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Session 7 Track 3: Oligonucleotide Delivery
Session Chair(s)
Ramin Darvari, PhD, MS
Associate Research Fellow
Pfizer Inc., United States
Rohit Tiwari, PhD
Senior Research Scientist, Global Regulatory Affairs-CMC
Eli Lilly & Company, United States
Efficient delivery of oligonucleotide therapeutics to their intended target organs remains a hot topic for enhanced selectivity beyond the liver. Oligonucleotides conjugated to targeting moieties or encapsulated within nanoparticle modalities have enabled commercialization of drug products by improving the pharmacokinetic and pharmacodynamic properties of oligonucleotide therapeutics. This session will feature some of the advancements in this area along with developmental and chemistry, manufacturing and controls related to regulatory aspects.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the technology landscape for oligonucleotide delivery
- Recognize the CMC challenges associated with novel Oligonucleotide delivery approaches
- Learn about developmental and regulatory considerations regarding novel oligonucleotide delivery systems
Speaker(s)
CMC Considerations for Protein-Oligonucleotide Conjugates
Adam Dinerman, PhD
Aro Biotherapeutics, United States
Executive Director, Head of Chemistry, Manufacturing and Controls (CMC)
Regulatory Reliance in the Age of Complex Modalities
Ramin Darvari, PhD, MS
Pfizer Inc., United States
Associate Research Fellow
Panelists
Brian Dooley, MPharm, MSc
European Medicines Agency, Netherlands
Quality Specialist
Panelists
Rachel Johns, PhD
Avidity Biosciences, Inc., United States
Senior Director, Analytics and Formulations
Panelists
Donald Parsons, PhD
Moderna, United States
Vice President, Early Technical Development and LNP Process Development
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