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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.

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Session 2A: Control Strategy for Double-Stranded Oligonucleotides

Session Chair(s)

Samantha Gao-Sheridan, PhD

Samantha Gao-Sheridan, PhD

Senior Director, Regulatory Affairs CMC

Alnylam Pharmaceuticals, United States

To date there have been no double-stranded oligonucleotide therapies marketed. This session will focus on the control strategy elements to be considered for the development and registration of double-stranded oligonucleotide therapies. Joined by both industry and regulatory agency presenters and panelists, this session will review and discuss the key principles and challenges in the double-stranded oligonucleotide API and drug product process control strategy (e.g., control of impurities, annealing, sterilization), as well as analytical development and product life cycle management. Both oligonucleotide conjugates and other different drug product formulations will be considered.

Learning Objective :
  • Define control strategy elements that are specific for double-stranded oligonucleotides
  • Identify different approaches in characterizing and controling product quality

    • Speaker(s)

    René Thürmer, PhD

    European Regulatory Perspective on Double-Stranded Oligonucleotides

    René Thürmer, PhD

    Federal Institute for Drugs and Medical Devices, Germany

    Quality Assessor

    Matthias Kretschmer, PhD

    Characterization and Control of siRNA Impurities

    Matthias Kretschmer, PhD

    Alnylam Pharmaceuticals, United States

    Senior Director, Analytical Development

    Panel Discussion

    Panel Discussion

    All Session Speakers, United States

    Ramesh Raghavachari, PhD

    Panelist

    Ramesh Raghavachari, PhD

    FDA, United States

    Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER

    Vidhya Gopalakrishnan, PhD

    Panelist

    Vidhya Gopalakrishnan, PhD

    Quark Pharmaceuticals, Inc, United States

    Senior Vice President, Pharmaceutical Development

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