Friday, August 17, 2007

Why UVa will spend $20 million on 6 professors

Why UVa will spend $20 million on 6 professors-- This concept was one of the key recommendations that came out of the Governor's Commission on Biotechnology.


Why UVa will spend $20 million on 6 professors
By Brian McNeill
bmcneill@dailyprogress.com | 978-7266
Sunday, August 12, 2007

In five labs at the University of Virginia, Joe C. Campbell’s research team is developing more efficient ways to transfer data over fiber optic networks, advancing night vision technology and building a better bioterrorism detector.
“Here at UVa, I sense that there is a growing emphasis on research in engineering and science,” said Camp-bell, sitting in his office in Thornton Hall. “It’s fun to be a part of something that seems to be growing into something even better.”
Campbell, a professor of electrical and computer engineering, is one of six world-renowned researchers recently hired by UVa as part of a $126 million initiative.
The university’s Board of Visitors launched the “research enhancement initiative” in 2004 to boost UVa’s standings in science and technology research.
Though U.S. News & World Report ranks UVa as the nation’s No. 2 public institution of higher education, UVa’s scientific research rankings are a bit less lustrous. UVa’s School of Engineering and Applied Science graduate program, for example, is ranked 38th.
“To achieve the reputation that UVa wants to achieve, it’s got to move up in the rankings and everyone - except for No. 1 - is trying to do the exact same thing,” Campbell said. “If UVa wants to be a top-rated institution, it’s going to be very expensive.”
UVa has spent $20 million so far to attract Campbell and the five other “superstar” faculty members from research facilities around the world. A committee of UVa scientists selected the superstars - as many UVa administrators refer to new hires - out more than 175 applicants.
More money from the $126 million fund will be allocated to attract mid-level and junior faculty members to fill out the beefed-up research capabilities.
“If we hire the right people, it will create a whole new world at UVa,” said R. Ariel Gomez, vice president for research and graduate studies. “Not too many universities will say that they’re going to put over $100 million toward hiring the very best.”
As part of the initiative, geneticists Christine and Bernard Thisse will join UVa’s faculty this month. Recruited from the Institute of Genetics and Molecular and Cellular Biology in Strasburg, France, the Thisses are among the world’s leading experts in zebrafish genomics.
Because embryos of the tropical fish are large and transparent, researchers such as the Thisses can study zebrafish embryonic development to gain insights into how cells form and mutate.
The Thisses’ research may one day help unravel the mysteries of human birth defects, how cancer cells form and much more.
The Thisses did not come cheap. To lure them from France, UVa spent $4.5 million. On average, hiring a faculty member in science, medicine or engineering carries a one-time cost of $500,000, according to UVa planning documents.
Meanwhile, the university spent another $3.35 million to snag Stephen S. Rich, a genetic epidemiologist leading a worldwide effort to better understand the genetics behind Type 1 diabetes.
There are 20.8 million Americans living with diabetes, and 4,100 new cases are diagnosed each day. Rich’s research may one day reveal who has a genetic predisposition to complications - such as blindness, or the loss of a limb - from diabetes, thereby allowing for preventative medicine. His research may also be applied to finding better treatments for cancer and other ailments.
The superstar faculty members are fetching some of the most lucrative salaries among UVa’s 11,962 employees. Campbell earns $310,600 per year, while Rich earns $300,000. Fewer than 15 faculty members earn $300,000 or more, according to public employment records.
A big draw
The university’s pricey investment in the six researchers will be worth it, top administrators said, because it will draw millions in public and private research grants, could generate profits from new discoveries and will help attract top-tier junior faculty members and graduate students.
“This program brings to the university a number of people who are very well known in their particular fields,” said Dr. Arthur “Tim” Garson, UVa’s provost. “And they are capable of tremendous collaboration across the university. Their talent will be leveraged throughout UVa.”
The six superstars will “seed” UVa’s scientific research efforts, Garson said. Eventually, their areas of expertise - genomics, biomedical engineering, nanotechnology and more - will be filled out at UVa with additional faculty members, graduate students and postdoctoral researchers.
One area of cutting-edge research that is coming into focus at UVa is known as morphogenesis, or the study of how cells form to create organs and tissue.
At UVa’s Morphogenesis and Regenerative Medicine Institute, research spearheaded by faculty members including the Thisses may eventually allow physicians to use a patient’s cells to grow them a new kidney, ligaments or even a limb.
By using a patient’s own cells to regenerate organs or tissue, there is much less chance of rejection than in the case of organ donation.
“This is the future of medicine,” Gomez said.
The project received an additional $1.8 million in UVa’s current budget. Garson said morphogenesis and regenerative medicine is considered the “next step beyond stem-cell research.”
Their space
In addition to UVa’s researcher recruitment effort, additional funds from the initiative will go toward expanding the university’s research space. A $40 million, 85,000-square-foot research facility, under construction at Fontaine Research Park, will house the researchers’ new labs and offices starting in the spring.
Not everyone at UVa is pleased with the mega investment in research. Kevin Simowitz, an organizer of a campaign to implement a “living wage” for UVa workers and a fourth-year American studies student, said the initiative represents skewed priorities.
“If UVa put as much time and effort into making sure that its workers weren’t below the poverty line as they spend hiring faculty members from France, I think we’d all be better off,” he said.
But Del. Tom Rust, R-Herndon, chairman of the House of Delegates subcommittee that oversees the state’s higher education system, said UVa’s efforts reflect a statewide push to increase the amount of valuable scientific discoveries in college labs across Virginia.
“It is in keeping with the direction we want the higher education institutions in Virginia to go,” he said. “We’re looking to become more of a leader than we are now in research.”

THE RESEARCHERS

Joe C. Campbell
Department of Computer and Electrical Engineering
Innovator in fiber optics, researching night vision technology and bioterrorism detection
Hired January 2006

Stephen S. Rich
Director of UVa’s Center for Public Health Genomics
A genetic epidemiologist, he is leading a worldwide effort to understand the genetics of Type 1 diabetes
Hired January 2007

John T. Yates Jr.
Department of Chemistry
A top investigator in the fields of surface chemistry and physics, he researches photochemistry as well as astrochemistry in the solar system and deep space
Hired January 2007

Dr. Mark Yeager
Chairman of the Department of Molecular Physiology and Biological Physics
A practicing cardiologist, he also conducts research that may provide new strategies for treating heart failure
Hired July 2007

Christine and Bernard Thisse
Department of Cell Biology
Experts in zebrafish genetics, a field that may unlock the secrets of human birth defects, cancer and more
Hired August 2007

Wednesday, August 15, 2007

NPR on Generic Biologics

Interesting story done by NPR on the generic biologics issue.


http://www.npr.org/templates/story/story.php?storyId=12638437

Health & Science
Are Generic Biotech Drugs Coming Soon?

Listen to this story... by Joanne Silberner

Correction: At the time this story aired neither the House nor Senate had voted on legislation. There have been two hearings in subcommittees of the House of Representatives, and a Senate committee has approved legislation.

All Things Considered, August 9, 2007 · While Congress is away this month, House and Senate staffers are working on a bill aimed at helping patients who rely on innovative biotech drugs that can cost as much as several thousand dollars per month.

Generic versions of the drugs would surely be cheaper, but opponents of generic versions say that making sure the knockoffs are safe and effective may be trickier than it sounds.

Donna Gosbee, 51, came from Wyoming to Washington, D.C., to attend a meeting of the Multiple Sclerosis Society. She is using a walker.

"I never know from one day to the next until I put my feet down on the floor whether I'm going to be able to walk," Gosbee says.

Gosbee was diagnosed with multiple sclerosis four years ago.

"The doctors put me on one of the biologics, Betaseron," she says. "I've been on it for three years now and this drug costs $1,500 a month."

The government helps Gosbee with some of the cost, but she's worried the help won't always be there. So she came to Washington to lobby Congress.

Lobbying for Change

"I'm going to talk to Wyoming legislators to try to convince them that medications are just out of reach of the normal person," Gosbee says.

A generic could significantly cut her medical bill. At www.drugstore.com, for example, the generic version of the statin drug, Mevacor, is only one-third of Mevacor's price.

But Gosbee's drug is manufactured very differently — by living, bioengineered cells.

They make molecules that are much bigger than most conventional drugs, and a lot more complex, says Roger Williams, CEO of U.S. Pharmacopeia, a nonprofit organization that sets standards for drug manufacturers.

"If I showed you on a page the molecular structure of a biologic, it might cover two pages just of carbons and nitrogens and hydrogens and oxygens," Williams says.

In contrast, he says the structure of many conventional drugs fill less than half a page.

Williams says making conventional drugs is like snapping together Tinker Toys. You add one chemical after another, and the manufacturer is very much in control.

Making a biotech drug is more like farming. You start with a living cell, then keep the temperature, the nutrients and other growing conditions just right. Just as wheat grown from a different seed stock or under different conditions will produce slightly different grain, different versions of biotech drugs can vary — even when made by the same company.

The Process of Biotech

In Gaithersburg, Md., a company called MedImmune makes the biotech drug Synagis. The drug fights a virus called RSV that can kill premature babies.

Just getting into MedImmune takes work — you have to put on gloves, booties and a double set of what look like surgical scrubs.

You must also go through multiple airlocks. Sterility is important for conventional drugs, too, but it's especially important here. If bacteria or viruses get into the cell cultures, they could disrupt the manufacturing process and wind up in the final drug.

Workers take large beakers of living cells in culture from a refrigerator. The cells go into gleaming metal vats the size of small cars.

"This is the start of our bioreactor train," explains Tony Luttrell, MedImmune's vice president.

There are enough pressure monitors and temperature gauges and pipes to make a science-fiction movie proud.

Conventional manufacturers use temperature gauges too, as well as vats filled with buckets of chemicals.

But these biotech vats hold mouse cells, each one loaded up with human DNA. The human DNA is directing the cells to produce a particular protein — an antibody that can fight RSV.

If you want to make a copy of MedImmune's drug, you would have to insert some human DNA into mouse cells in a precise way — a way that will produce that protein. It's a real challenge.

"One little genetic change, one little change in the way the protein is configured or the way the proteins fold onto each other may have an effect on how it actually acts in the clinic," Luttrell says.

Then you have to be really careful about how you grow the cells, Williams says. For example, temperature can make a big difference. Look at albumen — the protein in egg whites.

"If you take egg white and cook it, that's OK to eat, but it's no good to the chicken anymore," Williams says.

Generic Outlook

Williams thinks some biotech drugs could be made generically. But the only way to know for sure that a different version would be just as safe and effective is to perform lengthy and expensive testing in animals or people — something that's not required for conventional generics.

There have been two hearings in subcommittees of the House of Represenatives, and a Senate committee has approved legislation. Staffers are now working to develop legislation that can win approval.

But don't hold your breath — companies that make brand name drugs are still adamant that testing in people should be required.

Patients and generic companies waiting for less expensive drugs aren't happy either. Both bills would make generic companies wait 12 years before they could market a cheaper drug, not much different from conventional generics, but a long time when you're spending several thousand dollars a month to fill a prescription.

Monday, August 06, 2007

Zakour Named Head of MdBio

Tech Council of Maryland/MdBio Appoints Richard Zakour Executive Director of MdBio and MdBio Foundation

ROCKVILLE, Md.--(BUSINESS WIRE)--The Tech Council of Maryland/MdBio (TCM/MdBio) announced today that it has appointed Richard A. (Ric) Zakour, Ph.D. to lead MdBio and the MdBio Foundation as executive director. Zakour is a 23-year veteran of the biotechnology/pharmaceutical industry and is tasked with the daily management, membership recruitment, event promotion, education and other programs for the MdBio division of TCM/MdBio and the MdBio Foundation.

“The search committee conducted a thorough exploration to identify well-qualified candidates, and I truly believe we found the best person for the job,” said Jim Leslie, chairman of the MdBio Foundation. “Ric has a stellar reputation and is highly capable of taking the charitable mission and programs of the MdBio Foundation to a new level.”

Before joining TCM/MdBio, Zakour was the general manager for Fisher BioSciences, where he was responsible for a 300-employee unit that included both government and commercial business divisions providing pharmaceutical and biological support services. Prior to his time at Fisher, Zakour held various senior management positions with McKesson Clinical Services, DynCorp and Cambridge Biotech Corporation. Zakour’s research and studies have been published in numerous national publications. He is active in the local community and holds a Ph.D. in biology from Rice University.

No stranger to TCM/MdBio, Zakour served on TCM’s board of directors from 2003 until earlier this year as well as on the MdBio Foundation board. He has participated in the organization’s volunteer program and awards committees, chairing both groups.

“Ric’s dedication to TCM/MdBio has been unwavering. He’s a proven industry leader and well known in the community and within our organization. As a long-time volunteer and executive, he fully understands TCM/MdBio’s strategic objectives and goals,” said Steve Trevisan, chairman of the MdBio board.

The MdBio division of TCM/MdBio produces educational programs, collaborative member roundtables and benefits specifically for TCM/MdBio members that specialize in life sciences. The MdBio Foundation is a private, non-profit organization dedicated to advancing the growth of bioscience in Maryland through a variety of programs, with a special emphasis on education, training and communications. Zakour’s position complements the recent promotion of Rick Harris to executive director of the Tech Alliance.

“TCM/MdBio has grown into the preeminent technology association in Maryland. We have assembled a first-class senior management staff to lead us as we continue to expand. Ric is a wonderful addition to our talented team,” said Julie Coons, CEO of TCM/MdBio.

Thursday, August 02, 2007

PRA International Goes Private Again

PRA International Enters Into Merger Agreement With Genstar Capital

RESTON, Va., July 25 /PRNewswire-FirstCall/ -- PRA International , a leading global clinical research organization, today announced that it has entered into a definitive merger agreement to be acquired by affiliates of Genstar Capital, LLC ("Genstar"), a private equity firm and a beneficial owner of 12.8% of the outstanding PRA shares. The transaction is valued at approximately $790 million.

Under the terms of the agreement, PRA stockholders will be entitled to receive $30.50 in cash for each share of PRA common stock, representing a premium of approximately 13% to PRA's closing share price on July 24, 2007, and a premium of approximately 24% to PRA's average closing share price for the three months ended July 24, 2007.

The members of the Board of Directors of PRA, with the exception of management and those affiliated with Genstar, following the unanimous recommendation of a Special Committee composed entirely of independent directors, has approved the agreement and recommends that PRA stockholders approve the merger.

Armin M. Kessler, Chairman of the Special Committee, added: "After extensive negotiations and careful and thorough analysis, together with our independent advisors, the Special Committee and our Board endorsed this transaction as being in the best interest of the Company and our stockholders. We are pleased that this transaction appropriately recognizes the value of PRA as one of the world's leading global CROs while providing our stockholders with an immediate cash premium for their investment in PRA. In Genstar, we are pleased to have an experienced group of investors committed to maintaining our company's client-focused culture, building upon our core therapeutic expertise, and expanding our product offering across all business segments."

"We believe PRA has a strong business model and intend to invest in the strategic initiatives necessary to allow the company to capitalize on the favorable dynamics of the CRO industry. By making the right investments and empowering employees to succeed, we fully expect to accelerate PRA's current growth trajectory," said Jean-Pierre Conte, Chairman and Managing Director of Genstar Capital.

Under the agreement, PRA may solicit proposals for alternative transactions from third parties for a 50-day period ending on September 12, 2007. To the extent that a superior proposal solicited during this period leads to the execution of a definitive agreement, PRA would be obligated to pay approximately a $7.9 million break-up fee to Genstar. In accordance with the agreement, the Board of Directors, through its Special Committee and with the assistance of its independent advisors, intends to actively solicit superior proposals during this period. There can be no assurances that this solicitation will result in an alternative transaction. PRA does not intend to disclose publicly developments with respect to this solicitation process unless and until its Board of Directors has made a decision regarding any alternative proposals.

Pending the receipt of stockholder approval and expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as well as satisfaction of other customary closing conditions, the transaction is expected to be completed in the fourth quarter of 2007. There is no financing condition to the obligations of Genstar to consummate the transaction.

Credit Suisse Securities (USA) LLC is acting as financial advisor to the Special Committee. Dewey Ballantine LLP is acting as legal advisor to the Special Committee.

UBS Investment Bank is acting as financial advisor, and Latham & Watkins LLP is acting as legal advisor, to Genstar.

PRA will hold a conference call today, Wednesday, July 25, 2007 at 9:00 a.m. EDT to discuss this announcement, as well as second-quarter results. The call will be available via live webcast at www.prainternational.com. Please go to the website at least 15 minutes early to register, download and install any necessary audio software. The call may also be accessed by dialing 800-322- 2803 or 617-614-4925. A replay of the call will remain available at the site for 30 days.

Additional Information and Where to Find It

In connection with the proposed merger, a proxy statement and other materials will be filed with the SEC. PRA INVESTORS ARE URGED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER. Investors will be able to obtain, without charge, a copy of the proxy statement (when available) and other relevant documents filed with the SEC from the SEC's website at http://www.sec.gov. Investors will also be able to obtain, without charge, a copy of the proxy statement and other relevant documents (when available) by directing a request by mail or telephone to PRA International, 12120 Sunset Hills Road, Suite 600, Reston, VA 20190, telephone: (703) 464-6300, or from the Company's website at http://www.prainternational.com.

Participants in the Solicitation

The Company, its directors, executive officers and certain other members of management and employees may be deemed to be participants in the solicitation of proxies from the Company's stockholders with respect to the proposed merger. Additional information regarding the interests of potential participants in the proxy solicitation will be set forth in the proxy statement and other relevant documents regarding the merger when they are filed with the SEC.

About PRA International

PRA International is one of the world's leading global clinical development organizations, with over 2,700 employees working from offices in North America, Europe, South America, Africa, Australia, and Asia. PRA delivers services to its clients through a unique approach called Project Assurance(R), which represents the Company's commitment to reliable service delivery, program-level therapeutic expertise, easy global access to knowledge and involved senior management.

To learn more about PRA International, please visit http://www.prainternational.com or call our World Headquarters at +1 (703) 464-6300.

About Genstar Capital LLC

Based in San Francisco, Genstar Capital (www.gencap.com) is a private equity investment firm that makes leveraged investments in quality middle- market companies. Genstar Capital works in partnership with management to transform its portfolio companies into industry-leading businesses. With more than $3 billion of committed capital under management and significant experience investing in businesses, Genstar focuses on selected segments of life science and healthcare services, industrial technology, business services and software services.