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Mon, May 11
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Thu, May 14
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Thursday, May 14, 2026
8:30 AM - 2:00 PM
PT
Registration Hours
8:30 AM - 2:00 PM
PT
Registration Hours
Location: Pacific Jewel Foyer
8:30 AM - 2:00 PM
PT
Speaker Ready Room
8:30 AM - 2:00 PM
PT
Speaker Ready Room
Location: Tidepool 4
9:00 AM - 10:30 AM
PT
Symposium: Advancing Cross-Modality Bioanalytics and Translational Biomarkers for Complex and Personalized Therapeutics
Moderator:
Jason Pennucci
– Moderna Therapeutics
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:00 AM - 10:30 AM
PT
Symposium: Advancing Cross-Modality Bioanalytics and Translational Biomarkers for Complex and Personalized Therapeutics
Moderator:
Jason Pennucci
– Moderna Therapeutics
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:00 AM - 9:30 AM
PT
Neutralizing Antibody Assessment for Tri-specific Biotherapeutics Amid Pre-existing Anti-drug Antibodies
Speaker:
Bonnie Wu, N/A, Ph.D.
– Johnson & Johnson Innovation Medicine
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:30 AM - 10:00 AM
PT
Validated WES Assay for Biomarker Discovery and Clinical Development
Speaker:
Kirthi Kumar Kutumbaka, MS, PhD (he/him/his)
– Eurofins Clinical Trial Solutions
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
10:00 AM - 10:30 AM
PT
Implementing Flow Cytometry to Evaluate Novel Modalities in Clinical Trials
Speaker:
MICHELLE T. GRAHAM, PhD (she/her/hers)
– Abbvie
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:00 AM - 10:30 AM
PT
Symposium: Bridging from Registrational Trials to Commercialization
Applying Translational Principles Across the Development Lifecycle
9:00 AM - 10:30 AM
PT
Symposium: Bridging from Registrational Trials to Commercialization
Applying Translational Principles Across the Development Lifecycle
9:00 AM - 9:30 AM
PT
Development Pathways and Considerations for Subcutaneous Biologic Formulations
Speaker:
Charles Theuer, MD PhD
– Halozyme Inc
Applying Translational Principles Across the Development Lifecycle
9:30 AM - 10:00 AM
PT
Inherited Deafness AAV-Based GTx: Data-Driven Approach to Immunogenicity, Distribution, Shedding
Speaker:
Susan Irvin, PhD, PMP (she/her/hers)
– Regeneron Pharmaceuticals
Applying Translational Principles Across the Development Lifecycle
10:00 AM - 10:30 AM
PT
Biomarker Strategies for Enabling Registrational Non-oncology Clinical Trials
Speaker:
Mohamed Hassanein, PhD
– Pfizer
Applying Translational Principles Across the Development Lifecycle
9:30 AM - 10:30 AM
PT
Hot Topic: Laboratory AI Literacy: Accelerating Research Through Human-AI Training Parallelization
9:30 AM - 10:30 AM
PT
Hot Topic: Laboratory AI Literacy: Accelerating Research Through Human-AI Training Parallelization
Hot Topic Speaker:
Richard Jaenisch, MPH
– Open Biopharma Research and Training Institute
Applying Translational Principles Across the Development Lifecycle
10:30 AM - 11:00 AM
PT
Coffee Break
10:30 AM - 11:00 AM
PT
Coffee Break
Location: Pacific Jewel Foyer
11:00 AM - 12:00 PM
PT
Keynote: Finding the Right Patients: Diagnostic-Driven Commercialization for Emerging Therapies
Keynote Speaker:
Hannah Mamuszka
Moderator:
Swetha Thiyagarajan
– North Dakota State University
Applying Translational Principles Across the Development Lifecycle
11:00 AM - 12:00 PM
PT
Keynote: Finding the Right Patients: Diagnostic-Driven Commercialization for Emerging Therapies
Keynote Speaker:
Hannah Mamuszka
Moderator:
Swetha Thiyagarajan
– North Dakota State University
Applying Translational Principles Across the Development Lifecycle
11:00 AM - 12:00 PM
PT
Keynote: Strategic Implementation of AI in Regulated Bioanalytical Testing During Clinical Development
Keynote Speaker:
Jean-Claude Marshall, MSc, PhD
– Moderna
Moderator:
Darshana Jani, PhD (she/her/hers)
– Moderna
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
11:00 AM - 12:00 PM
PT
Keynote: Strategic Implementation of AI in Regulated Bioanalytical Testing During Clinical Development
Keynote Speaker:
Jean-Claude Marshall, MSc, PhD
– Moderna
Moderator:
Darshana Jani, PhD (she/her/hers)
– Moderna
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
12:00 PM - 1:30 PM
PT
Networking Lunch
12:00 PM - 1:30 PM
PT
Networking Lunch
Location: Coral 3-5
1:30 PM - 2:30 PM
PT
Hot Topic: Organ Chip Clinical Mimicry and NAMs Applied to the Development of New and Follow‑On Therapeutics
Hot Topic Moderator:
Weiping Shao, PhD
– AstraZeneca
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:30 PM - 2:30 PM
PT
Hot Topic: Organ Chip Clinical Mimicry and NAMs Applied to the Development of New and Follow‑On Therapeutics
Location: Coral 1-2
Hot Topic Moderator:
Weiping Shao, PhD
– AstraZeneca
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:30 PM - 1:45 PM
PT
Clinical Mimicry and Drug Discovery on Organ Chips
Location: Coral 1-2
Hot Topic Speaker:
Chandrav De, PhD (he/him/his)
– Wyss Institute at Harvard University
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:45 PM - 2:00 PM
PT
Application of NAMs to Immunogenicity Risk Mitigation of New and Follow-on Products
Location: Coral 1-2
Hot Topic Speaker:
Daniela Verthelyi, MD,PhD (she/her/hers)
– Thimmus LLC
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:00 PM - 2:30 PM
PT
Panel Discussion
Location: Coral 1-2
Hot Topic Moderator:
Weiping Shao, PhD
– AstraZeneca
Hot Topic Speaker:
Chandrav De, PhD (he/him/his)
– Wyss Institute at Harvard University
Hot Topic Speaker:
Daniela Verthelyi, MD,PhD (she/her/hers)
– Thimmus LLC
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:30 PM - 2:30 PM
PT
Rapid Fires: Advancing Cross-Modality Bioanalytics and Translational Biomarkers for Complex and Personalized Therapeutics
Rapid Fire Moderator:
Jo Goodman, BSc (she/her/hers)
– Celerion
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:30 PM - 2:30 PM
PT
Rapid Fires: Advancing Cross-Modality Bioanalytics and Translational Biomarkers for Complex and Personalized Therapeutics
Rapid Fire Moderator:
Jo Goodman, BSc (she/her/hers)
– Celerion
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:30 PM - 1:45 PM
PT
Translational In Vitro Tools to Predict Bioavailability of Inhalation Products
Rapid Fire Speaker:
Alexandre Ribeiro
– Hovione
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:45 PM - 2:00 PM
PT
Plasma–Liver Proteomic Signatures Enable Biomarker Discovery in MASH
Speaker:
Xuemei Yang, MS
– Takeda Global Research & Development Center, Inc
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:00 PM - 2:15 PM
PT
Flow Cytometry Analysis in Clinical Trails: A Logistic Challenge
Rapid Fire Speaker:
Laura Golusda
– CheckImmune GmbH
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:15 PM - 2:30 PM
PT
Considerations for Free Biomarker Assay Development of Multimeric Analytes
Rapid Fire Speaker:
Tanya Treynor, PhD (she/her/hers)
– BioAgilytix Labs
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:30 PM - 2:30 PM
PT
Rapid Fires: Bridging from Registrational Trials to Commercialization
Rapid Fire Moderator:
Charles Theuer, MD PhD
– Halozyme Inc
Applying Translational Principles Across the Development Lifecycle
1:30 PM - 2:30 PM
PT
Rapid Fires: Bridging from Registrational Trials to Commercialization
Rapid Fire Moderator:
Charles Theuer, MD PhD
– Halozyme Inc
Applying Translational Principles Across the Development Lifecycle
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
1:45 PM - 2:00 PM
PT
Drug Delivery Preferences: Insights from Patients and Healthcare Provider Perspectives
Rapid Fire Speaker:
David Kang, BS
– Halozyme Therapeutics, Inc.
Applying Translational Principles Across the Development Lifecycle
2:00 PM - 2:15 PM
PT
Next-Gen Biotherapeutics: Accelerating Multispecifics to the Finish Line
Rapid Fire Speaker:
Vandana Chakravartty, Ph.D.
– Pfizer Inc.
Applying Translational Principles Across the Development Lifecycle
2:15 PM - 2:30 PM
PT
Glycan Profiling of FDA-Approved Therapeutic Antibodies Informed by Regulatory Submissions
Rapid Fire Speaker:
Baolin Zhang, PhD (he/him/his)
– Food & Drug Administration
Applying Translational Principles Across the Development Lifecycle
2:00 PM - 2:30 PM
PT
Coffee Break in the Solution Center
2:00 PM - 2:30 PM
PT
Coffee Break in the Solution Center
Location: Eventide
2:45 PM - 4:00 PM
PT
Closing Plenary with Dr. Lingle Wang
Plenary Speaker:
Lingle Wang
2:45 PM - 4:00 PM
PT
Closing Plenary with Dr. Lingle Wang
Location: Pacific Jewel Ballroom BC
Plenary Speaker:
Lingle Wang
