BioCentury This Week Ep. 328 - Brain Shuttles, GSK Q&A and FDA Vouchers
Oct 21, 2025
Discover groundbreaking innovations for delivering medicines to the brain, including advances in blood-brain-barrier shuttles. Explore GSK's strategic focus on RNA modalities and its emphasis on causal biology in drug development. Dive into the complexities of FDA's new national priority vouchers and their implications for the biopharma landscape. Learn how staffing challenges at the FDA might influence the industry's future. Each topic offers insights into the evolving world of biotech and drug delivery.
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Blood-Brain Barrier Is The Core CNS Bottleneck
- The blood-brain barrier excludes most antibodies and limits small molecules, creating a major CNS drug-delivery challenge.
- Solving delivery could expand biologics into neurology and psychiatry beyond rare severe cases.
Engineering Determines Shuttle Success
- Successful shuttles exploit endothelial receptors like transferrin to transcytose biologics into the brain.
- Engineering choices—target conformation, affinity and valency—determine whether cargo is trafficked across or degraded.
Hunter Syndrome Shows Early Shuttle Wins
- Denali pioneered shuttle-enabled delivery and has a therapy under FDA review for Hunter syndrome.
- JCR Pharmaceuticals already won approval in Japan for a similar approach in Hunter syndrome.