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Bethesda North Marriott Hotel and Conference Center

25 oct 2017 7:00 a.m. - 27 oct 2017 3:00 p.m.

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

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Convening industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development.

Session 2B: Assessing the Implications of Oligonucleotide Uptake into Cells

Session Chair(s)

Xuan  Chi, PhD

Xuan Chi, PhD

Supervisory Pharmacologist

CDER, FDA, United States

This session will examine the cellular uptake and lysosomal processing of single-stranded oligonucleotides by the most frequently affected tissues and cells following systemic administration (kidney and macrophages) and intrathecal administration (neurons). The histopathologic changes associated with uptake will be presented and discussed relative to assessing adversity of the findings. The conclusion of the European Society of Toxicologic Pathology (ESTP) expert panel on adversity of lysosomal accumulation relative to oligonucleotides will also be discussed.

Learning Objective :
  • Recognize the histopathologic patterns of cellular uptake of oligonucleotide by systemic and intrathecal administration
  • Define and assess the adversity of lysosomal uptake of oligonucleotides
  • Interpret the findings and differentiate adverse from nonadverse effects
  • Speaker(s)

    Jeffery  Engelhardt, DVM, PhD

    Co-Chair

    Jeffery Engelhardt, DVM, PhD

    Ionis Pharmaceuticals, Inc., United States

    Vice President, Pathology and Nonclinical Drug Safety

    Kendall  Frazier, DVM, PhD

    Renal and Macrophage Uptake of Systemically Administered Oligonucleotides

    Kendall Frazier, DVM, PhD

    Retired, United States

    Jeffery  Engelhardt, DVM, PhD

    Neuronal Uptake of Intrathecally Administered Oligonucleotides

    Jeffery Engelhardt, DVM, PhD

    Ionis Pharmaceuticals, Inc., United States

    Vice President, Pathology and Nonclinical Drug Safety

    James M. Willard

    A Report from the ESTP Expert Panel on Adversity of Lysosomal Accumulation

    James M. Willard

    FDA, United States

    Pharmacologist, DCaRP, CDER

      Panel Discussion

    Panel Discussion

    All Session Speakers, United States

    Vidhya  Gopalakrishnan, PhD

    Panelist

    Vidhya Gopalakrishnan, PhD

    Quark Pharmaceuticals, Inc, United States

    Senior Vice President, Pharmaceutical Development

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