New Publication: Paving the Way for Scalable, Individualized Therapies in Rare Disease

IRDiRC is proud to announce the publication of the latest article in Therapeutic Advances in Rare Disease: “From Roadmap to a Sustainable End-to-End Individualized Therapy Pathway.”

This publication builds on the foundational work of the IRDiRC N-of-1 Task Force, expanding from the initial roadmap to explore how N-of-1 therapies—custom treatments for individuals with ultra-rare genetic conditions—can evolve from experimental efforts into a scalable, sustainable healthcare model.

Key themes:

  • Bridging the gap between one-off experimental treatments and broader implementation
  • Prioritizing patient safety, efficacy, and clear regulatory pathways
  • Establishing registries, data-sharing platforms, and systems for long-term monitoring
  • Partnering with patient communities and developing new reimbursement frameworks
  • Addressing ethical considerations, promoting education, and fostering cross-sector collaboration

This work envisions a future where individualized therapies become a practical, integrated option within the healthcare system—not just rare exceptions.

Read the full article here: https://journals.sagepub.com/doi/10.1177/26330040251339204