Strategically located near Federal institutions (like the National Institutes of Health) and regulatory agencies (like the Food and Drug Administration), Virginia is an ideal place for life science companies.
According to the Virginia Biotechnology Association (www.vabio.org), about 160 pharmaceutical, biotechnology, and medical device companies are dispersed throughout the state in clusters surrounding Richmond, Charlottesville, Blacksburg/ Roanoke, and Norfolk.
"We have an eclectic mix of companies all over the state," says Terry Woodworth, Ph.D., director of life sciences at Virginia's Center for Innovation and Technology (www. cit.org) in Charlottesville, a state economic development group that supports early-stage companies.
The Virginia BioTechnology Research Park (www. vabiotech. com) in Richmond is home to 45 bioscience companies, research institutions affiliated with Virginia Commonwealth University, and national and government laboratories.
The 10-year-old park covers 34 acres, and 1,350 researchers work in its eight completed buildings, which represent a third of the master plan.
The first building opened in 1995. "We had the foresight to know that we needed incubator space for companies to grow," says Robert Skunda, president and CEO of the park.
A unique mix of tenants contributes to its growth. The non-profit United Network for Organ Sharing is headquartered at the park, and serves as a magnet to "attract companies involved in organ transplant and related research," adds Skunda.
Other bioscience research parks are in various stages of development in Roanoke, Fairfax, and Norfolk, according to Keith Oing of the Virginia Economic Development Partnership (www. yesvirginia.org).
Virginia's universities, including Virginia Commonwealth University in Richmond, Virginia Tech in Blacksburg, University of Virginia in Charlottesville, and Eastern Virginia Medical School in Norfolk, award more than 8,300 bioscience degrees yearly. The state is home to 19,000 doctoral scientists and engineers. The Howard Hughes Medical Institute is building a new $500 million biomedical science center near Richmond.
Several large pharmaceutical companies, including Merck, Eli Lilly, and Wyeth, operate facilities in Virginia. Overall, Virginia life science companies, including some smaller ones highlighted here, contribute $2.5 billion annually to the state's economy.
A safer screening test to replace amniocentesis is being developed by researchers at Living Microsystems (www.livingmicrosystems.com). The company's first product detects rare fetal cells in a blood sample taken from pregnant women in the first trimester. The simple blood test detects Down syndrome and other genetic abnormalities and is less risky than amniocentesis, which carries a fetal death rate of 1%.
The technology was licensed from the Massachusetts Institute of Technology. "We have a technology that could make a big difference in fetal and maternal well being," says Mike Grisham, president and CEO of Living Microsystems in Richmond.
When obesity expert Richard Atkinson, M.D., retired from the University of Wisconsin he moved back to his home state and founded Obetech (www.obetech.com) in Richmond.
Since the mid-1990s, he has investigated the link between a specific common cold virus, adenovirus-36 (Ad-36), and obesity. He's shown that 70% of mice and 100% of monkeys infected with Ad-36 become obese.
In cell cultures, Ad-36 makes more fat cells, and they accumulate fat faster. When Dr. Atkinson measures antibodies to Ad-36 in people, he finds that about 30% of obese people have antibodies to Ad-36, compared to 10% of non-obese people.
At Obetech, Dr. Atkinson patented an assay for Ad-36 antibodies. He believes that it is as important to know your Ad-36 status as your cholesterol levels. Normal weight people who test positive for Ad-36 can make lifestyle changes to prevent weight gain. Obese people who test positive can feel less guilty.
"If someone sneezes on you in an elevator, you can become fat," says Dr. Atkinson. The Ad-36 assay is available from Obetech, whose long-term goal is to develop a home test kit.
Luna Innovations (www. lunainnovations.com), headquartered in Blacksburg, created a new carbon material for nanotechnology called Trimetaspheres. Harry Dorn, Ph.D., a chemist at nearby Virginia Tech University, discovered Trimetaspheres, and Luna licensed the technology.
Trimetaspheres can contain up to 80 carbon atoms, which are stabilized by three metal atoms and a nitrogen core. Luna improved the technology and produces large quantities of Trimetaspheres that are stable in air and water-soluble.
"Our technology is a unique carbon material that's like a fullerine, but the three metal atoms inside give it highly unusual properties," says Robert Lenk, Ph.D., CEO of Luna NanoWorks, a new division located in Danville.
Luna NanoWorks renovated a 24,000-sq-ft tobacco warehouse into a manufacturing facility to produce Trimetaspheres. The nanomaterial is so new, that "we don't know all its potential applications," says Dr. Lenk.
The metal magnets inside the spheres make them ideal for medical-imaging applications. The first product being developed is a contrast agent for MRI, which is safer and gives better images than current agents. The metals used in MRI contrast agents must be encapsulated to prevent toxicity, yet some metals escape.
In contrast, the metals inside Trimetaspheres cannot escape, and they give 25-fold better image quality. Luna NanoWorks also will supply others with Trimetaspheres for research and industrial applications.
Early in 2005, Insmed (www.insmed.com) in Glen Allen filed an NDA for its drug candidate SomatoKine, a novel once-daily therapy for the treatment of growth hormone insensitivity syndrome (GHIS). Children with GHIS do not respond to growth hormone, which stimulates the production of IGF-1 in healthy people.
SomatoKine, an orphan drug, "is a simple replacement therapy," says Baxter Phillips, director of industrial relations at Insmed. A pivotal Phase III trial showed high-velocity growth in GHIS patients receiving a daily injection of SomatoKine. The company targets metabolic and endocrine disorders.
In Radford, New River Pharmaceuticals (www.nrpharma.com) uses its Carrierwave technology to create improved versions of widely prescribed drugs. "We attach one or more essential amino acids to an existing drug," says Krish Krishnan, CFO and COO.
The new formulations are eligible for new patent protection. Because the amino acids are generally recognized as safe, and the active drugs (often generics) are also proven safe, development time is reduced.
The company's first products are intended to prevent abuse and overdose problems of opioids and amphetamines. The new formulations are not active if the drugs are inhaled or injected.
They must be swallowed, then intestinal enzymes release them in a controlled manner. The technology also is broadly applicable to improve the bioavailability or reduce side effects of other classes of drugs.
The molecular tools company Genomatix (www.genomatix. com) moved to Roanoke from Cincinnati. "We manufacture DNA vectors as agents to modulate subcellular events," says Robert Beech, CEO.
By examining such protein-protein interactions, their customers find new drug targets or predict toxicity problems. For example, in cardiomyocytes (heart muscle cells), the suborganelle called the cardiac sarcoplasmic reticulum, carries out calcium pumping.
When just one specific kinase is inhibited, severe cardiac hypertrophy occurs. "We make DNA vectors for other companies that want to modulate specific targets in subcellular locations," explains Beech.
The family-owned and operated business Valley Biomedical (www.valleybiomedical.com) has made specialty reagents and cell culture sera for 20 years.
Founded by chemical engineer Mario Romano in Winchester, Valley Biomedical's manufacturing facility is FDA registered and operates under cGMP guidelines. They provide specialty biological products and contract manufacturing services to biotechnology and clinical diagnostic companies.
Among their traditional specialty products are control serum standards, such as the reference cholesterol standards used to measure cholesterol in patient blood. Valley Biomedical also supplies fetal bovine serum used to grow cells in culture.
"Now the trend is to use human serum and plasma as supplements in cell culture media," says Romano. Because of the recent contamination of stem cell lines with chemicals in fetal bovine serum, some laboratories are changing their protocols to replace fetal bovine serum with human serum, and "we supply it," says Romano.
Physicist Maciek Sasinowski, Ph.D., founded Incogen (www. incogen.com) in Williamsburg to provide user-friendly bioinformatics software.
Previously, Dr. Sasinowski directed the bioinformatics center at Clemson University in South Carolina, where he saw biologists and computer programmers struggle to create software that was flexible enough to incorporate changing biological systems.
The outcome was VIBE (Visual Integrated Bioinformatic Environment), a drag-and-drop workflow management system. VIBE uses icons to build complex analysis pipelines without prior knowledge of computer languages. "We were the first in our space to apply visual programming to bioinformatics, and it put us on the map," boasts Dr. Sasinowki, president and CEO of Incogen.
The company also makes GenePort, a web browser and data-mining and management software. GenePort "allows users to look at DNA sequencing data and microarray data together," says Dr. Sasinowski.
Researchers at academic and government laboratories and in pharmaceutical companies use VIBE and GenePort. The systems are useful for target discovery and allow researchers to coordinate and follow potential leads. In addition, third-party software can be integrated into VIBE.
The mission at BioTrack (www.bio-track.com) in Richmond is to promote biomedical engineering in Virginia. Founder, president, and biomedical engineer Mark Licata offers a range of contract services, including design, engineering, regulatory, and manufacturing help.
BioTrack has developed low technology products, like a user-friendly cabinet for defibrillators, as well as more sophisticated items, like a blood analyzer.
A biomedical engineer from California, Licata relocated to Virginia, and he was surprised to discover that "Virginia has a great infrastructure for biomedical engineering, because the equipment and technology used to make cigarettes is similar to that used to build medical devices."
Licata notes that even the FDA calls cigarettes a nicotine delivery device, but "we want to build more beneficial devices."
Twin brothers Eric and Evan Edwards, who suffered from severe allergies as children, know firsthand the disadvantages of the common drug injector called EpiPen. They always carried one with them in case a severe allergic reaction required epinephrine.
Now Evan is an engineer, who designed a device that improves on the EpiPen, and Eric took a leave of absence from medical school to run Intelliject (www. intelliject.com), the company they founded in Richmond.
Their technology is "the first credit-card size, auto-injector in the world," says Eric Edwards. The compact drug delivery system fits into a wallet, pocket, and purse. Pharmaceutical companies are evaluating the platform, which could be used to deliver up to 40 different drugs, including antidotes for nerve toxins used as by terrorists.