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Bethesda North Marriott Hotel and Conference Center

Apr 25, 2022 7:00 AM - Apr 27, 2022 12:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!

Session 3 Track 1: Clinical Development of Oligonucleotide Therapeutics for Viral and Kidney Diseases

Session Chair(s)

Laura  Sepp-Lorenzino, PhD

Laura Sepp-Lorenzino, PhD

Chief Scientific Officer

Intellia Therapeutics, Inc., United States

Zheng Li Li, PhD

Zheng Li Li, PhD


FDA, United States

This session will provide updates on siRNAs in clinical development for chronic hepatitis and cancer. Liver-targeted silencers of Hepatitis B Virus are being developed in combination with viral life cycle inhibitors and immune enhancing therapies, with the goal of breaking tolerance and establishing a functional cure in chronic hepatitis B patients. Phase ½ mono and combination therapy data for two HBV silencers will be presented. The last talk will highlight the clinical experience with an extra-hepatic siRNA candidate being developed for renal cell carcinoma, targeting HIF2.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Compare and contrast various oligonucleotide modalities and their applications
  • Recognize clinical development considerations and trial designs for mono and combination therapies
  • Discuss data from most advanced oligonucleotide drug/candidates for liver and kidney disease targets


Daniel  Cloutier, PharmD

Clinical Development of VIR-2218, a GalNAc-siRNA Targeting Hepatitis B, in Combination with Immune Enhancing Therapies: Daniel Cloutier, PharmD

Senior Director, Clinical Research, Clinical Lead, HBV Program

Vir Biotechnology, Inc., United States

Michael  Biermer, MD

Short Interfering RNA JNJ-3989 Combination Therapy: Michael Biermer, MD

Senior Medical Director, Clinical Development

Janssen Pharmaceuticals, Belgium

James Hamilton Hamilton, MD, MBA

ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma Ph1b: James Hamilton Hamilton, MD, MBA

Senior Vice President, Discovery and Transitional Medicine

Arrowhead Pharmaceuticals, United States

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