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Results of FDA Reform Poll: speed up clinical trials & expand compassionate use

The poll I put up asking people their #1 top priority for FDA reform drew relatively big numbers of respondents. Speeding up clinical trials was clearly way out in front at #1. Expanding compassionate use was #2. These were followed by changing policy to no longer define lab-grown stem cells as drugs and FDA being …

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Interview with Arnold Caplan, Part 4: the FDA and the Future

Today is part of 4 (the last) of my interview with Dr. Arnold Caplan, MSC godfather and guru. You can read parts 1-3 of the interview here, here, and here. In this post I focus on my discussion with Caplan on translation of stem cells to patients and the FDA. During our conversation we talked about some …

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Interview with Arnold Caplan, Part 3: challenges & opportunities for clinical use of MSCs

I recently had a phone interview with Dr. Arnold Caplan, the founder of the MSC field. You can read parts 1 and 2 of the interview here and here. Today’s post, part 3, is focused on clinical use of MSCs. I want to start off today’s post with a wonderful quote from Caplan: “All MSCs …

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CIRM Ethics & Regulatory Steps: highly responsive to IOM

CIRM has indicated that the Institute of Medicine (IOM) recommended that CIRM provide funding for training and research on ethics and regulatory issues. In response to this recommendation and with the perspectives of various “CIRM funded researchers and other experts”, CIRM has responded with a new ethics & regulatory recommendation document. I have read it …

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Insightful interview with Arnold Caplan: Part 1: MSC history, nomenclature, & properties

A few days ago I had a long, very enjoyable phone conversation with the father of the mesenchymal stem cells (MSC) field, Dr. Arnold Caplan. Dr. Caplan is Professor of Biology, Director Skeletal Research Center at Case Western. He coined the phrase “mesenchymal stem cell” in the late 1980s. I’m going to break the interview …

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Bald heads & big smiles: St. Baldrick’s 2013 Sac Event Inspires

Last night there was a great fund-raising event for the St. Baldrick’s Foundation for children’s cancer research here in Sacramento. I was honored to captain the UC Davis School of Medicine Team (see at left). So far we have raised almost $2,500 for St. Baldrick’s. Please consider pitching in via this link. You can help …

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Viacyte & Mesoblast present at CIRM Meeting

Allan Robins of Viacyte (pictured at left–sorry for the fuzzy image) and Paul Simmons of Mesoblast presented this morning at the CIRM Grantee Meeting. Both talks were outstanding. Robins went first. He started by saying how Viacyte had a productive pre-IND meeting with the FDA last year. I believe a target for them is to …

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How baldness can cure kid’s cancer: find out & please help!

Hi everyone, St. Baldrick’s is the top children’s cancer foundation and does amazing work for kids with cancer and their families. Their top fundraising event is a head-shaving program where people make pledges in support of a “shavee” who gets their head shaved in solidarity with kids with cancer who often lose their hair due …

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