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DIA/FDA Oligonucleotide-Based Therapeutics Conference

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Session 7 Track 3: Oligonucleotide Delivery

Session Chair(s)

Ramin Darvari, PhD, MS

Ramin Darvari, PhD, MS

  • Associate Research Fellow
  • Pfizer Inc., United States
Rohit Tiwari, PhD

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)

Adam Dinerman, PhD

CMC Considerations for Protein-Oligonucleotide Conjugates

Adam Dinerman, PhD

  • Executive Director, Head of Chemistry, Manufacturing and Controls (CMC)
  • Aro Biotherapeutics, United States
Ramin Darvari, PhD, MS

Regulatory Reliance in the Age of Complex Modalities

Ramin Darvari, PhD, MS

  • Associate Research Fellow
  • Pfizer Inc., United States
Brian Dooley, MPharm, MSc

Panelists

Brian Dooley, MPharm, MSc

  • Quality Specialist
  • European Medicines Agency, Netherlands
Rachel Johns, PhD

Panelists

Rachel Johns, PhD

  • Senior Director, Analytics and Formulations
  • Avidity Biosciences, Inc., United States
Donald Parsons, PhD

Panelists

Donald Parsons, PhD

  • Vice President, Early Technical Development and LNP Process Development
  • Moderna, United States

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