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Session 3 Track 3: Emerging Oligonucleotide CMC Guidance
Session Chair(s)
Benjamin Stevens, MPH
Senior Director, Regulatory Affairs CMC Policy and Advocacy, Alnylam Pharmaceuticals, Inc., United States
Paresma (Pinky) Patel, PhD
Division Director, Office of Product Quality Assessment III, FDA, United States
This session will provide updates on emerging regulatory guidances from key global regulators such as FDA and EMA. Special emphasis will be placed on the forthcoming EMA guidance on synthetic oligonucleotides given the 2023 publication of the concept paper and feedback from industry. A panel discussion including both regulator and industry perspectives will follow to address audience questions and any future directions that will impact the global regulatory landscape for oligonucleotides.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify key emerging global oligonucleotide guidance and standards
- Apply concepts from the session to establishing regulatory strategies for meeting the requirements of global regulators for oligonucleotides
- Analyze and discuss new or evolving elements of the emerging regulatory landscape for oligonucleotides, particularly potential risks or gaps
Speaker(s)
René Thürmer, PhD
Quality Assessor, Federal Institute for Drugs and Medical Devices, Germany
Update on the EMA Draft Guideline on the Development and Manufacture of Oligonucleotides
Katherine Windsor, PhD
Senior Pharmaceutical Quality Assessor, CDER, Food and Drug Administration, United States
Speaker
Kevin Carrick, PhD
Senior Director, Science and Standards, Biologics, United States Pharmacopeia, United States
Quality Attributes of Starting Materials for Therapeutic Oligonucleotides
Brian Pack
Principal Research Scientist , Eli Lilly & Company, United States
Speaker