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Webinar – Biomarkers In Immuno-Oncology: Identifying And Implementing Biomarker Testing From Exploratory Research To Clinical Trials

Biomarkers are at the heart of Immuno-Oncology. In this webinar, we will walk you through three case studies to highlight the importance of biomarkers, using different methodologies. Why do some patients respond better to I/O therapeutics than others? What is Flow Cytometry’s role in immunophenotyping? Where does Immunohistochemistry come in? What is the Tumor Mutation Burden, how does it impact I/O research?

Amanda Finan, Head of IHC R&D Cerba Research, Nithianandan Selliah, Global Head of Flow Cytometry Cerba Research, and Raouf Ben Abdelali, Head of the Hematology and Oncology Division, Cerba Laboratory will guide you through their respective fields of expertise and answer the above questions.

Biomarkers in Immuno Oncology: Identifying and Implementing Biomarker Testing

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White Paper – COVID-19 Therapy Development and Clinical Diagnostics – A Clinical Approach To A Multifaceted Evolving Disease

While most people with COVID-19 recover within a few weeks, a notable percentage experience symptoms that last for 12 weeks or longer. With therapy development, we look into clinical diagnostics.

As scientists discover new variants, new questions become more relevant: How will variants impact vaccine efficacy? Who will need booster shots? Will we need new vaccines? Targeting a multifaceted disease such as COVID-19 requires a diverse team of infectious disease experts; it will also require a central lab and clinical diagnostics partner with the expertise and portfolio of testing to serve sponsors’ varied needs.

As the effort to develop more effective COVID-19 treatments and vaccines and protect the global public continues, therapy and vaccine developers must partner with central labs that offer a broad scope of services. A diverse portfolio of exploratory tools and tests is paramount when studying an unpredictable virus.

Find out more about Cerba’s research into COVID-19 by downloading our white paper.

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Poster – Flow Cytometry At Cerba Research – From Client Conversations To Central Review

Complex flow cytometry is critical for today’s personalized medicine. With 25 years of extensive expertise in providing flow cytometry testing for clinical trials ranging from phase I to phase III, Cerba Research has a strong track record of developing and validating custom-made flow cytometry panels. Monitor immunophenotyping, immune cell activation, receptor occupancy of the drug, and the workings of CAR-T cells through flow cytometry on blood samples and bone marrow aspirate.

Discover in a nutshell how we at Cerba Research perform flow cytometry, from a to z, from client to central review.

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White Paper – Flow Cytometry Advantages In Immunotherapy Clinical Trials

More than three decades ago, scientists at the National Cancer Institute began exploring ways to fight cancer using the patient’s immune system. Their work formed the basis of what is now a promising cancer treatment that doesn’t require surgery or radiation. The global immunotherapy market as well as cell and gene therapy, such as CAR T, adoptive cell therapies, checkpoint inhibitors and other immunotherapies, is expected to grow by 10.1% CAGR between 2020 and 2028.

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. Each sample they give is precious, as they all provide a wealth of biological data that contributes to therapy development. To ensure samples arrive at the lab intact, robust sample transportation and global logistics are critical. The deep scientific expertise housed within those labs ensures the highest-quality analysis and reporting.

Our white paper takes an in-depth look at the world of flow cytometry. Nithianandan Selliah, Global Head of Flow Cytometry, and collaborators at Cerba Research, examine its unique benefits and future potential. They highlight the latest trends in technology and set out the key points to consider when planning a flow cytometry-based clinical trial and choosing a partner lab.

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Case Study – Hemato-Oncology Multiple Myeloma

Discover how our experts helped our sponsor set up a randomized, open-label, multicentre Phase 3 study to compare progression-free survival upon two different combination therapies (with a targeted MoA) in patients with relapsed or refractory multiple myeloma. 

See how we were able to handle: 

  • aggressive study timelines
  • frequent changes to the protocol
  • the adding CD138+, FISH, and cell clonality added after the study started
  • Japan added as a separate study later as well
  • the sponsor monitored TAT closely and wanted centralized genomics testing and aggregate reporting.
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Poster – Immune Cell Checkpoint Profiling Of Solid Tumors By Multiplex Immunofluorescence

Immune checkpoint proteins are important regulators in self-tolerance but also allow cancer cells to evade immune destruction. Checkpoint inhibitor (CKI) blockade therapies can help restore antitumoral immunity. Combination blockade has demonstrated the potential to result in greater tumor growth inhibition than monotherapies in preclinical studies.

Multiplex immunofluorescence offers a technical advantage by allowing for the detection of co-expression and spatial organization of multiple targets within a preserved tissue architecture on a single slide. We have developed the HISTOPROFILE®-CKI multiplex immunohistochemistry panel to offer personalized immune cell checkpoint profiling.

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Poster – Assessing Clinical Response In Multiple Myeloma (MM) Patients Treated With Monoclonal Antibodies (Mabs): Validation Of A Daratumumab IFE Reflect Assay (DIRA) To Distinguish Malignant M-Protein From Therapeutic Antibody

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Fact Sheet – Autoimmune Diseases Clinical Trials- Enhance Your Success In Tackling Autoimmune Diseases

Discover our expertise in the field of Auto Immune diseases.

Investigations into autoimmunity benefit from a multifaceted approach.  

Genetic Testing/NGS

Along with infections and other exposures, genes play a significant role in disease development. Read more

Diagnosis & development

Tissue diagnosis and routine testing register pathology and the course of the disease

Immune monitoring

Gauge response to treatment by following up on the status of immune cells via flow cytometry

Biomarker Testing

Develop and follow serum markers for both diagnosis and prognosis of autoimmune diseases Read more

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Fact Sheet – NASH Clinical Trials – Supporting The Biggest Phase 3 Study In NASH

In a meta-analysis of several studies using various methodologies, worldwide prevalence of NAFLD (Non-alcoholic fatty liver disease) is 25.2% and 6.45% for NASH (Non-Alcoholic SteatoHepatitis). NASH prevalence is expected to increase by 63% between 2015 and 2030, yet the condition is still poorly understood and there is no known treatment. The need for therapeutic agents is urgent.

At Cerba Research, we are committed to improving the diagnosis and treatment for NASH. In 2016, after we successfully supported their Phase II NASH study, a midsize biotech engaged our services for Phase III. Gratified to have gained their trust and eager to continue our productive collaboration with this meticulous client, we rolled up our sleeves and took on the challenge of supporting the largest NASH Phase III study to date.

Discover how Cerba Research was able to support one of the biggest Phase 3 studies in NASH

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Article – The Value Of Biomarkers From Discovery To Commercialization

Why do some patients respond to therapy while others do not? The answer can be found in the concept of biomarkers: objective, measurable indicators of the
presence or severity of disease. Used for decades to aid medical diagnosis, researchers today use biomarkers in every phase of drug discovery and development.
There’s good reason. Biomarkers can triple drug development success rates, accelerating the availability of new therapeutics.

Download our article by Jérôme Sallette, CSO at Cerba Research, to learn more on the advantages of biomarkers in clinical research.

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