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Session 4 Track A & B: Evaluation of QT Prolongation Potential and Assessment of Immunogenicity
Session Chair(s)
Hobart Rogers, PharmD, PhD
Pharmacologist
FDA, United States
Scott Henry, PhD
Vice President, Nonclinical Development
Ionis Pharmaceuticals, Inc., United States
Oligonucleotide therapeutics have unique characteristics that often require differential pre-clinical and clinical assessment compared to small molecules. This session will address two of these topics: Topic One will focus on the nonclinical and clinical aspects of the assessment of QT prolongation potential; Topic Two will focus on the evaluation of the nonclinical and clinical aspects regarding immunogenicity. Both topics will have perspective presentations from both industry and regulatory speakers. Following the presentations, a joint panel will convene to further discuss these topics with implications for guiding future regulatory oversight.
Speaker(s)
Are Oligonucleotide Therapeutics Too “Large” to Interact with Cardiac Ion Channels: Insights from the FDA Database
Wendy Wu, PhD
FDA, United States
Pharmacologist
Oligonucleotide Cardiovascular Safety Testing
James Kramer, PhD
Charles River Laboratories, United States
Principal Scientist
Clinical QT Assessment for Oligonucleotide-Based Therapeutics: Regulatory Experience and Current Thinking
Nan Zheng, PhD
Office of Clinical Pharmacology/CDER, FDA, United States
Scientific Lead
QT Evaluation for Antisense Oligonucleotides: Ionis Experience
Yanfeng Wang, PhD
Ionis Pharmaceuticals, United States
Executive Director
Panel Discussion
Panel Discussion
All Session Speakers, United States
FDA Presentation: Assessment of Immunogenicity Studies
Zhenzhen Liu
CDER, FDA, United States
Biologist
Immunogenicity Assessments for Antisense Oligonucleotides
Zhenrong Yu, PhD
Ionis Pharmaceuticals, Inc, United States
Executive Director
Perspectives on the Designation of Oligonucleotide Starting Materials
Daniel Mytych, PhD
Department of Translational Medicine, Amgen, Inc. , United States
Scientific Director, Clinical Immunology