Spain's Biotech Revolution

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Joan Ballesteros had built up a successful biotechnology company called Novasite Pharmaceuticals in San Diego. The company took a known, validated technology—flow cytometry—which evaluates blood samples, and fully automated the system. Suddenly, a machine that could evaluate perhaps some dozens of handfed samples a day was transformed into one that could handle thousands, automatically.

Ballesteros saw a wealth of possibilities with the new technology. He imagined how this could aid in the personalization of medicine for leukemia patients: a doctor could put a patient’s blood into the machine and check it against thousands of options for fighting leukemia, drugs alone or in combination, in a variety of strengths. And that, to him, was just the beginning.

To make the most out of his ideas, he knew he had to do something that might surprise his research colleagues in the San Diego area, considered one of the world centers of biotechnology. He had to move back home to Spain.

“I turned to my investors and said, ‘We should be screening known drugs on patient samples … They told me, ‘You will lose our money,’” says Ballesteros. “If I’m wrong, and it doesn’t work, they’ll lose money. If I’m right, and we’re successful, then we’ll have so many lawsuits that we’ll lose money.”

The problem resides with the legal system in the U.S., says Ballesteros, with a culture of easily bringing suits to trial. If a private company were to sign agreements with hospital patients to use their samples for research to help treat diseases, and if that company makes money, the patients could sue for a percentage of the profits.

Because of this, biotechnology companies in the U.S. do not work with fresh patient samples; that falls to public institutions such as the National Institutes of Health or public hospitals and universities. “But there have even been cases where the NIH has been sued,” says Ballesteros.

In Europe, he explains, if patients have been fully informed and signed a consent form in accordance with all legal and ethical principles (which are essentially the same as In the U.S.), the legal system won’t allow such a case to be brought to court. “A key differentiating factor between the U.S. and Europe, particularly Spain, is the access to fresh human samples,” he says.

Ballesteros left his first company in San Diego and brought some of his team to Spain, where in 2007 he founded a new company, Vivia Biotech, with his brother Andres.

Vivia Biotech is partnering with hospitals that have samples of blood and bone marrow samples, and signed consent forms, from leukemia patients. He says his system can test thousands of combinations of the less than dozen approved leukemia drugs. “We’re already seeing tremendous differences” in how different patients’ cancers respond to different drug combinations, he says. In theory, a doctor in the future would be able to send his patient’s blood in to be tested, and he could get an answer back in 24 hours about the patient’s best course of treatment. “This is what doctors have been doing for years, one drug at a time,” says Ballesteros. “We’re only altering the scale.” Ballesteros hopes that this method will be validated within a year.

Ballesteros doesn’t stop there. He’s particularly excited about the prospect of using this machine to discover new cancer-fighting drugs from existing, approved drugs that treat unrelated diseases.

Most researchers are investigating what genes or proteins differ in cancer and trying to create molecules to kill cancer that don’t kill healthy cells, says Ballesteros, “but we do exactly the opposite. We say, let’s get all the drugs that don’t kill you. And of those, let’s see if some of them kill cancer.” He ticks off antibiotics, drugs for the flu, for headaches, for Parkinson’s. So far, he says, “the data is amazing, much better than what we had expected.”

“We’ve found ten very safe drugs that have the same efficacy in killing cancer as the harmful chemotherapy drugs,” he says; but it will take at least three to five years to go through the necessary trials before any will be validated for cancer treatment.