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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)
Brian Pack, PHD
Associate Vice President, Eli Lilly, United States
A Novel Approach to Stability Platform Definition In Support of Clinical Trial Dating
Joshua Leo Brooks, PHD
Director of Process Validation, Alnylam Pharmaceuticals, United States
Platform Approach to siRNA Drug Substance Manufacturing Process Validation
Lawrence Perez, PHD
Senior Pharmaceutical Quality Assessor, CDER, FDA, United States
Speaker
Yannick Fillon, PHD
Head of Oligonucleotide Process Chemistry, Biogen, United States
Operational Range Assessment for Oligonucleotide Characterization
Brian Dooley, MPHARM, MSC
Pharmaceutical Quality Senior Specialist, European Medicines Agency, Netherlands
Panel Discussion:
Andreas Kuhn, PHD
Senior Vice President RNA Biochemistry & CMC Development, Biontech SE, Germany
Towards a Bracketing / Matrix approach for PPQ Covering a Defined mRNA Sequence and Process Space
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