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Session 10 Track 3: Streamlining Oligonucleotide Development with Platform Approaches Roundtable
Session Chair(s)
Dominik Altevogt, PhD
Director Regulatory Affairs CMC
Novartis, Switzerland
This session will discuss the benefits of using platform approaches in the development of therapeutic oligonucleotides, including streamlining processes and expediting regulatory submissions. The session will feature mini talks on platform strategies, where experts will share their insights and experiences. Following the talks, there will be a round table discussion with regulators and industry experts on the challenges and opportunities of implementing these strategies. The discussion will provide a forum for an open exchange of ideas and perspectives, and participants will have the opportunity to engage with the experts and learn from their experiences.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify benefits of using platform approaches in the development of therapeutic oligonucleotides
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Recognize the regulatory challenges associated with using platform approaches
- Apply concepts from the session to enable the use of platform approaches
Speaker(s)
A Novel Approach to Stability Platform Definition In Support of Clinical Trial Dating
Brian Pack, PhD
Eli Lilly, United States
Associate Vice President
Platform Approach to siRNA Drug Substance Manufacturing Process Validation
Joshua Leo Brooks, PhD
Alnylam Pharmaceuticals, United States
Director of Process Validation
Speaker
Lawrence Perez, PhD
FDA, United States
Senior Pharmaceutical Quality Assessor, CDER
Operational Range Assessment for Oligonucleotide Characterization
Yannick Fillon, PhD
Biogen, United States
Head of Oligonucleotide Process Chemistry
Panel Discussion:
Brian Dooley, MPharm, MSc
European Medicines Agency, Netherlands
Pharmaceutical Quality Senior Specialist
Towards a Bracketing / Matrix approach for PPQ Covering a Defined mRNA Sequence and Process Space
Andreas Kuhn, PhD
Biontech SE, Germany
Senior Vice President RNA Biochemistry & CMC Development