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Washington Court Hotel

Sep 25, 2013 8:00 AM - Sep 27, 2013 5:00 PM

525 New Jersey Avenue NW, Washington, DC 20001

DIA/FDA Oligonucleotide-based Therapeutics Conference

Session 3A (Nonclinical Track): Immunogenicity Assessment for Oligonucleotides

Session Chair(s)

Rosanne  Seguin, PhD

Rosanne Seguin, PhD

McGill University, Canada

L. Peyton  Myers, PhD

L. Peyton Myers, PhD

Senior Pharmacology and Toxicology Reviewer; Div of Antiviral Products, CDER

FDA, United States

Instances of immunogenicity have been shown to affect the safety and pharmacokinetics of individual drug products. Is immunogenicity an important consideration for oligonucleotide therapeutics? This session will begin with a general overview of oligonucleotide immunogenicity then continue with presentations exploring assessments of immunogenicity associated with short- and long-duration oligonucleotide therapy.

Speaker(s)

David  Pisetsky, MD, PhD

Immunogenicity of Oligonucleotides

David Pisetsky, MD, PhD

Duke University Medical Center, United States

Department of Medicine

John S. Grundy, PhD

Assessments of Immunogenicity Associated with Long-Term Oligonucleotide Administration

John S. Grundy, PhD

Ionis Pharmaceuticals, Inc., United States

Vice President, DMPK & Toxicology

Philip  Oldfield, PhD, MSc

Immunogenicity of Oligonucleotide Therapeutics – Points to Consider

Philip Oldfield, PhD, MSc

Philip Oldfield Bioanalytical Consulting, Canada

President

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