Financing the Future of Individualized Medicine: Funding Models for Rare Genetic Therapies

Roger Paxton, PhD serves as research manager for the Precision Medicine Institute at Children’s Hospital Colorado. He and his team support safety, quality, and sustainability standards for novel therapeutic trials. Additionally, he supports genomic diagnostics research operations at his home institution.

Ashley Kuniholm is the Regulatory Affairs Manager at Boston Children’s Hospital, assisting investigators across the Hospital with their FDA-regulated research, submissions to the Agency, including N=1 INDs, regulatory strategy for product development, and providing regulatory education to the BCH Research Community. She has previously held roles at BCH as an IRB administrator and Clinical Research Project Manager. Ashley is an active member of the N=1 Collaborative, as a member of the Operations Committee and co-lead of the Data Coordination, Institutional Implementation, and Regulatory Workgroups.