Oligonucleotide-Based Therapeutics Conference

Convening industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development.

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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.

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