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Bethesda North Marriott Hotel and Conference Center

2017 年 10 月 25 日 7:00 上午 - 2017 年 10 月 27 日 3:00 下午

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 6BC: What, Where, and How: Biomarkers Inform Disease Targets, Biodistribution, and Function of Oligonucleotide Therapeutics

Session Chair(s)

Aimee L. Jackson, PhD

Aimee L. Jackson, PhD

Chief Scientific Officer

Atalanta Therapeutics, United States

This session will present preclinical and clinical data on the identification and validation of biomarkers for oligonucleotide therapeutics. Discussions will include methods to identify pharmacodynamic biomarkers, use of biomarkers to define PK/PD and dose-response relationships, the application of biomarkers to establish mechanistic proof-of-concept and guide dose optimization, and how biomarkers can inform disease status and patient enrichment.

Learning Objective :
  • Identify pharmacodynamic and disease biomarkers for oligonucleotide therapeutics
  • Use biomarkers to interpret PK/PD (dose/response) relationships and provide mechanistic insight
  • Use biomarkers to guide dose optimization
  • Implement biomarker approaches to inform disease status and identify patients more likely to respond to the drug
  • Speaker(s)

    Imran  Khan, PhD

    Session Co-Chair

    Imran Khan, PhD

    FDA, United States

    Pharmacologist, OMPT, OND, ODEI, DPP, CDER

    Aimee L. Jackson, PhD

    Translating PD Biomarkers from Preclinical Studies to Clinical Trials: MRG-106, an Oligonucleotide Inhibitor of miR-155, Coordinately Regulates Multiple Survival Pathways to Reduce Cellular Proliferation, and Survival in Cutaneous T-Cell Lymphoma

    Aimee L. Jackson, PhD

    Atalanta Therapeutics, United States

    Chief Scientific Officer

    Corrie L Gallant-Behm, PhD

    Translating PD Biomarkers from Preclinical Studies to Clinical Trials: MRG-201, an Oligonucleotide Mimic of miR-29, Inhibits Collagen Expression, and Reduces Fibroplasia in Cutaneous Wounds

    Corrie L Gallant-Behm, PhD

    Miragen Therapeutics, Inc., United States

    Research Scientist III

    William  Querbes, PhD

    Use of Biomarkers in the Development of RNAi Therapeutics

    William Querbes, PhD

    Alnylam Pharmaceuticals, United States

    Director, Research

      Panel Discussion

    Panel Discussion

    All Session Speakers, United States

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