Wednesday, August 22, 2012

Text of Klein's Comments Supporting Rejected Applications

Robert Klein, who served 6 ½ years as the first chairman of the $3 billion California stem cell agency,  testified before the agency's board for the first time on July 26, 2012. Klein, a real estate investment banker and attorney, spoke on behalf of two applicants whose grants had been rejected by the agency's reviewers. The appearance has raised questions about the propriety of Klein's actions.

Here is a link to an item on his appearance. Here is the text of his comments as reported in the transcript of the meeting.
“As the board knows, I've never addressed any grant from the floor. It is critical here to understand that we have here StemCells, Inc., which is the only company in North America and, for that matter, maybe in the world, that has had two stem cell therapies in the brain with these specific neural stem cells. They have a huge body of experience here. 
“Secondly, one of the fundamental issues here that it (the company's grant application) was downgraded on was the issue of the fundamental concept, the platform concept, of injecting two focal injections in the brain, in the hippocampus of the brain. It's important to note that I've sat on three (CIRM)peer reviews where the scientists really affirmed this specific approach with extremely high scores, three different views. All right.
“So it's very important to realize we have a standard deviation here of 12 (on the review scores). These scientists were completely split. With some recusals on that panel, if you have 12 or 13 that can really vote, three or four very low scores can bring it out of the funding category all the way down. It is in the region where this board is looking where the other three peer reviews, right, early translation, the one before that was the planning grant review, that the hippocampus was a good platform.
“Then they said the key weakness was you can't show migration. Dr. Laferla (a co-PI on the application) has told me that today the Journal of Neuroscience accepted the publication of the data demonstrating migration. It was stated previously in the application, but it wasn't accepted for publication. It now is. That is the fundamental weakness that they identified in this approach.  
“So we have a reaffirmed approach to the hippocampus by three different peer review groups and a substantial portion of these reviewers along with data dealing with the weak point. I'm sorry it happened today. The data was out there, accepted for publication today, means that it should definitely fall into this category. And, of course, Dr. (Alan) Trounson (president of CIRM) wouldn't have been able to review that in process because he was recused from this grant by his own voluntary recusal. So the progress of this data being accepted for publication is new information today. 
“If I look at the entire history of CIRM, as Leeza (Gibbons, a CIRM director) says, building up to this point, we have reaffirmed this approach from the very beginning with Dr. Laferla, with multiple scientific approvals, and board approval, and we have the best company in North America with the greatest experience with these neural stem cells, with the best researcher we have for the potential to address this disease, and we have brand-new data that demonstrates and totally contradicts the key weakness on which it was downgraded.”
Here is the text of Klein's remarks on behalf of a second application, also rejected by CIRM reviewers.
“This is the only other disease team grant I will address. Very specifically, this was a disease team grant that I was on the peer review in the planning grant stage. There are some fundamental issues here. Is the international company on which the one antibody that's not coming from Stanford, the two for sorting are coming from Stanford, is the other antibody coming from this international company a commitment that you can rely on? 
“The reviewers said this was a showstopper. That's the word they used. They made a decision this was a showstopper because they did not believe the company because they thought that the documentation was inadequate. You now have a letter that goes into great proprietary depth about the depth of this company's commitments written by the head of development and translation internationally for the company. 
“If we cannot depend on company commitments of this type, and you will review the letter in executive session, if you have one, I will not understand how we'll be able to collaborate with companies with proprietary products and processes where they're making commitments to academic institutions of the highest standard. I believe this company is going to perform. I was on an hour call to confirm with eight members of that company their level of commitment, and I am completely convinced by that point. 
“The review is completely factually wrong on this issue about the other two antibodies for sorting this. Dr. (Irv) Weissman has just said they have not only been developed, they have been used in clinical trials. There's data on them. And they are, in fact, being thawed under FDA direction to reuse in this trial. 
“So I believe there's a major factual difference. Remember with Karen Aboody there was a major factual error that was pivotal in elevating that, and we found tremendous performance on that grant by Karen Aboody of City of Hope
“So you have a decision to make. As a risk issue, do we believe this company? Finally, this is broader than SCID. 
Donald Kohn has written a letter that's in the public domain that I suggest you read. It makes it very clear that opening the niche for repopulating the immune system without chemotherapy and radiation is a key contribution to every form of genetically modified stem cells for an entire range of childhood diseases and other genetic diseases in addition to therapies like sickle cell or aids. 
“I suggest that that profound contribution that can be made to the field is a risk that is worth taking early on because of his contribution to so many other areas. You have 12 other letters from North America's leading pediatric geneticists that fundamentally provide extraordinary support for this position and this approach.”
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