and commercial customers.

WoundStat was developed in VCU Medical Center's Reanimation Engineering Shock Center.

"Our interest is in all things that have to do with critical illness and injury -- how to save the most critically ill and injured person and return them back to productive lives," said Dr. Kevin Ward, an emergency physician and associate director at the shock center.

Part of that group, called Operation Purple Heart, focuses on treating combat casualties.

"We took a step back and examined what the strengths and weaknesses were with the current [blood-stopping] products that were out there to see if there was something we could improve upon," Ward said. Research began in December 2004.

Ward and two colleagues -- biochemist Robert Diegelmann and biomedical engineer Gary Bowlin -- developed a tan-colored concoction of minerals that looks like a cross between flour, sand and cat litter. After its use, WoundStat can be peeled off the injury.

With the help of VCU's Office of Technology Transfer, the men were introduced to bioscience and entrepreneurial expert Jack McDonnell. Impressed by WoundStat's potential, McDonnell licensed the technology and established the company in May 2006. He is TraumaCure's chairman and executive vice president.

Chief Executive Officer Devinder S. Bawa and President and Chief Operating Officer Rhonda Friedman have expertise managing entrepreneurial and established health-care and technology firms.

"These three people have this combination of skills that are really required to make a company a success," said Ivelina Metcheva, director of VCU's tech transfer office, which works to spin out university research into products, services or businesses.

TraumaCure has landed "seven figures" worth of capital, McDonnell said, and it is seeking more. Money will be easier to find if talent is in place, Metcheva notes. "Venture capitalists bet on jockeys, not on horses."

McDonnell expects FDA approval before October, and then efforts go to selling to the military. The company also plans to market WoundStat to first responders such as emergency medical technicians, police and firefighters.

Blanck, the retired surgeon general and an outside director of TraumaCure, said current hemorrhage-stopping products -- specifically, HemCon and QuikClot -- have been a step in the right direction but that there is room for improvement.

"I'm not critical of them because I think they've been responsible for saving lives. Our goal is to save even more," he said. A spokeswoman for HemCon said its standard-issue bandages work best on large, high-blood flow wounds but are limited on smaller but serious injuries such as a gunshot. QuikClot clots blood but produces a reaction when used that creates excessive heat, and studies have found that it may damage organs and tissues.

An independent study by the Army's Institute of Surgical Research found WoundStat to be a highly effective wound dressing that does not produce a heat reaction. The report said the product's primary limitation is that it will stop blood flow on damaged vessels, acting as a granular tourniquet in areas where a traditional tourniquet cannot be tied, such as the groin. Such occlusion of the vessels could become a problem in a neck injury where blood must continue to flow.

The report also noted that more studies are needed to prove the product's efficacy and safety -- but Ward and his colleagues maintain it is harmless and lifesaving.

Should WoundStat hit the market, the VCU inventors will receive 40 percent of royalties on sales under terms of the university licensing agreements. The remaining 60 percent is disbursed across VCU.

"Not only is it great [business] potential, but look at what good it does in the world," McDonnell said. "It's fabulous."

New Lab Space for NoVa?

Developer plots NoVa lab space to attract biotechs
Washington Business Journal - May 11, 2007
by Vandana Sinha
Staff Reporter

After years of coming up dry, Northern Virginia is winning new wet lab space.

The area -- long lambasted for lacking the lab space that could attract a vibrant biotech community -- may be seeing early signs of a long-term turnaround with new plots of lab-worthy land.

Pasadena, Calif.-based Alexandria Real Estate Equities, a leading national lab property owner and developer, is in preliminary plans to market a new 20-acre stretch of research and development land near George Mason University at Innovation @ Prince William Technology Business Park.

Meanwhile, Rockville-based Scheer Partners is helping develop a 50-acre section of the Innovation park for tech and biotech prospects. The local real estate firm also recently began marketing 35,000 square feet of empty office and lab space in a Chantilly office park building.

In addition, when pharmaceutical giant Eli Lilly pulled out of its $325 million development deal in January, the company left Northern Virginia with 10,000 square feet of lab space about six miles from Prince William's Innovation park, where its half-built insulin manufacturing plant still sits on 120 acres now back on the market.

The combination has area leaders excited about starting to bridge one of the chasms separating them from a successful biotech community. But they may need to remain patient. Much of that lab space is, or likely will be, fit only for larger tenants with deeper pockets, forcing biotech startups to keep hunting for smaller headquarters along Interstate 270 in Maryland.

"What happens down in Prince William County will, I think, be the bellwether," says Dan Gonzalez, executive vice president in Scheer Partners' McLean office. "There will be a vibrant biotech community in Northern Virginia, but it won't look anything like Maryland. The 2,000- to 5,000-square-feet startups won't be in Northern Virginia for a long time."

Most of that comes down to economics, Gonzalez says.

With the high costs of building lab space from scratch, developers get more payoff from a larger, established tenant willing to snatch up 30,000 square feet at a time, rather than from the risky startups that can only afford one-tenth of that for their first several years.

The question is: How many of those larger biotechs are eyeing Northern Virginia?

So far, for its 35,000-square-foot Chantilly lab space at Avion Business Park -- former federal government quarters that can't be physically subdivided into smaller pieces for startup companies -- Scheer Partners has found more "tire-kickers" than tenants.

Scheer Partners is in talks with an undisclosed New Jersey cell-therapy diagnostics company that needs 20,000 to 60,000 square feet, Gonzalez says. But he adds, until public or private entities put their dollars toward incubator space for startups, demand for Northern Virginia lab space could remain slow.

At Prince William County's 50-acre Waterford Development plot, which Scheer is helping develop, there is room for 1 million square feet of office and lab space. But the developers say market demand calls for building only 650,000 square feet.

Alexandria Real Estate also says it doesn't plan any lab construction until it scores some tenants. It is aiming for a single, sizable company to fill up its 20-acre plot, originally 40 acres before it sold 10 acres apiece to the neighboring George Mason University biocontainment lab and Virginia Department of Forensic Science lab, both poised to break ground within weeks.

"A big part of this is where we see the market demand," says Jim Richardson, president of Alexandria Real Estate, which has an office in Gaithersburg. "This is an emerging market. It's at an embryonic stage. So we're going to be very careful and prudent when we move through this."

Both real estate parties could find a customer in George Mason. The university's leaders expect to issue a request for proposals by the fall to lease a projected 10,000 to 30,000 square feet of lab space for faculty research, now crowded into the Prince William and Fairfax campus labs.

But the university, whose own biotech spinoff Theranostics Health was shipped to Rockville in March for lack of Northern Virginia lab space, says it is also discussing whether to include an incubator setting in its proposed space to help those startups and future spinoffs.

"Is there demand out there for companies to lease 1,000 square feet? I think there is. Are there 30 of them? Probably not," says Jerry Coughter, assistant vice president for regional economic development at George Mason University. "That's part of the quandary that developers are in."

Gov. Kaine against use of taxpayer money to fund stem cell research

From the DC Examiner:

Virginia legislators have long opposed embryonic stem cell research. Some have even tried to ban state-funded universities from using private money to fund the research, but Gov. Tim Kaine said he opposes restrictions on private efforts.

Virginia legislators have long opposed embryonic stem cell research. Some have even tried to ban state-funded universities from using private money to fund the research, but Gov. Tim Kaine said he opposes restrictions on private efforts.

Melissa Frederick and Joseph Rogalsky, The Examiner
Mar 28, 2007 3:00 AM (20 days ago)
Current rank: Not ranked
WASHINGTON - While Virginia Gov. Tim Kaine said he supports the $500,000 allocation in the budget bill lawmakers approved last month to fund adult stem cell research in Virginia, he does not want to see taxpayer money used for embryonic stem cell research.

“I don’t think we should be publicly funding it in Virginia,” Kaine, who is Catholic, said Tuesday during his monthly appearance on WTOP radio. “You will not see me proposing that. I think there are huge advances that can be made in adult stem cell research. I think that’s the way to go.”

Virginia legislators have long opposed embryonic stem cell research. Some have even tried to ban state-funded universities from using private money to fund embryonic research, but Kaine said he opposes restrictions on private efforts.

The news that Virginia will not receive funding for the research did not come as a surprise to its technology community, according to Virginia Biotechnology Association Executive Director Mark Herzog.

“Really, it has no impact because we haven’t previously had state funding, so it’s not as if it’s going to create a loss of jobs,” Herzog said.

His group instead has focused its efforts over the past few years on advocating for research money in general for the state, Herzog said.

Neighboring Maryland allotted $15 million in funding for stem cell research, including embryonic, last year. The state has received 81 applications from research institutions and companies for the funding, which has not yet been distributed, according to Technology Council

of Maryland CEO Julie Coons.

The Technology Council has requested $25 million this year from the state for stem cell research, and is optimistic it will receive close to that when the state budget is approved next week, Coons said.

The funding will help drive economic activity and jobs in the years to come, though it will take time before research can be translated into commercial products, Coons said.

melissa.frederick@dcexaminer.com

jrogalsky@dcexaminer.com
Examiner

Tragedy at Virginia Tech

It is hard to comprehend the scope of this tragedy. Our thoughts and prayers are with all of the families who have lost their loved ones.

Biotech Sees Record Growth

Biotech sees red-hot growth in U.S. and Europe

Ernst & Young crunched the numbers on the U.S. biotech industry for 2006 and found that the industry produced a record $23 billion in drug development alliances involving U.S. developers while merger and acquisition activity hit its second-highest level in biotech history. Analysts for E&Y were quick to point to the swelling valuations in drug discovery as a key reason for the burgeoning growth, while noting that the global biotech industry boosted the total amount of capital raised by 42 percent, to $27.9 billion. Venture capital hit a record $5.4 billion. Double-digit revenue growth was achieved by publicly traded biotech companies in Europe, the U.S. and Canada.

"The industry in the U.S. has never been stronger and we're seeing its success story spreading to other parts of the world, particularly Europe," said Glen Giovannetti, Ernst & Young's Global Biotechnology Leader. "Time will determine whether these trends will be sustained, but there's reason for optimism. Innovation is being rewarded with record revenues and unprecedented premiums in M&A transactions."

MedImmune is for Sale

This is from the Associated press:

***********

MedImmune considering sale, stock up

By STEPHEN MANNING AP Business Writer

CHEVY CHASE, Md. — Drug company MedImmune Inc. said Thursday it is willing to consider takeover offers, reversing its stand against a sale because of interest from big pharmaceutical companies and investor unhappiness with the company's performance.

MedImmune said its board of directors authorized company management to gauge interest from potential bidders. It also hired Goldman Sachs & Co. and the law firm Dewey Ballantine to help with a possible sale.

MedImmune shares jumped more than 13 percent in late afternoon trading on the Nasdaq Stock Market.

The company, based in Gaithersburg, has a market capitalization of nearly $9 billion and posted $1.28 billion in revenue last year, mostly from its childhood respiratory drug Synagis. MedImmune also makes the inhaled influenza vaccine FluMist. A company spokeswoman did not immediately return a request for comment.

But the company's recent performance has rankled some major shareholders, who said MedImmune should consider selling itself because its failure to meet some major milestones has hurt investors.

The shareholders' concerns centered on a disappointing launch of FluMist, once thought to be a blockbuster drug that fizzled when it was released four years ago because of problems with storage, price and limitations on who could use it. MedImmune also revealed in February a delayed filing for federal approval of a new version of Synagis, helping to push its stock down sharply.

In the past, MedImmune has deflected proposals that it should sell, saying it would continue with its business plan rather than find a buyer. It reaffirmed that position in February when investor Matrix Asset Advisors urged it to explore a sale. Billionaire investor Carl Icahn, who often pushes for major changes at companies he invests in, also said in February that he held 2.8 million MedImmune shares, slightly more than 1 percent of the company's stock.

David Katz, president of Matrix, which owns 1.79 million shares of MedImmune, said he was pleased MedImmune has finally agreed to consider a sale and estimated the company could be sold for between $45 to $50 per share.

Icahn's involvement likely helped convince MedImmune's board to weigh a sale, Katz said.

"Even if he wasn't terribly active behind the scenes, just the specter of him getting active probably was a good motivator," Katz said.

MedImmune said earlier this week that it expects earnings to nearly triple when it reports second quarter results in May. The company also recently released results of a study showing that a new formulation of FluMist may be more effective than the traditional shot in children, which will likely boost its chances of approval by federal regulators this year.

MedImmune said it will not provide any information on a possible sale until it has a deal or decides to go ahead as a stand-alone business. The company said in a statement that "there can be no assurance that an acquisition" will occur.

Shares of MedImmune traded up $5.13 to $42.97 in afternoon trading Thursday, well above the stock's 52-week high of $38.34.

Virginia's DNA Databank Records 4,000th Hit

From the Richmond Times-Dispatch...

Hits keep coming for DNA databank
From Staff Reports
Wednesday, April 4, 2007

Virginia's forensic DNA databank, the oldest state databank in the country, has recorded its 4,000th so-called hit.

A hit occurs when DNA found at a crime scene matches the profile of one of 277,000 offenders in the databank, or when DNA found at one crime scene matches DNA found at another.

According to Gov. Timothy M. Kaine's office, the 4,000th hit matched an offender's DNA profile in Virginia's databank with a rape that occurred in California in 2002.

Virginia passed the country's first databank law in 1989. At first, all convicted sex offenders had to provide a DNA sample. In 1990, the law was changed to include all felons, and in 2003, individuals arrested in violent felonies were included.

It took the state 8 years to reach 1,000 hits; just 18 months longer to reach 2,000; and 2½ more years to double.

The number of convictions resulting from the hits is not known. But about 10 percent of the investigations assisted or solved by hits were homicides; 17 percent, sex crimes; and 10 percent, other violent crimes. About 55 percent involved property crimes.

Virginia's databank also has helped law enforcement in 31 states identify possible perpetrators in almost 400 criminal cases.

Peter Marone, director of the Virginia Department of Forensic Science, said the number of people DNA testing has cleared of crimes - or prevented from being charged in the first place - is not known but would also likely number in the thousands.

"Roughly . . . 25 percent of the time when we have a named suspect, we eliminate them," Marone said.

Carilion Biomedical Institute is creating dividends

Here is an op-ed from the Roanoke Times...

Carilion Biomedical Institute is creating dividends
Daniel Barchi

Barchi is president of the Carilion Biomedical Institute and chief information officer of Carilion.

The Carilion Biomedical Institute has achieved many exciting milestones since its creation in 1999. Some are visible, such as the activity at the Riverside Center on Reserve Avenue. Some are less visible, but just as important to the development of the region. The CBI board of directors has asked me to share our progress report with the community.

The Carilion Biomedical Institute was established to stimulate regional economic development through medical technology advancement, business creation and research collaboration.

We have delivered on these goals with more than $33 million in economic impact, 10 new companies and 60 new jobs in the Roanoke and New River valleys since 2003. Another milestone will be reached when CBI moves into its new building on Riverside Center next month.

More important than these accomplishments, however, are the relationships and institutions that have sprung from CBI that are now creating growth even beyond CBI's long-term targets.

CBI's goal is to stimulate research by investing in partnerships among Carilion, Virginia Tech and the University of Virginia. By the end of 2006, these three institutions had collaborated to conduct $17 million in laboratory research which has resulted in 100 discoveries, 68 inventions and 22 patents.

While those numbers are significant, the longer-term outcome of this work has been the full-blown partnership between Carilion and Virginia Tech that now includes the recently announced joint medical school and a Carilion/Virginia Tech research institute, which will have the expertise to continue advancing the research mission and spawn research that far exceeds CBI's early lofty goals.

CBI's medical technology advancement goal has been built around our ability to create new companies from university research and attract other growing companies to this area to join a growing bioscience enterprise.

One of the companies that CBI created from laboratory research is OcuCure, Inc., which used CBI-sponsored technology and investment to create an eye-drop formula to stop macular degeneration, blood vessel growth at the back of the eye that blinds 200,000 Americans annually.

OcuCure, headquartered in Roanoke, has now raised more than $2 million in investment and is working to develop the compound into an FDA-approved drug.

CBI used a small seed investment to start OcuCure and several other companies, which are young but growing. CBI's incubation work for small companies led Carilion and Virginia Tech to discuss the need for more investment capital in the region to relocate or fund larger companies and facilitate faster growth.

The result of that conversation is NewVa Capital Partners, a $14 million investment pool funded by Virginia Tech, Carilion and Third Security of Radford, which now invests in promising companies that operate in the Roanoke and New River valleys.

With its move into the new building, CBI is helping to achieve the goal of developing Riverside Center from a brownfield into a business park.

With the partnership of the Roanoke Redevelopment and Housing Authority and the city of Roanoke, Carilion has developed the first biomedical building ahead of schedule, secured a hotel that is now under construction, made plans for a 200,000-square-foot Carilion Clinic building and identified the site for the Carilion/Virginia Tech joint medical school.

By developing new research, companies and jobs, CBI has already created more economic impact than the capital invested in it at its inception. CBI could continue to grow itself and its staff to achieve its goals independently.

Instead, we will focus on our primary business of assisting physician researchers and facilitating medical technology transfer. More important, by facilitating the partnerships and collaborations outlined above, CBI has helped create for this region independent research, business development and education organizations that will help the Roanoke and New River valleys achieve even greater economic success.

Generic Biologics Debated in Congressional Hearing

Representatives from the biotechnology industry squared off this week on opposing sides of the debate on generic biologics. Biologics comprise one of the fastest growing and most expensive categories of drugs. By 2009, sales are estimated to reach $90 billion. Many biopharmaceutical drugs are already off patent or will come off-patent, allowing for a generic pathway to create biologics. According to published reports, an estimated $10 billion worth of biopharmaceutical drugs are expected to come off patent by 2010.

Geoffrey Allan, Ph. D., president and CEO of Richmond-based Insmed, Inc., testified this week at a congressional hearing in support of the bill (H.R. 1038) sponsored by Rep. Henry A. Waxman (D-CA) that would authorize the FDA to grant approval of generic biologics.

Dr. Allan was a witness before the House of Representatives Oversight and Government Reform Committee Majority Staff hearing. In his testimony, Dr. Allan stated, "Insmed has developed significant intellectual capital focused towards protein characterization and purification. We have invested in building the facilities required to manufacture quality proteins...The combination of our proprietary protein platform with a biogeneric protein platform meets our goal to sustain innovation along with the ability to provide safe and affordable drugs to address a growing economic issue."

In contrast, Jim Greenwood, President of the Biotechnology Industry Organization, strongly opposes the legislation. "Any legislative discussion of creating a pathway for follow-on biologics must ensure patient safety and preserve incentives for biomedical research and innovation," said Mr. Greenwood. "We strongly oppose H.R. 1038 as it fails to do either. H.R. 1038 would permit the approval of follow-on biologics that do not meet the same rigorous standards of safety, purity, and potency that innovator products must meet; would restrict the ability of the FDA to require whatever clinical testing it believes appropriate to determine the safety and efficacy of such products; would prohibit the FDA from requesting post-marketing safety studies; and would improperly dictate scientific conclusions that the FDA should reach about the comparability or similarity of such products. The legislation also eviscerates incentives to develop new therapies through its one-sided alteration of long-standing patent law in ways that favor follow-on biologics' manufacturers, who would be able to restrict and infringe the intellectual property rights of various parties including universities and innovative biotechnology companies."

At the same hearing, FDA Deputy Commissioner Janet Woodcock told lawmakers it could be a decade or more before the science is available to safely approve generic versions of biotech drugs in the way the FDA approves generics of traditional drugs derived from chemical synthesis.

Dr. Allen told the committee that his company would be well positioned to produce generic biologics, opening up a new level of competition in the industry. "The science has reached a level of sophistication to make this endeavor entirely possible, all we need now is the regulatory go ahead."

Bob Eaton Resigns As President & CEO of MdBio, Inc.

After more than ten years as president and chief executive officer of MdBio, Inc., C. Robert Eaton announced his resignation effective Friday, March 30. According to the Tech Council of Maryland (TCM), Mr. Eaton resigned to pursue opportunities in the private sector.

"Leading MdBio has been rewarding and challenging," said Mr. Eaton. "I am proud of the programs MdBio has developed over the last 10 years that support the growth of bioscience companies in Maryland."

Under Mr. Eaton's leadership, MdBio was instrumental in forging close ties to regional trade associations sharing a common interest in promoting the mid-Atlantic region's bioscience assets. "Bob's commitment to regionalism made the Mid-Atlantic Bio events possible," said Mark A. Herzog, executive director of the Virginia Biotechnology Association. "The political and economic divide between the two states can be pretty wide, but Bob was one of the first to recognize that the industry would benefit by bridging those gaps."

"The respect that MdBio enjoys not only in the state but also nationally is due in large part to Bob's tremendous commitment and hard work over the years," said Jim Leslie, Chair of the MdBio Foundation board of directors. "Through Bob's creativity and leadership, MdBio has been a significant contributor to the growth of Maryland's bioscience industry and also planted the seeds for future generations of industry employees through the organization's early education efforts like MdBioLab. Bob's work ethic and respect from both government and industry leaders is evidenced by his appointment to the Board of Visitors at the University of Maryland Biotechnology Institute and the Board of Advisors at the Sloan Biotechnology Industry Center," added Leslie.

"Bob's efforts were instrumental in supporting the growth of our company and so many others across the state," said Dr. Lawrence Tamarkin, President and CEO of CytImmune Sciences, Inc. "His leadership will be missed."

According to the Baltimore Sun, there has been speculation that the merger and a loss of autonomy led to Mr. Eaton's resignation. When asked to comment by the newspaper, Mr. Eaton declined to comment.

MdBio and MdBio Foundation will conduct a national search for the next president. Until a replacement is named, Julie Coons, CEO of the Tech Council, will serve as interim president of MdBio and the MdBio Foundation.