One man died and four were injured in January after a clinical trial went awry in Rennes, France. Now, Biotrial, the company that ran that study, said it has opened a new research facility in Newark, N.J.
Biotrial conducts clinical trials on behalf of drugmakers and biotechnology companies. Most are phase 1 trials, in which an experimental drug is tried in a small group of volunteers to make a preliminary assessment of its safety before the drug moves on to larger human studies to further evaluate safety and also its effectiveness in treating an illness.
An announcement Friday from the company said that the new facility would be able to conduct up to 50 phase 1 trials a year, involving as many as 2,000 volunteers. With 110 hospital beds, the facility is just slightly smaller than the company's phase 1 research center in Rennes, which Biotrial says is considered Europe's largest.
The company started conducting trials at the new $30 million facility a few months ago. François Peaucelle, managing director at Biotrial, says it has already completed four, and there are plans or discussions about 20 more.
Peaucelle says that about 55,000 people have participated in company trials since its founding in 1989. He says the tragedy in January was a freak accident. "I compare it to a plane crash. It's very rare, but it can happen," he says. "Medications are never risk free, but diseases are always a risk, so it's important to continue the research. And in drug development, phase 1 is a necessary step."
But John LaMattina, former head of research and development at Pfizer, says the accident strikes him as an important warning. "I don't think the trial was badly done," he says, but it showed poor judgment. LaMattina says that if he were in his old position at Pfizer and someone suggested conducting a trial with Biotrial, "I'd have to say that my response would be 'No.' "
Jack Reynolds, a pathologist who worked for pharmaceutical companies including Pfizer, Bayer, and Bristol-Myers Squibb before founding a preclinical drug discovery company, agrees.
"How does a potential customer look at this?" asks Reynolds. "Not very well, that's for sure. In this business, credibility and reputation are really important."
Biotrial president Jean-Marc Gandon told a French publication that, after the botched trial, the company dropped from doing about 60 phase 1 trials a year to less than six. "The stakes are very high for us because the U.S. market represents 50 percent of global studies on healthy volunteers," he said.
The U.S. Food and Drug Administration said in August that the experimental medication that killed the healthy volunteer and injured four others in France has "a unique toxicity" and wasn't tested in U.S. subjects.
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