Dan Vorhaus

Dan Vorhaus is a lawyer with Robinson Bradshaw and Hinson in Charlotte, N.C. where a portion of his practice comprises the growing field of personal genomics law. Given the interest in personal genomics in the Triangle, I thought I’d create an expanded version of the short question-and-answer interview I did with him for an up-coming issue of the Sci-Tech section in the Charlotte Observer and the Raleigh News and Observer (be on the lookout for that next Monday in print and online), and post it here. Vorhaus also authors the Genomics Law Report, a blog about the legal side of personal genomics, and he will be giving testimony to the Food and Drug Administration in the near future as the agency attempts to sort out particulars of how it plans to regulate genomic diagnostic testing.

How did you become interested in concentrating on personal genomics as an area of the law?
I have a master’s in bioethics; I did that degree before I went to law school. So as I started thinking about the areas of law and policy that were most interesting to me, that was clearly one of them. And it seemed like there was a tremendous opportunity for a field that is developing and emerging and creating all sorts of new and exciting legal issues. And it’s something that I’ve always had an interest in the underlying science and technology, and I was fortunate enough in law school to start working with some real pioneers in the field, specifically George Church in the personal genome field. Everything sort of built from there. Now, it’s how I make my living, it’s my career. And I love it. It’s something new and fascinating every single day and I can’t get enough of it.

It sounds like the bioethics degree had a big influence on you.
It did, although I already had this interest before, that was what caused me to pursue the bioethics degree. And I knew I was going to law school. I kind of applied those two things simultaneously. So, they have kind of worked together simultaneously. And I decided kind of early on that I was more interested in pursuing the law than some of the pure policy or philosophy or ethical issues behind a lot of these technologies. I think there is a real need… One thing you find with the law is that new areas tend to lag in new areas of technology and new areas of social development. And that is certainly true in the areas of personal genomics, personalized medicine, there is a long way for the law to go to catch up to where science and technology already are. And they continue to press on ahead. And the law continues to play catch up. So it seems that there is a real opportunity to be involved in helping to lay the legal framework for what I think will be important and meaningful technologies and services in people lives for years and decades to come.

That formalizes what I had suspected, with some of the things I’ve read about the Myriad ruling and the FDA announcing its intent to regulate direct-to-consumer genomic testing, it does seem that these formal regulations and policies are lagging behind the business practices.
That’s right. Both the examples you gave, the Myriad litigation — and really, the state of biotechnology patents more broadly – and the FDA and Congress’s involvement in genetic testing, especially consumer genetic testing, both of those are areas where there is a lot of uncertainty right now whether the law today is doing as good a job as it could be as far as protecting individuals and enabling commerce, and really striking the right balance between allowing the science and the technology to press forward while making sure that we have the right protections in place for people using these technologies. That is always going to be a tension in this area, I don’t ever foresee that dissipating; but that does not mean that we should work any less hard to get that balance as close as we can as quickly as we can.

You’ve posted about the Myriad gene patent litigation, in which a federal judge invalidated patents that Myriad held for human genes, BRCA-1 and BRCA-2, which are used to test for the likelihood of developing breast cancer. What was the most unusual thing about this ruling, because it seems to have caused quite a splash?
You’re right, it does cause a splash, but I would say the splash that it caused is probably greater than its legal significance, at least for right now. It’s important to keep in mind that this was a district court ruling, so without getting to much into the weeds, there is a long way to go with this litigation before it gets to the point where it will really impact the commercial landscape, before it really impacts what people feel comfortable doing in laboratories – whether it is research laboratories or commercial laboratories – it needs to .. It’s already been appealed to the federal circuit, which is the federal appeals court that hears patent cases. And it’s quite possible that from there it will go to the Supreme Court, and we’re talking at least another year. Perhaps two. Maybe even three more years before we get a final resolution in this case. The reason I think it garnered so much attention is because it really struck a nerve – and going back to this idea of law not always keeping up with where science is – it really struck a nerve when people heard that there were companies out there that held patents on human genes. And we are talking about isolated human genes, genes outside the body, no one owns you, but it is the case that some companies have patents on genes, and they have the ability if they want – and Myriad has done this because of the way patents work – they grant the patent holders monopoly rights, they have the ability to keep other people from doing tests to analyze those genes, to sequence those genes, to ask what does this mean, in the case of BRCA, for the susceptibility of a woman’s or a man’s, risk of getting breast cancer. And I think that struck a nerve with a lot of people.

It’s not the only sort of development with this area… [Other reports] have gone to the Secretary of Health and Human Services that looked at these issues and looked at the gene patent landscape and said this is a problem, this is impeding our ability to do the type of diagnostic or clinical work that we need to do, to advance the state of science and technology. There is another supreme court case that will likely come out on Monday, that also may be significant as far as the extent of biotech patents, in terms of how far they can reach. And it all goes back to this question of trying to strike the right balance. In the case of patents, we’re trying to strike the right balance of information disclosure and getting these technologies out there and allowing people to benefit from them, and preserving the commercial incentive to investments. That is how our legal system works, we build up this body of law over years and decades – in this case, patenting of human genes which reaches back to a 1980s Supreme Court case, probably even further, and it built up incrementally. And science does not work that way, it moves much faster. It was only 10 years ago that we published the first draft of the human genome sequence, and now, 10 years later, we are routinely sequencing whole genomes, let alone individual genes. And so, again, it’s that pace of technological innovation and scientific advancement that is much faster than we have the ability to move in the legal realm. So that causes a conflict in cases like Myriad where now everyone has to sit down and ask, do we have the right balance here? Should genes be patentable? Is this where we want to be? I think there is plenty of debate about that. It may be something that litigation solves, or maybe Congress steps in, or maybe there are people out there working on industry private solutions to work things out without having to wait on the courts to solve it.

One thing that confused me about this, is the idea of patenting human genes. In the case of Myriad, one of the things I was wondering was why do they have to patent a human gene? Why can’t they just patent their test? That seems like a more level playing field.
You’re right, that would be a more level playing field, and I think the simple answer is that if you are going to invest a lot of money into developing a test and researching an association between a gene a certain disease, and then figuring out the corresponding test, you may not want a level playing field. You may want to do all the testing, and that is what Myriad does. I should mention, there are other companies out there that have patents on human genes, and they have a patent that allows them to have exclusive rights to practice that patent. So, to conduct a test, or even to examine the gene, if the patent is one the gene itself; but they license out that patent or set of patents. Myriad, for example, I think has several dozen patents with almost two hundred claims, so we’re not talking about one or two patents, they have a whole suite of patents, that protects this business they’ve built around diagnostic testing for breast cancer, but there are other companies out there that have similar patents that do license them out to other people, and they say, here you can use this technology, you can use this gene that we’ve patented, there is going to be some sort of commercial terms with that, you’ll pay us some sort of royalty, or some kind of fee based on tests that you do, but you can get in the game too and essentially provide the same sort of service that we are providing.

Or, Myriad is a good example. They did not actually patent this themselves, they licensed this from the University of Utah. And so it is interesting because one of the reasons why Myriad was swept up in this litigation is because there are thousands of genes that are patented, Myriad only has patents on a handful, but the reason they became a target in this litigation is partly due t otheir practice of not licensing out their IP, their intellectual property, and not giving people a chance to conduct or to develop competing gene tests. But that is the prerogative of a patent-holder. You have the right to exclude everybody else from practicing your patented invention. You can wave that right, in the form of a license, out to other people, if you want, but you don’t have to. So that is why there is this big question over what should be patentable. The technical discussion centers around section 101 of the Patent Act which defines what is patentable subject matter. And the question is, are genes patentable subject matter, or are they what is considered to be a product of nature?

Is it that things in the natural world can’t be patented?
Well, it doesn’t specifically say that in the Patent Act, but that is the way it has developed in the case law over time. The 1980 case that I referred to earlier … said that what is patentable is anything under the sun made by man. And there is this products of nature doctrine, and it says, well the Supreme Court says, that something that is a product of nature can’t be patented. And then the question is, what is a product of nature? And Myriad argues, in this case, that this is not a product of nature because you are taking genes, which occur naturally in the body, and you are separating them out, you are isolating them, you are doing things to them technically that make them no longer products of nature. And in the technical sense, that is correct because genes do not naturally occur in laboratories. But what Judge Sweet ruled is that what is fundamentally important in these genes, what really makes them significant, is the information that they carry. And that is the same whether you are talking about a BRCA gene in your body, in my body, or in Myriad’s laboratory. The information content is the same, and that is what is significant, so they are products of nature and they can not be patented. Whether that ruling stands up, remains to be seen. There is quite a good chance that it won’t.

That’s an interesting interpretation.
And it’s one that people share. I think it resonates quite strongly with people at a gut level. But again, there are limits to how that can be implemented by law in courts. Congress of course has the ability to change the law. As has happened in many, many cases, if Congress does not like a law they have the ability to go out and change the law.

The Food and Drug Administration is constricting regulations for direct-to-consumer genetic testing services offered by companies that scan a person’s genome and offer analysis for health risks or ancestry. What are the FDA’s specific concerns?
It’s interesting… since the whole Walgreens-Pathways thing blew up about five or six weeks ago now, they went after five or six companies. They’ve taken a step back and said, you know, we think we need to regulate all genetic testing. It’s important to remember that most genetic testing is not what is known as DTC [direct to consumer] or commercial or consumer genetic testing. Most of it occurs in a clinical context, done in clinical laboratories, and that is the vast majority of genetic testing on the market right now. Now, the concerns they raise about taking a risk-based approach to regulation, and specifically they are concerned about the safety and efficacy of these tests. So, making sure that the tests are accurate, making sure that – accurate in the sense that when you test for X, you actually get X – that’s what’s called analytical validity.

And then also what is known as clinical validity, which is making sure that the association or the link reported by the tests so that if you do have X, that means you have an increased risk of getting breast cancer, is actually a valid one. And in an area of science that is so new and so changing, that is something that can be difficult to show. Or it may be controversial. So there is a lot of recorded genetic associations that require confirmation, maybe they need more traditional studies to confirm the results, and some studies that have disproved associations, so that is a concern too.

Then there is a third problem which is what is known as clinical utility which is that even if you measure the association correctly and it does mean what you say it does, so you have X, you’ve actually measured X accurately and it does mean that you have an increased risk of disease Y, then clinical utility asks, Can I do anything with this? Can I take this to my doctor and can he start me on a new medication, or tell me that if I lose 15 pounds, then I can prevent myself from developing condition Y. That’s the clinical utility prong, and there is a lot of disagreement there about whether that is something the FDA should really be concerned with, or if that is something that should be left up to individuals. And there are varying definitions as to what constituted clinical utility. Alzheimers is a good example. There aren’t many drugs on the market right now that can be used to reverse the effects of Alzheimers, or be used as a preventative measure for preventing Alzhiemers.

But there are a lot of lifestyle changes that have some evidence that they might help. And there are lot of people that argue that for me, clinical utility means just knowing. If I want to know, then I should be able to know because then I can engage in family planning. I might decide to take an earlier retirement. I might do other things differently. There is going to be a big public meeting July 19 and 20 in DC where I will be at the FDA to talk about some of these issue and give them feedback as they start writing regulations. And of course, in addition to the FDA, the House of Representatives, Congressman Waxman’s committee, have gotten involved with writing letters and they appear to be gearing up to hold hearings and maybe do something in this area. I heard recently that Senator Hatch has a bill out that would address genetic tests and specifically create a new division within the FDA to address those. There is another bill on the House side, I think,… that would also wade into this area. So there are a number of different pathways on the table right now for how the regulation of genetic tests may develop. It’s a bit of a scramble right now.

Even though you said that direct-to consumer genomic tests are a small slice of the genomic testing pie, what legal concerns do consumers need to be aware of when using personal genomic testing?
Well, it is a small… let me back up by saying that consumer genetic testing is a small slice of the overall genetic testing pie, but diagnostics — and that includes an increasingly large percentage of what we think about when we talk about personalized health care – and there are some people that believe that within the not-to-distant future, it’s going to be diagnostics riving therapeutics, so drugs and pharmaceuticals, and not the other way around. Right now, you’ve got these big diagnostic companies, and you’ve got big pharmaceutical companies, but that may flip. We are really looking at, I think, a shift coming down the road. There are some questions associated with consumer tests. A lot of the issues are similar to just the issues associated with learning about genetic information in any context. You want to know that you understand… what information you will find out, if it will be useful to you.

There have always been concerns about somebody else getting ahold of that information and somebody else using that against you. That’s one reason we passed the information non-discrimination act in 2008, to prevent employers and health insurers from using that information. But, that doesn’t mean that other people can not potentially get access to that information and use it against you. That could be your friends, or your co-workers or your family workers.

One thing you hear happening is non-paternity as a result of genetic testing, so you go get tested and your father gets tested and you find out, wait a second, our DNA doesn’t match. I think it’s something like a 10 percent non-paternity rate in this country, which is pretty high compared to what the known rate of non-paternity is. So there is a lot of those cases out there that I think are probably unknown to the family. So you can find out information that might be upsetting to you, or that might be surprising to you. You can also find out information that might be very useful, or interesting to you. That is a balance that everybody needs to sort of strike for themselves and think carefully about. So there are privacy concerns, discrimination concerns. The accuracy of the information… you have to be prepared that it’s not always accurate. There is clinical genetic testing and consumer genetic testing.

Have you tested your genome?
I have. I’ve had myself genotyped by 23AndMe, which is one of the companies that is in the middle of all this. Probably one of the most prominent companies. I paid for it myself. I did not want a conflict of interest because they have gien away a number of reduced cost or low-cost kits and I did not want to have any conflict there. And I think that is all I’ll say about that, because I’m going to be talking publicly about that in the not-too-distant future.

U.S. Rep. Dick Gephardt

He carried a to-do list with him that he plans to take to Congress and the Obama Administration.

Changing the way the Food and Drug Administration regulates the development of new medicines,  making the research and development tax credit for companies permanent and establishing a federal office to spearhead public-private partnerships between universities, the National Institutes of Health and R&D companies were among the suggestions on the list.

“It needs to be the new space program in my view,” Gephardt told about 100 people at the packed Capital City Club in Raleigh. 

Gov. Beverly Perdue, mayors and economic development officials from across the state attended the event, which was meant as a first step to build grassroots support for Gephardt’s to-do list.

At stake is the global leadership position the U.S. built in the past 30 years in discovering new medical treatments, improving quality of life and advancing health care, according to a report the Battelle Technology Partnership Practice released June 10. The Council for American Medical Innovation, or CAMI, an advocacy group Gephardt chairs, commissioned the report.

Experts, investors and bright minds from industry, universities and foundations whose brains the Battelle researchers picked, pinpointed several risk factors that the U.S. is in danger of losing its medical innovation edge.

Among those factors is the declining number of novel medicines that have come to market in the past decade. Between 2005 and 2008, the FDA approved on average 19 per year compared to an average 31 per year during the 1990s. A nearly 29 percent decline in venture capital that set emerging biomedical companies back during the recession was also troublesome. So were the science scores among 12th graders, which declined almost 3 percent from 1996 to 2005.

Health care and research to find new treatments have long been among Gephardt’s interests. What caught his attention was a novel triple cancer therapy that saved his son’s life nearly 40 years ago, he said. Gephardt supported a form of universal health care and helped double the NIH’s budget to support basic research to about $30 billion in 2003.

The unprecedented increase in NIH funding several years ago and a $10 billion boost the NIH received in stimulus funds last year benefited research institutions across the Triangle, including Duke University, RTI International and the University of North Carolina.

But Gephardt’s agenda to spur medical innovation and create more R&D jobs in the U.S. will face a Congress and a White House trying to gain control over a ballooning federal deficit. Gephardt didn’t think the NIH’s budget will be cut, but he acknowledged the belt-tightening mood in Washington by saying that his to-do list isn’t a “big ticket item. Yes,” he added, “this costs money, but the payoff is enormous.”

The visitors made it clear they and other investors remain skittish, but they also noted signs of hope, such as the handful of initial public offerings by biotech companies in past months and an adjustment in venture funding last year in favor of early-stage companies.

Stephen Sands

“When we look at a year ago, we’re really all taking a breath of relief that the Dow [Jones stock index] is over 10,000,” said Stephen Sands, vice chairman of U.S. investment banking in Lazard’s healthcare group, who moderated a panel addressing the future of biotech funding at the conference.

But Sands and panel members, which included Cecilia Gonzalo, managing director at Warburg Pincus, a firm that has invested more than $35 billion in the past 40 years; Ed Mathers, a partner at the venture capital firm New Enterprise Associates; and Lauren Silverman, managing director of an investment fund Swiss drugmaker Novartis established in 2007; provided few clues about new ways of financing innovation and job creation to help the U.S. compete with lower-cost countries such as China and India.

Mathers suggested companies take more advantage of government grants, which are becoming more plentiful, especially for the development of “green” technology. But don’t become a government contractor, Silverman warned.

So what’s an entrepreneurial researchers to do whose innovation doesn’t catch the eye of a traditional investor?

Dr. Allen Roses

Dr. Allen Roses, a Duke University professor and former executive at GlaxoSmithKline’s U.S. Headquarters in RTP who spent years researching genetic risks of developing Alzheimer’s disease, offered one solution at the conference: “You can go it alone,” he said.

That’s what Roses did to develop a novel approach that promises to delay the onset of Alzheimer’s. The approach combines a test to detect a genetic marker linked to an increased risk for Alzheimer’s and a medicine that addresses the gene-based risk factor. Such a combination of test and therapy is generally known as personalized medicine, a new area of drug development.

Roses said he used his house to borrow money from the bank and established three companies to generate revenue and pursue regulatory approval of the test-and-therapy combo over the next five years. One company offers consulting services to large drugmakers also looking into personalized medicine. A second company develops diagnostics, including the test for the Alzheimer’s marker. The third company is focused on getting the rights to a diabetes drug that, Roses believes, addresses the gene-based risk factor that about one-fourth of the U.S. population carry for developing Alzheimer’s.

The test, which will be used in a clinical study the Food and Drug Administration approved of in October, looks for a protein that transports cholesterol in the bloodstream. A gene provides the instructions to make the protein, known as apolipoprotein E4, or APOE4. Research involving the APOE gene has shown that Type 2 diabetes may be linked to dementia, but it is unclear how.

GSK studied rosiglitazone, also known as its diabetes drug Avandia, as an Alzheimer’s therapy, but the clinical trial results were disappointing.

Roses declined to provide details about the diabetes drug he’s interested in for his test-and-therapy combo.

“It’s a new way of looking at a complex disease,” he said.

Monday

Tuesday

Wednesday

Thursday

Friday

Nanofibers make a better lightbulb

Scientists at RTI International build a lightbulb that is five times more efficient by using a blue light emitting diode, or LED, and nanofibers.

The RTI lightbulb uses a material that is made from fibers much smaller than human hair. The fibers are then coated with photoluminescent material and mounted on a housing that contains a blue LED. But the light that the fibers reflect is white and more pleasing than other energy-efficient lightbulbs.

“Because lighting consumes almost one-fourth of all electricity generated in the United States, our technology could have a significant impact in reducing energy consumption and carbon dioxide emissions,” said Lynn Davis, director of RTI’s Nanoscale Materials Program, in a prepared statement. “The technology also does not contain mercury, which makes it more environmentally friendly.”

Funding for the project came from the U.S. Department of Energy. Watch an RTI video how the lightbulb is made here.

Bayer CropScience loses second case in GM rice dispute

A St. Louis jury sided with three farmers in Arkansas and Mississippi, who claimed Bayer CropScience was responsible for contaminating U.S. rice crops with a genetically modified strain it was testing. The jury ordered the German company, which has its U.S. headquarters in Research Triangle Park, to pay $1.5 million.

Four years ago, Japan and Europe restricted imports of U.S. rice after the GM strain was found in the U.S. food supply. Prices dropped and U.S. rice farmers suffered extensive losses. Thousands have filed claims against Bayer CropScience.

This is the second case the company has lost. Two Missouri farmers were awarded $2 million in December.

Forum aims to stoke creativity

The unemployment rate isn’t budging. In December, it was 11.2 percent statewide and 9 percent in the Research Triangle area. But speakers during the two-day Emerging Issues Forum in Raleigh had a few suggestions to help us get out of our funk.

The forum, which is a brainchild of former Gov. Jim Hunt, was all about creativity this year – from the role the arts play in economic development to ways that promote out-of-the-box thinking.

One interesting suggestion that came up during the forum that could have particular application in research and product development: Bonuses, organizational charts and patents stifle creativity. More on that here.

Measuring twice the size of a Super Wal-Mart store, the plant (photo below) will be the first in the U.S. to use millions of factory-grown cells rather than millions of fertilized chicken eggs to make seasonal and pandemic flu vaccine. With a production capacity of up to 150 million doses per year and room for expansions on the 167-acre site, the Novartis vaccine manufacturing plant in Holly Springs will also be one of the largest.

Company officials expect that the first dose made in Holly Springs will be sold in 2011 – a milestone in U.S. flu vaccine manufacturing, which has relied on fertilized chicken eggs since the end of World War II.

On Tuesday, Novartis offered a rare look inside the facility. Gov. Beverly Perdue, Congressman David Price and Kathleen Sebelius, U.S. secretary of health and human services, toured the facility. Daniel Vasella, chief executive of Novartis, and Dr. Andrin Oswald, head of Novartis’ vaccines and diagnostics division, were on hand to host the guests.

“It’s the beginning of modern cell-based flu manufacturing,” Oswald (photo at right) said during a media briefing. “This facility is a promise for the next 20 to 40 years.”

Cells cultured in the laboratory and grown in a series of ever larger tanks have been used to make biotech medicines for more than a decade. The Triangle, the center of the North Carolina biotech hub, got its first commercial biotech manufacturing facility in 1997, when Boston drugmaker Biogen Idec opened its cell-based production plant in RTP.

Cell cultures are also used to make some vaccines, including those protecting against polio, hepatitis B and types of the human papilloma virus that can cause cervical cancer. But the handful of companies that make flu vaccines have long been reluctant to switch from chicken eggs to cell cultures.

Flu vaccines aren’t profitable enough to justify the large investment necessary to build cell-based production facilities, said Novartis CEO Vasella. (Photo at right)

The Holly Springs plant required more than $1 billion in investments – about $600 million from Novartis and $487 million from the U.S. Department of Health and Human Services.

Without the public-private partnership, Vasella said, “a $1 billion investment would be a real stretch” for Novartis.

Announced about 10 months ago, the partnership followed four years after Swiss-based Novartis bought Chiron, the second largest supplier of U.S. flu vaccine, for about $5 billion.

Like other large pharmaceutical companies, Novartis wanted to beef up its vaccine business. But the company also saw the Chiron deal as an opportunity to pursue cell-based production technologies, Vasella said.

In 2004, quality problems with Chiron’s egg-based production method caused a shortage of seasonal flu vaccine supplies in the U.S. The same year, the first avian flu virus to infect people emerged in Asia. The virus, also known as H5N1, killed half of the about 250 people it infected over the next two years before its advance stopped in Europe.

The 2004 shortage of U.S. seasonal flu vaccine supplies and the threat of a deadly avian flu epidemic alarmed federal public health officials and led to the partnership that made construction of the Holly Springs facility possible, Vasella said.

Novartis officials said they hope the H1N1 virus (photo at left), which arrived in the U.S. in April and has killed nearly 4,000 nationwide, will help them with an immune response booster, or adjuvant, they want to make at the plant.

The adjuvant not only reduces the amount of H1N1 pandemic vaccine needed per shot by 75 percent, clinical tests have shown it also gives better protection for young children and the elderly.

Like the cell-based pandemic flu vaccine, Novartis’ adjuvant still requires regulatory approval in the U.S. Both are approved in Europe, the adjuvant for more than a decade.

The Food and Drug Administration, long reluctant to consider approving a vaccine adjuvant because of safety concerns, now is at least talking about what it would take to bring it to market, Oswald said.

In the past year, Novartis has tested pandemic flu vaccine with an adjuvant in the U.S. and started collecting data from the tests, said Russell Thirsk, head of Novartis’ U.K. vaccine manufacturing site in Liverpool.

While FDA approvals for the cell-based vaccine and the adjuvant are far from guaranteed, Novartis officials said there is a chance.

Last week, Protein Sciences was sent looking for more safety data for its cell-based seasonal flu vaccine. But the Connecticut biotech company uses insect cells to grow the one crucial protein that produces an immune response. Novartis’ approach is less experimental, using canine kidney cells the company has long cultured in the lab and inactivated virus.

The current shortage of H1N1 pandemic vaccine – brought on by the virus’ slower-than-expected growth in chicken eggs – could also become a factor.

Cell cultures grow much faster than chicken embryos, are available on demand and don’t pose the risk of allergic reactions to the vaccine. Also, the virus produced in eggs is slightly altered.

At the Holly Springs plant the steps of making flu vaccines with the help of cells is spread across three floors: from growing the cells in tanks holding up to 5,000 liters, about 1,250 gallons, to infecting the cells, harvesting and inactivating the virus and filling up to 600 vials per minute on a packaging line that is equipped with the latest technology available.

The plant already employs about 200. The work force is projected to increase to 350 by 2013.

That’s what Rick Williams, chief business officer at the Hamner Institutes of Health Sciences, thinks. (Photo at right.)

China, which has a great scientific heritage, is establishing about 100 research parks, about half of them the size of Research Triangle Park. Large pharmaceutical companies, including GlaxoSmithKline, have begun to take notice, setting up shop and shifting research and development jobs to China.

The Hamner has also staked its claim in one of them. In May, the Research Triangle Park-based research center established a partnership with China Medical City, the largest medical research park in China.

North Carolina’s Gov. Beverly Perdue not only announced the deal, but last month she went on an economic development mission to China, which is already one of the state’s largest trading partners.

Following a one-year crash course in learning about China, which included three trips there and visits from eight Chinese delegations, Williams acknowledges that challenges remain. He compares China to a combination of the Gold Rush and the Wild West – an assessment shared by William Zarit of the U.S. Commercial Service, the trade promotion unit of the International Trade Administration. At a business forum in Raleigh four months ago, Zarit said that ”China is not for sissies.”

But focusing on business development, translational research and labor force training, Williams said, “will lead to long-term economic development opportunities for North Carolina with China.

“These opportunities will begin with the Research Triangle Park,” he said, and then expand to research parks in the Triad, Kannapolis and western North Carolina.

Listen to a podcast of Williams’ thoughts about China at: www.thehamner.org/docs/Rick_Williams_-_China_podcast.mp3

MONDAY

3 p.m. to 5 p.m.
N.C. Biotechnology Center, 15 T.W. Alexander Drive, Research Triangle Park
Why global health matters to North Carolina
Presented by the Center for Strategic & International Studies Global Health Policy Center and the Triangle Global Health Consortium, the forum will highlight how North Carolina generates knowledge, skills, jobs and partnerships essential to U.S. leadership in global health.

4 p.m. to 7 p.m.
N.C. Biotechnology Center, 15 T.W. Alexander Drive, Research Triangle Park
Medifacts International conference series: An educational seminar on the cardiac safety continuum
More information here.

TUESDAY

11 a.m. to noon
National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park
Seminar: From protein sequence to structure to function
Speaker: Dr. Dukka Bahadur K.C., UNC-Charlotte
Rall Bldg. Room B321

11:30 a.m. to 4:30 p.m.
NIEHS, 111 T.W. Alexander Drive, Research Triangle Park
Seminar: Beckman technical presentation
Rall Bldg. Rodbell A

11:30 a.m. to 1 p.m.
Brasa Steak House, 8551 Brier Creek Parkway, Raleigh
RTP networking luncheon of the Healthcare Businesswomen’s Association
More information here.

4:30 p.m. to 7:30 p.m.
RTP Headquarters, 12 Davis Drive, Research Triangle Park
Techie Tuesday
Free, bi-monthly events for RTP employees that provide the opportunity for networking and collaboration. This event is not just for “techies”…it is for any employee who works at a company within the boundaries of The Research Triangle Park.
Caterer: Nantucket Grill

6:30 p.m. to 8:30 p.m.
Irregardless Cafe, 901 W. Morgan St., Raleigh
Science Cafe: Memories
Speaker: Dr. Sandeep Vaishnavi, medical directorof the N.C. Neuropsychiatry Clinic in Raleigh
Presented by the Museum of Natural Sciences and the RTP Chapter of Sigma Xi, the program will explore types of memory, the neurobiological basis of memory and ways to tell normal aging from the beginnings of significant memory loss.

More information here.

WEDNESDAY

7 a.m. to 6 p.m.
Duke University, Fuqua School of Business, 1 Towerview Drive, Durham
Medical Innovation and Strategies Conference 2009: Wireless and consumer health
($450 per person)
More information here.

THURSDAY

10 a.m. to 11 a.m.
NIEHS, 111 T.W. Alexander Drive, Research Triangle Park
Seminar: Understanding and designing gene regulation by PUF proteins
Speaker: Traci Hall, NIEHS, laboratory of structural biology
Rall Bldg. Room D450

11:30 a.m. to 1:30 p.m.
N.C. Biotechnology Center, 15 T.W. Alexander Drive, Research Triangle Park
Data storage seminar: Methods for managing large and rapidly growing data stores in life science research environments
Speaker: Chris Dagdigian, Founder of the BioTeam
More information here.

Noon to 1:30 p.m.
Sigma Xi, 3106 E. Hwy. 54, Research Triangle Park
American Scientist’s pizza lunch (for science journalists/communicators)
Speaker: Thomas J. Meyer, director of UNC-CH’s new solar fuel research center
Topic: Efforts to develop alternative energy sources that are safer than greenhouse gas emitting fuels.
RSVP required at cclabby@amsci.org.

FRIDAY

11 a.m. to noon
NIEHS, 111 T.W. Alexander Drive, Research Triangle Park
Seminar: Altered drug clearance pathways and metabolic regulation associated with cancer: Role of impaired hepatic nuclear receptor action
Speaker: Dr. Graham Robertson, University of Sydney, cancer pharmacology unit
Rall Bldg. Rodbell A

SATURDAY

8 a.m.
Cambria Suites, 300 Airgate Drive. Morrisville (RDU Airport)
ProductCamp RTP: A collaborative unconference about product management and marketing.
More information here.

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.