Recommended reads: Valentina Greco, CRISPR trials halted on safety, JAX acquisition, Prasad vs. CBER

It seems like there’s still chaos inside the FDA’s biologics branch CBER led by Vinay Prasad.

As many of you will remember, Prasad was forced out shortly after becoming CBER Director earlier this year. Then Makary and RFK Jr. pushed successfully to bring him back.

Since then apparently things have not been great between Prasad and his CBER team as well as other offices at the FDA where he is a leader.

This could impact the field of cell and gene therapies with delayed decisions and the possibility of political decisions.

Prasad vs. his own staff at CBER

Here’s the new STAT piece on what’s going on:Under Vinay Prasad, employees at a key FDA center fear speaking out, look for the exits. The biologics branch has remained functional this year largely because of retention of experienced not-so-high-profile leaders and reviewers there. If even a dozen more such people leave, biologics oversight could be in real trouble. The field could suffer.

I’m still waiting for some kind of shoe to fall from the FDA on biologics related to Kennedy’s priorities. Maybe on stem cells.

More recommended reads

• Shared responsibility and global progress in stem cell research, Nat Med. This was written by past ISSCR President Valentina Greco. I share her optimism about the state of the field. It’s helpful that she noted some key challenges.
• Intellia pauses two late-stage CRISPR gene-editing trials after emergence of safety concern Treated patient is hospitalized with liver damage, a known risk of therapy. STAT News. This is a big setback. Liver damage is a known risk factor for gene therapies more generally.
• The Jackson Laboratory completes acquisition of New York Stem Cell Foundation, Hartford Business. I’m not clear on the rationale here.
• FDA clears UCLA heart tissue regeneration drug AD-NP1 for clinical trials, UCLA.
• Justice Department unexpectedly drops fraud case against Alzheimer’s scientist, Science. This is weird by the DOJ.
• Stem cells sound magical, but they’re not all created equal. Here’s what you need to know, The Conversation.