Papers and Presentations
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Best Practices for In-Use Stability and Compatibility Studies
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Summary Papers: CMC Strategy Forum North America 2024 -
IQ Biologics Specifications Setting Challenges and Opportunities Working Group Endotoxin Subgroup Readout
Speaker Presentation: CMC Strategy Forum North America 2025Kearns Katrina, Pfizer, Inc., 2025
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Practical and Regulatory Considerations for Machine Learning Models Applied to Process Development and Control
Speaker Presentation: CMC Strategy Forum North America 2025Stevens Ben, GlaxoSmithKline, 2025
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Enhanced Approaches Support Robust Harmonized Vaccine Potency Specifications
Speaker Presentation: CMC Strategy Forum North America 2025Smith Dean, Health Canada, 2025
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Regulatory Expectations for Data Models to Support a Marketing Application
Speaker Presentation: CMC Strategy Forum North America 2025Siggers Jayda, Health Canada, 2025
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Enhanced Approaches to Setting Specifications – A Regulatory Perspective
Speaker Presentation: CMC Strategy Forum North America 2025Siggers Jayda, Health Canada, 2025
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Development of Realistic and Safe AI/ML Applications for Biotherapeutic Characterization and Process Development
Speaker Presentation: CMC Strategy Forum North America 2025Shaver Jeremy, Pfizer, Inc., 2025
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What Is Meant by Patient-Centric Quality Standards?
Speaker Presentation: CMC Strategy Forum North America 2025Krause Phil, Independent Consultant, 2025
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Case Studies for Patient-Centric Specification Setting for a Therapeutic Protein and IQ Readout on Endotoxin Acceptance Criteria Part 1
Speaker Presentation: CMC Strategy Forum North America 2025Kearns Katrina, Pfizer, Inc., 2025
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Empowering 5.0 BioSolutions Through Realtime PAT and Computational Controls
Speaker Presentation: CMC Strategy Forum North America 2025Botonjic-Sehic Edita, ReciBioPharm, 2025
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Leveraging Biotransformation Data to Refine Bioprocesses and Derisk PQAs
Speaker Presentation: CMC Strategy Forum North America 2025Beaumont Maribel, Eli Lilly and Company, …
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AI-Accelerated Stability for Biologics
Speaker Presentation: CMC Strategy Forum North America 2025Bayrak Seyma, Amgen Inc., 2025
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The Challenge and Criticality of Data Contextualization to Support Effective AI/ML/Modeling in Bioprocess Development – an Industrial Case Study
Speaker Presentation: CMC Strategy Forum North America 2025Airiau Christian, Sanofi, 2025
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CMC Strategy Forum North America 2025 Scientific Program
Scientific Program: CMC Strategy Forum North America 2025
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CMC Strategy Forum North America 2025 Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2025
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Patient and User Centric Considerationson In-Use Study Design
Speaker Presentation Weiser Sarah Pfizer, Inc. 2024
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Leveraging Platforms to Accelerate ADC Formulation and Drug Product Development
Speaker Presentation Rutherford Karen Seagen, Inc. 2024
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Leveraging Prior Knowledge for Practical Application of Platform Analytical Procedures in Late-Stage Development of Monoclonal Antibodies
Speaker Presentation Patel Hetal Pfizer, Inc. 2024
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Pharmaceutical Industry Perspective on Closed System Transfer Devices (CSTDs): Balancing Overfill, Evaluating, Communicating
Speaker Presentation Lehermayr Christian Novartis Pharma AG 2024
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In-Use Studies Microbial Challenge Studies: Cross-Industry Efforts to Harmonize Strategies in Collaboration with Health Authorities
Speaker Presentation Kirwan J. Paul Amgen Inc. 2024