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Critical Path Institute Launches 'One to Millions' to Reshape the Future of Individualized Medicine at Global Scale

On Thursday, the Critical Path Institute launched One to Millions, a global public-private initiative designed to scale development of advanced therapies for highly individualized conditions.
Existing regulatory frameworks built for population-based medicines create access gaps; Janet Woodcock, former FDA Acting Commissioner, noted that progress stalls when information remains unavailable for collective analysis.
Klaus Romero, chief executive officer of C-Path, described a centralized, regulatory-ready data platform that standardizes manufacturing protocols, reducing disproportionate expenses in small-volume drug development.
Partners including the n-Lorem Foundation, Mila's Miracle Foundation, and N=1 Collaborative joined the effort, with Sarah Glass, chief operating officer of n-Lorem, citing 'substantial momentum' to solve nano-rare challenges.
Timothy Yu of Boston Children's Hospital called the framework a 'critical new tentpole' for genetics, noting it enables developers to leverage data across therapies without restarting regulatory processes.

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New initiative aims to scale individualized therapies for rare diseases

Critical Path Institute (C-Path) today announced the launch of One to Millions, a global, multi-stakeholder public-private initiative to enable scalable development of advanced therapies for highly individualized conditions.

4 days ago·United States

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