Cetero execs look for a silver lining in bankruptcy sale

Posted under bankruptcy, Blog, Cetero Research, Companies, CRO, Diagnostics, Ed Silverman, Funding, MDS Pharma Services, Medical Devices, Medical Supply, outsourcing, Pharmaceuticals, Startups, Universities, Videos by john

The CRO crowd tracking the fate of troubled Cetero Research over the past year has been treated to a series of twists and turns as the story developed. Slammed by the FDA for producing falsified data at its Houston lab--which the company blamed on a handful of errant employees--Cetero recently filed for bankruptcy protection while scouting for a buyer. As we reported earlier, the company's lenders have filed a "stalking horse" bid for the CRO, looking for a new buyer who can take over and move ahead.

Today, Pharmalot's Ed Silverman notes that a group of executives at the company are seeking court permission for a $1.3 million bonus on the sale of the company. As Pharmalot adds, it's quite common for key executives to look for bonuses when they steer a company through bankruptcy. They're the ones expected to hold it all together for the new owner.

Interestingly, Silverman also notes that some current and former execs at Cetero once worked for MDS Pharma Services, another CRO that had to defend its test results before it was sold. A hearing on the bankruptcy is slated for the end of the week.

- here's the story from Pharmalot

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Cetero preps for new owner after filing for bankruptcy protection
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Cetero preps for new owner after filing for bankruptcy protection

Posted under bankruptcy, Blog, Cetero Research, Companies, CRO, Diagnostics, Funding, M&A, Medical Devices, Medical Supply, outsourcing, Pharmaceuticals, Startups, Universities, Videos by john

Despite filing for Chapter 11 bankruptcy protection Monday, the Cary, NC-based CRO Cetero insists it has no plans to cease daily operations or ongoing research. And if all goes as planned, Cetero will find itself under new ownership within the next 120 days. "Throughout the reorganization process there will be no change to day‐to‐day operations at any of Cetero's facilities. Each and every one will continue to run and actively take on new studies," Cetero said in a statement to FierceCRO.  Report

FDA accusations of ‘corrupt’ lab practices push Cetero into bankruptcy

Posted under bankruptcy, Blog, Cetero Research, Companies, corruption, CRO, Diagnostics, FDA, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Just eight months after the FDA issued a scathing report accusing employees at the contract research firm Cetero of faking research work for clients, the CRO has filed for bankruptcy protection and is angling to sell its assets to the highest bidder.

Last July the FDA set off alarm bells for drug developers which had relied on Cetero for early-phase research work, warning them that they may be on the hook to pay for a do-over after finding hundreds of examples of faked research work over a 5-year period at the company's Houston lab. Significantly, the regulators noted that they doubted that the faked work had created any safety issues, but regulators concurred with the company's independent auditor, who wrote that: "this misconduct appears to be significant enough to cast doubt on the data generated ... If the foundation of the laboratory is corrupt, then the data generated will be also." 

According to a piece in Reuters, Cetero said that the FDA had never accused the company of fraud. But as word spread of the accusations against employees the company found itself in a liquidity squeeze. Working with its lenders Cetero has now established the ground rules, and floor prices, for its assets.

The company, which filed for bankruptcy under the name Contract Research Solutions in Case No. 12-11004, listed assets worth up to $10 million and debts in the range of $100 million to $500 million.

- here's the Reuters story

Related Articles:
FDA cites 'corrupt' CRO for widespread falsification
Cetero fires back at scathing FDA accusations

‘Dateline’ exposé snares Indian CROs in an ethics ‘sting’

Posted under Blog, Companies, CRO, Diagnostics, Funding, Lambda Therapeutic Research, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Synchron Research Services, Universities, Videos, Vioxx by John Carroll

When Chris Hansen of "Dateline" shows up at the door, you know some predator is about to get very publicly busted. So when he and his team journeyed to India to expose CROs for preying on the poor and operating without any ethical considerations or concern for people's health, you know that somebody is going to wind up running from a camera. In this case, Hansen nabbed two Indian CROs--Lambda Therapeutic Research and Synchron Research Services--willing to test a copy of Vioxx, the once promising treatment linked to heart attacks and thousands of deaths. Story