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OCTOBER 26 - 28 2026 | NEW ORLEANS, LOUISIANA
Booth #1110

AAPS PharmSci 360

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Bioanalytical & CMC Analytical Expertise for Modern Drug Development
From early development through commercial readiness, BioAgilytix delivers integrated bioanalytical and CMC analytical solutions that help sponsors generate reliable data, navigate complex scientific challenges, and make confident development decisions.

Event Overview

AAPS PharmSci 360 brings together scientists, researchers, and industry leaders across pharmaceutical sciences to explore the latest advances in drug discovery, development, manufacturing, and regulatory science. The meeting provides a collaborative forum for sharing scientific innovations, emerging technologies, and practical solutions that support the development of safe and effective therapies.

Whether you're advancing a novel therapeutic, preparing for clinical development, optimizing analytical methods, or supporting commercial manufacturing, PharmSci 360 offers a forum to exchange scientific perspectives across every stage of the drug development lifecycle

Denver

Details

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October 26-28, 2026
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Booth #1110
Ernest N. Morial Convention Center
New Orleans, Louisiana

Presentations

Amanda Hays from BioAgilytix

Presented by Amanda Hays, PhD

Scientific Office

BioAgilytix

Symposuim

Building Regulatory Confidence in Molecular Assays and Qualification Comparison of Two Hybridization LBA Methods for siRNA Quantification


Monday October 26, 2026

9:00 AM - 1:00 PM CT

 

White Paper to Practice

Building Regulatory Confidence in Molecular Assays


Monday October 26, 2026

9:00 AM - 9:30 AM CT

 

Rapid Fire

Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development


Tuesday October 27, 2026

2:45 PM - 3:00 PM CT

 

Symposium

Biomarker-to-Decision: Biomarker Contexts of Use and Fit-for-Purpose Strategies


Wednesday October 28, 2026

9:00 AM - 11:00 AM CT

 

Keynote

Context Matters: Why Biomarker Strategy Starts with Purpose


Wednesday October 28, 2026

1:30 PM - 2:30 PM CT

Jessica Weaver-1

Presented by Jessica Weaver

Scientific Office

BioAgilytix

Technical Presentation

The New Analytical Playbook: Accelerating Gene Therapy, ADC, and mAB Development Through Integrated CMC and GMP Testing


Tuesday October 27, 2026

3:00 PM - 4:00 PM CT

Luis Cruz

Presented by Luis Cruz

Scientific Operations

BioAgilytix

Rapid Fire

Comparing Applicability of Microsampling Devices for Generating Pharmacokinetic Drug Profiles


Tuesday October 27, 2026

3:45 PM - 4:00 PM CT

Supporting Critical Decisions Across Drug Development

Every development program presents unique analytical challenges. Whether you're establishing a bioanalytical strategy, navigating a challenging assay, preparing for regulated development, or advancing toward commercialization, our scientists work alongside your team to develop approaches aligned with your molecule, program phase, and support to make critical decisions for your program

 

Bioanalytical Services

Supporting discovery through clinical development with integrated strategies for:

 

  • Pharmacokinetics (PK)

  • Immunogenicity

  • Biomarkers

  • Assay development, validation, and sample analysis

CMC Analytical & GMP Testing Services

Supporting analytical development through commercialization with:

 

  • Analytical method development

  • Method qualification and validation

  • Product Characterization

  • GMP testing and release

  • Stability testing

Scientific Partnership
Our scientists work alongside sponsor teams to develop analytical strategies that align with program objectives, study design, and regulatory expectations. We believe the strongest outcomes come from collaboration and scientific dialogue.

Reliable, Decision-Ready Data
Reliable decisions begin with reliable data. Our integrated scientific teams generate reproducible, high-quality data that supports confident development, regulatory submissions, and commercialization.

Scalable Execution
Access integrated laboratory teams, advanced platforms, and global infrastructure designed to support programs as requirements, study volumes, and timelines evolve.

Questions We Can Help Answer

Can BioAgilytix support both bioanalytical and CMC analytical programs?

Yes. BioAgilytix provides integrated scientific support across bioanalysis and CMC analytical development, allowing sponsors to work with one scientific partner throughout the drug development lifecycle.

When should analytical strategies be developed?

The greatest value comes from planning analytical strategies early. Early collaboration helps ensure methods align with program goals, study design, regulatory expectations, and future development needs.

Can BioAgilytix support multiple therapeutic modalities?

Yes. Our scientific teams support biologics, monoclonal antibodies, antibody-drug conjugates (ADCs), peptides, oligonucleotides, cell and gene therapies, vaccines, small molecules, and other emerging therapeutic modalities.

How does BioAgilytix support regulatory readiness?

Our scientists develop and validate analytical methods using phase-appropriate approaches while generating data that supports regulatory submissions and commercialization.

Can BioAgilytix support global development programs?

Yes. With laboratories across North America, Europe, and Australia, we provide harmonized scientific support for global development programs while maintaining consistent quality and regulatory standards.

What makes an integrated scientific approach valuable?

Many development programs require expertise across multiple analytical disciplines. By combining bioanalysis, biomarkers, molecular biology, LC-MS, immunogenicity, and CMC analytical services, BioAgilytix helps sponsors answer complex scientific questions through a coordinated strategy rather than isolated testing.

Schedule a Meeting

Whether you're evaluating a new therapeutic, expanding an existing program, or preparing for the next stage of development, our scientists are available to discuss analytical strategies tailored to your goals.

Visit Booth #1110 or schedule a meeting with our team to explore how integrated scientific expertise can support your next development milestone
 

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