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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.

Speaker(s)

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