‘You Could Call This a Functional Cure’: What We Heard This Week

“If you define functional cure by accepting the requirement for immunosuppression, then I think you could call [this] a functional cure.” — Michael Rickels, MD, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, on an investigational stem cell-derived therapy that helped people with type 1 diabetes achieve insulin independence.
“It feels a little loosey-goosey, and it has the potential to be a big step away from FDA’s standard in all the other accelerated review programs: unmet medical need.” — FDA regulatory and policy consultant Steven Grossman, JD, discussing the agency’s new national priority voucher program for expedited approvals.
“I think the NIH director understands that if you would say ‘whenever possible,’ that’s the end. That’s the kiss of death.” — Helen Tager-Flusberg, PhD, of Boston University, discussing patient privacy in federal autism research.
“Just because an antibody didn’t kill a rabbit doesn’t mean it won’t then kill the first person you dose.” — Alexander Rubinsteyn, PhD, of the University of North Carolina at Chapel Hill, on animal testing being phased out in clinical trials.
“If next year we were unable to recruit international medical residents to fill our training program, it would have very, very serious consequences.” — Douglas DeLong, MD, of an internal medicine residency program in upstate New York, on the potential effect of suspended applications for student visas.
“Clinicians should be aware of the persistent and in some cases rising burden of specific perinatal complications.” — Muzamil Khan, MD, of the George Washington University School of Medicine and Health Sciences in Washington, D.C., discussing U.S. neonatal mortality.
“This is a model that will help predict progression-free survival at the individual patient level, which does not currently exist.” — Andrew Evens, DO, of the Rutgers Cancer Institute in New Brunswick, New Jersey, on a new risk calculator for survival in early classic Hodgkin’s lymphoma.



