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IRBM’s industry trained in vivo pharmacology team has extensive experience in pre-clinical drug development, from hit-to-lead through clinical candidate selection. Whether your candidate is a small molecule, peptide or monoclonal Ab, we’ll follow appropriate biomarkers and assess their therapeutic attributes and characteristics, using a range of in vivo pharmacological techniques including PK, PK/PD and, metabolite identification. For oncology, we can provide specific efficacy studies in various mouse models.

Our comprehensive and complementary capabilities will ensure we can determine your candidate’s mechanism of action (MoA), PK, bioavailability, efficacy, organ exposure, in vivo metabolism and potential toxicity in different animal models.

We’ll work with you in an agile and iterative way to meet your specific project needs. Whether it’s planning, designing and implementing a customized in vivo study in the most appropriate model, or performing a stand-alone in vivo analysis, IRBM is your partner of choice.

We’ll work closely with you to develop and implement a successful biomarker plan that is robust, sensitive, rigorously validated in vivo and translatable into the clinic.   We use integrated and automated sample processing and analysis platforms to provide highly reproducible and accurate data in the shortest possible timeframe.

Our proven expertise in designing and executing oncology studies, makes us the ideal partner to help you to determine your candidate’s maximum tolerated dose (MTD), establish PK/PD/efficacy relationships and demonstrate in vivo target engagement, using appropriate subcutaneous or orthotopic Xenograft models for both solid and hematologic tumors or models for metastatic tumors.  We are also equipped with In Vivo Imaging System (IVIS Spectrum) for tracking tumor progression.

With histology among our capabilities, our team will identify and validate from the outset suitable target engagement assays in the target tissue or in a surrogate tissue. Using feasibility studies we’ll reach a Go/No Go decision in the shortest possible time frame.

Our dedicated DMPK team designs, performs, analyses and reports pharmacokinetics (PK) experiments in rodents (both wild type and genetically modified), to support drug discovery programs. We can also offer PK experiments in large animals (dog, mini-pig and monkey), with the assistance of an external partner.

If the selected Target Engagement assay cannot be translated into the clinic, we can determine which is the most appropriate proximal or distal pharmacodynamic assay to apply and will develop bespoke, validated read-out tools and assays suited to your needs. We can generate and validate responder ID hypotheses using a comprehensive repertoire of in vitro tools and validate them in vivo using robust assays in the most appropriate rodent models.

OUR CAPABILITIES
  • 1,500 m2(16,146 ft2) facility for rodents (over 20,000 animals)
  • DMPK/Surgery and Necropsy areas
  • Institutional Animal Care and Use Committee
  • Experimental procedures executed to highest standards of animal welfare
  • Compliance with all EU regulations

ONCOLOGY

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