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Tuesday, May 12, 2026
7:30 AM - 3:30 PM
PT
Registration Hours
7:30 AM - 3:30 PM
PT
Registration Hours
Location: Pacific Jewel Foyer
8:00 AM - 9:30 AM
PT
Charting Your Path: Strategic Career Direction for Mid-Career Biotech Professionals in a Dynamic Market
Career Center Speaker:
Katrina Rogers, ASQ Certified Manager of Quality/Operational Excellence and ASQ Certified Pharmaceutical GMP Professional (she/her/hers)
– KATRINA ROGERS CONSULTING LLC
8:00 AM - 9:30 AM
PT
Charting Your Path: Strategic Career Direction for Mid-Career Biotech Professionals in a Dynamic Market
Location: Coral 1-2
Career Center Speaker:
Katrina Rogers, ASQ Certified Manager of Quality/Operational Excellence and ASQ Certified Pharmaceutical GMP Professional (she/her/hers)
– KATRINA ROGERS CONSULTING LLC
8:30 AM - 3:30 PM
PT
Speaker Ready Room
8:30 AM - 3:30 PM
PT
Speaker Ready Room
Location: Tidepool 4
9:00 AM - 4:30 PM
PT
Solution Center Hours & Poster Presentations
9:00 AM - 4:30 PM
PT
Solution Center Hours & Poster Presentations
Location: Eventide
9:30 AM - 11:00 AM
PT
Symposium: Advancing Precision Therapeutics through AI Innovation and Global Regulatory Harmonization
Moderator:
Timothy P. Hickling, PhD
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:30 AM - 11:00 AM
PT
Symposium: Advancing Precision Therapeutics Through AI Innovation and Global Regulatory Harmonization
Moderator:
Timothy P. Hickling, PhD
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:30 AM - 10:00 AM
PT
Advancing Precision Medicine: Accurate, Cost-Effective, Predictive Responses Through Harmonization
Speaker:
Dhiman Ghosh
– Wave Life Sciences
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
10:00 AM - 10:30 AM
PT
Embedding AI/ML through Ethical and Regulatory Strategy in Precision Therapeutics
Speaker:
Shannon Ryan (she/her/hers)
– Veritas Automata
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
10:30 AM - 11:00 AM
PT
AI-Driven Analysis of Inspection Outcomes for Optimized Clinical Site Selection
Speaker:
Jerry L. Chapman, BS (he/him/his)
– REDICA Systems
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:30 AM - 11:00 AM
PT
Symposium: Bridging from Therapeutic Concept to First in Human
Moderator:
Preeyam Patel, PhD (she/her/hers)
– Spyre Therapeutics
Applying Translational Principles Across the Development Lifecycle
9:30 AM - 11:00 AM
PT
Symposium: Bridging from Therapeutic Concept to First in Human
Moderator:
Preeyam Patel, PhD (she/her/hers)
– Spyre Therapeutics
Applying Translational Principles Across the Development Lifecycle
9:30 AM - 10:00 AM
PT
Regulatory Qualification of Microphysiological Systems (MPS) as Drug Development Tools: The NIH-FDA Translational Centers for MPS
Speaker:
Passley Hargrove
Applying Translational Principles Across the Development Lifecycle
10:00 AM - 10:30 AM
PT
Integrating Advanced Cellular Models, Multiomics, and AI for Safety Prediction
Speaker:
Jurre J. Kamphorst, PhD
– AstraZeneca
Applying Translational Principles Across the Development Lifecycle
10:30 AM - 11:00 AM
PT
Micro-Physiological Systems: Developing a Functional Precision Medicine Platform for Immuno-Oncology
Speaker:
Amir Aref, PhD (he/him/his)
– MGB
Applying Translational Principles Across the Development Lifecycle
10:00 AM - 11:00 AM
PT
Coffee Break in the Solution Center
10:00 AM - 11:00 AM
PT
Coffee Break in the Solution Center
Location: Eventide
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
Hot Topic Speaker:
Sheetal S. Pai-Wechsung, PhD (she/her/hers)
– Pfizer Inc
Hot Topic Speaker:
Stephen T. Buckley, PhD (he/him/his)
– Novo Nordisk A/S
Hot Topic Moderator:
Robert Dodge, PhD
– Dodge
Applying Translational Principles Across the Development Lifecycle
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:
Sheetal S. Pai-Wechsung, PhD (she/her/hers)
– Pfizer Inc
Hot Topic Speaker:
Stephen T. Buckley, PhD (he/him/his)
– Novo Nordisk A/S
Hot Topic Moderator:
Robert Dodge, PhD
– Dodge
Applying Translational Principles Across the Development Lifecycle
11:00 AM - 1:00 PM
PT
Dedicated Solution Center Hours
11:00 AM - 1:00 PM
PT
Dedicated Solution Center Hours
Location: Eventide
11:30 AM - 1:00 PM
PT
Lunch in the Solution Center
11:30 AM - 1:00 PM
PT
Lunch in the Solution Center
Location: Eventide
1:00 PM - 2:00 PM
PT
Keynote: Implementation of Generative AI for Drug Discovery and Safety
Moderator:
Jason Pennucci
– Moderna Therapeutics
Keynote Speaker:
Weida Tong, PhD (he/him/his)
– National Center for Toxicological Research, FDA
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:00 PM - 2:00 PM
PT
Keynote: Implementation of Generative AI for Drug Discovery and Safety
Moderator:
Jason Pennucci
– Moderna Therapeutics
Keynote Speaker:
Weida Tong, PhD (he/him/his)
– National Center for Toxicological Research, FDA
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:00 PM - 2:00 PM
PT
Keynote: New Approach Methods – From Ugly Ducklings to Beautiful Swans
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
1:00 PM - 2:00 PM
PT
Keynote: New Approach Methods – From Ugly Ducklings to Beautiful Swans
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
2:30 PM - 3:30 PM
PT
Hot Topic: Because Ellie Can’t Wait: Breaking Barriers in Advanced Therapy Development
Hot Topic Moderator:
Timothy P. Hickling, PhD
Hot Topic Speaker:
Mimoun Azzouz
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:30 PM - 3:30 PM
PT
Hot Topic: Because Ellie Can’t Wait: Breaking Barriers in Advanced Therapy Development
Hot Topic Moderator:
Timothy P. Hickling, PhD
Hot Topic Speaker:
Mimoun Azzouz
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:30 PM - 3:30 PM
PT
Rapid Fires: Advancing Precision Therapeutics through AI Innovation and Global Regulatory Harmonization
Rapid Fire Moderator:
Soumya Sundaram, MS
– Celerion
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:30 PM - 3:30 PM
PT
Rapid Fires: Advancing Precision Therapeutics through AI Innovation and Global Regulatory Harmonization
Rapid Fire Moderator:
Soumya Sundaram, MS
– Celerion
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:30 PM - 2:45 PM
PT
Application of Machine Learning for Product Stability Characterization and Control
Speaker:
Dave Thomas
– Lumetics Inc.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:45 PM - 3:00 PM
PT
Auditable GenAI for Authoring eCTD Table
Rapid Fire Speaker:
Bingjia Yang, PhD (she/her/hers)
– Merck & Co.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
3:00 PM - 3:15 PM
PT
Machine Learning for Particle Identification and Characterization of Novel Medicines
Rapid Fire Speaker:
Amber Raines, PhD (she/her/hers)
– Coriolis Pharma U.S.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
3:15 PM - 3:30 PM
PT
Benching AI: Unlock Optimal Processes faster with Your Data and AI
Rapid Fire Speaker:
Jason Boyd, MBA
– Benchling
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:30 PM - 3:30 PM
PT
Rapid Fires: Bridging from Therapeutic Concept to First in Human
Rapid Fire Moderator:
Pankajini Mallick, PhD (she/her/hers)
– Neurocrine Biosciences
Applying Translational Principles Across the Development Lifecycle
2:30 PM - 3:30 PM
PT
Rapid Fires: Bridging from Therapeutic Concept to First in Human
Rapid Fire Moderator:
Pankajini Mallick, PhD (she/her/hers)
– Neurocrine Biosciences
Applying Translational Principles Across the Development Lifecycle
2:30 PM - 2:45 PM
PT
PK/PD Essentials- A Pragmatic Approach to mAb Dosing
Rapid Fire Speaker:
Marc Presler, PhD
– Certara
Applying Translational Principles Across the Development Lifecycle
2:45 PM - 3:00 PM
PT
When Humanized FcRn Changes Your Answer
Rapid Fire Speaker:
Anup Zutshi, PhD (he/him/his)
– Chinar Pharmaceutical Sciences LLC
Applying Translational Principles Across the Development Lifecycle
3:00 PM - 3:15 PM
PT
Systems Modelling for Gene Therapies (siRNA, FDC, BiTE)
Rapid Fire Speaker:
Devam A. Desai, MS (he/him/his)
– University of Florida
Applying Translational Principles Across the Development Lifecycle
3:15 PM - 3:30 PM
PT
From Lipids to Protein Expression: Determinants of mRNA-LNP Biodistribution
Rapid Fire Speaker:
Mokshada Kumar, MS (she/her/hers)
– University At Buffalo, SUNY
Applying Translational Principles Across the Development Lifecycle
5:00 PM - 6:30 PM
PT
Sustaining Partner Reception (by invitation only)
5:00 PM - 6:30 PM
PT
Sustaining Partner Reception (by invitation only)
Location: Eventide Gardens
