Wednesday, August 20, 2008

UNOS Hires Richmond TV Anchor for PR & Marketing

Congratulations, UNOS! This is a great catch.

August 20, 2008
Signing Off

After nearly a quarter-century, Channel 8 news anchor Lisa Schaffner bows out.
by Lisa Antonelli Bacon

Last Thursday was a bit weird for WRIC-TV news anchor Lisa Schaffner. As local chairwoman of the American Cancer Society’s Making Strides Against Breast Cancer walk in October, she spent the morning of Aug. 14 pumping up the crowd at the event’s kick-off breakfast. Afterward, she was feeling a little uncomfortable.

Although no one at the breakfast knew, when the walk takes place in October, she won’t be the Lisa Schaffner they chose for the job.

After 22 years at WRIC — becoming the city’s first female newscaster to anchor a 6 o’clock news broadcast in March 1991 — Schaffner is leaving broadcast journalism.

WRIC General Manager Bob Peterson says he was blindsided when Schaffner recently broke the news. “I was shocked by Lisa’s decision,” he says. “I appreciate everything Lisa has done for the years she has been here. I wish she was staying.” Peterson says Schaffner’s replacement has already been chosen, but won’t yet say who it is.

Schaffner says the tipping point was her children. Danielle, 14, starts attending James River High School in September, and Jesse, 11, heads to Robious Middle School. “I’ve never been home to put them to bed on a weekday,” Shaffner says.

Beginning Oct. 1, Schaffner will be director of public relations and marketing for the United Network for Organ Sharing, known as UNOS, a national nonprofit based in the Virginia BioTechnology Research Park downtown. As it turns out, the position was created for Schaffner when rumblings of her retirement began to circulate during the last few months.

“We created it for her because we saw the opportunity,” says its executive director, Walter Graham. “She has the ability to bring focus and attention to UNOS and its mission, particularly in the Richmond area, and to help us expand into new areas.”

For Schaffner, parting is sweet sorrow. “I love my job. I’ve done so much for myself,” she says, fighting back tears. “It’s the right decision for my children. Sometimes you have to push yourself to do things you normally wouldn’t do, but you’re doing it for all the right reasons. I have two very important reasons.”

At 46, an age she says she’s “not ashamed of,” Schaffner has spent nearly all of her career at Channel 8. When she arrived in 1986, she had only a few years of experience as a general assignment reporter for WBAY-TV in Green Bay, Wis. A visit with her brother in Leesburg impressed her. Then nature intervened.

“The next winter was the snowiest Green Bay ever had,” she recalls. “I thought it might be time to leave.” Coincidentally, there was a job opening at what was then WXEX-TV, based in Petersburg. In the 22 years since, she’s hung on as WXEX turned into WRIC and moved its base of operations to Richmond. She emerged as the face of the operation in 1991, during a tumultuous time for the station. She succeeded former anchor Kevin McGraw, who was fired because of low ratings and the station’s perennial spot as the No. 3 station, behind WWBT-12 and WTVR-6.

At the time, McGraw was allegedly having an affair with reporter Gretchen Carlson, a former Miss America, who got her start in Richmond. Carlson moved on to become co-anchor of the Saturday Early Show on CBS, and now co-anchors the nationally televised morning show, Fox & Friends.

Schaffner’s watched the station’s rankings shuffle back and forth with the competition, and survived it all. In one notorious incident, she was allegedly shoved onto a desk while trying to break up a shouting match between former co-anchor Steve Coleman and news directors in December 1992.

Schaffner became a stabilizing force at the station, and has watched the broadcast industry go through a multitude of changes. Today, local television news competes with a plethora of cable news shows and the Internet.

“When I came on board, we had a noon, a six o’clock, and an 11 o’clock broadcast. Now we have an additional two hours in the morning, an additional 4:30 broadcast and all the Internet coverage. We did live coverage, but now it’s live 24/7,” Schaffner says. “The lifespan of the story changes. When viewers see a story at 6, they think, ‘What are you going to give me at 11?’ We’re constantly trying to pull in that new information. It takes more resources and more time.”

Meanwhile, WRIC has largely taken a backseat to WWBT and anchors Sabrina Squire and Gene Cox in the echelon of local television news. While WTVR has seen anchors come and go, Schaffner has remained the face of WRIC for nearly two decades.

“She is a scrappy competitor who outlasted a lot of her competition,” says the newly retired Douglas Durden, former television critic for the Richmond Times-Dispatch. “Her perky hair and delivery have been a welcome constant through decades of change. Unlike a lot of people who were brought in to be anchors, Richmond audiences watched her evolve from reporter to anchor.”

Meanwhile, Schaffner’s lived many stages of adulthood in Richmond. “I’ve been married here, had two children here, and divorced here,” she says. And although cooking dinner was rarely on her to-do list, she did learn how to make some mean chocolate-chip cookies, which she’s looking forward to doing more often.

Her last day on the anchor desk is Sept. 15. Two weeks later, she’ll show up at UNOS, where there is no clothing allowance. Female newscasters often receive a stipend for clothing as the equivalent of celebrity models for local fashion. “Anything you saw on the air and liked, you’ll see me in again at UNOS,” she says.

Coming to terms with the change in persona weighs heavily. “People always ask if I’m nervous when I get on TV. I’m never nervous,” she says, adding the caveat: “About this, I’m nervous. It’s a big life change.

“Sometimes you need to walk away from who you are to find who you are to become. That’s where I am.”

Wednesday, August 13, 2008

Insmed Lands Front Page Story in WaPo

Geoff Allen and his team must be thrilled with this great coverage in today's Washington Post...

Biotech Campaigns for Easier Access to Generic Drug Market
Richmond Firm Wants Congress to Revamp FDA Approval Process

By Kendra Marr
Washington Post Staff Writer
Wednesday, August 13, 2008; D01

Geoffrey Allan has been giving Congress a lesson in biotechnology.

He's explained protein structures and how they work. He's reviewed how drugs are absorbed into the body.

If lawmakers understand the difference between chemical and biologic drugs, Allan reasons, they'll be more invested in his cause: getting quick approval for generic biotech drugs. Today the generics market for chemical drugs like aspirin is booming, but there is no way to get cheaper copies of pricey biologics, for complex life-threatening diseases like cancer, into patients' hands.

Allan, who has worked in the drug industry for 28 years, has a lot at stake. As chief executive of Insmed -- a small Richmond biotech whose goal is to be the first U.S. company to develop a portfolio of biotech generics, or "biosimilars" -- his company's success rides on Congress overhauling the laws to permit competition that would result in lower biologic drug prices.

"You have to talk to people and educate people to expand the possibilities in this field," he said.

The difference between chemical and biologic drugs lies in manufacturing. Chemical drugs are small, simple molecules. Because these drugs are made with tightly controlled chemical recipes, a lab test can easily confirm that a generic such as acetaminophen is identical to the original product Tylenol.

Biologics are much larger and more complex. Biotech companies manipulate living cells into mini-factories to produce the desired molecules for drugs. Any divergence in production processes can change the entire function of the product, potentially jeopardizing patient safety. It's impossible to create perfectly identical products -- hence the term biosimilar -- and tricky to compare divergences.

Last month, Insmed demonstrated that its version of Neupogen, which stimulates white blood cell growth, was equivalent in 32 healthy volunteers to the original product from Amgen. But, for Insmed's version, there is no pathway for approval. And some argue the process should be different than for chemical drugs.

"With a biosimilar, that's not enough," said Andrew Fox, Amgen's director of regulatory affairs. "You need to go into larger trials for safety and efficacy. Insmed's limited data appeared to be good data. However, bioequivalence testing in healthy volunteers does not provide the necessary data on how the biologic actually works in the body, which can only be determined through more extensive clinical testing in patients where safety and efficacy are evaluated."

Two decades ago, as prices for chemical drugs skyrocketed, Congress passed the Hatch-Waxman Act, which opened the doors for generic competition after patent expiration. Once a company demonstrates that its generic is chemically identical to a brand-name drug, it can use the approval of the brand-name drug as evidence that its copycat works just as well without additional human trials.

When the Hatch-Waxman Act passed, the biotech industry was young, and lawmakers didn't think to give the Food and Drug Administration an abbreviated review process to swiftly approve biosimilars. Now, escalating health-care expenditures have prompted Congress to consider one. Last year, two bills were introduced into the House and are still pending. Then, in March, representatives drafted yet another.

A recent Congressional Budget Office analysis of a Senate bill, which passed unanimously last year in committee, found that biosimilar competition would reduce expenditures on biologics by about $200 million by 2013 and about $25 billion by 2018. These savings would represent about 0.5 percent of national spending on prescription drugs, at wholesale prices, over the next decade.

The main point of contention among these bills: the length of an innovator company's "data exclusivity." Not to be confused with patents, data exclusivity is the period after the FDA approves a product during which an imitator can't rely on the innovator's clinical data for safety and effectiveness. It can run during and longer than the period of patent protection.

Insmed, along with consumer groups such as AARP and the National Organization for Rare Disorders, are lobbying for five years, the same length as chemical drug data exclusivity, to get cheaper drugs to patients sooner and spur biosimilar growth.

"These types of drugs make an enormous amount of money," Allan said regarding a longer period. "If generics come into the marketplace, it'll eradicate the monopoly. Let's be clear. This is all about protecting monopoly."

Established companies deny such a motive.

"We've always supported a pathway," said Genentech spokeswoman Megan Pace. "We just want to make sure patient safety and data protection for innovators will be a part of the bill."

Because biosimilars aren't exact duplicates of the original drugs, they don't violate the original drug's patent, enabling legal distribution before patent expiration. As a result, the Biotechnology Industry Organization, as well as the handful of biotechs that control most of the market, supports a 14-year period to allow companies to recoup their investment and conduct further clinical trials to improve the product.

"The biologics industry, even now, is largely made up of small companies that are losing money," said Sara Radcliffe, the organization's vice president of science and regulatory affairs.

And because biosimilars aren't perfect copies, patients rights groups and biotechs are asserting that patients should not be forced to take them. It is up the discretion of individual physicians, not insurance companies or pharmacies, to substitute a branded biologic for a biosimilar, they said.

Substitution has been slow in the European Union, where patients already have access to these drugs. In the first six months of introducing Omnitrope, a biosimilar growth hormone, in France, about 20 percent of new patients requiring the hormone took the biosimilar under doctors' advice, said Andreas Rummelt, chief executive of Sandoz, the generic division of Swiss drugmaker Novartis.

Last month Insmed, a spinout from the University of Virginia, brought on Bill Thomas, the former chairman of the House Ways and Means Committee, to aid its lobbying as a strategic adviser. Thomas, who played a key role in creating Medicare Part D prescription drug coverage for seniors, was intrigued by the company's progress in duplicating Neupogen.

"You don't have to create hypothetical," Thomas said. "Insmed is real. You want to say yes to these people or no to these people."

Thomas said he is doing what he can to help move legislation by the end of this Congress.

"People are waiting for us to do our job," Thomas said. "If we don't, we'll be buying European or Asian products when we could be buying American products produced by Americans."

Biotech drugs are the money-makers in today's drug market. Global prescription sales of biotech drugs increased 12.5 percent in 2007 -- nearly double the rate of the overall pharmaceutical market, which includes the biotech sector -- to more than $75 billion, according to a June report by IMS Health, a health-care information company.

Neupogen generated $1.3 billion in worldwide sales last year.

Insmed certainly isn't alone. Large European pharmaceutical companies are already selling biosimilars in Europe. There are also smaller U.S. companies, such as Hospira in Lake Forest, Ill., breaking in. But the complexity of these biologics guarantees that few companies have the resources to jump into the market.

Insmed's research and development has increased, totaling $10.8 million for the first half of this year, as it continues to develop biosimilars and innovator drugs at its facility in Boulder, Colo. The company posted a loss of $9.5 million for the quarter ended June 30.

But the potential market is big. Four of the six FDA-approved drugs for multiple sclerosis are biologics. Treatment can cost a patient more than $30,000 a year, prohibiting many from obtaining drugs, said Shawn O'Neail, an associate vice president at the National MS Society.

"The bottom line is that it's a good business model," Allan said.

Monday, August 04, 2008

Firebombings at Homes of 2 California Researchers

Anti-science violence at UCSC...

August 4, 2008
Firebombings at Homes of 2 California Researchers

SANTA CRUZ, Calif. — The police and federal authorities are investigating firebombings at the homes of two researchers at the University of California, Santa Cruz.

The attacks, which the university described as “antiscience violence,” occurred nearly simultaneously before dawn on Saturday, just days after the police in Santa Cruz discovered pamphlets in a coffee shop warning of attacks against “animal abusers everywhere.” The pamphlets included the names, addresses and other personal information of several researchers at the university, according to a news release put out on Friday by the university.

About 5:30 a.m. Saturday, two small bombs ignited outside the researchers’ homes. In one of the attacks, a vehicle was destroyed in a faculty member’s driveway. At the second residence, a two-story home near the university’s front gates, the fire forced the researcher, his wife and two children to flee the home from an upstairs window. The fires were quickly extinguished.

One minor injury was reported, according to The Santa Cruz Sentinel, which also said the police were viewing the attacks as acts of attempted homicide and domestic terrorism. The Santa Cruz Police Department would not comment on their investigation on Sunday.

But the researcher whose house caught fire was identified by The Associated Press as David Feldheim, a molecular biologist, who was listed in the pamphlet. The other researcher was not identified.

The fires provoked an angry response from the university’s chancellor, who said the attacks were being investigated by the Federal Bureau of Investigation and the Bureau of Alcohol, Tobacco, Firearms and Explosives, as well as by the campus police and the state fire marshal’s office.

“These unconscionable acts put the researchers, their families — including their children — and their neighbors in grave danger,” the chancellor, George R. Blumenthal, said in a news release.

The university described the attacks as the latest in a series of threats and provocations from those opposed to “biomedical research using animals,” including a February incident in which several masked intruders entered a researcher’s home. After a confrontation, the intruders fled. That incident followed harassing phone calls and vandalism of researchers’ homes, the university said.

In December, the 10 chancellors at the University of California campuses affirmed in a statement their support of animal research and the university system’s commitment to “the highest standards of animal care, safety and health.”

At one of the bombed properties, the porch was badly scorched and a plastic watering can lay melted next to the charred front door. Two small windows in the door had also melted.

The attacks surprised some in Santa Cruz, a genial beachfront town where laid-back college students and equally relaxed day-trippers make up much of the landscape.

Chris Conway, who lives across the street from one of the homes that was attacked, said investigators had combed the site all day Saturday.

“I don’t know what they did to deserve that,” said Mr. Conway, a 19-year-old student. “I think that’s kind of messed up to do that to someone’s home.”