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Tuesday, May 12th
9:30 AM - 11:00 AM PT
Symposium: Bridging from Therapeutic Concept to First in Human
Location: Pacific Jewel A
Moderator: Preeyam Patel, PhD (she/her/hers) – Spyre Therapeutics
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
9:30 AM - 10:00 AM PT
Regulatory Qualification of Microphysiological Systems (MPS) as Drug Development Tools: The NIH-FDA Translational Centers for MPS
Location: Pacific Jewel A
Speaker: Passley Hargrove (she/her/hers) – n/a
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
10:00 AM - 10:30 AM PT
Integrating Advanced Cellular Models, Multiomics, and AI for Safety Prediction
Location: Pacific Jewel A
Speaker: Jurre J. Kamphorst, PhD – AstraZeneca
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
10:30 AM - 11:00 AM PT
Micro-Physiological Systems: Developing a Functional Precision Medicine Platform for Immuno-Oncology
Location: Pacific Jewel A
Speaker: Amir Aref, PhD (he/him/his) – MGB
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
10:00 AM - 11:00 AM PT
Hot Topic: Advances in Predictive Modeling and Machine Learning to Optimize Process Development and Formulation Design of Biologics
Location: Coral 1-2
Hot Topic Speaker: Stephen T. Buckley, PhD (he/him/his) – Novo Nordisk A/S
Hot Topic Moderator: Robert Dodge, PhD – Dodge
Hot Topic Speaker: Pauric Bannigan, PhD (he/him/his) – Intrepid Labs
Hot Topic Speaker: Jeremy Shaver, PhD (he/him/his) – Pfizer
Hot Topic Speaker: Kenan Pandza, PhD (he/him/his) – Persist AI
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
11:15 AM - 12:00 PM PT
Linking Shear-Dependent Viscosity to Cluster Size and Injection Force in High-Concentration Monoclonal Antibody Formulations
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Soheila Shabaniverki, PhD – RheoSense Inc
Applying Translational Principles Across the Development Lifecycle
Sponsored By
Tuesday, May 12th
11:30 AM - 12:30 PM PT
Special Poster Collection
Location: Eventide
Poster Collection Host: Meena Subramanyam, PhD (she/her/hers) – Takeda
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
12:15 PM - 1:00 PM PT
Efficiency Unlocked: The Case for Single-Well Assessment in Bioanalysis
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Katherine Malone, BS, RQAP-GLP (she/her/hers) – Charles River
Applying Translational Principles Across the Development Lifecycle
Sponsored By
Tuesday, May 12th
1:00 PM - 2:00 PM PT
Keynote: New Approach Methods – From Ugly Ducklings to Beautiful Swans
Location: Pacific Jewel A
Keynote Speaker: Thomas Hartung, MD, PhD (he/him/his) – Johns Hopkins University
Moderator: Babak Basiri, PhD (he/him/his) – Dyne Therapeutics
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
1:30 PM - 2:15 PM PT
Integrated Bioanalysis: LC MS/MS, Hybrid, and LBA Case Studies
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Prakash Bhosale, PhD, MBA (he/him/his) – IQ Labs
Partner Presentation Speaker: Chris Dishinger, BS – IQ Labs
Applying Translational Principles Across the Development Lifecycle
Sponsored By
Tuesday, May 12th
2:30 PM - 3:30 PM PT
Rapid Fires: Bridging from Therapeutic Concept to First in Human
Location: Pacific Jewel A
Rapid Fire Moderator: Pankajini Mallick, PhD (she/her/hers) – Neurocrine Biosciences
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
2:30 PM - 2:45 PM PT
PK/PD Essentials- A Pragmatic Approach to mAb Dosing
Location: Pacific Jewel A
Rapid Fire Speaker: Marc Presler, PhD – Certara
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
2:45 PM - 3:00 PM PT
When Humanized FcRn Changes Your Answer
Location: Pacific Jewel A
Rapid Fire Speaker: Anup Zutshi, PhD (he/him/his) – Chinar Pharmaceutical Sciences LLC
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
3:00 PM - 3:15 PM PT
Systems Modelling for Gene Therapies (siRNA, FDC, BiTE)
Location: Pacific Jewel A
Rapid Fire Speaker: Devam A. Desai, MS (he/him/his) – University of Florida
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
3:15 PM - 3:30 PM PT
From Lipids to Protein Expression: Determinants of mRNA-LNP Biodistribution
Location: Pacific Jewel A
Rapid Fire Speaker: Mokshada Kumar, MS (she/her/hers) – University At Buffalo, SUNY
Applying Translational Principles Across the Development Lifecycle
Tuesday, May 12th
3:30 PM - 4:15 PM PT
Enabling Translational Decisions Through Quantitative Target Biology
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Alok Pandey, PhD – PBL Assay Science
Applying Translational Principles Across the Development Lifecycle
Sponsored By
Wednesday, May 13th
9:30 AM - 11:00 AM PT
Symposium: Bridging from First-in-Human to Registrational Trials
Location: Pacific Jewel A
Moderator: Anup Zutshi, PhD (he/him/his) – Chinar Pharmaceutical Sciences LLC
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
9:30 AM - 10:00 AM PT
Quantitative Systems Pharmacology/Machine Learning for Inflammatory Bowel Disease Biologics
Location: Pacific Jewel A
Speaker: Douglas W. Chung, M.S. (he/him/his) – Certara
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
10:00 AM - 10:30 AM PT
Predictive Modeling of CRS in TCE Immune Activating Therapies
Location: Pacific Jewel A
Speaker: Guido H. Jajamovich, PhD – Amgen
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
10:30 AM - 11:00 AM PT
Quantitative Mechanistic Pharmacology of Cell and Gene Therapies
Location: Pacific Jewel A
Speaker: Armin Sepp, PhD – Certara UK (Simcyp Division)
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
10:15 AM - 11:00 AM PT
Immunogenicity Assessment for Biotherapeutics and Target Binding Reagents Beyond Antibodies
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Emilee Knowlton, PhD (she/her/hers) – ProImmune, Inc.
Applying Translational Principles Across the Development Lifecycle
Sponsored By
Wednesday, May 13th
12:15 PM - 1:00 PM PT
Longitudinal and Lifecycle Management of Potency Release Assays
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Reginald Clayton, PhD (he/him/his) – Solvias
Applying Translational Principles Across the Development Lifecycle
Sponsored By
Wednesday, May 13th
1:00 PM - 2:00 PM PT
Keynote: Beyond Translation: Accelerating Development to Bring Breakthroughs to Patients Faster
Location: Pacific Jewel A
Keynote Speaker: Amit Rakhit, MD, MBA (he/him/his) – BlueRock Therapeutics
Moderator: Amritangshu Chakravarty, PhD (he/him/his) – KCAS Bio
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
2:30 PM - 3:30 PM PT
Rapid Fires: Bridging from First-in-Human to Registrational Trials
Location: Pacific Jewel A
Rapid Fire Moderator: Bill Nowatzke, PhD – Immunovant
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
2:30 PM - 2:45 PM PT
Challenges in Biomarker Translation: The Long and Torturous Path to Commercialization
Location: Pacific Jewel A
Rapid Fire Speaker: Steven P. Piccoli, PhD (he/him/his) – SPARC
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
2:30 PM - 3:30 PM PT
Hot Topic: Transparency to Predictive Insights: Lessons from Complete Response Letters
Location: Coral 1-2
Hot Topic Moderator: Allison Elizabeth Radwick, PhD (she/her/hers) – USP
Hot Topic Speaker: Grace McNally – ELIQUENT Life Sciences, Inc.
Hot Topic Speaker: Alison Sathe – Redica Systems
Hot Topic Speaker: Matthew Vankoski, MBA, MS Reg Sci (he/him/his) – USP
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
2:45 PM - 3:00 PM PT
FDA LDT Rule: Implications for Biomarker Development
Location: Pacific Jewel A
Rapid Fire Speaker: Alok Pandey, PhD – PBL Assay Science
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
3:00 PM - 3:15 PM PT
Developing a Machine Learning–Based-Virtual-Neutralizing Antibody Assay to Support Immunogenicity Assessment
Location: Pacific Jewel A
Rapid Fire Speaker: Robert Dodge, PhD – Dodge
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
3:15 PM - 3:30 PM PT
Leveraging Biomarker Data in the Context of Early to Late Clinical Trials
Location: Pacific Jewel A
Rapid Fire Speaker: Preeyam Patel, PhD (she/her/hers) – Spyre Therapeutics
Applying Translational Principles Across the Development Lifecycle
Wednesday, May 13th
3:30 PM - 4:15 PM PT
Development and Qualification of a Multiplexed Immunoassay to Assess the Immunogenicity of Shigella Vaccines
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Paul Rhyne, NA – Luminex
Applying Translational Principles Across the Development Lifecycle
Sponsored By
Thursday, May 14th
9:00 AM - 10:30 AM PT
Symposium: Bridging from Registrational Trials to Commercialization
Location: Pacific Jewel A
Moderator: Paul Rhyne, NA – Luminex
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
9:00 AM - 9:30 AM PT
Development Pathways and Considerations for Subcutaneous Biologic Formulations
Location: Pacific Jewel A
Speaker: Charles Theuer, MD PhD – Halozyme Inc
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
9:30 AM - 10:00 AM PT
Inherited Deafness AAV-Based GTx: Data-Driven Approach to Immunogenicity, Distribution, Shedding
Location: Pacific Jewel A
Speaker: Susan Irvin, PhD, PMP (she/her/hers) – Regeneron Pharmaceuticals
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
10:00 AM - 10:30 AM PT
Biomarker Strategies for Enabling Registrational Non-oncology Clinical Trials
Location: Pacific Jewel A
Speaker: Mohamed Hassanein, PhD – Pfizer
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
9:30 AM - 10:30 AM PT
Hot Topic: Laboratory AI Literacy: Accelerating Research Through Human-AI Training Parallelization
Location: Coral 1-2
Hot Topic Speaker: Richard Jaenisch, MPH – Open Biopharma Research and Training Institute
Hot Topic Moderator: Stephanie A. Pasas-Farmer, PhD (she/her/hers) – spfarmer@bdatasolutions.com
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
11:00 AM - 12:00 PM PT
Keynote: Finding the Right Patients: Diagnostic-Driven Commercialization for Emerging Therapies
Location: Pacific Jewel A
Keynote Speaker: Hannah Mamuszka, MS – Alva10
Moderator: Swetha Thiyagarajan – North Dakota State University
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
1:30 PM - 2:15 PM PT
Rapid Fires: Bridging from Registrational Trials to Commercialization
Location: Pacific Jewel A
Rapid Fire Moderator: Charles Theuer, MD PhD – Halozyme Inc
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
1:45 PM - 2:00 PM PT
Next-Gen Biotherapeutics: Accelerating Multispecifics to the Finish Line
Location: Pacific Jewel A
Rapid Fire Speaker: Vandana Chakravartty, PhD – Pfizer Inc.
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
2:00 PM - 2:15 PM PT
Rapid Transfer, Validation and Scaling of a Cell-Based Potency Assay
Location: Pacific Jewel A
Rapid Fire Speaker: Reginald Clayton, PhD (he/him/his) – Solvias
Applying Translational Principles Across the Development Lifecycle
Thursday, May 14th
1:30 PM - 1:45 PM PT
Quantitative Systems Pharmacology and Rheumatoid Arthritis: Population Targeting for Biotherapeutics
Rapid Fire Speaker: Maria Jesus Munoz Lopez – Certara
Applying Translational Principles Across the Development Lifecycle