Director, FDA Center for Biologics Evaluation and Research
Appears in 4 stories
Reversed the initial refusal to review mRNA-1010
For 80 years, flu vaccines grew in chicken eggs — a process effective against roughly 40% of infections in good years. On May 8, the New England Journal of Medicine published Moderna's Phase 3 data: mRNA-1010 reduced influenza illness by 26.6% more than a standard shot in 40,805 adults aged 50 and older. Moderna's stock rose 16% that day.
Updated May 31
Returned to CBER director role after brief departure in mid-2025
For decades, the FDA required all drugs to prove effectiveness through controlled trials with sufficient sample sizes, a standard that made sense for common diseases but created an impossible barrier for ultra-rare conditions. On February 23, 2026, the FDA issued draft guidance for a new standard—the 'plausible mechanism' framework. Developers of gene-editing and ribonucleic acid (RNA) therapies could win full approval by showing that their treatment targets the root genetic cause, engages it, and improves outcomes compared to the disease's natural course.
Updated May 29
Active, serving in dual roles
For 63 years, the FDA required drugmakers to prove their products worked in at least two rigorous clinical trials. On February 18, 2026, Commissioner Marty Makary formally ended that standard. Now one trial is the 'default position' for all new drugs—from rare diseases to common conditions affecting millions of patients. In accompanying articles published in the New England Journal of Medicine and JAMA, Makary and Deputy Commissioner Vinay Prasad emphasized that the single-trial standard doesn't eliminate evidence requirements. Instead, sponsors must provide 'confirmative evidence' through mechanistic data, findings from related indications, animal models, real-world evidence, or data from drugs in the same class.
Co-developing guidance on personalized therapy approvals
In August 2024, KJ Muldoon was born with a death sentence encoded in his DNA—a single broken letter among three billion that left his body unable to process protein. Six months later, he walked out of Children's Hospital of Philadelphia, cured by a gene-editing therapy designed, manufactured, approved, and delivered in 180 days.
Updated May 19
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