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Mon, May 11
Tue, May 12
Wed, May 13
Thu, May 14
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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
