Lisa Kammerman, Ph.D.

Lisa Kammerman, Ph.D., spent 24 years as an FDA statistical reviewer, including as an FDA Master Statistical Reviewer — one of the agency's most senior statistical positions. She is best known for her role in the Makena case, where she was the sole reviewer to argue against approval, a position later vindicated when the drug was withdrawn from the market. She now consults for biotech and pharma companies navigating NDA and BLA submissions, helping teams build the statistical strategies that hold up under FDA review.