When a gene therapy sponsor pauses a clinical program, the operational machinery responds within hours. The medical monitor convenes a safety review. Regulatory...
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When Trace Neuroscience announced on June 22 that first patients had been dosed in the LAUNCH ALS trial, it felt like the right moment to revisit our original p...
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On June 23, 2026, the US Department of Health and Human Services launched Operation Trailblazer, a cross-agency initiative coordinated across the FDA, NCI, NCAT...
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Most genetic medicine is built for populations large enough to support a clinical trial. N-of-1 medicine is built for the opposite case: a single patient whose ...
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On June 2, 2026, the FDA released draft guidance that could reshape how gene therapies reach patients. The document, "Leveraging Prior Knowledge in the Developm...
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What four episodes of The Genetics Podcast reveal about the future of Alzheimer’s precision medicine
Alzheimer’s research is entering a new phase. For decades, the field has been shaped by the biology of amyloid plaques and tau tangles. Those remain central to ...
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Precision medicine sponsors invest heavily to identify, educate, screen, consent, genotype, and support rare patients. In many programs, once a trial ends, that...
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UK Biobank and similar resources have made an extraordinary contribution to biomedical research, enabling important advances across genomics, population health,...
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Recruitment in precision medicine and rare disease trials remains constrained by fragmented data, low prevalence populations, and heavy reliance on site-based p...
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Rare disease exposes the limits of current clinical development models. Small, fragmented populations make patient identification difficult. Heterogeneous biolo...
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