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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

René Thürmer

Quality Assessor, Federal Institute for Drugs and Medical Devices, Germany

European Regulatory Perspective on Double-Stranded Oligonucleotides

Matthias Kretschmer, PhD

Senior Director, Analytical Development, Alnylam Pharmaceuticals, United States

Characterization and Control of siRNA Impurities

Panel Discussion

, All Session Speakers, United States

Ramesh Raghavachari, PhD

Ramesh Raghavachari, PhD

Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER, FDA, United States

Panelist

Vidhya Gopalakrishnan, PhD

Senior Vice President, Pharmaceutical Development, Quark Pharmaceuticals, Inc, United States

Panelist