Abstract
The current regulatory landscape for the development of oligonucleotide drugs may lead companies to perform a variety of small molecule-focussed absorption, distribution, metabolism and elimination (ADME) studies in support of filing packages. Asking the question, if the current activities are suitable for these modalities and should science-driven decisions on development of such molecules be implemented more in the industry. Challenges and opportunities within oligonucleotide ADME were presented and discussed at the online oligonucleotide ADME workshop (17th and 18th of November 2021). This article summarises the presentations and discussions from the workshop. The following topics were covered: Introduction to Delivery of Antisense RNA Therapeutics (DARTER), Nucleic Acid Therapy Accelerator (NATA) and OligoNova initiatives. Presentation of various oligonucleotide ADME strategies. Update on the Oligonucleotide Safety Working Group (OSWG) pharmacokinetics (PK)/ADME subcommittee’s recommendations. Oligonucleotide quantitative whole-body autoradiography (QWBA) hot or not? Multimodal imaging of therapeutic oligonucleotides.
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