Full Schedule

8:30 AM – 9:30 AM PT

AAPS Bioanalytical Community Membership Meeting

Location: Yosemite A

Community Leader: – Merck Research Laboratories

8:30 AM – 3:30 PM PT

Registration Hours

Location: Yosemite Foyer

8:30 AM – 3:30 PM PT

Speaker Ready Room

Location: Executive Boardroom

9:30 AM – 11:00 AM PT

Executive Track - Cell and Gene Therapies at the Intersection of Business and Science

Location: Franciscan A&B

Moderator: – Potens Pharmaceuticals

Executive Education Speaker: – CTMC

Executive Education Speaker: – QPS

Executive Education Speaker: – iXCells Biotechnologies

Executive Education Speaker: – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics

Executive Track

9:30 AM – 11:00 AM PT

Symposium: Development Strategy for Novel Targeted Therapeutic Delivery

Location: Plaza A

Moderator: – BioAgilytix Labs

Novel Strategies to Advance Biotherapeutic Development

9:30 AM – 10:00 AM PT

An Ultra-Sensitive Human pS413 Tau Assay in Cerebrospinal Fluid

Location: Plaza A

Speaker: – Merck

Novel Strategies to Advance Biotherapeutic Development

10:00 AM – 10:30 AM PT

The Advancement of High-Plex Bioanalytical Technology and its Data Integration

Location: Plaza A

Speaker: – Takeda Pharmaceutical Company Limited

Novel Strategies to Advance Biotherapeutic Development

10:30 AM – 11:00 AM PT

Hybrid LBA LC-MS Assay: Does One Size Fit All?

Location: Plaza A

Speaker: – US Food and Drug Administration

Novel Strategies to Advance Biotherapeutic Development

9:30 AM – 11:00 AM PT

Symposium: Preformulation and Formulation Approaches for Biologics and New Modalities

Location: Yosemite BC

Moderator: – Teva Pharmaceuticals

Advances in Discovery, Formulation, and Delivery of New Modalities

9:30 AM – 10:00 AM PT

Novel Approaches to Cancer Immunotherapy: a Strategic Overview

Location: Yosemite BC

Speaker: – Teva Pharmaceuticals

Advances in Discovery, Formulation, and Delivery of New Modalities

10:00 AM – 10:30 AM PT

High-Throughput Screening and Structural Characterization for Oligonucleotide LNP

Location: Yosemite BC

Speaker: – Genentech, Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

10:30 AM – 11:00 AM PT

Structure-Function Relationships in Lyophilized Biologics for Stability Prediction

Location: Yosemite BC

Speaker: – Purdue University/Industrial and Physical Pharmacy

Advances in Discovery, Formulation, and Delivery of New Modalities

10:00 AM – 11:00 AM PT

Coffee Break in the Solution Center

Location: Grand Ballroom AB

10:00 AM – 11:00 AM PT

Hot Topic: Particle Safety and Size Threshold for Particle Visibility Revisited

Location: Yosemite A

Hot Topic Moderator: – Takeda

Advances in Discovery, Formulation, and Delivery of New Modalities

10:00 AM – 10:20 AM PT

Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility

Location: Yosemite A

Hot Topic Speaker: – Genentech

Advances in Discovery, Formulation, and Delivery of New Modalities

10:20 AM – 10:40 AM PT

Silicone Oil Particles in Protein Drug Product – Are These a Significant Immunogenicity Risk Factor?

Location: Yosemite A

Hot Topic Speaker: – Amgen

Advances in Discovery, Formulation, and Delivery of New Modalities

10:40 AM – 11:00 AM PT

Panel Discussion

Location: Yosemite A

Hot Topic Speaker: – Genentech

Hot Topic Speaker: – Spyre Therapeutics

Hot Topic Speaker: – Amgen

Hot Topic Moderator: – Takeda

Advances in Discovery, Formulation, and Delivery of New Modalities

10:00 AM – 4:30 PM PT

Solution Center Hours & Poster Presentations

Location: Grand Ballroom AB

10:15 AM – 11:00 AM PT

High Resolution Accurate Mass Analysis: Addressing Sensitivity and Specificity

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – Q Squared Solutions

Novel Strategies to Advance Biotherapeutic Development

11:00 AM – 1:00 PM PT

Dedicated Solution Center Hours

Location: Grand Ballroom AB

11:15 AM – 12:00 PM PT

High-Speed Microdroplet Reactions for Faster Therapeutic Protein Analysis

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – Gilead Sciences

Novel Strategies to Advance Biotherapeutic Development

11:30 AM – 12:30 PM PT

Special Poster Collection

Location: Grand Ballroom AB, Poster Forum 1

Poster Collection Host: – BioAgilytix

Advances in Discovery, Formulation, and Delivery of New Modalities

11:30 AM – 1:00 PM PT

Light Lunch in the Solution Center

Location: Grand Ballroom AB

12:15 PM – 1:00 PM PT

Mass Photometry – an Analytical Technology for Biomolecular Characterization

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – Refeyn Inc.

Novel Strategies to Advance Biotherapeutic Development

1:00 PM – 2:00 PM PT

Keynote: Crafting Complex Biologics: A Fusion of Art and Science?

Location: Yosemite BC

Keynote Speaker: – Merck & Co, Inc.

Moderator: – Merck & Co., Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

1:00 PM – 2:00 PM PT

Keynote: Using Biomarkers to Accelerate Development of Disease Modifying Therapies for Rare Disease

Location: Plaza A

Keynote Speaker: – Ultragenyx

Moderator: – Prothena Biosciences

Novel Strategies to Advance Biotherapeutic Development

1:30 PM – 2:15 PM PT

Advances in Accelerated Quantification of Oligonucleotides with Automated, Microfluidic Methods

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – Gyros Protein Technologies

Novel Strategies to Advance Biotherapeutic Development

2:00 PM – 2:30 PM PT

Coffee Break in the Solution Center

Location: Grand Ballroom AB

2:30 PM – 3:15 PM PT

Formulation Development of sa-RNA Lipid Nanoparticles and Adjuvants for Regulating Immune Response

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – Labcorp

Advances in Discovery, Formulation, and Delivery of New Modalities

2:30 PM – 3:30 PM PT

Hot Topic: Biomarkers and Accelerated Approval for Advanced Therapy

Location: Yosemite A

Hot Topic Speaker: – Center for Biologics Evaluation and Research,FDA

Hot Topic Speaker: – Passage Bio

Hot Topic Moderator: – Passage Bio

Hot Topic Speaker: – Ultragenyx

Novel Strategies to Advance Biotherapeutic Development

2:30 PM – 3:30 PM PT

Rapid Fire: Development Strategy for Novel Targeted Therapeutic Delivery

Location: Plaza A

Rapid Fire Moderator: – Boehringer Ingelheim

Novel Strategies to Advance Biotherapeutic Development

2:30 PM – 2:45 PM PT

Advanced ADA-Domain-Characterization for T-cell-Engager-Drugs to Understand Exposure and Activity Impact

Location: Plaza A

Rapid Fire Speaker: – Roche Diagnostics GmbH

Novel Strategies to Advance Biotherapeutic Development

2:45 PM – 3:00 PM PT

Spectral Unmixing Impact Comparison Across Immunophenotyping Panels and Matrices

Location: Plaza A

Rapid Fire Speaker: – KCAS Bio

Novel Strategies to Advance Biotherapeutic Development

3:00 PM – 3:15 PM PT

Identifying Inflammatory Biomarkers in Small-Cell Lung Cancer Using Olink Assays

Location: Plaza A

Rapid Fire Speaker: – AstraZeneca

Novel Strategies to Advance Biotherapeutic Development

3:15 PM – 3:30 PM PT

High-Dimensional Immunophenotyping Panel to Characterize Chimeric-Antigen-Receptor T Cells in Clinical-Trials

Location: Plaza A

Rapid Fire Speaker: – Astrazeneca

Novel Strategies to Advance Biotherapeutic Development

2:30 PM – 3:30 PM PT

Rapid Fire: Preformulation and Formulation Approaches for Biologics and New Modalities

Location: Yosemite BC

Rapid Fire Moderator: – SynerG Biopharma Group

Advances in Discovery, Formulation, and Delivery of New Modalities

2:30 PM – 2:45 PM PT

Atomic Level Characterization of Excipient Interactions with Monoclonal Antibodies

Location: Yosemite BC

Rapid Fire Speaker: – Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology & University of Maryland

Advances in Discovery, Formulation, and Delivery of New Modalities

2:45 PM – 3:00 PM PT

Using Artificial Extracellular Matrices in Injectable Formulation Development

Location: Yosemite BC

Rapid Fire Speaker: – Pion Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

3:00 PM – 3:15 PM PT

Beyond mRNA and Lipid Nanoparticles: Formulation and Process Innovations

Location: Yosemite BC

Rapid Fire Speaker: – Landmark Bio

Advances in Discovery, Formulation, and Delivery of New Modalities

3:15 PM – 3:30 PM PT

Cell Therapy CMC Case Studies

Location: Yosemite BC

Rapid Fire Speaker: – Syner-G Biopharma Group

Advances in Discovery, Formulation, and Delivery of New Modalities

3:30 PM – 4:15 PM PT

Immunogenicity Assessment and Target Binding Reagents Beyond Antibodies

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – ProImmune, Inc.

Novel Strategies to Advance Biotherapeutic Development

3:30 PM – 4:30 PM PT

Happy Hour Sponsored by Aragen Lifesciences Ltd

Location: Booth #208, Grand Ballroom AB

3:30 PM – 4:30 PM PT

Special Poster Collection

Location: Grand Ballroom AB, Poster Forum 1

Poster Collection Host: – Larimartx

5:00 PM – 6:30 PM PT

Sustaining Partner Reception (by invitation only)

Location: Vista Lounge (45th Floor)