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DIA/FDA Oligonucleotide-Based Therapeutics Conference

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Session 10 Track 3: CMC and Regulatory Experience for Novel Oligonucleotide Therapeutics

Session Chair(s)

Rima Patel-Goel, MS

Rima Patel-Goel, MS

  • Senior Director Regulatory CMC
  • AADi Biosciences, Inc., United States
Benjamin Stevens, PhD, MPH

Benjamin Stevens, PhD, MPH

  • Director CMC Policy and Advocacy
  • GlaxoSmithKline, United States
Several oligonucleotide classes (e.g., siRNAs, ASOs) have recently matured to validated therapeutic approaches with demonstrated utility across several indications. While industry and regulatory authorities have worked together to establish pathways for commercialization of these leading oligonucleotide classes, novel modalities present unique challenges to CMC development and broad regulatory acceptability. This session will include industry presentations representing two distinct novel oligonucleotide therapeutic modalities and their perspectives on CMC development challenges and experience with regulatory acceptability. The presentations will be followed by a panel discussion with representatives from both industry and regulatory authorities.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Formulate approaches for early stage CMC and regulatory development of novel oligonucleotide therapeutics
  • Plan strategic interactions with regulators to ensure acceptability of CMC development approaches for novel oligonucleotide therapeutics
  • Identify risks associated with CMC and regulatory development of novel oligonucleotide therapeutics

Speaker(s)

Kristy Wood, PhD

Speaker

Kristy Wood, PhD

  • Vice President Nucleic Acid Therapeutics Development & Manufacturing
  • Intellia Therapeutics, United States
Rachel Johns, PhD

Antibody Oligonucleotide Therapeutics – from Development to the Clinic

Rachel Johns, PhD

  • Senior Director, Analytics and Formulations
  • Avidity Biosciences, Inc., United States
Adam Dinerman, PhD

Panelists

Adam Dinerman, PhD

  • Executive Director, Head of Chemistry, Manufacturing and Controls (CMC)
  • Aro Biotherapeutics, United States
Martin Nemec, PhD

Panelists

Martin Nemec, PhD

  • Senior Biologist/Evaluator
  • Health Canada, Canada
Olen M. Stephens, PhD

Panelists

Olen M. Stephens, PhD

  • Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP
  • FDA, United States

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