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Multiple readouts, one interpretation

Each is interpretable alone. None is decisive on its own. Generated and interpreted by one team on one site, together they answer the only question that matters at this stage: does this molecule advance.

Methods and platforms

Dosing
SC, IV, IP, PO, IM, intrasplenic, intracranial and intranasal administration. Single-dose, repeat-dose, and continuous infusion paradigms.
Sampling
Microsampling and longitudinal biofluid collection, paired with optimized tissue processing for bioanalysis, pathology and comprehensive molecular profiling.
Imaging
Optical and ultrasound in vivo imaging (IVIS Spectrum and Vevo 770) enabling longitudinal assessment of disease progression, therapeutic response, target engagement and anatomical changes.
CNS delivery
Precise stereotaxic delivery of diverse therapeutic modalities, complemented by region-specific brain microdissection and optimized CSF sampling and analytical workflows.
PK & ADME
Robust pharmacokinetic profiling with assessment of bioavailability, tissue exposure, biodistribution, bioanalysis, and metabolite identification and characterization.
Modalities
Small molecules, peptides, monoclonal antibodies, antibody-drug conjugates (ADCs), oligonucleotides, and advanced cell and gene therapies.

Therapeutic expertise

Oncology and immuno-oncology

50+

validated CDX models, already characterized in-house, enable immediate study initiation without the need for model development.

Model formats
Subcutaneous cell-line-derived xenograft (CDX), with more than 50 validated models. Orthotopic CDX. Syngeneic models, both spontaneous and induced.
Settings
Solid tumors, hematologic malignancies and metastatic disease models.
Readouts
Tumor growth inhibition by caliper measurement, overall survival, longitudinal bioluminescence and fluorescence imaging, PK/PD, maximum tolerated dose (MTD), and histology-confirmed target engagement.
MODALITIES
Small molecules, peptides, biologics, ADCs, and cell & gene therapies.

Neurodegeneration

Successful central nervous system (CNS) drug development depends on demonstrating delivery of the therapeutic modality to the intended neuroanatomical target and quantifying its distribution, target engagement, and pharmacodynamic effects within the CNS.

Models
Huntington’s disease and ataxia models.
Delivery
Automated stereotaxic administration to defined brain structures supporting small molecules, oligonucleotides, viral and non-viral vectors, and cell-based therapies.
Sampling
Microscope-guided microdissection of anatomically defined brain regions combined with validated CSF collection procedures, enabling quantitative assessment of tissue distribution, pharmacokinetics, and biomarker modulation within targeted CNS compartments.
Readouts
Quantification of therapeutic distribution in CSF and discrete brain regions, target engagement assays, pharmacodynamic biomarkers, BBB penetration, and HTT protein analyses to support exposure-response relationships and mechanism-of-action studies.

Immunology, inflammation and metabolic disease

Well-established diet-induced obesity models supporting evaluation of metabolic therapies, target engagement, and translational biomarker responses.

Models
Diet-induced obesity (DiO) models for assessment of obesity, insulin resistance, and metabolic dysfunction.
Readouts
Body weight, body composition, food intake, glucose tolerance, insulin sensitivity, metabolic biomarkers, and pharmacodynamic responses.
Published work
CNTF-driven weight loss and its effects on insulin and glucose, PLOS ONE. 10.1371/journal.pone.0265749

The standard behind the data

All in vivo research at IRBM is conducted within an AAALAC International accredited environment. Accreditation is voluntary and peer-reviewed, awarded only where governance, facilities, and scientific practice exceed regulatory baselines. Today, only about 1,140 organizations in 52 countries hold this accreditation.

For your program, this provides independent, third-party validation that the data informing your critical decisions were generated within a system verified for quality, reproducibility, and ethical conduct, reducing potential concerns during due diligence and regulatory review.

More at AAALAC International and in our accreditation announcement.

  • Scientific rigor
  • Operational consistency
  • Ethical oversight
AAALAC International accreditation seal

One program, one team, one site

An integrated scientific framework with in vivo pharmacology at the center of translational insight and decision-making.

In vivo pharmacologists, DMPK scientists, bioanalysts, discovery biologists, histologists, and medicinal chemists work within the same scientific framework, on a single research site. Exposure, effect, and mechanism are interpreted together rather than reviewed as separate data streams arriving from separate providers.

Our team is industry-trained, with methodologies rooted in IRBM’s heritage as Merck Research Laboratories. A study that must be repeated, particularly once a project reaches the in vivo testing stage, does not just add experimental cost, it can set an entire development timeline back by months. The true cost of choosing the wrong CRO is lost time, and our integrated approach is designed to minimize that risk.

Move faster from target to preclinical candidate

IRBM’s Integrated Drug Discovery platform unites chemistry, biology, DMPK, and in vivo pharmacology under one scientific framework so candidates advance through fewer handoffs, stronger data continuity, and better-informed decisions.

Frequently asked questions

Is IRBM’s in vivo pharmacology platform AAALAC accredited?
Yes. IRBM holds AAALAC International accreditation, awarded in 2026 following peer-reviewed program assessment and an on-site evaluation by an independent panel. All in vivo research at IRBM is conducted within that accredited environment, and under the governance of an Animal Welfare Body (OPBA) and in full alignment with Directive 2010/63/EU and Italian DL 26/2014.
Are IRBM’s in vivo studies conducted to GLP?
For discovery-stage and candidate-selection studies, IRBM provides a non-GLP in vivo environment that combines the flexibility needed to answer complex scientific questions with the operational rigor expected in drug development. QC-tracked processes and GLP-trained staff help ensure reliable, decision-ready data.
Which oncology models are available at IRBM?
IRBM provides access to more than 50 validated cell-line-derived xenograft (CDX)  models, complemented by orthotopic and syngeneic platforms spanning solid tumors, hematologic malignancies, and metastatic disease. Quantitative monitoring of disease progression is enabled through caliper-based tumor measurements and longitudinal IVIS Spectrum imaging, generating robust efficacy data to support candidate selection and development decisions.
Can PK/PD, efficacy and biomarker readouts run within a single program?
Yes. IRBM’s in vivo pharmacology, DMPK, bioanalysis, and discovery biology teams operate within a single scientific framework at one research site, enabling exposure, efficacy, mechanism-of-action, and biomarker data to be generated and interpreted as an integrated dataset rather than assembled across multiple providers.
What quality systems, governance, and facilities support IRBM’s in vivo research?
  • Oversight by an Animal Welfare Body (AWB, Organismo per il Benessere Animale, OPBA)
  • 3Rs (Replace, Reduce, Refine) applied at study design
  • Full alignment with Directive 2010/63/EU and Italian DL 26/2014
  • 1,500+ m² (16,000+ ft²) purpose-built facility, including SPF and quarantine areas
  • 13 dedicated housing rooms, with closed-bottom enriched IVC caging connected to the building monitoring system
  • Dedicated surgery, necropsy and sample-processing areas
  • GLP-trained personnel and QC-tracked documentation in a non-GLP environment

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