Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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


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

FDA, United States


James  Kramer, PhD

Oligonucleotide Cardiovascular Safety Testing

James Kramer, PhD

Charles River Laboratories, United States

Principal Scientist

Nan  Zheng, PhD

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

Yanfeng  Wang, PhD

QT Evaluation for Antisense Oligonucleotides: Ionis Experience

Yanfeng Wang, PhD

Ionis Pharmaceuticals, United States

Executive Director

  Panel Discussion

Panel Discussion

Panel Discussion

All Session Speakers, United States

Zhenzhen  Liu

FDA Presentation: Assessment of Immunogenicity Studies

Zhenzhen Liu

CDER, FDA, United States


Zhenrong  Yu, PhD

Immunogenicity Assessments for Antisense Oligonucleotides

Zhenrong Yu, PhD

Ionis Pharmaceuticals, Inc, United States

Executive Director

Daniel  Mytych, PhD

Perspectives on the Designation of Oligonucleotide Starting Materials

Daniel Mytych, PhD

Department of Translational Medicine, Amgen, Inc. , United States

Scientific Director, Clinical Immunology

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.