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Bethesda North Marriott Hotel and Conference Center

Apr 25, 2022 7:00 AM - Apr 27, 2022 12:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!

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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