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Meeting report: oligonucleotide ADME workshop.

Steve Hood1, David Kenworthy1, Jesper Kammersgaard Christensen2

  • 1Department of Research, In Vitro/In Vivo Translation, GlaxoSmithKline, Stevenage, UK.

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Summary

Current regulatory approaches for oligonucleotide drug development may not align with the unique needs of these therapies. This workshop highlighted challenges and opportunities in oligonucleotide ADME, advocating for science-driven decisions in the industry.

Keywords:
ADMEADME strategiesOligonucleotide initiativesOligonucleotidesdrug development

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Area of Science:

  • Pharmacology
  • Drug Development
  • Biochemistry

Background:

  • Current regulatory frameworks for oligonucleotide drug development often rely on small molecule-focused ADME studies.
  • This approach may not be optimal for the unique characteristics of oligonucleotide therapeutics.
  • There is a need to re-evaluate and adapt ADME strategies for these novel modalities.

Purpose of the Study:

  • To discuss challenges and opportunities in oligonucleotide ADME.
  • To summarize key findings and recommendations from the oligonucleotide ADME workshop.
  • To promote science-driven decision-making in oligonucleotide drug development.

Main Methods:

  • Summary of presentations and discussions from an online oligonucleotide ADME workshop.
  • Review of initiatives like DARTER, NATA, and OligoNova.
  • Discussion of various oligonucleotide ADME strategies and recommendations from the OSWG PK/ADME subcommittee.

Main Results:

  • Identified gaps between current ADME practices and oligonucleotide therapeutic needs.
  • Explored various strategies for assessing oligonucleotide ADME, including QWBA and multimodal imaging.
  • Highlighted the importance of adapting regulatory expectations and industry practices.

Conclusions:

  • Existing ADME study designs may require modification for oligonucleotide therapeutics.
  • Adoption of specialized ADME strategies and imaging techniques is crucial for successful development.
  • Industry-wide adoption of science-driven decisions is recommended for advancing oligonucleotide therapies.