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Bethesda North Marriott Hotel and Conference Center

2017年10月25日 (水) 午前 7:00 - 2017年10月27日 (金) 午後 3:00

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 1: The Emerging Landscape of mRNA-Based Drugs: A New Modality in Vaccines and Therapeutics

Learning Objective :
  • Analyze the general approach to CMC regulation of mRNA drugs and differentiate relative to synthetic oligonucleotides
  • Describe the current development status of mRNA vaccines and therapeutics
  • Speaker(s)

    Ramachandra G Naik, MD

    Session Co-Chair

    Ramachandra G Naik, MD

    FDA, United States

    Primary Reviewer, Regulatory Project Manager, OVRR, CBER

    Tal  Zaks, MD, PhD

    Translating mRNA Vaccines and Therapeutics: First Clinical Steps

    Tal Zaks, MD, PhD

    OrbiMed, United States

    Venture Partner

    Sarah Beach Voytek

    Considerations for the Nonclinical Development of Systemically-Administered Therapeutic mRNA

    Sarah Beach Voytek

    Novartis Institutes For Biomedical Research, Inc., United States

    Principal Scientist

    Ulrike  Gnad-Vogt, MD

    Clinical Development of mRNA Vaccines and Immunotherapies: Experiences and Lessons Learned

    Ulrike Gnad-Vogt, MD

    Curevac, Germany

    Chief Medical Officer

    Keith  Peden, PhD

    Regulatory Perspective on the Product-Related (CMC) Aspects of mRNA Vaccines

    Keith Peden, PhD

    FDA, United States

    Laboratory Chief, Laboratory of DNA Viruses, DVP, CBER

      Panel Discussion

    Panel Discussion

    All Session Speakers, United States

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