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Session 7 Track 3: Oligonucleotide Delivery
Session Chair(s)
Ramin Darvari, PhD, MS
Research Fellow, Pfizer Inc., United States
Rohit Tiwari, PhD
Director, 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)
Adam Dinerman, PhD
Executive Director, Head of Chemistry, Manufacturing and Controls (CMC), Aro Biotherapeutics, United States
CMC Considerations for Protein-Oligonucleotide Conjugates
Ramin Darvari, PhD, MS
Research Fellow, Pfizer Inc., United States
Regulatory Reliance in the Age of Complex Modalities
Brian Dooley, MPharm, MSc
Pharmaceutical Quality Senior Specialist, European Medicines Agency, Netherlands
Panelists
Rachel Johns, PhD
Senior Director, Analytics and Formulations, Avidity Biosciences, Inc., United States
Panelists
Donald Parsons, PhD
Vice President, Early Technical Development and LNP Process Development , Moderna, United States
Panelists
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