Oligonucleotide therapeutics safety considerations across drug development

Developing safe oligonucleotide therapeutics requires careful consideration of challenges that differ from those of traditional drug modalities. As antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs) continue to transform therapy, understanding their unique nonclinical safety profile has become increasingly important. 

This session explores species selection, tissue distribution, immune effects and class-specific toxicities, alongside current regulatory expectations and industry perspectives.

Through practical case examples, attendees will gain a deeper understanding of the challenges associated with oligonucleotide therapeutics and the considerations that support their safe and successful development. 

What you’ll learn:

• Understand the unique safety considerations of oligonucleotide therapeutics, including mechanisms of action, pharmacokinetics, biodistribution and class-specific toxicities.
• Explore the key translational challenges of predicting clinical safety from nonclinical studies,including on-target, off-target and chemistry-driven toxicities.
• Learn how global regulatory expectations are evolving for oligonucleotide therapeutics and what sponsors should consider when designing nonclinical safety programmes.
• Ask the expert speakers your questions during the live Q&A.

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Meet your speakers:

Dr Xiaoxia Li – Executive Technical Director, Toxicology

Dr Xiaoxia Li joined WuXi AppTec in 2020 and has more than 17 years of experience in preclinical drug development. She specialises in nonclinical drug development, including the design and conduct of toxicology programmes, toxicokinetic modelling and in silico mutagenicity prediction. 

Before joining WuXi AppTec, Dr Li was a scientific leader in nonclinical development at a pharmaceutical company in Toronto, Canada, before establishing her own consultancy, Sunrise Innovative Drug Development (IDD). She began her career at Bozo (Biology and Zoology) Research Center, a preclinical contract research organisation (CRO) in Tokyo, Japan, before spending more than 13 years as a study director and principal toxicologist at ITR Laboratories in Montreal, Canada.

Dr Li holds an MD and MSc from Heilongjiang and Liaoning University of Traditional Chinese Medicine in China, and a PhD in Pharmacology from Tokyo Medical University in Japan. She is also a Diplomate of the American Board of Toxicology (DABT).