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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.

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

Session Chair(s)

Tal Zaks, MD, PhD

Tal Zaks, MD, PhD

Venture Partner

OrbiMed, United States

mRNA therapeutics are unique, relative to most oligonucleotide-based modalities like antisense, siRNAs, and aptapers in that mRNAs enable expression of the encoded protein rather than act as antagonists to inhibit target protein translation or activity. Early clinical data indicate that mRNA-based drugs may be effective vaccines and their potential as therapeutics is now emerging. This session will describe the general approach to mRNA manufacture, present emerging preclinical and clinical data on mRNA vaccines and therapeutics, and provide a regulatory perspective on the product-related (CMC) aspects of mRNA drug development.

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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