Single Clinical Trial Strategy to Accelerate your Drug’s Path to Market
Recent FDA discussions surrounding plausible mechanism and confirmatory evidence frameworks reflect this broader shift. Increasingly, translational success may depend not only on demonstrating that a therapy produced a measurable effect, but also on confirming how that effect emerged within intact biological systems. FDA guidance and recent regulatory discussions increasingly reference mechanistic, pharmacodynamic, and target engagement evidence as important components of confirmatory evidence frameworks.
As spatial biology moves closer to regulated translational and clinical development environments, the challenge is no longer simply generating more molecular data. The next phase of the field will depend on the ability to generate biologically coherent, reproducible, scalable, and clinically actionable mechanistic evidence.
Download the white paper to learn how spatial biology can support the FDA’s Evolving Confirmatory Evidence Framework.
A Spatial PK/PD Framework to Predict ADC Response in Solid Tumors
Antibody-drug conjugates achieve therapeutic activity only when payload delivery, target accessibility, and microenvironmental readiness align within tumor tissue. Conventional biomarkers capture isolated components of this biology but fail to resolve the spatial coordination that ultimately governs pharmacodynamic activity.
To address this gap, we developed a translational spatial PK/PD framework integrating MSI, spatial proteomics/transcriptomics, and multiplex tissue imaging to spatially interpret coordinated ADC activity within solid tumors
Download the poster, recently presented at EACR 2026 in Budapest, Hungary to learn more.
Qualification of Translational Spatial Biomarker Panel to Enable Predictive Tissue Profiling in Oncology Drug Development
Spatial biology technologies are transforming translational oncology by enabling high-resolution characterization of tumor–immune ecosystems. However, the clinical utility of spatial biomarkers remains limited by a lack of standardized, qualified panels capable of generating reproducible and decision-enabling data across studies. To address this gap, we developed a framework for the qualification of translational spatial biomarker panels designed to support drug development and clinical trial biomarker strategies. By integrating multiplex immunofluorescence, digital pathology, and AI-assisted image analysis, our objective was to establish reproducible workflows capable of generating biologically relevant and analytically robust spatial biomarkers suitable for translational oncology applications.
Download the poster, recently presented at EACR 2026 in Budapest, Hungary to learn more.
Spatial Multi-Omics Meets AI: Turning Tissue into Actionable Insight, Designing Insightful Spatial Multi-Omics Studies: From Sample to Signal
Precision medicine requires technologies capable of capturing both molecular heterogeneity and tissue architecture. Unlike conventional bulk approaches, spatial multi-omics preserves tissue context, enabling the characterization of genes, proteins, metabolites, and cell–cell interactions within their native environment. Combined with AI-driven image analysis and multimodal data integration, spatial multi-omics provides a powerful framework for biomarker discovery, patient stratification, and treatment response prediction.
To demonstrate the potential of AI-enabled spatial multi-omics for precision medicine, we applied an established machine learning framework to identify treatment-associated molecular signatures in cervical cancer using integrated proteomic, transcriptomic, and metabolomic data.
Download our poster, recently presented at AI in Oncology Paris to learn more.
Aliri Clinical APEX Process Overview
Aliri’s Clinical Analysis and Precision Execution (APEX) Process is built to run large clinical trials without the loss of scientific control, ensuring data remains robust, interpretable, and decision-ready as studies grow.
It’s not just about capacity. Clinical studies succeed or fail in the details. Selecting a strong CRO partner for your molecule’s late-phase bioanalysis means prioritizing:
- Direct access to senior scientists
- Industry-leading, fit-for-purpose methods
- Embedded automation
- The best-available instruments for the job
- Regulatory-ready, defensible data
- A team you never have to wait on
Download the fact sheet to learn more.
Optimizing Surrogate Matrix Selection for Endogenous Biomarker LC-MS/MS Quantitation Assays
Historically, LC-MS/MS focused on synthetic drug pharmacokinetics. However, improved sensitivity now allows the analysis of endogenous biomarkers (lipids, proteins, etc.) previously reserved for Ligand Binding Assays (LBA). A primary challenge in biomarker bioanalysis is that these compounds are endogenous to biological matrices, and the matrix could present challenging physicochemical properties. Unlike conventional drug testing, there is no true blank matrix available to build calibration standards. To quantify these levels accurately, researchers must develop a surrogate matrix that mimics the behavior of authentic patient samples without the background interference of the natural analyte. Selecting and validating this surrogate is the most critical step in establishing a reliable LC-MS/MS method for any naturally occurring compound.
Download our poster, recently presented at WRIB 2026 to learn more.
Advanced Bioanalytical Support for Oligonucleotides
Aliri has supported 5 of the 20 approved OGNs on market as they transitioned from preclinical to clinical to FDA approval Aliri is proud to be a trailblazer in the bioanalysis of RNAi therapeutics with significant experience supporting the development of oligonucleotides, which includes siRNAs, ASOs, PPMOs, ARCs/AOCs, and other RNAi conjugates.
Our tenured team of scientists are continuously innovating and adapting our methodologies for improved
assay sensitivity and specificity to deliver accurate and reliable data to our sponsors.
This has led to the critical application and optimization of available analytical approaches, including novel SPE and hybridization extraction techniques that can achieve subnanogram per milliter LLOQ’s with the
specificity of LC/MS detection.
Download the fact sheet to learn more.
The Complexity of the Gastrointestinal Tract: A Multilayered Challenge for Drug and Biomarker Studies
The gastrointestinal (GI) tract is a highly specialized and dynamic system, playing a central role in digestion, absorption, immune response, and microbiome interaction. From the stomach to the small intestine (duodenum, jejunum, ileum) and the large intestine (colon, rectum), each segment presents unique physiological and structural characteristics that influence drug delivery and disease progression.
Aliri’s spatial imaging capabilities allows you to understand drug behavior and biomarker expression across the four main layers of the intestinal wall.
Download the fact sheet to learn more.
Oligonucleotide Hybridization LCMS Workflows and Probe Optimization
In this scientific poster recently presented at EBF Open Symposium, we investigated the biodistribution and potential toxicity of lipid nanoparticles (LNP1 and LPN2), which are crucial carriers for mRNA-based treatments after administration to male and female mice, analyzing their distribution in whole-body carcasses and specific organs using MALDI-MSI.
Download our poster to learn more.
Mapping mRNA–Lipid Nanoparticle Distribution in Mouse Whole Body and Organs by MALDI-MSI
In this scientific poster recently presented at EBF Open Symposium, we investigated the biodistribution and potential toxicity of lipid nanoparticles (LNP1 and LPN2), which are crucial carriers for mRNA-based treatments after administration to male and female mice, analyzing their distribution in whole-body carcasses and specific organs using MALDI-MSI.
Download our poster to learn more.