A new approach to oncology research

The treatment of cancer remains one of the most prolific challenges of our generation. With new cancer cases predicted to rise to over 35 million globally by 2050, the demand for new and innovative treatment options has never been greater.

In the past decade, oncology research has increasingly focused on personalized treatments, designed to target cancerous cells, improving safety and survival rates, as well as quality of life for the patient.

However, the rapid advancements in cancer treatment have come accompanied by new challenges, including stringent regulatory compliance and the need for specialized technologies and laboratory testing.

Providing solutions to the challenges in laboratory testing for oncology

Early engagement for optimal results

Laboratory testing starts with selecting the most appropriate assay.  Our team of Research & Development experts leverage their experience and knowledge to provide insight into the most suitable biomarkers and assays for your study.

Design, validation and delivery of assays to regulatory standards

Cerba Research has the technology platforms, instruments and experts to execute a range of oncology testing including Flow Cytometry, Histopathology, Molecular Testing and Next Generation Sequencing.

Laboratory services for all phases

Laboratory services at every stage of the development process, from pre-clinical to phase IV, enables smooth transition between phases with continuity of assay availability and reducing the risk of delays.

Central Laboratory set-up timelines that meet study requirements

Proven Central Laboratory study set-up timelines, ranging from 6 to 8 weeks, depending on the complexity of the study.

Global deployment of assays

Assays are globally accessible, with our proven expertise in method/technology transfer and compliance with regional and local regulatory standards.

Track record of experience and success

170

oncology trials supported since 2018

~75%

Of trials involve specialty testing

26k+

screened patients

28

market authorizations / expansions

We perform specialty testing in ~75% of our oncology portfolio

We have had ~200 oncology trials since 2018 and growing. We perform specialty testing in ~75% of cases within those trials. Specifically, we can perform immunohistochemistry (IHC), flow cytometry (FCM), and/or NGS, amongst other innovative techniques. We can also perform any routine testing (aka safety testing), such as, but not limited to, coagulation, biochemistry, urinalysis, pregnancy test, COVID testing and serology, which are essential for any oncology trial and patient inclusion / exclusion criteria. We can also help design and validate specialty-based assays that account for the complex tumor microenvironment of both solid tumors and hematological malignancies.

End-to-end solutions across all phases

Cerba Research can execute upon every oncology trial phase, ranging from discovery/pre-clinical (data not shown) to post-market authorization trials. As such, our most decisive experience in oncology is with first-in-human (FIH) phase I and phase II trials, which comprise close to 80% of our oncology portfolio. We engage early on in oncology trials where our sponsors often continue to work with us on full asset programs until registration trials and beyond. This intelligence, along with custom assays and on-target protocol advice, can accelerate your program to market.

Cerba Research has supported biopharma and pharmaceutical companies in developing oncology therapies. Our heritage in specialty labs and our experience in central lab services enable us to develop research techniques to underpin the next generation of clinical trials. A new kind of research where diagnostics are driven by clinical data and insights, supported by specific therapeutic expertise.

Our areas of expertise in oncology

We have expertise in both solid tumors and hematological malignancies (almost half and half). We participated in the approval of 24 novel oncology therapies marketed for various indications, such as, but not limited to, relapse and/or refractory multiple myeloma, diffuse large B-cell lymphoma, metastatic breast cancer, neuroblastoma, and non-small cell lung cancer (NSCLC) amongst other indications.

Our therapy class experience is highest with small molecules (42% of our oncology trials), followed by antibody-specific therapies (28%) such as monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and bispecific antibodies. We also have rich experience with complex CGTs (21%), mostly with chimeric antigen receptor-T cell therapies (CAR T) that are often evaluated in hematological malignancies.

Immunogenicity in oncology

Our clients are supported from pre-clinical to post-market authorization with our in-depth biologics and biosimilars experience. We offer long-standing scientific expertise in pharmacokinetics (PK) and immunogenicity (antibody-drug antibodies (ADAs) and neutralizing antibodies (NAbs)) with a standardized or a customized approach as per your vision.

Did you know that Cerba Research Canada was instrumental in the PK and immunogenicity validation and implementation of bevacizumab? A mAb approved globally for various solid tumours, such as metastatic colorectal cancer, advanced or metastatic NSCLC, and recurrent glioblastoma among other tumour types (6). We were also instrumental in the PK and immunogenicity implementation of pegfilgrastim, a recombinant protein marketed for supportive care oncology (e.g. chemotherapy-induced febrile neutropenia (7). Our focus extends from mAbs to CGTs, ADCs and more. In addition, we are good laboratory practice (GLP), college of American pathologists (CAP), clinical laboratory improvement amendments (CLIA) accredited for your regulatory requirements

Reach out to our experts and see how we can transform research and advance health together