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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 6A: Thinking Ahead: Oligonucleotide Drug-Device Combination Products

Session Chair(s)

Mohan K. Sapru, PhD, MS

Mohan K. Sapru, PhD, MS

CMC Lead, Office of Pharmaceutical Quality, CDER

FDA, United States

The session is aimed to broadly discuss oligonucleotide drug-device combination products, an emerging trend in oligonucleotide-based therapeutics, from industry and regulatory perspectives. Specifically, the presentations and panel discussion will focus on:

  • Industry perspective concerning salient considerations and challenges of developing drug device combination products for oligonucleotide therapeutics
  • Design control, drug device verification, and validation processes
  • Promises and challenges in using drug/device combination approach for targeted oligonucleotide drug delivery
  • Strategies for ensuring product quality, including uniformity of dose delivery, under conditions of use
  • Regulatory perspective concerning human factors studies and related clinical study considerations in combination product design and development

    • Learning Objective :
  • Describe major technical and regulatory considerations for developing oligonucleotide drug/device combination products
  • List major considerations for designing and validating device combination products
  • Discuss underlying principles of human factors studies aimed to ensure that a device will be safe and effective for use by the intended users under the intended use environments

    • Speaker(s)

    Bret Coldren, PhD

    Development Considerations for Oligonucleotide Combination Products

    Bret Coldren, PhD

    Ionis Pharmaceuticals , United States

    Director, Pharmaceutical Development

    Quynh Nhu Nguyen, MS

    Human Factors Studies - Related Considerations in Combination Product Design and Development

    Quynh Nhu Nguyen, MS

    FDA, United States

    Associate Director for Human Factors, DMEPA, CDER

    Panel Discussion

    Panel Discussion

    All Session Speakers, United States

    Ryan McGowan

    Panelist

    Ryan McGowan

    AstraZeneca, United States

    Associate Director, Combination Products

    Mike Stelmah

    Panelist

    Mike Stelmah

    Alnylam Pharmaceuticals, United States

    Director, Regulatory Affairs, CMC & Combination Products

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