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Post by CM kipper007 on Jul 16, 2014 21:51:03 GMT
www.courthousenews.com/2014/07/16/69532.htmGot this off twitter. Just reading it now. abs: OAKLAND, Calif. (CN) - A stem cell research company fired a manager after he complained that deficiencies in the company's cell lines put patients at risk of infection or death during clinical trials, the man claims in court. Rob Williams sued StemCells Inc. on Monday in Alameda County Court, alleging wrongful termination, retaliation and violation of the California False Claims Act. To receive millions of dollars in government funding, including grants from the California Institute for Regenerative Medicine, StemCells claims that its manufacturing processes yield stem cells that are "safe for human stem cell transplantation," the complaint states.
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Post by stemboat on Jul 16, 2014 21:54:57 GMT
This casts a very dark shadow on STEM and CIRM, not surprised but very disappointed. I appreciate the overly cautious approach that ACTC has taken and continues to pursue.
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irvarons
New Member
Retired, former consultant to the ophthalmic industry
Posts: 12
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Post by irvarons on Jul 16, 2014 21:59:14 GMT
Here's the full story, as I just posted on iCell.
Irv
StemCells Inc. Problems?
Whistle-Blower Alarmed at Stem Cell Work By ELIZABETH WARMERDAM
Wednesday, July 16, 2014 Last Update: 7:43 AM PT
OAKLAND, Calif. (CN) - A stem cell research company fired a manager after he complained that deficiencies in the company's cell lines put patients at risk of infection or death during clinical trials, the man claims in court.
Rob Williams sued StemCells Inc. on Monday in Alameda County Court, alleging wrongful termination, retaliation and violation of the California False Claims Act.
To receive millions of dollars in government funding, including grants from the California Institute for Regenerative Medicine, StemCells claims that its manufacturing processes yield stem cells that are "safe for human stem cell transplantation," the complaint states.
StemCells must follow a set of standards - Good Manufacturing Practices - set forth by the FDA to protect the public, according to the complaint. Williams says he was hired as the company's senior manager of manufacturing in December 2013 to oversee its manufacturing facility, where stem cell cultures are cultivated for use in clinical trials.
"Shortly after beginning his employment, plaintiff noted poor sterile technique, failure to adhere to current Good Manufacturing Practices in the company's manufacturing process, and substantial deficiencies in the company's Manual Aseptic Processing of HuCNS-SC (Human Central Nervous System Stem Cells) cell lines - failure and deficiencies that put patients at risk of infection or death during ongoing clinical trials," Williams says.
Williams claims he also saw manufacturing deviations during cryopreservation of Working Cell Bank lots, leading to numerous stem cell lots with dangerously high numbers of damaged cells.
"Knowing that these cells were to be injected into human patients, and that the high level of damaged cells and the possibility of contaminating microorganisms could cause serious harm to patients, plaintiff immediately took his concerns to upper management. He also noted that the use of adulterated stem cells lots could skew patient test results, effectively jeopardizing data behind years of clinical trials and research," the complaint states.
Williams says he was told to conceal his findings from reports, and the company suspended him shortly thereafter. Williams sent emails to company leadership and members of the company's executive team reiterating his concerns about the processes used to create the stem cell lines for use in human patients. He also described the suspension he faced as retaliation for bringing the issue out into the open, the complaint states.
StemCells fired Williams a few weeks later, he says.
Williams seeks punitive damages. He is represented by Daniel Velton with Velton Zegelman, of Sunnyvale. StemCells did not immediately respond to a request for comment.
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Post by CM kipper007 on Jul 16, 2014 22:12:00 GMT
This casts a very dark shadow on STEM and CIRM, not surprised but very disappointed. I appreciate the overly cautious approach that ACTC has taken and continues to pursue. Slow and steady wins the race? If there is any truth to this, STEM are going to hurt. It leads to questions as to why they were injecting so many cells now, if it is their ocular program anyway. I am really interested what the application for the cells were!
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Post by tmfbmf on Jul 16, 2014 22:18:29 GMT
It's hard to believe any company would act so unethically. Could just be a disgruntled employee. But if there's any truth to this and any evidence to back it up, the company will be out of business and there will be a few perp walks.
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Post by tmfbmf on Jul 16, 2014 22:22:20 GMT
But if there was evidence, I don't think they'd be stupid enough to fire him.
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Post by tradeup on Jul 16, 2014 22:35:21 GMT
This is who is suing STEM: Rob Williams www.linkedin.com/pub/rob-williams/4/561/141Senior Manufacturing Manager at StemCells, Inc. Previous: Alvine Pharmaceuticals, Inc., Global Biologic Supply Chain, Johnson & Johnson, Scios Education: Humboldt State University Manufacturing & Process Development Manager with 15 years of experience. I have had the opportunity to work on successful projects from the research stage through commercial cGMP manufacturing. My major accomplishments have come from leading process development, tech transfer and scale-up activities with multiple external Contract Manufacturing Organizations. I have a reputation for bringing large data sets to life with clear graphics enabling scientists to see correlations, hidden trends, and solutions to problems quickly. • More than 15 years manufacturing & fermentation process development experience. • Experience managing projects in development, pilot plants and GMP facilities. • Extensive expertise in Contract Manufacturing Organization oversight. • Served as technical lead for assessing GMP process deviations and conducting manufacturing investigations. • Solid foundation in cell culture & fermentation, recovery, purification and analytical methods. • Led technology transfer to multiple sites inside and outside US. • Strong statistical background including DOE, data summary & analysis.
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Post by stemboat on Jul 16, 2014 22:36:43 GMT
My sense is the FDA will get involved. I never felt comfortable that STEM was following all the rules. CA taxpayers should follow this closely.
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Post by tradeup on Jul 16, 2014 22:41:08 GMT
Speculating here, I think there's ample reason to believe CIRM may pull their funding commitment ... hence the recent capital raise?
Conflict-of-interest probe into Alan Trounson (ex-CIRM) appointment and now this.
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Post by stemboat on Jul 16, 2014 22:56:39 GMT
Tradeup, i agree, and Rob Williams could possibly win a fair piece of that capital raise. This is a potentially ugly situation for STEM and CIRM.
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Post by CM kipper007 on Jul 16, 2014 23:36:50 GMT
Something doesn't seem right though. Williams was hired as the manager of manufacturing, then gets silenced when he is doing his job for reporting poor standards?
This is extremely interesting....
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Post by tradeup on Jul 17, 2014 0:21:19 GMT
The big question is if this suit has any merit. And if so, how may this affect clinical progress across the HuCNS-SC platform?
If the market overreacts, I'll probably try and catch the falling knife. At the moment this looks like a tsunami of bad news (conflict of interest + capital raise + lawsuit). Although any question into GMP standards could get the FDA's attention.
The CIRM funding, which may or may not be in jeopardy, is not really the important issue at the moment. But it's worth noting, if not merely coincidental, the CIRM loan to support their ALZ trial (intended for IND this year) was a similar amount to the recent capital raise. The CIRM loan agreement provides for various termination rights (e.g., failure of compliance, business conduct of the recipient, etc.) as well as the ability to suspend funding if it's reasonable to determine trial delays may occur.
STEM 8-K Re: CIRM Loan to fund ALZ trial ...
Effective April 9, 2013, we entered into a loan agreement with the California Institute for Regenerative Medicine (“CIRM”) for approximately $19.3 million to fund preclinical research in Alzheimer’s disease (the “CIRM Loan Agreement”). CIRM was established by the voters of the State of California pursuant to Proposition 71 to advance the biotech industry in California through grants and loans for stem cell research, research facilities and other vital research opportunities. The loan was made pursuant to a research award by CIRM’s governing board in September 2012 under CIRM’s Disease Team Therapy Award program (RFA 10-05).
A stated aim of our CIRM-funded research project is to file, within a four-year project period, an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration for a clinical study of our proprietary HuCNS-SC cells as a treatment for Alzheimer’s disease.
Funds under the CIRM Loan Agreement are expected to be disbursed periodically by CIRM over the four-year project period, although the disbursements are subject to a number of preconditions, including the achievement of certain progress milestones and compliance with certain financial covenants.
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Post by tradeup on Jul 17, 2014 0:25:56 GMT
California Stem Cell Report: California Lawsuit Charges StemCells, Inc., with Putting Patients at Risk californiastemcellreport.blogspot.com/2014/07/california-lawsuit-charges-stemcells.htmlA former senior manager at StemCells, Inc., which holds a $19.4 million award from the California stem cell agency, has filed a lawsuit alleging that “deficiencies in the company's cell lines put patients at risk of infection or death during clinical trials.” The charges were contained in a suit by Rob Williams in Alameda County court, according to an article on Courthouse News Service written by Elizabeth Warmerdam. Williams is suing for wrongful termination, retaliation and violation of the California False Claims Act. ...
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Post by Keybridge - Cult Member 003 on Jul 17, 2014 3:08:41 GMT
"The lawsuit said that Williams was told to conceal his finding from unspecified reports and that he was suspended shortly thereafter. It said that he sent emails to upper level management about his concerns and that he was fired a few weeks later."
If you go back to when the results from the clinical PI were announced, there were at least a couple of posters who noted that the methodology and how the results were presented were incomplete and not to standard. There may be a pattern of concealment going on within the organization - and when you add the appointment to STEM's board of CIRM's former president, then you have to ask about the culture within management as well. Just five days earlier:
"On Wednesday, the California Institute for Regenerative Medicine said it is addressing a "risk of conflict of interest" after the organization's former president recently was named to the board of directors of StemCells Inc. John Simpson, director of Consumer Watchdog's stem cell project, said the move appears to be a conflict of interest because CIRM had awarded StemCells Inc. $19 million."
I don't believe that the new capital raised has closed either - which means that could be delayed or withdrawn as well.
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Post by HeyNow on Jul 17, 2014 3:25:24 GMT
This company has more red flags then ACTC at this point. Maybe they'll hire Gary Rabin to come in and clean things up.
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Post by Keybridge - Cult Member 003 on Jul 17, 2014 3:30:24 GMT
If you ask me, M. West is now licking his chops to turn STEM into a subsidiary of BTX.
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Post by tradeup on Jul 17, 2014 11:46:05 GMT
This company has more red flags then ACTC at this point. Maybe they'll hire Gary Rabin to come in and clean things up. GR is tied into a one-year contract at SeaWorld. He's busy explaining to tour groups how the new sea turtle exhibit will be bigger than Disneyland.
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Post by tradeup on Jul 17, 2014 12:18:00 GMT
The complaint is 8 pages. Despite this being filed on 7/14, I don't think we've seen the market fully react to this yet.
For Williams to go public with the allegation, he puts himself at risk of a libel suit if this gets dismissed. Would a veteran in the industry do that? I'm leaning towards this guy may have some serious dirt on the company, and because he has now gone public with his claims I doubt we see this result in a quick settlement and swept under the rug.
Case Number: RG14732694 Title: Williams VS Stemcells, Inc Case Type: Civil Complaint Type: Wrongful Termination Case Subtype: General Civil Filing Date: 7/14/2014 Filing Location: Rene C. Davidson Alameda County Courthouse
7/15/2014 Notice of Assignment of Judge for All Purposes Issued 7/15/2014 Initial Case Management Conference 11/26/2014 09:00 AM D- 25 7/14/2014 Summons on Complaint Issued and Filed 7/14/2014 Civil Case Cover Sheet Filed for Rob Williams 7/14/2014 Complaint - Wrongful Termination Filed
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Post by tradeup on Jul 17, 2014 12:39:51 GMT
Stem's entire pipeline is tied to HuCNS-SC (Spinal, PMD, AMD, ALZ and Stroke).
How does this not get the FDA's attention?
The more I look at this the less I want to touch it. As I said, it's going to have to get real bloody this week for me to want to take on this risk.
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Post by tradeup on Jul 17, 2014 12:58:43 GMT
Was able to find a copy of the complaint:
www.scribd.com/fullscreen/234155532?access_key=key-d9GFh0kbbzfnK96RQzDJ&allow_share=true&escape=false&show_recommendations=false&view_mode=scroll
And it looks like I was on to something ... California Stem Agency (CIRM) Examining Lawsuit Alleging Patient Endangerment and 'False Certification'
The California stem cell agency today said it is reviewing a lawsuit involving the recipient of a $19.4 million award that alleges the firm is manufacturing human cells in a process that puts “patients at risk of infection or death.”
The most serious allegations against StemCells, Inc., of Newark, Ca., involve its clinical trials. The stem cell agency’s $19.4 million research award to StemCells, Inc., does not involve human beings, only initial development of a possible therapy for Alzheimer’s over the next three years. Both the clinical trials and the Alzheimer’s research use the same proprietary cells, HuCNS-SC.
The company said in a 2013 press release,
"We know from the preclinical work that our proprietary HuCNS-SC cells survive in the toxic environment of the Alzheimer's disease brain and restore memory under the regulation of the host."
The lawsuit was filed by a former senior manager, Rob Williams, of the publicly traded StemCells, Inc. He alleged he was fired after complaining about the cell problem to senior management.
In addition to possible injury, the lawsuit said that “the use of adulterated stem cells lots could skew patient test results, effectively jeopardizing data behind years of clinical trials and research.”
The lawsuit said that StemCells, Inc., receives
“…millions of dollars in government funding, including grants from the California Institute for Regenerative Medicine (CIRM). As part of certifications that Defendants made and, on information and belief, continue to make, to the State of California in order to obtain such funding, Defendants represent that their manufacturing processes yield stem cells that are ‘safe for human stem cell transplantation.’ Additionally, in order to secure CIRM funding, Defendants represented and represent that the company follows current Good Manufacturing Practices (cGMPs) promulgated by the U.S. Food and Drug Administration (FDA), a set of standards designed to protect the public from dangers to consumer/patient health and safety. Plaintiffs protected activity, as described above, included efforts to stop, complaints about and refusal to engage in or cover up violations of these standards, and by extension the false certifications submitted to the government, certifications that the company used and uses in order to secure substantial funding.”
The lawsuit also alleged that StemCells, Inc., violated FDA standards and provided false information to the FDA, which has not yet responded to queries from the California Stem Cell Report.
In response to a query, Kevin McCormack, spokesman for the $3 billion stem cell agency, said the agency was carefully reviewing the lawsuit.
Williams attorney, Daniel Velton, has not responded to queries about whether he or Williams informed the FDA of the issues raised in the lawsuit.
StemCells, Inc., did not respond to queries about the matter.
The company was founded by Stanford researcher, Irv Weissman, who sits on its board and is chairman of its scientific advisory board. His wife, Ann Tsukamoto, is executive vice president. Last week the stem cell agency announced that it was conducting a full review of its activities with the firm after it appointed the agency's former president, Alan Trounson, to its board seven days after he left the agency.
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