Papers and Presentations
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Code, Care, and Conscience: How AI, Ethics, and Lived Experience Are Redefining the Future of Pharma
Speaker Presentation: WCBP 2026 Hayes-Mota Guadalupe, Santa Clara University, 2026 -
Side-by-Side Stress Studies Designed to Support Post-Change Shelf Life
Speaker Presentation: WCBP 2026 Flick Tawnya, Gilead Sciences, Inc., 2026 -
International Collaboration and Reliance
Speaker Presentation: WCBP 2026 Dooley Brian, European Medicines Agency, 2026 -
Insights to Industry Led CMC PAC Reliance Pilots on Behalf of EFPIA
Speaker Presentation: WCBP 2026 Ban Cynthia, Sanofi Pasteur Limited Canada, 2026 -
Keynote Session III - The Heart of Innovation: Patients Shaping the Future of Biologics
Speaker Presentation: WCBP 2026Abernathy Michael, Amgen Inc., 2026 -
30th Anniversary Workshop: Pet Peeves and Roadblocks in CMC: Improving your Quality Submissions through the Product Lifecycle Redux – The 2026 Version
Speaker Presentation: WCBP 2026Marjorie Shapiro, Chana Fuchs, 2026 -
Vaccine Specific Regulatory Considerations
Roundtable Notes: Session 2 Table 9 WCBP 2026 Vaccine Specific Regulatory Considerations -
Vaccine Potency - Compare and Contrast Potency Tests for Different Vaccine Modalities
Roundtable Notes: Session 2 Table 2 WCBP 2026Vaccine Potency - Compare and Contrast Potency Tests for … -
Using Accelerated Degradation Studies to Support Comparability Assessments
Roundtable Notes: Session 2 Table 13 WCBP 2026Using Accelerated Degradation Studies to Support Comparability … -
Use of Machine Learning (ML) and Artificial Intelligence (AI) in Content Creation of Early Phase Development and Managing Submissions and Information Requests with Health Authorities
Roundtable Notes: Session 1 Table 16 WCBP 2026Use of Machine Learning (ML) and Artificial Intelligence … -
Use of Chromatography Resins Across Multiple Products
Roundtable Notes: Session 1 Table 11 WCBP 2026Use of Chromatography Resins Across Multiple Products -
Use of Artificial Intelligence for Process and Analytical Method Development
Roundtable Notes: Session 2 Table 12 WCBP 2026Use of Artificial Intelligence for Process and Analytical … -
Strategies for Leveraging Clinical Stability Data for Commercial Shelf Life
Roundtable Notes: Session 1 Table 15 WCBP 2026Strategies for Leveraging Clinical Stability Data for Commercial … -
Speed to Clinic - Phase-Appropriate Strategies to Accelerate CMC Development Timelines
Roundtable Notes: Session 1 Table 4 WCBP 2026Speed to Clinic - Phase-Appropriate Strategies to Accelerate … -
Recent Trends in Questions from Health Authorities [Session 2]
Roundtable Notes: Session 2 Table 1 WCBP 2026Recent Trends in Questions from Health Authorities [Session … -
Recent Trends in Questions from Health Authorities [Session 1]
Roundtable Notes: Session 1 Table 1 WCBP 2026Recent Trends in Questions from Health Authorities [Session … -
Novel Applications of Molecular and Structural Biology in Characterization of Well Characterized Biologics
Roundtable Notes: Session 1 Table 3 WCBP 2026Novel Applications of Molecular and Structural Biology in … -
Novel Applications of Molecular and Structural Biology in Characterization of ATMPS
Roundtable Notes: Session 2 Table 3 WCBP 2026Novel Applications of Molecular and Structural Biology in … -
In-Use Studies - Compatibility and Stability Studies
Roundtable Notes: Session 2 Table 17 WCBP 2026In-Use Studies - Compatibility and Stability Studies -
Interpreting Confidence Intervals in Analytical Validation under ICH Q2(R2): From Statistical Reporting to Decision-Making
Roundtable Notes: Session 2 Table 11 WCBP 2026Interpreting Confidence Intervals in Analytical Validation …