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Session 7 Track 3: Oligonucleotide Delivery: New Developments and Regulatory Strategies
Session Chair(s)
Ramin Darvari, PhD, MS
Research Fellow, Pfizer Inc., United States
Rohit Tiwari, PhD
Director, Global Regulatory Affairs-CMC, Eli Lilly and Company, United States
This session will cover the regulatory strategies associated with any modifications made to oligonucleotides to overcome and/or supplement delivery. Conjugation of oligonucleotides with targeting entities has been explored to improve their pharmacokinetic and pharmacodynamic properties. Bridging considerations: Ease of use, improved adherence, reduced health care resource use are some of the advantages of drug-device combination products such as autoinjectors. However, the introduction of any combination product late in the development brings regulatory considerations for bridging the early phase presentations with the commercial presentations.
Learning Objective : - Describe some of the regulatory strategies for the control of oligonucleotide-linkers for the antibody-oligonucleotide conjugates
- Explain the potential regulatory hurdles for the bridging of the drug device combination products along with the science and risk-based solutions
- Outline some of the potential strategies and opportunities for alignment between industry and regulators to facilitate patient centric oligonucleotide drug development
Speaker(s)
Speaker
Andrea Redd
Senior Vice President, Head of US Regulatory Affairs and Pharmacovigilence, Fresenius Kabi USA LLC, United States
Speaker
Sebastien Caille
Senior Director, Avidity, United States
Speaker
Firoz Antia, PhD
Vice President, Oligonucleotide and Small Molecule CMC, Denali Therapeutics, United States
Speaker
Rumi Raquel Young, MS
Director, Regulatory Policy, Novo Nordisk A/S, United States
Speaker
Lawrence Blas Perez, PhD
Senior Pharmaceutical Quality Assessor, CDER, FDA, United States