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A Multistakeholder Perspective on Advancing Individualized Therapeutics.

Michael Pacanowski1, Julia Vitarello2,3,4, Insoo Hyun5

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Summary
This summary is machine-generated.

Precision medicine is advancing towards "N-of-1" therapies for individual patients with severe diseases. Realizing this potential requires addressing scientific, clinical, and regulatory challenges through collaboration.

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Area of Science:

  • Biomedical Sciences
  • Genetics
  • Pharmacology

Background:

  • Precision medicine has evolved from pharmacogenetics to highly individualized therapies.
  • The concept of

Purpose of the Study:

  • To explore the challenges and opportunities in developing and implementing "N-of-1" medicines.
  • To highlight the need for a multistakeholder approach in advancing individualized therapies.

Main Methods:

  • Review and synthesis of current trends in precision medicine.
  • Identification of key scientific, clinical, and regulatory hurdles.
  • Exploration of collaborative strategies for access and evidence generation.

Main Results:

  • "N-of-1" medicines offer unprecedented opportunities for patients with severe diseases.
  • Significant scientific, clinical, and regulatory challenges impede the realization of individualized therapies.
  • A multistakeholder approach is crucial for progress.

Conclusions:

  • Advancing "N-of-1" medicine requires streamlined diagnostics, improved enabling technologies, and collaborative frameworks.
  • Addressing challenges in access and evidence generation is critical for realizing the promise of individualized therapies.
  • Future efforts must focus on a coordinated, multistakeholder strategy to overcome barriers and facilitate patient access.