Clinical-trial industry has healthy presence in Springs

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It doesn’t have a large brick-and-mortar presence, but the clinical-trial industry brings notoriety and business to Colorado Springs.

In fact, Penrose-St. Francis Health Services won an award from the American College of Surgeon’s Commission on Cancer based in part on its participation in cancer drug trials. It’s the only hospital in Colorado to have earned the National Achievement Award.

“We participate in all kinds of trials,” said Dr. James Young, an oncologist and director of the Penrose Cancer Center. “It’s how we innovate, and move the field along. It’s the way to chip away at the disease and remain on the cutting edge of the treatments available.”

Recently, the Pharmaceutical Research and Manufacturers of America reported that the nation’s biopharmaceutical companies have conducted more than 3,000 clinical trials of new drugs in the state — and 481 of those are in Colorado Springs.

But even that number doesn’t tell the whole story — the industry association only tracked drug trials paid for by pharmaceutical companies. Trials sponsored by universities or the federal government aren’t included in the report. Colorado is one of 17 states for its biopharmaceutical company clients.

Even so, the numbers are impressive — and important. In the Springs, there are 11 active asthma trials, mainly conducted at the Asthma and Allergy Associates and the Storms Clinical Research Institute. There are 13 active cancer trials going on at both hospitals, and the Colorado Cardiac Alliance is performing 11 trials for drugs dealing with heart disease and two with stroke. There are also trials involving diabetes and mental illness medications.

“This is a big impact on the state and on business in the state,” said Jeff Trewhitt, senior director of communications and public affairs for the industry group. “The clinical trials don’t have a prominent bricks-and-mortar presence, but it does mean that the state has a strong biopharmaceutical base.”

The base includes 300 companies with more than 5,410 employees, with average salaries of $93,000 a year. Another study by Archstone Consulting found that biopharmaceutical companies invested $279.9 million in research and development in the state, while producing $10.8 billion in products and services.

While most of those companies are located in Boulder, much of the research needed for Federal Drug Administration approval is done right here in Colorado Springs.

“The city is second only behind Denver,” Trewhitt said. “It’s important to realize that these trials don’t happen overnight. The trials in the state account for seven out of the 10 to 15 years needed to develop a new medicine.”

Still it isn’t easy to be on the cusp of medical breakthroughs. Penrose has about 15 percent response rate when they ask patients to participate in clinical trials — and that’s far above the national response rate of 3 to 4 percent.

“It’s hard to get patients involved,” Young said. “It’s voluntary, but not every patient is eligible for every trial. It’s something we focus on, so our rate is much higher. It’s important, however, for everyone. Too few patients slows down progress in the field.”

And the efforts at Penrose have created some potent drugs in the fight against cancer. Denosunab is a drug that helps patients after cancer has metastasized in their bones. The drug replaces bone density in cancer patients. It’s just one of many new medications on the market thanks to drug research trials.

Penrose isn’t alone. Nearly half of the clinical trials in the state target the nation’s six most debilitating chronic diseases — asthma, cancer, heart disease, diabetes and mental illness. In fact, biopharmaceutical companies are developing 74 new medicines for asthma alone — with more than 100 trials in Colorado.

“These are new generation technology drugs,” Trewhitt said. “That means they are being developed through biological processes, using living cells and organisms, instead of through chemical synthesis. Through biotechnology, our companies are developing new ways to more efficiently treat disease and to predict, preempt and prevent it.”

The U.S. system of approvals is the most rigorous in the world, Trewhitt said. Only five in every 5,000 compounds that enter preclinical testing make it to human testing and only one in five is approved for sale.

Getting that single drug approved is complicated: pre-clinical testing involves lab and animal studies to check for safety and efficacy. After that, a company files an investigational new drug application with the FDA that shows previous experiments and outlines how, where and by whom the new studies will be conducted. It explains the chemical structure of the compound, how it works in the body and any side effects. Clinical trials then must be approved by an institutional review board and annual progress reports submitted.

And that’s where hospitals like Penrose St. Francis come onto the scene. The first tests involve 20 to 100 normal, healthy volunteers to test how safe a drug is, how it’s absorbed, distributed metabolized and excreted, as well as how long it works.

The second phase involves controlled trials of 100 to 500 patients suffering from the disuse to determine a drug’s effectiveness and early side effects. The third and final phase involves 1,000 to 5,000 patients in clinics and hospitals, and doctors monitor patients to conform that the medication works and to identify adverse effects.

Then, the company applies for a new drug application with the FDA, once the data is analyzed. Applications typically run about 1000,000 pages.

And, once the FEDA approves it, it becomes available for prescriptions. A company has to submit regular reports to the FDA.

All those steps add up to big money. The industry spent $67.4 billion in research and development in 2010.

But for doctors like Young, it adds up to more than dollars and cents.

“This is the chance we have to cure people,” he said. “We consider offering these trials part of our care program.”