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Mon, May 11
Tue, May 12
Wed, May 13
Thu, May 14
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Monday, May 11, 2026
7:30 AM - 6:00 PM
PT
Registration Hours
7:30 AM - 6:00 PM
PT
Registration Hours
Location: Pacific Jewel Foyer
8:00 AM - 3:00 PM
PT
Exhibitor Move-In
8:00 AM - 3:00 PM
PT
Exhibitor Move-In
Location: Eventide
12:00 PM - 3:00 PM
PT
Speaker Ready Room
12:00 PM - 3:00 PM
PT
Speaker Ready Room
Location: Tidepool 4
3:00 PM - 4:30 PM
PT
Opening Plenary
3:00 PM - 4:30 PM
PT
Opening Plenary
Location: Pacific Jewel Ballroom BC
4:30 PM - 6:00 PM
PT
Welcome Reception in the Solution Center
4:30 PM - 6:00 PM
PT
Welcome Reception in the Solution Center
Location: Eventide
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
Wednesday, May 13, 2026
7:30 AM - 3:30 PM
PT
Registration Hours
7:30 AM - 3:30 PM
PT
Registration Hours
Location: Pacific Jewel Foyer
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 Manufacturing and Delivery for Complex Modalities
Moderator:
Weiping Shao, PhD
– AstraZeneca
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:30 AM - 11:00 AM
PT
Symposium: Advancing Precision Manufacturing and Delivery for Complex Modalities
Moderator:
Weiping Shao, PhD
– AstraZeneca
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:30 AM - 10:00 AM
PT
Formulation Forward: Mapping the Biophysical Blueprint for Next-Gen Biologics
Speaker:
Aslin M. Rodriguez Nassif, PhD (she/her/hers)
– Pfizer Inc.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
10:00 AM - 10:30 AM
PT
Microfluidics-Driven Strategies for Scalable Personalized Nanomedicine
Speaker:
Jennica Zaro, PhD
– University of Southern California
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
10:30 AM - 11:00 AM
PT
Compliance in Cell and Gene Therapy Manufacturing: Anticipating Global Trends
Speaker:
Yelena Ionova, Pharm.D.
– Redica Systems
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
9:30 AM - 11:00 AM
PT
Symposium: Bridging from First-in-Human to Registrational Trials
Moderator:
Anup Zutshi, PhD (he/him/his)
– Chinar Pharmaceutical Sciences LLC
Applying Translational Principles Across the Development Lifecycle
9:30 AM - 11:00 AM
PT
Symposium: Bridging from First-in-Human to Registrational Trials
Moderator:
Anup Zutshi, PhD (he/him/his)
– Chinar Pharmaceutical Sciences LLC
Applying Translational Principles Across the Development Lifecycle
9:30 AM - 10:00 AM
PT
Quantitative Systems Pharmacology/Machine Learning for Inflammatory Bowel Disease Biologics
Speaker:
Douglas W. Chung, M.S. (he/him/his)
– Certara
Applying Translational Principles Across the Development Lifecycle
10:00 AM - 10:30 AM
PT
Predictive Modeling of CRS in TCE Immune Activating Therapies
Speaker:
Khamir Mehta, PhD
– Clinical Pharmacology, Modeling & Simulation, Amgen, Inc
Applying Translational Principles Across the Development Lifecycle
10:30 AM - 11:00 AM
PT
Quantitative Mechanistic Pharmacology of Cell and Gene Therapies
Speaker:
Armin Sepp, PhD
– Certara Plc
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: Advancing Precision Manufacturing and Delivery for Complex Modalities
Hot Topic Moderator:
Jo Goodman, BSc (she/her/hers)
– Celerion
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
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
10:00 AM - 10:30 AM
PT
What’s Required vs. What’s Possible: Translational Bioanalytics for IND Success
Speaker:
Vibha Jawa, Ph.D., FAAPS
– EpiVax, Inc.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
10:30 AM - 11:00 AM
PT
Evolution in Immunogenicity Analysis: When are stand-alone Nabs required?
Speaker:
Lynn A. Kamen, PhD
– BioAgilytix Labs
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
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: Advancing the Design Logic of mRNA Nanomedicines
Keynote Speaker:
Owen Fenton
Moderator:
Weiping Shao, PhD
– AstraZeneca
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:00 PM - 2:00 PM
PT
Keynote: Advancing the Design Logic of mRNA Nanomedicines
Keynote Speaker:
Owen Fenton
Moderator:
Weiping Shao, PhD
– AstraZeneca
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
1:00 PM - 2:00 PM
PT
Keynote: Beyond Translation: Accelerating Development to Bring Breakthroughs to Patients Faster
Keynote Speaker:
Amit Rakhit, MD, MBA (he/him/his)
– BlueRock Therapeutics
Moderator:
Amrit Chakravarty, PhD (he/him/his)
– KCAS Bio
Applying Translational Principles Across the Development Lifecycle
1:00 PM - 2:00 PM
PT
Keynote: Beyond Translation: Accelerating Development to Bring Breakthroughs to Patients Faster
Keynote Speaker:
Amit Rakhit, MD, MBA (he/him/his)
– BlueRock Therapeutics
Moderator:
Amrit Chakravarty, PhD (he/him/his)
– KCAS Bio
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
2:30 PM - 3:30 PM
PT
Hot Topic: Transparency to Predictive Insights: Lessons from Complete Response Letters
Hot Topic Moderator:
Allison Elizabeth Radwick, PhD (she/her/hers)
– USP
Hot Topic Speaker:
Michael Delatorre
– Redica Systems
Hot Topic Speaker:
Brett Howard, PhD, JD (he/him/his)
– USP
Hot Topic Speaker:
Grace McNally
– ELIQUENT Life Sciences, Inc.
Applying Translational Principles Across the Development Lifecycle
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:
Michael Delatorre
– Redica Systems
Hot Topic Speaker:
Brett Howard, PhD, JD (he/him/his)
– USP
Hot Topic Speaker:
Grace McNally
– ELIQUENT Life Sciences, Inc.
Applying Translational Principles Across the Development Lifecycle
2:30 PM - 3:30 PM
PT
Rapid Fires: Advancing Precision Manufacturing and Delivery for Complex Modalities
Rapid Fire Moderator:
Sanjeev Bhardwaj, PhD (he/him/his)
– Moderna Therapeutics
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:30 PM - 3:30 PM
PT
Rapid Fires: Advancing Precision Manufacturing and Delivery for Complex Modalities
Rapid Fire Moderator:
Sanjeev Bhardwaj, PhD (he/him/his)
– Moderna Therapeutics
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:30 PM - 2:45 PM
PT
“Particulates” in Cell Therapy Products: Challenges and Opportunities
Rapid Fire Speaker:
Rafi Mohammad, PhD
– Bayer
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:45 PM - 3:00 PM
PT
Translating Rheology and Microstructure-Informed Strategies to Vaccine Suspension Development
Rapid Fire Speaker:
Alex Langford, MS (he/him/his)
– Pfizer
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
3:00 PM - 3:15 PM
PT
AI Meets Aggregates: Machine Learning in Biophysical Formulation Design
Rapid Fire Speaker:
Christine Allen, PhD (she/her/hers)
– University of Toronto/Intrepid Labs Inc.
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
3:15 PM - 3:30 PM
PT
Precision Injectable Biodegradable Implants for Long-Acting Retinal Disease Treatment
Rapid Fire Speaker:
Husam M. Younes, PhD (he/him/his)
– Qatar University - Tissue Engineering & Nanopharmaceuticals Research Laboratory
Advancing Novel Medicine through Precision Science and Patient-Centric Innovation
2:30 PM - 3:30 PM
PT
Rapid Fires: Bridging from First-in-Human to Registrational Trials
Rapid Fire Moderator:
Joleen T. White, PhD (she/her/hers)
– BioData Solutions LLC
Applying Translational Principles Across the Development Lifecycle
2:30 PM - 3:30 PM
PT
Rapid Fires: Bridging from First-in-Human to Registrational Trials
Rapid Fire Moderator:
Joleen T. White, PhD (she/her/hers)
– BioData Solutions LLC
Applying Translational Principles Across the Development Lifecycle
2:30 PM - 2:45 PM
PT
Challenges in Biomarker Translation: The Long and Torturous Path to Commercialization
Rapid Fire Speaker:
Steven P. Piccoli, PhD (he/him/his)
– SPARC
Applying Translational Principles Across the Development Lifecycle
2:45 PM - 3:00 PM
PT
FDA LDT Rule: Implications for Biomarker Development
Rapid Fire Speaker:
Alok Pandey, PhD
– PBL Assay Science
Applying Translational Principles Across the Development Lifecycle
3:00 PM - 3:15 PM
PT
Developing a Machine Learning–Based-Virtual-Neutralizing Antibody Assay to Support Immunogenicity Assessment
Rapid Fire Speaker:
Robert Dodge, PhD
– Dodge
Applying Translational Principles Across the Development Lifecycle
3:15 PM - 3:30 PM
PT
Leveraging Biomarker Data in the Context of Early to Late Clinical Trials
Rapid Fire Speaker:
Preeyam Patel, PhD (she/her/hers)
– Spyre Therapeutics
Applying Translational Principles Across the Development Lifecycle
4:30 PM - 8:00 PM
PT
Exhibitor Move-Out
4:30 PM - 8:00 PM
PT
Exhibitor Move-Out
Location: Eventide
5:00 PM - 6:30 PM
PT
Women in Biotech Reception
5:00 PM - 6:30 PM
PT
Women in Biotech Reception
Location: Eventide Gardens
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
2:45 PM - 4:00 PM
PT
Closing Plenary
Location: Pacific Jewel Ballroom BC
