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.
Thursday, June 07, 2007
New Leadership at PRA International
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.
Sunday, June 03, 2007
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.
Friday, June 01, 2007
GMU Seeking Donations for Tech Transfer
GMU turns to the public to help fund tech innovation
t investing for a piece of the company or a return on their dollars.
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 no
Tuesday, May 29, 2007
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."
Wednesday, May 23, 2007
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."
Tuesday, April 17, 2007
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
Monday, April 16, 2007
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."
Friday, April 13, 2007
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.
Wednesday, April 04, 2007
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.
Tuesday, March 27, 2007
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
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
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.
"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
"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.
Thursday, March 15, 2007
New BioLife Fund Set to Invest in Life Sciences Sector
New BioLife Fund Set to Invest in Life Sciences SectorBy Kim Hart
Washington Post Staff Writer
Thursday, March 15, 2007; VA12The Center for Innovative Technology this week started a venture fund that will invest in the life sciences sector. The new BioLife Fund is an outgrowth of CIT's growth acceleration program, a three-year-old fund that finances early-stage technology companies in Virginia.
Johnson & Johnson provided the initial investment of $250,000, which will be matched by CIT. The BioLife Fund will finance start-ups in the pharmaceutical, medical devices and health services fields, said Peter Jobse, CIT president and chief executive.
About a third of the companies that looked for financing through the original venture fund came from the biotechnology industry, Jobse said. CIT makes an investment of up to $100,000 and helps to trigger the interest of other angel investors or venture capitalists. CIT's growth acceleration program has invested in 17 firms since it opened in December 2004.
A large concentration of life sciences start-ups has come out of the Charlottesville area, in connection with the University of Virginia, as well as Richmond and Virginia Commonwealth University. About a third of the companies are setting up shop in Northern Virginia, with some scientists coming out of George Mason University.
"The fund is not specific to firms coming out of universities," Jobse said. "We would like this fund to address the needs of the community as a whole, not just one aspect. Technology doesn't necessarily roll out of the [university] labs."
Some venture capitalists are wary of financing life sciences companies because they take much longer to generate a profit or a return on the investment. Jobse said the "social mission" of the fund helps balance out the risk of a long-term investment.
"If it takes nine years and $100 million to produce a great drug, there may not be an immediate payback," he said. "There isn't necessarily a great return on the financial side, but there will be on the social side."
The new fund is looking to provide cash to first-time entrepreneurs with advanced intellectual property, he said.
Friday, March 09, 2007
European Official Urges Caution on Generic Biologics
Caution urged on biologic drugs
By Diedtra Henderson, Globe Staff | March 8, 2007
WASHINGTON -- European regulators told a Congressional panel today that some biological drugs -- such as insulin and human growth hormones -- are simple enough to produce in generic versions, but others are too complex to be safely duplicated.
Generic versions of certain biologics have been allowed in Europe for the last four years, but approval came only after manufacturers conducted rigorous human clinical trials. European regulators recommended today that the United States adopt the same standards.
The testimony came during a Senate Health, Education, Labor and Pensions committee that is considering a bill to permit United States regulators to approve generic versions of biologics, drugs based on living organisms and cells.
Too much flexibility for generic manufacturers in Europe would have “spread suspicion” that the generic biologic products were unsafe, said Nicolas Rossignol, who is responsible for implementing the European Commission’s legislation governing generic biologics. Rossignol testified from Brussels.
Senator Edward M. Kennedy, who chairs the committee, called biologic drugs “miracle medicines” that can come at a steep price to the healthcare system tens to hundreds of thousands of dollars annually per patient. Americans spent an estimated $60 billion on such products last year, according to IMS Health, a healthcare information company, compared with $53 billion in 2005.
Generics that are chemical equivalents to conventional drugs save Americans at least $10 billion per year. The Food and Drug Administration, however, lacks the legal ability to approve generic versions of biologics.
Kennedy, Democrat of Massachusetts, said such legislation should be “led by the science,” while protecting patient safety and valuing the investments made by innovator companies.
Opponents of the current measure, including Senator Orrin Hatch, Republican of Utah, say it lowers safety standards and could imperil patients. Hatch cosponsored legislation that speeds to market generic versions of conventional drugs. He favors requiring that prospective generic biologic manufacturers test their drugs in humans before approval. Hatch also supports establishing patient registries to track side effects that may not occur until years after patients start using a product.
“What we need to do is keep working to get the best legislation,” Hatch said.
Monday, March 05, 2007
VaBIO Podcast Noted in RTD Article
Podcasting a tool for firms
Experts say shows can be helpful in getting message out to public
BY JEFFREY KELLEY
TIMES-DISPATCH STAFF WRITER
Saturday, March 3, 2007
Since its early days circa 2004, podcasting has touched on such subjects as gardening, video games, cooking and sports.
But the online audio or video shows have also become a tool for businesses that want to share a message with their clients, investors or the general public.
Podcasting's audience? Largely male, folks who work out and commuters and business travelers who want something other than music or the newspaper to pass the time.
Lasting about a half hour, podcasts made by Ironworks Consulting revolve around corporate information-technology topics the average person would find perplexing "open source" software, anyone? But such content has an audience: folks who know and work in information-technology, and understand all of its jargon.
"It's kind of a marketing thing because we're showing our perspective on technologies we help clients implement," said Will Loving, the Henrico County firm's chief operating officer. "If someone listens to it, they can actually learn something from it and use it in their day-to-day work."
That's precisely how podcasts should be done, experts say. If made correctly, a corporate podcast can become a marketing and public-relations tool, but it shouldn't look or sound that way.
Steven Hearn, a former Richmonder and president of podcastGO.com, said the programs should be considered "infotainment" -- in other words, listeners should learn something, yet stay amused.
A little more than one in 10 Web users in the U.S. have downloaded a podcast, the Pew Internet & American Life Project said in November. Few consumers appear to download podcasts with great frequency, perhaps a sign the technology is still young. Forrester Research says the adoption of broadband and spread of MP3 players will push podcasting's popularity in the future.
Still, Forrester said last month, Internet videos, blogs and networking sites such as MySpace are still much more trendy with consumers than podcasts.
"My caution is that companies shouldn't be dashing out to create expensive original content for a small audience -- unless they gain value from being seen as innovative," Charlene Li, a Forrester analyst, wrote last year in her blog.
As people who use podcasts know, listeners can subscribe to the programming as they would a magazine, through services such as Apple's iTunes. When a new show is published, it is sent to software on the user's computer or hand-held device such as the Palm Treo.
Chesterfield County-based PrecisionIR Group converts corporate earnings calls and shareholder meetings into podcasts for some clients. It handles investor-relations services for thousands of public and private companies.
"If you're a Wall Street analyst you can download all the earnings calls and listen to them on the treadmills while you work out, or on the train back [home], and listen to what the CEOs have to say," said J. Patrick Galleher, PrecisionIR's chief executive, a frequent flier who, on his iPod, has everything from Guns N' Roses tunes to corporate podcasts from paper and packaging firm Stora Enso.
PrecisionIR began its podcasting service in June 2005, and that year turned 116 corporate events into podcasts. Last year, the firm offered 1,286 podcasts, which were downloaded 64,692 times.
Galleher projects his company will have thousands of podcasts available this year.
Virginia Biotechnology Association Executive Director Mark Herzog has hosted seven podcasts since September. He's interviewed state life-sciences entrepreneurs, government officials, and others involved in the creation of a biotechnology industry in Virginia.
The programs, running anywhere from 10 to 15 minutes, are as much an advertisement for the association as they are informative to those who are engrossed in science.
"Some [listeners] are interested in policy aspects, some are concerned about new trends in science. . . . The podcasts are a way that we can [cover] different topics and people can download those topics to meet their needs," Herzog said.
The association has tracked about 200 downloads of the podcast each month since December. People can subscribe to the podcast for free on the association's Web site, VaBio.org, or through iTunes.
The Federal Reserve Bank of Richmond has been podcasting the speeches of its president, Jeffrey M. Lacker, since December 2005. "It's one of the most popular features on our Web site," Fed spokeswoman Lisa Oliva said, although she did not provide figures.
"It just gives you a greater dissemination of information. Our audience is broader because of podcasting."
Contact staff writer Jeffrey Kelley at jkelley@timesdispatch.com or (804) 649-6348.
This story can be found at: http://www.timesdispatch.com/servlet/Satellite?pagename=RTD/MGArticle/RTD_BasicArticle&c=MGArticle&cid=1149193496236
Friday, February 16, 2007
More on Generic Biologics
This was in the Washington Post:
Generic Biotech Drugs Could Save $71B
By THERESA AGOVINO
The Associated Press
Thursday, February 15, 2007; 12:06 AM
NEW YORK -- Patients and health insurance providers could save at least $71 billion over 10 years if there was a regulatory mechanism that allowed for the marketing of generic biotech medicines, according to a study being released Thursday.
Currently there is no legal pathway that allows generic drug makers to produce biotech medicines, so the pricey treatments, which are derived from a living source such as proteins, have never had to compete with copycat products that drive pharmaceutical costs lower.
Controlling the cost of biotech medicines has become a top priority for those providing health insurance because the cost of such treatments is dramatically increasing. Biotech treatments now account for 25 percent to 30 percent of a company's overall drug costs, according to pharmacy benefit manager Express Scripts Inc., which conducted the study.
Express Scripts said that the average biotech drug costs $71,600 a year, compared with the annual average for a traditional drug of $1,200. It said that escalating biotech drug costs, which reached $40 billion in 2005, are expected to more than double in four years to a total of $90 billion in 2009, a rate three times faster than traditional drug costs.
But on Wednesday, a bill was introduced by a group of bipartisan lawmakers in Washington, D.C., that would give the U.S. Food and Drug Administration the authority to approve copies of biotech drugs. Similar legislation was introduced last year.
Express Scripts conducted the study by taking a 25 percent discount off brand name medicines in four classes of drugs that would already have generic competition because of patent expirations if copycat biologics were allowed. Express Scripts decided on that discount because it said that the generic version of human growth hormone sells at a 25 percent discount to its brand name counterparts in Europe.
The four categories of drugs were: insulin for diabetes, erythropoietins for anemia, growth hormones and treatments for multiple sclerosis.
Dr. Steve Miller, chief medical officer at Express Scripts, said its estimates were conservative because it didn't include other drugs that would lose patent protection over the next 10 years.
Express Scripts said a generic drug typically costs 60 percent less than its brand name counterpart. However, some experts have said that generic biologics may not be that much cheaper than their branded counterparts because it is likely the FDA will require more testing on generic biologics than chemical drug copycats. Biotech drugs are also more expensive to produce.
Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Association, said her trade group supports the new legislation and that numerous companies within the organization had expressed interest in entering the biotech arena, even though the process might be more expensive and complicated than producing generic chemical drugs.
Jaeger said that even if generic biologics were only 25 percent less than their brand name counterparts, it would be a huge savings for consumers.
"If it (the legislation) gets passed it will be a great win for consumers," she said.
Jim Greenwood, president and CEO of the Biotechnology Industry Organization, cautioned against forecasting any savings from generic biotech drugs without knowing how much testing regulators would require. BIO maintains the drugs won't be true generics because a product made from a living source can never be exactly copied.
"We would be happy to support follow-on biologics legislation as long as that legislation is consistent with some very critical principles: first and foremost of course is safety," Greenwood said.
FDA spokesman Kathleen Quinn said the agency hadn't seen the newly introduced legislation but that it plans to provide technical assistance on the bill. She added that as science has evolved, the agency may be able to eventually approve generic biologic drugs.
Democrats in Congress Press for Generic Biologics
Legislation Would Allow Generic Biotech Drugs in U.S. (Update1)
By Justin Blum
Feb. 14 (Bloomberg) -- Lawmakers in the U.S. House and Senate introduced legislation that would for the first time routinely allow copies of medicines made using biotechnology.
The measures offered today would permit generic drugmakers, such as Barr Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd., to produce medications that are now off limits to competition.
``Without action, the manufacturers of these biotech drugs can continue to charge monopoly prices indefinitely,'' Senator Hillary Clinton, a Democrat from New York, said at a news conference in Washington. ``Biotech drugs hold great promise, but we break that promise when the costs push treatments out of reach.''
Generic biotech drugs may reduce prices by almost a third and cut into the profits of brand-name biotech companies including Amgen Inc. and Genentech Inc., analysts say. Opponents of the legislation say attempts to copy complex gene-based medications could pose health risks.
Sponsors of the legislation in the House include Henry Waxman, a Democrat from California, and Jo Ann Emerson, a Republican from Missouri. Backers of a matching Senate version include Clinton and Charles Schumer, Democrats from New York.
Lawmakers introduced similar measures last year that didn't advance in the Republican-controlled Congress. Supporters say prospects have improved with Democrats in control.
Opposition is being led by the Biotechnology Industry Organization, a Washington-based group that represents makers of brand-name biotech drugs.
Passage of the legislation ``may mean that these drugs come onto the market without the testing necessary to make sure they are safe and effective,'' said Paul Winters, a spokesman for the Biotechnology Industry Organization.
FDA's Authority
U.S. law allows the Food and Drug Administration to approve generic versions of conventional drugs, made mostly through chemical synthesis, after patents expire. There is no similar process for most biotech medicines, genetically engineered versions of human proteins such as insulin or growth hormone.
Biotech drugs generated revenue of about $32.8 billion, 13 percent of the $251.8 billion in prescription sales to U.S. pharmacies in 2005, according to IMS Health Inc., a research company in Fairfield, Connecticut.
Many biotech medicines carry high price tags, and generic versions could lower prices by 20 percent to 30 percent, Elise Wang, an analyst with Citigroup Inc. in New York, said in an interview. One of the most expensive biotech medicines is Genzyme Corp.'s Cerezyme, a treatment for a rare enzyme disorder that can cost $200,000 a year.
Expiring Patents
Barr of Woodcliff Lake, New Jersey, says in lobbying literature that patents have already expired for some top- selling biotech medications, making them vulnerable to competition if lawmakers act. Among the products listed is an anemia treatment sold in the U.S. by Amgen as Epogen and by Johnson & Johnson as Procrit. U.S. sales of the drugs, sold by both companies under a marketing agreement, totaled $4.71 billion in 2005.
A report from Citigroup says that one of Amgen's patents lapsed in 2004 and others expire in 2012 through 2015.
Conventional drugs are small molecules that generic makers can reproduce in versions that are almost identical to the original product and change little from batch to batch.
Biotech medications use bacterial cells to produce human proteins, and the final composition can vary, depending on the techniques used.
The legislation would permit the FDA to decide whether generic makers can skip or abbreviate human clinical trials, and supporters say that would give the agency full authority to guarantee the copies are safe. Such studies aren't required for copies of conventional drugs.
Proponents of the legislation use the term ``generics'' for the biotech drugs they want to reproduce. Some brand-name makers say the drugs should be called ``follow-on biologics'' because the new versions aren't identical. European regulators call them ``biosimilars.''
Thursday, February 01, 2007
MdBio & VaBIO Launch Mid-Atlantic Bio Encyclopedia
As part of the ongoing efforts to meet the industry's long-term workforce needs, as well as to help the Mid-Atlantic community understand what the bioscience industry brings to our region and the world, the Virginia Biotechnology Association (VaBIO) is pleased to announce a new partnership with MdBIO and the National Institute of Science Media (NISM). NISM is a non-profit organization that is publishing a series of illustrated biotech encyclopedias, titled Working to Improve Lives. This is a nationally distributed series of books, published in a permanent, high quality, hardcover format. NISM recently published the first book in the series, the San Diego Life Science story, and is currently developing books covering the Mid-Atlantic region, the Bay Area, Massachusetts and Pennsylvania.
We encourage everyone to consider this opportunity to document their unique contribution to the bioscience industry. VaBIO & MdBio have worked to ensure that various levels of participation are available to meet each company's time and budget constraints. Please review each option and help us to create an amazing book showing the world the uniqueness of the Mid-Atlantic bioscience community.
Please direct any inquiries you have regarding this project to:
Joel Ball, Director, NISM
8639-B 16th St. , Silver Spring, MD 20910
1.866.NISM-123 Ext. 701/ Fax 1.866.647.6123
jb@nism.org