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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 & 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.