{"id":1063569,"date":"2012-08-26T15:50:51","date_gmt":"2012-08-26T15:50:51","guid":{"rendered":"https:\/\/www.immortalitymedicine.tv\/text-of-kleins-comments-supporting-rejected-applications\/"},"modified":"2024-08-17T20:30:48","modified_gmt":"2024-08-18T00:30:48","slug":"text-of-kleins-comments-supporting-rejected-applications-3","status":"publish","type":"post","link":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/stem-cell-therapy\/text-of-kleins-comments-supporting-rejected-applications-3.php","title":{"rendered":"Text of Klein&#8217;s Comments Supporting Rejected Applications"},"content":{"rendered":"<p><a href=\"http:\/\/feedads.g.doubleclick.net\/~a\/InhmU3QQKUVaXj1RG7Qq-cqp0I8\/0\/da\"><img decoding=\"async\" src=\"https:\/\/www.immortalitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/dd823_di\" border=\"0\" style=\"padding-left:10px; padding-right: 10px;\"><\/a><br><a href=\"http:\/\/feedads.g.doubleclick.net\/~a\/InhmU3QQKUVaXj1RG7Qq-cqp0I8\/1\/da\"><img decoding=\"async\" src=\"https:\/\/www.immortalitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/dd823_di\" border=\"0\" style=\"padding-left:10px; padding-right: 10px;\"><\/a><\/p><p><b>Robert Klein<\/b>, who served 6 &frac12; years as the first chairman<br>of the $3 billion California stem cell agency, &nbsp;testified before the agency's board&nbsp;for the first time on July 26, 2012. Klein, a real<br>estate investment banker and attorney, spoke on behalf of two applicants whose<br>grants had been rejected by the agency's reviewers. The appearance<br>has raised questions about the propriety of Klein's actions.<\/p><p>Here is a link to an item on his appearance. Here is the text of<br>his comments as reported in<a href=\"http:\/\/www.cirm.ca.gov\/files\/transcripts\/pdf\/2012\/07-26-12_ICOC.pdf\"> the transcript of the meeting.<\/a><\/p><blockquote><p>&ldquo;As the board knows, I've never addressed any grant from the<br>floor.  It is critical here to understand that we have here<br><b>StemCells, Inc.<\/b>, which is the only company in North America<br>and, for that matter, maybe in the world, that has had two stem cell<br>therapies in the brain with these specific neural stem cells. They<br>have a huge body of experience here.&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;Secondly, one of the fundamental issues here that it (the<br>company's grant application) was downgraded on was the issue of the<br>fundamental concept, the platform concept, of injecting two focal<br>injections in the brain, in the hippocampus of the brain.  It's<br>important to note that I've sat on three (CIRM)peer reviews where the<br>scientists really affirmed this specific approach with extremely high<br>scores, three different views. All right.<\/p><\/blockquote><blockquote><p>&ldquo;So it's very important to realize we have a standard deviation<br>here of 12 (on the review scores).  These scientists were completely<br>split.  With some recusals on that panel, if you have 12 or 13 that<br>can really vote, three or four very low scores can bring it out of<br>the funding category all the way down.  It is in the region where<br>this board is looking where the other three peer reviews, right,<br>early translation, the one before that was the planning grant review,<br>that the hippocampus was a good platform.<\/p><\/blockquote><blockquote><p>&ldquo;Then they said the key weakness was you can't show migration.<br>Dr. <b>Laferla<\/b> (a co-PI on the application) has told me that<br>today the <b>Journal of Neuroscience<\/b> accepted the publication of<br>the data demonstrating migration.  It was stated previously in the<br>application, but it wasn't accepted for publication.  It now is.<br>That is the fundamental weakness that they identified in this<br>approach.&nbsp;&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;So we have a reaffirmed approach to the hippocampus by three<br>different peer review groups and a substantial portion of these<br>reviewers along with data dealing with the weak point. I'm sorry it<br>happened today.  The data was out there, accepted for publication<br>today, means that it should definitely fall into this category.  And,<br>of course, Dr. (<b>Alan) Trounson<\/b> (president of CIRM) wouldn't<br>have been able to review that in process because he was recused from<br>this grant by his own voluntary recusal.  So the progress of this<br>data being accepted for publication is new information today.&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;If I look at the entire history of CIRM, as <b>Leeza (Gibbons<\/b>,<br>a CIRM director) says, building up to this point, we have reaffirmed<br>this approach from the very beginning with Dr. Laferla, with multiple<br>scientific approvals, and board approval, and we have the best<br>company in North America with the greatest experience with these<br>neural stem cells, with the best researcher we have for the potential<br>to address this disease, and we have brand-new data that demonstrates<br>and totally contradicts the key weakness on which it was downgraded.&rdquo;<\/p><\/blockquote><div>Here is the text of Klein's remarks on<br>behalf of a second application, also rejected by CIRM reviewers.<\/div><blockquote><p>&ldquo;This is the only other disease team grant I will address.  Very<br>specifically, this was a disease team grant that I was on the peer<br>review in the planning grant stage.  There are some fundamental<br>issues here.  Is the international company on which the one antibody<br>that's not coming from <b>Stanford<\/b>, the two for sorting are<br>coming from Stanford, is the other antibody coming from this<br>international company a commitment that you can rely on?&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;The reviewers said this was a showstopper. That's the word they<br>used.  They made a decision this was a showstopper because they did<br>not believe the company because they thought that the documentation<br>was inadequate.  You now have a letter that goes into great<br>proprietary depth about the depth of this company's commitments<br>written by the head of development and translation internationally<br>for the company.&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;If we cannot depend on company commitments of this type, and<br>you will review the letter in executive session, if you have one, I<br>will not understand how we'll be able to collaborate with companies<br>with proprietary products and processes where they're making<br>commitments to academic institutions of the highest standard.  I<br>believe this company is going to perform.  I was on an hour call to<br>confirm with eight members of that company their level of commitment,<br>and I am completely convinced by that point.&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;The review is completely factually wrong on this issue about<br>the other two antibodies for sorting this.  Dr. (<b>Irv) Weissman<\/b><br>has just said they have not only been developed, they have been used<br>in clinical trials.  There's data on them.  And they are, in fact,<br>being thawed under <b>FDA<\/b> direction to reuse in this trial.&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;So I believe there's a major factual difference.  Remember with<br><b>Karen Aboody<\/b> there was a major factual error that was pivotal<br>in elevating that, and we found tremendous performance on that grant<br>by Karen Aboody of <b>City of Hope<\/b>.&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;So you have a decision to make.  As a risk issue, do we believe<br>this company? Finally, this is broader than SCID.&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;<b>Donald Kohn<\/b> has written a letter that's in the public<br>domain that I suggest you read.  It makes it very clear that opening<br>the niche for repopulating the immune system without chemotherapy and<br>radiation is a key contribution to every form of genetically modified<br>stem cells for an entire range of childhood diseases and other<br>genetic diseases in addition to therapies like sickle cell or aids.&nbsp;<\/p><\/blockquote><blockquote><p>&ldquo;I suggest that that profound contribution that can be made to<br>the field is a risk that is worth taking early on because of his<br>contribution to so many other areas.  You have 12 other letters from<br>North America's leading pediatric geneticists that fundamentally<br>provide extraordinary support for this position and this approach.&rdquo;<\/p><\/blockquote><div><img loading=\"lazy\" decoding=\"async\" width=\"1\" height=\"1\" src=\"https:\/\/www.immortalitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/dd823_10000891-6826529663906735882?l=californiastemcellreport.blogspot.com\" alt=\"\" style=\"padding-left:10px; padding-right: 10px;\"><\/div><p><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.immortalitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/dd823_FIhxEzEUc5c\" height=\"1\" width=\"1\" style=\"padding-left:10px; padding-right: 10px;\">Source:<br><a href=\"http:\/\/californiastemcellreport.blogspot.com\/feeds\/posts\/default?alt=rss\">http:\/\/californiastemcellreport.blogspot.com\/feeds\/posts\/default?alt=rss<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Robert Klein, who served 6 &frac12; years as the first chairmanof the $3 billion California stem cell agency, &nbsp;testified before the agency's board&nbsp;for the first time on July 26, 2012. Klein, a realestate investment banker and attorney, spoke on behalf &hellip; <a href=\"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/stem-cell-therapy\/text-of-kleins-comments-supporting-rejected-applications-3.php\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":64,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"limit_modified_date":"","last_modified_date":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[25,1246878],"tags":[],"class_list":["post-1063569","post","type-post","status-publish","format-standard","hentry","category-stem-cell-therapy","category-stem-cells"],"modified_by":null,"_links":{"self":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/1063569"}],"collection":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/users\/64"}],"replies":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/comments?post=1063569"}],"version-history":[{"count":0,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/1063569\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/media?parent=1063569"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/categories?post=1063569"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/tags?post=1063569"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}