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SRT Board Member Jeff Coller argues that the regulatory framework must be redesigned to treat personalized mRNA-CRISPR gene editing as "molecular surgery," validated once rather than approved as a new drug each time. The approach would transform KJ Muldoon's rescue from a singular miracle into a repeatable model for thousands of children born with rare mutations. The Society for RNA Therapeutics is positioned to provide the professional governance infrastructure this vision requires: setting manufacturing standards, establishing clinical guidelines, and brokering the public-private-regulatory partnerships that could make accredited Molecular Surgery Centers a reality.
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