Search Results for: rmat

Transformative idea for peer review: reviewing & grading the reviewers

Do you feel frustrated with the current peer review system in science? I have an idea that might help and it involves the revolutionary idea of reviewer accountability. In other words, authors and grant writers in essence review their reviewers. I’ve made this all the easier for you with templates that you can simply and …

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Dr Lookgood, dermatologist to the stars, gets FDA warning letter

Dr-LookGood1

If you ever had a really bad day, March 13, 2012 might have been just such a bad day for one Dr. Steven Victor, aka “Dr LookGood”, because he received an official warning letter from the FDA. Why? Dr. Victor, who reportedly greets each patient with the catch phrase “You look so much more beautiful than your picture”, is …

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Histone code series: H3K27me3 & H3K27ac functions & roles in diseases like DIPG

ASCL1 in K27M tumors, H3K27me3 loss

Histone proteins such as histone H3 are often popping up in science writing and news sometimes includes specific modified forms of H3 including one that we scientists call H3K27me3. What is in this article What is H3K27me3? | The histone code | H3K27ac and H3K27me3 function | H3K27 and human disease | References The goal of today’s post …

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What are CAR-T cells & are they regenerative medicine?

CAR-T cells regenerative medicine

The first time I heard CAR-T cells referred to as a regenerative medicine it made me stop and think. Are CAR-T therapies really a type of regenerative medicine? Generally, CAR-T cells are a designer immune cell therapy. They work by killing cancer cells and that’s what came to mind to me. I don’t tend to …

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Weekly reads: teratoma in iPSC trial, Piero Anversa & friends, Athersys, China Initiative

Dr-Piero-Anversa

It’s been mostly a downbeat week on the stem cell news front including a deep revisit by Reuters to the Piero Anversa case that has new revelations. It’s ugly stuff involving other folks too. We’ll start on the iPS cell front, where a trial participant had a teratoma. I’ve had a long-standing interest in the …

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What is an FDA warning letter & how should firms respond

FDA warning letter

Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come …

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Paolo Macchiarini guilty in criminal stem cell case but does a Houdini again

Paolo-Macchiarini

Dr. Paolo Macchiarini exemplifies how things can change quickly in the stem cell world and go from sky highs to deep lows. Stem cell rollercoasters Over the years, a few academic stem cell researchers as well as some operators in the unproven clinic sphere have had dizzying ups and downs. There’s John Kosolcharoen. His company …

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The Niche foreign language outreach program: 2.5 million reads

stem cells

There was a time when The Niche was just about the only stem cell blog or even stem cell-dedicated website more generally across the globe. I realized early on that I needed to reach people who don’t speak English or for whom English is not their first language. This goal was crucial for effective educational …

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Weekly reads: neural stem cells, CRISPR brain, Vertex, cytoplasm surprise

neural stem cells

Some people consider the brain to be equivalent to a living computer and in that sense it’s too bad that computers don’t have the equal of neural stem cells to help them fix themselves. Is the internet one big neural network-like web? There was a quake in the stem cell internet as CIRM’s main website …

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End of FDA “grace period” impacted perinatal cell therapy biotechs

knot in umbilical cord, perinatal cell therapy

If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …

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