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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, CDER, FDA, United States
Scott Henry, PhD
Senior 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)
Wendy Wu, PhD
Pharmacologist, FDA, United States
Are Oligonucleotide Therapeutics Too “Large” to Interact with Cardiac Ion Channels: Insights from the FDA Database
James Kramer, PhD
Principal Scientist, Charles River Laboratories, United States
Oligonucleotide Cardiovascular Safety Testing
Nan Zheng, PhD
Scientific Lead, Office of Clinical Pharmacology/CDER, FDA, United States
Clinical QT Assessment for Oligonucleotide-Based Therapeutics: Regulatory Experience and Current Thinking
Yanfeng Wang, PhD
Executive Director, Ionis Pharmaceuticals, United States
QT Evaluation for Antisense Oligonucleotides: Ionis Experience
Panel Discussion
, All Session Speakers, United States
Panel Discussion
Zhenzhen Liu
Biologist, CDER, FDA, United States
FDA Presentation: Assessment of Immunogenicity Studies
Zhenrong Yu, PhD
Executive Director, Ionis Pharmaceuticals, Inc, United States
Immunogenicity Assessments for Antisense Oligonucleotides
Daniel Mytych, PhD
Scientific Director, Clinical Immunology, Department of Translational Medicine, Amgen, Inc. , United States
Perspectives on the Designation of Oligonucleotide Starting Materials
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