Biotech venture capital is risky business, inherently at the mercy of regulators and binary outcomes. Now it may face a new challenge in the form of Vinay Prasad, who this week was named to lead the FDA's Center for Biologics Evaluation and Research.

Not Vinay Prasad. The new top regulator of vaccines and gene therapies at the Food and Drug Administration has never shied away from speaking his mind — whether in academic papers, on social media, or on a diary-esque Substack called “Vinay Prasad’s Observations and Thoughts.”

In his new role with the FDA, Dr. Vinay Prasad will oversee the regulation of costly drugs, including vaccines, gene therapies, and blood supply.