October 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEWARK, N.J. – Biotrial, the French clinical research company perhaps most infamously known for running a trial that left one patient dead and five others hospitalized earlier this year, has opened a new research facility in the United States.The new site is a 70,000 square-foot space and includes 110 hospital bed, which is larger than the company’s Rennes, France facility, which is among Europe’s largest, NPR said. It opened at the end of September. NPR reported the facility will be able to conduct up to 50 Phase I trials per year. François Peaucelle, managing director at Biotrial, told NPR the company has already completed four early stage trials at the new Newark, N.J. site and is in the planning stages to conduct 20 more in coming months.
As Biotrial expands to the United States though, the company has to overcome the shadow of the fatal trials earlier this year. When Biotrial celebrated the opening of its New Jersey site, Peaucelle told NPR the Rennes tragedy was a freak accident, one he compared to a plane crash—“very rare, but it can happen.”
A French health ministry report found fault with both Biotrial and the drug company, Bial-Portela. The ministry criticized what appeared to be a breakdown of responsibility between Biotrial, the contract research organization conducting the trial, and Bial, the developer of the drug. In its report, investigators from the France’s IGAS social affairs inspectorate said Biotrial “had not properly informed volunteers and had followed a flawed testing protocol.” The French ministry criticized the lab for the slow reaction time of staff. In February Touraine released initial findings of its investigation, which said the lab should have halted trials after the first patient was hospitalized. However, the ministry said the drug was administered to five more patients the next day. The French ministry investigation followed the failure of a Phase I clinical trial studying an experimental fatty acid amide hydrolase inhibitor being developed by Portugal-based Bial-Portela at a Biotrial facility.
Following the ministry’s announcement, Biotrial sharply criticized that statement, saying it complied with the law and noted the drug was one developed by Bial and not them. The company also criticized the French ministry for not allowing it to provide any input into the report regarding actions it had taken in the wake of the tragedy in January.
The trial that left one man dead, was an early trial of an FAAH inhibitor designed to break down endocannabinoids. The drug was administered to 108 patients, but only six were negatively affected.
That trial stigma though could cause some potential customers to rethink a partnership with Biotrial. John LaMattina, the former head of research and development at Pfizer , told NPR that he would balk at working with Biotrial on a clinical trial if he were in his old position at the global drug giant.
And LaMattina isn’t the only one to balk. Jean-Marc Gandon, Biotrial’s president, said after the Bial death and hospitalizations happened, the number of Phase I trials the company was conducting dropped from about 60 to six, NPR said.
