A former clinical researcher at Genentech has filed a whistleblower suit against the big Roche ($RHHBY) subsidiary, claiming that the company put trial subjects at risk as they forced a rapid march through the clinic on a high profile Pi3 Kinase study, disregarding established clinical practices in fear that Roche would snatch the drug away.
The suit alleges that the Pi3 Kinase team was guilty of "illegal and unethical conduct" by skirting established scientific and ethical standards required of drug researchers. Juliet Kniley claims she complained in 2008 and then was sidelined in 2009 with a demotion after being instructed to push ahead on the study. And she says she was told twice that Roche would "take this molecule away from us" if they saw her proposed timelines.
Kniley says her troubles started two years after she was hired by the company in 2005. That's when she was named the "operational leader" of the Pi3 Kinase study, which Genentech executives identified as "the most important program at the company."
Later, though, Genentech failed to file a protocol amendment for Phase I, as required by federal rules as the company pursued "premature and inappropriate safety testing in humans..." And she later refused to submit "unrealistic clinical timelines" to senior management.
"This was the first time this drug was being tested in humans so they didn't know what to expect. What was happening is management was speeding ahead without first waiting for the results of the earlier studies," lawyer Emily St. John Cohen, who represents Kniley, told the Daily Journal.
Late on Tuesday evening, Genentech fired back.
"Genentech vigorously denies the allegations made by Juliet Kniley," noted the company in an e-mail to FierceBiotech. "Genentech's clinical trials are crucial to the exploration of new medicines that may treat people with serious or life-threatening medical conditions. All of our clinical studies are conducted in compliance with international guidelines according to Good Clinical Practice and must be approved by regulatory authorities and Ethics Committees or local Institutional Review Boards. Studies conducted in the United States or under a U.S. IND comply with U.S. FDA regulations and applicable local, state, and federal laws. Genentech is committed to ethical and legal business practices and are confident in and proud of our strict standards in this regard."
Kniley's LinkedIn profile includes a long roster of studies she worked on over the years. Kniley notes that she "[b]rought 10 global Ph III pivotal trials to top-line data, delivered primary efficacy data for 15 global Phase II trials, and headed teams that conducted 76 Phase Ia, Ib,and Phase IIa safety and proof-of-concept trials, which were imperative to moving first-in-class products quickly through development."
But after the Pi3 Kinase run-in, she claims, her positive reviews turned sour and she was terminated last summer.
- see a copy of the lawsuit
- here's the story from the Daily Journal