The American Society of Gene and Cell Therapy (ASGCT) conference is currently underway in New Orleans, highlighting critical discussions in the field, including the notable case of Baby KJ in gene editing.

At the conference, Vinay Prasad, a hematologist known for his critical stance on the pharmaceutical industry, has taken over as head of the FDA's biologics division, succeeding Peter Marks, who was dismissed by the Trump administration.

Prasad's upcoming decisions regarding rare disease treatments are a significant area of speculation among industry advocates, who hope that these treatments will continue to receive approval despite limited evidence.

Marks was previously viewed favorably by stakeholders for his support of gene therapy approvals, which raises questions about how Prasad's regulatory approach may differ.