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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 4AB: Chemistry and Safety Considerations for Impurities in Oligonucleotide Therapeutics

Session Chair(s)

Andrew Teasdale, PhD

Principal Scientist, Chair of Impurities Advisory Group

AstraZeneca , United Kingdom

Members of the Oligonucleotide Safety Working Group (OSWG) met regularly over the past 12 months to discuss oligonucleotide impurities. This joint session for the CMC and nonclinical tracks will feature two presentations that attempt to summarize the output of these discussions. Chemistry and safety aspects of oligonucleotide impurities will be presented. The presentations will be followed by a 30 minute panel discussion.

Questions:

What types of oligonucleotide impurities are commonly observed?

What are appropriate characterization expectations for oligonucleotide impurities?

What are appropriate reporting, identification, and qualification thresholds for oligonucleotide therapeutics?

How should oligonucleotide impurities be qualified?

Can platform data be used to help characterize and qualify oligonucleotide impurities?

Learning Objective :
Understand the importance of the reporting, identification, and qualification thresholds and their relationship to drug substance and drug product specifications
Discuss how oligonucleotide impurities may differ from impurities in small molecule drugs
Explain strategies for qualifying oligonucleotide impurities

Speaker(s)

Daniel Capaldi, PhD

Chemistry Considerations for Oligonucleotide Impurities

Daniel Capaldi, PhD

Ionis Pharmaceuticals, Inc, United States

Vice President, Analytical and Process Development

Scott Henry, PhD

Safety Considerations for Oligonucleotide Impurities

Scott Henry, PhD

Ionis Pharmaceuticals, Inc., United States

Senior Vice President, Nonclinical Development

Panel Discussion

All Session Speakers, United States

James Wild, PhD, MS

Panelist: Joining the Speakers

James Wild, PhD, MS

FDA, United States

Pharmacologist, CDER

Cathaline Den Besten, PhD, PMP

Panelist: Joining the Speakers

Cathaline Den Besten, PhD, PMP

Proqr Therapeutics, Netherlands

VP Toxicology