Immuno-Oncology Drug Development

The right solutions and services for your immuno-oncology clinical trials

Cancer immunotherapy continues to provide new ways to treat patients using the body’s own immune system, and immuno-oncology (I-O) drug development takes a combination of scientific and operational expertise.  There are many different approaches to I-O development, and Q2 Solutions provides novel and innovative immunotherapy laboratory services that combine scientific expertise, innovative technologies, and industry relationships.

End-to-end service

Q2 Solutions has a broad spectrum of technologies to address biomarker requirements, from early engagement through clinical trial testing and commercialization of assays. Q2 Solutions scientists can work with Translational and Biomarker scientists to develop a biomarker strategy early in clinical development and help deliver the strategy through clinical trials by engaging with a team with proven expertise and experience in executing and delivering science data for I-O clinical development programs.

Service offerings include:
  • Full suite of laboratory testing services available globally – Safety testing, Small and Large Molecule BioAnalytical, Anatomical Pathology with IHC & FISH, Genomics, Flow Cytometry, Immunoassay. Applications for these tests include safety, efficacy, proof of mechanism, pharmacodynamic and patient selection.
  • Data analytics – utilize data from both parent organizations for data mining to provide information relevant to identifying clinical trial sites, hotspots for a particular biomarker positive population, and information on biomarkers and associated treatment history that can assist in inclusion/exclusion into an I-O clinical trial.
  • Bioinformatics –  Services are provided at the US and China sites for next generation sequencing-based large data set solutions providing insights into interpretable outputs. Data can be extracted from high throughput RNA or DNA sequencing technologies for specific applications, for example, in determining tumor
  • Commercialization - the transition from a clinical trial assay to a commercial assay is key for market adoption of those assays that become standard of care or Companion Diagnostics (CDx). A parent organization participates in early validation programs and can receive training and gain proficiency through Q2 Solutions Pathologists, for example.

Global Footprint

Q2 Solutions is a premier global central laboratory service provider for I-O clinical development testing. With a global central laboratory network including a footprint in the Americas, Europe, Asia-Pacific, and China, a breadth of technological expertise and harmonized processes is available across the laboratories.

Broad Capabilities: Flow Cytometry and Immunoassay, Anatomic Pathology, and Genomics
  • Flow Cytometry – as an integral part of your comprehensive Immuno-oncology biomarker strategy, we provide flow cytometry services in preclinical and clinical studies, including in early clinical development when assessing mechanism of action (MOA) for therapeutic antibodies.
  • Immunoassay – a range of protein measurement services from basic ELISA to more automated immunoassays can be used for measurement of acute proteins and safety issues, from single-analyte to multiplex immunoassay technologies.
  • Anatomic Pathology – Commercial and clinical laboratories, full in-house global anatomic pathology services, digital pathology solutions, and global capacities provide comprehensive in-house end-to-end anatomic pathology and molecular methods, including PD-L1. We provide complex biomarker analysis to achieve higher-quality, more precise data to advance your I-O studies.
  • Genomics – our Q2 Solutions l EA Genomics Center of Excellence provides services that span clinical development from discovery to commercial testing. We offer a comprehensive portfolio of genomic assays for immuno-oncology applications, with a continuing expansion of genomics solutions.

Examples of Assays

Anatomic Pathology Flow Cytometry and Immunoassays Genomics
IHC (single and multiplex) Immuno-Phenotyping TCR Immune Sequencing
Tumor Infiltrating Lymphocytes (TILs)
Receptor Occupancy Immune Gene Signature / Epigenetic Signatures
Digital Pathology Tumor Infiltrating Lymphocytes (TILs) Digital Spatial Profiling (AP-gene and protein expression)
FISH Intracellular Cytokine Survey Tumor Mutational Burden (TMB)
Minimal Residual Disease (MRD) DNA-mismatch repair (MMR) Deficiency
Circulating Soluble Proteins Microsatellite instability (MSI)
HLA and KIR typing
Whole Exome Sequencing
NeoAntigen discovery

Integrated science team of experts – Q2 Solutions broad range of scientists and subject matter experts across the company include the following fields:
  • Immunologists
  • Geneticists
  • Technical experts
  • Pathologists
  • Clinical scientists
  • Bioinformaticists
  • Regulatory

Certain immuno-oncology programs also have an associated biomarker-based Companion Diagnostics (CDx) program, and Q2 Solutions can provide full support to develop your CDx.

Contact us to learn more about our integrated immuno-oncology solutions.
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