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WisBusiness: Experts Say New Tests And Technology Could Bring Better, Safer Drugs To Consumers Faster

By Brian E. Clark

MADISON – Drug creation is notoriously expensive, with each new medication costing an estimated $800 million to bring to market. It’s also time-consuming, often taking a decade to get a fledgling drug to consumers.

Advances in testing and other innovations, combined with breakthroughs in robotics, have the potential to trim that cost and shorten development time considerably.

That’s the thrust of what scientists and other experts will say at a seminar on automation at the upcoming Wisconsin Biotechnology and Medical Device Association (WBMDA) conference. It will be held Oct. 12 in Waukesha at the GE Healthcare Institute on Watertown Road.

The researchers said traditional high-throughput screening of drug candidates is changing dramatically with advances in live-cell analysis and the advent of pure, engineered tissue.

They also said advanced micro-array techniques with improved quality control enable expression studies to be done in much greater numbers and with greater accuracy at lower costs than in recent years.

The breakthroughs could have a big impact on the cell analysis market, which is worth more than $6 billion in the United States alone. And the therapeutic toxicity and efficacy markets have a value of more than $1 billion, according to analysts.

“It’s kind of like how the assembly line revolutionized building cars in the early part of the 20th century,” said Tetsuro (Ted) Wakatsuki, chief scientist at InvivoSciences in Milwaukee. He is also an assistant professor of physiology at the Medical College of Wisconsin.

His work at the start-up biotech firm he co-founded five years ago focuses on creating beating heart tissues similar to an intact heart that can be used to come up with ways to test and create new drugs.

Using cells from newborn rats, his company has developed a screening system that can test potential drugs in large numbers. The test is a “high-throughput” method that allows researchers to screen up to 3,000 samples daily.

Wakatsuki, who was lured to Milwaukee from Washington University in St. Louis, said the technique also eliminates cell-to-cell variability and reduce unrelated leads. The samples also can be made to suit large drug-screening projects on 96-well plates that can be assembled to provide models for specific medical conditions.

Ultimately, work done by companies like InvivoSciences could help drug firms rule out problems before products get to the market. Merck, for example, had to remove the arthritis drug Vioxx in 2004 after it was discovered that the drug increased the risk of heart attacks and strokes.

Wakatsuki also said his work might someday help scientists make artificial tissues to repair human hearts and other organs. With automation, he said, that goal could come faster.

“We want to do testing in a more rapid, cheaper and more reliable manner,” he said.

“There are a lot of things we used to do by hand that can be done in an automated fashion,” he explained.

He said his company is working closely with Gilson Inc. of Madison and will release a commercial prototype next month using robotics to test and measure tissues.

“In five years, most assays will be done this way,” he said.

Bryce Nelson, vice president of research and development at GenTel Biosciences in Madison, agreed that testing costs less, is more accurate and safer with automation.

His company, which was founded in 2000, is a leader in measuring protein expression in blood. Using technology that came from UW-Madison, GenTel’s tests – called mutliplex protein assays - can measure many different proteins in blood at the same time.

Also known as biochips, these coated glass laboratory slides can be customized to test for individual proteins in a patient’s bloodstream – in what has come to be known as personalized medicine.

“Traditionally, these kinds of tests had to be done by hand,” he said, meaning the technician had to place or “pipette” samples on a microscope slide. The new technology makes testing up to 2,000 times faster, he said.

With new high throughput screening developed by GenTel, the company has automated assays using handling systems and automation equipment adapted from drug companies and research labs.

“The amount of data is rather awesome,” he said. “Using a 96-well plate, we can look at 96 patients’ samples and do 20 tests for different proteins on individual data points.”

Tom Strader, president and CEO of Global GeneTechs, said automation also means fewer critters will have to die to get new drugs market.

“If you have fetal tissue growing in a well, you don’t need to test in on lab animals,” he said. “And that means a lot to scientists who don’t like destroying animals as part of their work.

“Besides that, automation is speeding things up,” he said. “That $800 million figure is a factor of time it takes to come up with a compound and then rule it out.

“If you can cut the time in half, you could cut the cost significantly – perhaps in half,” he mused.

“But more important, robotics means you can do things that are far beyond the ability of humans in terms of accuracy, speed and reliability.

“You start out with hundreds of thousands of compounds and come down to a Vioxx,” he said. “With better and more comprehensive testing, you can learn about potential problems later in a drug’s life.

“Then you don’t end up saying, “Whoops, that was the wrong one after it’s already on the market.”

For more information on the biotechnology conference, go to www.wisbiomed.org or call the association’s office at 608 252-9393.

Other sessions will include global biological threats, the convergence of biotechnology and information technology, personalized medicine, biofuels and opportunities for life science companies in China.

Former governor and U.S. Health and Human Services Secretary Tommy Thompson will give the keynote address. Gov. Jim Doyle is also expected to speak.

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