Full Schedule

7:30 AM - 3:30 PM PT

Registration Hours

Location: Pacific Jewel Foyer

8:00 AM - 9:00 AM PT

AAPS Bioanalytical Community Membership Meeting

Location: Pacific Jewel A

Community Leader: – Dodge

Community Leader: – Johnson & Johnson

8:00 AM - 9:30 AM PT

Executive Track: Guiding Good Science to Patients Through Evolving Markets and an Uncertain Regulatory Environment

Location: Coral 1-2

Moderator: – BioSpace

Executive Education Speaker: – Johns Hopkins University

Executive Education Speaker: – BlueRock Therapeutics

Executive Education Speaker: – LYZZ Capital Advisors

Executive Track

Sponsored By

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

Location: Eventide

9:30 AM - 10:30 AM PT

Symposium: Advancing Precision Manufacturing and Delivery for Complex Modalities

Location: Pacific Jewel BC

Moderator: – Astrazeneca

Advancing Novel Medicine through Precision Science and Patient-Centric Innovation

9:30 AM - 10:00 AM PT

Microfluidics-Driven Strategies for Scalable Personalized Nanomedicine

Location: Pacific Jewel BC

Speaker: – University of Southern California

Advancing Novel Medicine through Precision Science and Patient-Centric Innovation

10:00 AM - 10:30 AM PT

Compliance in Cell and Gene Therapy Manufacturing: Anticipating Global Trends

Location: Pacific Jewel BC

Speaker: – 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

Location: Pacific Jewel A

Moderator: – 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

Location: Pacific Jewel A

Speaker: – Certara

Applying Translational Principles Across the Development Lifecycle

10:00 AM - 10:30 AM PT

Predictive Modeling of CRS in TCE Immune Activating Therapies

Location: Pacific Jewel A

Speaker: – Amgen

Applying Translational Principles Across the Development Lifecycle

10:30 AM - 11:00 AM PT

Quantitative Mechanistic Pharmacology of Cell and Gene Therapies

Location: Pacific Jewel A

Speaker: – Certara UK (Simcyp Division)

Applying Translational Principles Across the Development Lifecycle

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

Location: Coral 1-2

Hot Topic Moderator: – 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

Location: Coral 1-2

Hot Topic Speaker: – 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?

Location: Coral 1-2

Hot Topic Speaker: – BioAgilytix Labs

Advancing Novel Medicine through Precision Science and Patient-Centric Innovation

10:15 AM - 11:00 AM PT

Immunogenicity Assessment for Biotherapeutics and Target Binding Reagents Beyond Antibodies

Location: Learning Lab, Exhibit Hall

Partner Presentation Speaker: – ProImmune, Inc.

Applying Translational Principles Across the Development Lifecycle

Sponsored By

11:00 AM - 1:00 PM PT

Dedicated Solution Center Hours

Location: Eventide

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: – KCAS Bio

Advancing Novel Medicine through Precision Science and Patient-Centric Innovation

Sponsored By

11:30 AM - 12:30 PM PT

Special Poster Collection

Location: Eventide

Poster Collection Host: – AbbVie

Advancing Novel Medicine through Precision Science and Patient-Centric Innovation

11:30 AM - 1:00 PM PT

Lunch in the Solution Center

Location: Eventide

12:15 PM - 1:00 PM PT

Longitudinal and Lifecycle Management of Potency Release Assays

Location: Learning Lab, Exhibit Hall

Partner Presentation Speaker: – Solvias

Applying Translational Principles Across the Development Lifecycle

Sponsored By

1:00 PM - 2:00 PM PT

Keynote: Advancing the Design Logic of mRNA Nanomedicines

Location: Pacific Jewel BC

Keynote Speaker:

Moderator: – 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

Location: Pacific Jewel A

Keynote Speaker: – BlueRock Therapeutics

Moderator: – KCAS Bio

Applying Translational Principles Across the Development Lifecycle

1:30 PM - 2:15 PM PT

Automated Immunoassays Address Analytical Bottlenecks in ADC Drug Development

Location: Learning Lab, Exhibit Hall

Partner Presentation Speaker: – Gyros Protein Technologies

Advancing Novel Medicine through Precision Science and Patient-Centric Innovation

Sponsored By

2:00 PM - 2:30 PM PT

Coffee Break in the Solution Center

Location: Eventide

2:30 PM - 3:15 PM PT

Advancing GLP-1 Development with Next-Generation Analytical Tools

Location: Learning Lab, Exhibit Hall

Partner Presentation Speaker: – Waters Corporation

Advancing Novel Medicine through Precision Science and Patient-Centric Innovation

Sponsored By

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: – USP

Hot Topic Speaker: – ELIQUENT Life Sciences, Inc.

Hot Topic Speaker: – Redica Systems

Hot Topic Speaker: – USP

Applying Translational Principles Across the Development Lifecycle

2:30 PM - 3:30 PM PT

Rapid Fires: Advancing Precision Manufacturing and Delivery for Complex Modalities

Location: Pacific Jewel BC

Rapid Fire Moderator: – 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

Location: Pacific Jewel BC

Rapid Fire Speaker: – 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

Location: Pacific Jewel BC

Rapid Fire Speaker: – 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

Location: Pacific Jewel BC

Rapid Fire Speaker: – Intrepid Labs

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

Location: Pacific Jewel BC

Rapid Fire Speaker: – Qatar University

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

Location: Pacific Jewel A

Rapid Fire Moderator: – Immunovant

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

Location: Pacific Jewel A

Rapid Fire Speaker: – SPARC

Applying Translational Principles Across the Development Lifecycle

2:45 PM - 3:00 PM PT

FDA LDT Rule: Implications for Biomarker Development

Location: Pacific Jewel A

Rapid Fire Speaker: – 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

Location: Pacific Jewel A

Rapid Fire Speaker: – 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

Location: Pacific Jewel A

Rapid Fire Speaker: – Spyre Therapeutics

Applying Translational Principles Across the Development Lifecycle

3:30 PM - 4:15 PM PT

Development and Qualification of a Multiplexed Immunoassay to Assess the Immunogenicity of Shigella Vaccines

Location: Learning Lab, Exhibit Hall

Partner Presentation Speaker: – Luminex

Applying Translational Principles Across the Development Lifecycle

Sponsored By

3:30 PM - 4:30 PM PT

Happy Hour Sponsored by BioSpace

Location: Eventide

Sponsored By

4:30 PM - 8:00 PM PT

Exhibitor Move-Out

Location: Eventide

5:00 PM - 6:30 PM PT

Women in Biotech Reception

Location: Eventide Gardens