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Tuesday, May 12th
9:30 AM - 11:00 AM PT
Symposium: Advancing Precision Therapeutics Through AI Innovation and Global Regulatory Harmonization
Location: Pacific Jewel BC
Moderator: Timothy P. Hickling, PhD
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
9:30 AM - 10:00 AM PT
Advancing Precision Medicine: Accurate, Cost-Effective, Predictive Responses Through Harmonization
Location: Pacific Jewel BC
Speaker: Dhiman Ghosh, PhD (he/him/his) – Wave Life Sciences
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
10:00 AM - 10:30 AM PT
Embedding AI/ML through Ethical and Regulatory Strategy in Precision Therapeutics
Location: Pacific Jewel BC
Speaker: Shannon Ryan (she/her/hers) – Veritas Automata
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
10:30 AM - 11:00 AM PT
AI-Driven Analysis of Inspection Outcomes for Optimized Clinical Site Selection
Location: Pacific Jewel BC
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
10:15 AM - 11:00 AM PT
From Antibodies to Bioconjugates: Scalable Multi-Attribute Methods for Emerging Therapeutic Modalities
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Ganesh Bala, PhD (he/him/his) – Agilent Technologies
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Sponsored By
Tuesday, May 12th
1:00 PM - 2:00 PM PT
Keynote: Implementation of Generative AI for Drug Discovery and Safety
Location: Pacific Jewel BC
Moderator: Jason Pennucci, MS – Moderna
Keynote Speaker: Weida Tong, PhD (he/him/his) – National Center for Toxicological Research, FDA
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
2:30 PM - 3:15 PM PT
Advancing Bioanalysis with HRMS-based Quantitation
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Shane Needham, PhD (he/him/his) – Veloxity Labs, LLC
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Sponsored By
Tuesday, May 12th
2:30 PM - 3:30 PM PT
Hot Topic: Because Ellie Can’t Wait: Breaking Barriers in Advanced Therapy Development
Location: Pacific Jewel BC
Hot Topic Moderator: Timothy P. Hickling, PhD
Hot Topic Speaker: Mimoun Azzouz
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
2:30 PM - 3:30 PM PT
Rapid Fires: Advancing Precision Therapeutics through AI Innovation and Global Regulatory Harmonization
Location: Pacific Jewel BC
Rapid Fire Moderator: Soumya Sundaram, MS – Celerion
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
2:30 PM - 2:45 PM PT
Application of Machine Learning for Product Stability Characterization and Control
Location: Pacific Jewel BC
Speaker: Dave Thomas, B.Sc., MBA (he/him/his) – Lumetics Inc.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
2:45 PM - 3:00 PM PT
Auditable GenAI for Authoring eCTD Table
Location: Pacific Jewel BC
Rapid Fire Speaker: Bingjia Yang, PhD (she/her/hers) – Merck & Co.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
3:00 PM - 3:15 PM PT
Machine Learning for Particle Identification and Characterization of Novel Medicines
Location: Pacific Jewel BC
Rapid Fire Speaker: Amber Raines, PhD (she/her/hers) – Coriolis Pharma U.S.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Tuesday, May 12th
3:15 PM - 3:30 PM PT
Benching AI: Unlock Optimal Processes faster with Your Data and AI
Location: Pacific Jewel BC
Rapid Fire Speaker: Jason Boyd, MBA – Benchling
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
9:30 AM - 11:00 AM PT
Symposium: Advancing Precision Manufacturing and Delivery for Complex Modalities
Location: Pacific Jewel BC
Moderator: Weiping Shao, PhD – Astrazeneca
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
9:30 AM - 10:00 AM PT
Formulation Forward: Mapping the Biophysical Blueprint for Next-Gen Biologics
Location: Pacific Jewel BC
Speaker: Aslin M. Rodriguez Nassif, PhD (she/her/hers) – Pfizer Inc.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
10:00 AM - 10:30 AM PT
Microfluidics-Driven Strategies for Scalable Personalized Nanomedicine
Location: Pacific Jewel BC
Speaker: Jennica Zaro, PhD – University of Southern California
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
10:30 AM - 11:00 AM PT
Compliance in Cell and Gene Therapy Manufacturing: Anticipating Global Trends
Location: Pacific Jewel BC
Speaker: Yelena Ionova, Pharm.D. – Redica Systems
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
10:00 AM - 11:00 AM PT
Hot Topic: Advancing Precision Manufacturing and Delivery for Complex Modalities
Location: Coral 1-2
Hot Topic Moderator: Jo Goodman, BSc (she/her/hers) – Celerion
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
10:00 AM - 10:30 AM PT
What’s Required vs. What’s Possible: Translational Bioanalytics for IND Success
Location: Pacific Jewel BC
Speaker: Vibha Jawa, PhD, FAAPS (she/her/hers) – EpiVax, Inc.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
10:30 AM - 11:00 AM PT
Evolution in Immunogenicity Analysis: When are stand-alone Nabs required?
Location: Pacific Jewel BC
Speaker: Lynn A. Kamen, PhD – BioAgilytix Labs
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
11:15 AM - 12:00 PM PT
Development of a Quantitative Assay in Whole Blood using Microsampling
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Lindsay Rutherford, n/a – KCAS Bio
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Sponsored By
Wednesday, May 13th
11:30 AM - 12:30 PM PT
Special Poster Collection
Location: Eventide
Poster Collection Host: Carl Allenspach, PhD – Bristol Myers Squibb
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
1:00 PM - 2:00 PM PT
Keynote: Advancing the Design Logic of mRNA Nanomedicines
Location: Pacific Jewel BC
Keynote Speaker: Owen Fenton
Moderator: Weiping Shao, PhD – Astrazeneca
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
1:30 PM - 2:15 PM PT
Automated Immunoassays Address Analytical Bottlenecks in ADC Drug Development
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: John David Chappell, n/a – Gyros Protein Technologies
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Sponsored By
Wednesday, May 13th
2:30 PM - 3:15 PM PT
Advancing GLP-1 Development with Next-Generation Analytical Tools
Location: Learning Lab, Exhibit Hall
Partner Presentation Speaker: Andrew Leightner, n/a – Waters Corporation
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Sponsored By
Wednesday, May 13th
2:30 PM - 3:30 PM PT
Rapid Fires: Advancing Precision Manufacturing and Delivery for Complex Modalities
Location: Pacific Jewel BC
Rapid Fire Moderator: Sanjeev Bhardwaj, PhD (he/him/his) – Moderna Therapeutics
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
2:30 PM - 2:45 PM PT
“Particulates” in Cell Therapy Products: Challenges and Opportunities
Location: Pacific Jewel BC
Rapid Fire Speaker: Rafi Mohammad, PhD – Bayer
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
2:45 PM - 3:00 PM PT
Translating Rheology and Microstructure-Informed Strategies to Vaccine Suspension Development
Location: Pacific Jewel BC
Rapid Fire Speaker: Alex Langford, MS (he/him/his) – Pfizer
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
3:00 PM - 3:15 PM PT
AI Meets Aggregates: Machine Learning in Biophysical Formulation Design
Location: Pacific Jewel BC
Rapid Fire Speaker: Christine Allen, PhD (she/her/hers) – University of Toronto
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Wednesday, May 13th
3:15 PM - 3:30 PM PT
Precision Injectable Biodegradable Implants for Long-Acting Retinal Disease Treatment
Location: Pacific Jewel BC
Rapid Fire Speaker: Husam M. Younes, MSc, PhD (he/him/his) – Qatar University
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Thursday, May 14th
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
Thursday, May 14th
9:00 AM - 9:30 AM PT
Neutralizing Antibody Assessment for Tri-specific Biotherapeutics Amid Pre-existing Anti-drug Antibodies
Speaker: Bonnie Wu, PhD – Johnson & Johnson Innovation Medicine
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Thursday, May 14th
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
Thursday, May 14th
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
Thursday, May 14th
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
Thursday, May 14th
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
Thursday, May 14th
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
Thursday, May 14th
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
Thursday, May 14th
1:30 PM - 1:45 PM PT
Translational In Vitro Tools to Predict Bioavailability of Inhalation Products
Rapid Fire Speaker: Ana Filipa Ferreira, PharmD, PhD (she/her/hers) – Hovione
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
Thursday, May 14th
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
Thursday, May 14th
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
Thursday, May 14th
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
Thursday, May 14th
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
Thursday, May 14th
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