TUESDAY

11 a.m. to noon
National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park
Rall Bldg. Room D350
Seminar: Inference for marginal linear models for clustered longitudinal data with potentially informative cluster sizes
Speaker: Dr. Somnath Datta, University of Louisville

Noon
TARDC luncheon
RTP headquarters, 12 Davis Drive, RTP
The speakers series starts with Moritz Beckmann, chief executive of XinRay Systems.
XinRay, an RTP startup that spun out of the University of North Carolina at Chapel Hill in 2007, uses carbon nanotubes to develop X-ray machines that are smaller, simpler and able to produce more detailed pictures. The nanotube technology, which was developed in the laboratory of Otto Zhou, professor of materials sciences and physics at UNC-CH, can also be used for security screening at airports and XinRay recently received a $1.13 million contract from the Department of Homeland Security.
($35 for non-members)

WEDNESDAY

5:30 p.m. to 8 p.m.
CED biotech forum
N.C. Biotechnology Center, 15 T.W. Alexander Drive, RTP
Panel discussion on how to advance clinical development when raising funds is difficult.
(Onsite registration rate: $30 for CED members, $50 for non-members)

THURSDAY

8 a.m. to 5 p.m.
2009 North Carolina Management Systems Summit
N.C. State University, McKimmon Center, 1101 Gorman St., Raleigh
Dale Carroll, N.C. deputy secretary of commerce, will kick off the two-day summit on manufacturing best practices, continuous improvement and business retention and growh.
(Cost $395)

10 a.m. to 11 a.m.
NIEHS, 111 T.W. Alexander Drive, RTP
Rall Bldg. Room D450
Seminar: Chromatin and transcription
Speaker: Trevor K. Archer

2 p.m. to 3 p.m.
NIEHS, 111 T.W. Alexander Drive, RTP
Rall Bldg. Room D450
Seminar: The landscape of transcription initiation in D. melanogaster
Speaker: Dr. Uwe Ohler, Duke University

FRIDAY

8 a.m. to 5 p.m.
2009 North Carolina Management Systems Summit
N.C. State University, McKimmon Center, 1101 Gorman St., Raleigh

The FDA giveth and Wall Street taketh away

GlaxoSmithKline’s Cervarix got a boost from Food and Drug Administration staffers who said studies showed the vaccine successfully blocked the human papilloma virus, or HPV, nearly 93 percent of the times. HPV infection increases the risk of cervical cancer.

Cervarix ran into regulatory roadblocks in 2007 and a panel of experts has yet to approve the vaccine for sale in the U.S. Gardasil, a competitor made by Merck that generated about $1.5 billion in sales last year, has been on the market since 2006 and has the added benefit to thwart two kinds of HPV responsible for most genital warts.

GSK, which has its U.S. headquarters in Research Triangle Park, hopes Cervarix will be a big seller like Gardasil to help offset expected sales losses due to generic competition.

GSK’s best selling asthma treatment Advair could come under full pressure from generics by 2011, an analyst warned. Advair, which is filled at GSK’s plant in Zebulon, generated $7.6 billion in sales, more than any other GSK drug.

In other company news:

• The FDA approved Metozolv, a fast dissolving treatment for a diabetic stomach disorder. Salix Pharmaceuticals, a Morrisville company that specializes in gastrointestinal treatments, owns the rights to market Metozolv. If taken for extended periods of time, Metozolv can cause muscle spasms and a movement disorder.
• XinRay Systems, a nanotechnology startup in RTP, received a $1.13 million research contract to develop and test X-Ray equipment using carbon nanotubes for the Department of Homeland Security. The equipment will be designed to detect explosives in baggage and cargo.
• Oxygen Biotherapeutics, a Durham company developing wound care treatments, announced it will ask shareholders for approval to reduce the number of its outstanding shares. The company hopes the reverse stock split will boost its share price, enable a switch to a major stock exchange and make it easier to raise cash.
• Cempra Pharmaceuticals, a Chapel Hill drug development company, said it has begun testing an antibiotic treatment for drug-resistant infections in patients. Cempra recently raised $46 million in venture capital.

NC Biotech Center gets ready for expansion

The N.C. Biotechnology Center has raised the money needed to build a $10.4 million expansion on its RTP campus.

The expansion has been planned for at least a year and private donors provided much of the cash needed to complete construction next year.

Donors included the Duke Energy Foundation and Biogen Idec. The Boston-based drugmaker, which has a production plant in the Triangle, provided $1 million.

Clinical Research Education Day

Free health screenings, food and a raffle promise to draw a crowd Sept. 12 at North Carolina Central University.

There’s a reason for all the goodies. Organizers want people to stay and listen – to speakers like Dr. Robert Califf, who heads Duke University’s Clinical Research Institute; Dr. Wendy Brewster, director of women’s health research at the University of North Carolina at Chapel Hill; and executives from Quintiles Transnational and PPD, two North Carolina companies that help drugmakers test new medicines.

Hosted by the Center for Information and Study of Clinical Research Participation, the public education workshops at NCCU are part of an East Coast campaign aimed at getting more people, particularly more minorities, interested in participating in clinical trials.

More about the Clinical Research Education Day here and a Q&A with Sandy Kennedy, whose job duties at Quintiles Transnational will be a topic at one of the workshops, here.

The series, which is open to members of the Triangle Area Research Directors Council, or TARDC, taps executives from RTP area companies and leading university researchers who are advancing technology in various fields including medicine, drug development and diagnostics.

TARDC luncheon meetings featuring the speakers are held at noon every third Tuesday from September to May at 12 Davis Drive. Memberships are $275 per year.

During the coming program year, TARDC members will also hear from:

• Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest University,
• Rudy Juliano, director of the Carolina Center for Cancer Nanotechnology Excellence and pharmacy professor at the University of North Carolina at Chapel Hill and
• Troy Nagle, founding chairman of the joint department of biomedical engineering at N.C. State University and UNC-CH.

The RTP area is best known for drug development, but clusters of medical device and nanotechnology companies have been emerging.

XinRay, an RTP startup that spun out of the University of North Carolina at Chapel Hill in 2007, uses carbon nanotubes to develop X-ray machines that are smaller, simpler and able to produce more detailed pictures. Existing equipment still uses vaccuum tubes.

The company’s nanotube technology, which was developed in the laboratory of Otto Zhou, professor of materials sciences and physics at UNC-CH, could also be used for security screening ast airports and by engineers checking the structure of materials.

Beckmann, a Siemens executive, oversees XinRay’s efforts to build prototypes and bring them to market. Siemens Medical Solutions, which has operations in Cary, is a partner in XinRay.

For more information about TARDC go here.

Buying a better seed

Bayer CropScience announced it wants to buy Athenix, an RTP neighbor that has developed in its labs genetic traits to allow corn and soybean seeds to grow into plants able to withstand Roundup, a weed killer popular on farms.

Athenix’s 65 employees will become the core of the research and development lab Bayer CropScience plans to establish in Morrisville for as many as 128 staff.

Buying Athenix could give Bayer CropScience a chance to catch up – particularly in the race to win farmers over with new seeds for hardier corn, the largest crop grown in the U.S. and a critical component in food, animal feed and fuel ethanol.

Financial details for the deal, which is projected to close within a month or so, were not disclosed.

Bayer CropScience, which has its U.S. headquarters in RTP, also found technology it liked at Texas Tech University. It bought the rights to the technology to develop cotton seeds that produce plants with better fibers.

Avandia: GSK defends its diabetes drug

GSK’s U.S. operations, which are headquartered in RTP, came to the defense of diabetes drug, Avandia, after findings from a Canadian study suggested that Avandia carries a higher risk of heart failure and death than Actos, a competitor’s drug in the same class.

Bad news and controversy have trailed Avandia since it was linked to an increased risk of heart attack two years ago and U.S. sales of the pill dropped by nearly half to $800 million last year. Some doctors believe Avandia should not be used at all.

The Canadian study looked at nearly 40,000 patients with Type 2 diabetes who took either Avandia or Actos to lower their blood sugar and compared the results to hospital records for heart failure, heart attack and death.

GSK found the study results at odds with findings from other studies and faulted the Canadian researchers for not taking into account different doses of Actos and Avandia that patients received. Other critics pointed out that the patients taking Avandia in the Canadian study were sicker than their counterparts taking Actos.

Both drugs carry Food and Drug Administration warnings about heart failure and heart attack risks. Other possible side effects include weight gain and fluid retention.

Kudos and gatherings

The NC Biotechnology Center held a workshop that attracted more than 30 investors, entrepreneurs and attorneys interested in turning an idea into a company and getting it ready for a tire-kicking by investors. The center also hosted students from Duke University and the University of North Carolina at Chapel Hill who were interested in the industrial fellowship program. In its second year, the program helps scientists make the leap from academia to industry.

And the Triangle came in fourth after Boston, San Francisco and San Jose, Calif., as one of the nation’s leading regions for nanotech research.