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Systemic lupus erythematosus (SLE) is one of the most complex autoimmune diseases to model. It involves the activation of autoreactive lymphocytes, cytokine dysregulation, and multi-organ inflammation that vary widely among patients. This biological heterogeneity has made lupus one of the most challenging areas for drug development, with a likelihood of approval for Phase I candidates of only about 4.6 percent.

Multi-omics technologies have become indispensable in preclinical drug development, progressing from traditional genomics and transcriptomics to the great recent developments in access to patient samples, epigenomics, proteomics and AI analysis. Yet, most analyses are still performed on baseline samples, where cells remain at rest. For some types of drugs, this static picture can miss the most relevant signals for drug activity. For example, changes in key targets and signaling pathways responsible for activity and resistance for drugs whose mechanism of action require cell proliferation, may not be detected in the original resting sample. Volcano plot below shows the tremendous differences in RNAseq between original vs proliferating cells. Similar profound differences are observed with other multi-omics.

The development of multispecific T-cell engagers (TCEs) represents a promising strategy in hematologic malignancies, particularly in acute myeloid leukemia (AML). These molecules aim to redirect T-cell cytotoxicity toward leukemic blasts while sparing normal hematopoietic stem and progenitor cells. Despite encouraging preclinical concepts, demonstrating both efficacy and safety in translational models remains a major challenge prior to clinical entry.

As therapeutic options for hematologic malignancies advance, the clinical relevance of minimal residual disease (MRD) continues to grow. In multiple myeloma (MM), increasing numbers of patients achieve deep remissions, and MRD detection is rapidly shifting from a prognostic biomarker to a therapeutic decision point. Shortly, MRD may emerge as a defined therapeutic indication across multiple cancers.

In recent years the FDA has taken significant steps toward reducing the reliance on animal testing in drug development. Through the endorsement of New Approach Methodologies (NAMs) the agency is encouraging the use of human-relevant models that can offer faster, safer and more predictive insights into drug safety and efficacy.

Rheumatoid arthritis (RA) remains a significant unmet clinical need, with a high attrition rate for drug candidates in early development. Traditional preclinical models often fall short in capturing the complexity and heterogeneity of human disease. In this context, ex vivo models using synovial fibroblasts directly derived from RA patients offer a powerful translational platform to assess drug efficacy, explore mechanisms of action, and identify early biomarkers of therapeutic response.

Antibody–drug conjugates (ADCs) hold great promise for targeted cancer therapy, but their clinical success is often limited by hematotoxicity. Traditional models fail to predict these toxic effects with sufficient accuracy, particularly in the human bone marrow. In this post, we explore how Vivia Biotech’s proprietary ex vivo assay provides a translational solution to this challenge. By enabling simultaneous measurement of ADC efficacy and hematopoietic toxicity in a native microenvironment, this platform offers drug developers a powerful tool to optimize the therapeutic index, compare ADC candidates, and anticipate safety liabilities—early and reliably.

Despite advances in multiple myeloma therapy, predicting patient response remains a major challenge. Vivia Biotech addresses this gap with functional ex vivo profiling in whole bone marrow, revealing drug efficacy and resistance in real time. Learn how this approach enhances precision medicine in a complex treatment landscape.

Leading pharma and biotech companies rely on Vivia Biotech to generate human-relevant functional data early in the drug development process. Using patient-derived samples under native conditions, our ex vivo assays preserve the immune and stromal complexity of the tumor microenvironment—enabling precise evaluation of drug mechanisms, immune responses, and resistance pathways. With more than 190 projects completed, we provide mechanistic clarity and translational insight to accelerate oncology, hematology, and autoimmune disease pipelines.

The FDA’s regulatory shift away from animal testing has opened new avenues for preclinical innovation. Functional assays using native patient samples now offer a clinically translatable, ethical alternative for early drug evaluation. Learn how this paradigm is being implemented at Vivia Biotech to bridge discovery and clinical development.