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DIA/FDA Oligonucleotide-Based Therapeutics Conference

Session 4 Track A & B: Evaluation of QT Prolongation Potential and Assessment of Immunogenicity

Session Chair(s)

Hobart  Rogers, PharmD, PhD

Hobart Rogers, PharmD, PhD

  • Pharmacologist
  • FDA, United States
Scott  Henry, PhD

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.


Wendy  Wu, PhD

Are Oligonucleotide Therapeutics Too “Large” to Interact with Cardiac Ion Channels: Insights from the FDA Database

Wendy Wu, PhD

  • Pharmacologist
  • FDA, United States
James  Kramer, PhD

Oligonucleotide Cardiovascular Safety Testing

James Kramer, PhD

  • Principal Scientist
  • Charles River Laboratories, United States
Nan  Zheng, PhD

Clinical QT Assessment for Oligonucleotide-Based Therapeutics: Regulatory Experience and Current Thinking

Nan Zheng, PhD

  • Scientific Lead
  • Office of Clinical Pharmacology/CDER, FDA, United States
Yanfeng  Wang, PhD

QT Evaluation for Antisense Oligonucleotides: Ionis Experience

Yanfeng Wang, PhD

  • Executive Director
  • Ionis Pharmaceuticals, United States
  Panel Discussion

Panel Discussion

Panel Discussion

  • All Session Speakers, United States
Zhenzhen  Liu

FDA Presentation: Assessment of Immunogenicity Studies

Zhenzhen Liu

  • Biologist
  • CDER, FDA, United States
Zhenrong  Yu, PhD

Immunogenicity Assessments for Antisense Oligonucleotides

Zhenrong Yu, PhD

  • Executive Director
  • Ionis Pharmaceuticals, Inc, United States
Daniel  Mytych, PhD

Perspectives on the Designation of Oligonucleotide Starting Materials

Daniel Mytych, PhD

  • Scientific Director, Clinical Immunology
  • Department of Translational Medicine, Amgen, Inc. , United States