The challenges in immuno-oncology (I/O) drug development require deep scientific insights, generation and analysis of complex biological data, new state-of-the art technologies and both logistical & operational support across continents. The goal of immuno-oncology drug developers is to turn precision medicine into action, bringing life-changing therapies to patients.

In this webinar our experts discuss the use of Immunohistochemistry (IHC), Next-Generation Sequencing (NGS), and Flow Cytometry (FCM) within immuno-oncology, and how they can offer the comprehensive insights required for I/O clinical trials.

Speakers

• Jérôme Sallette, PhD, CSO Cerba Research
• Shu Jen Chen, PhD, CSO ACT Genomics
• Sofie Vandevyver, PhD, Head of Business Operations & Marketing Cerba Research
• George Wei, PhD, Vice President R&D ACT Genomics
• Renaud Burrer, PhD, Head of Histopathology Cerba Research
• Nithianandan Selliah, PhD, Global Head Flow Cytometry Cerba Research

It is now clear that the therapeutic future lies in biomarkers through the development of immunotherapies and companion diagnostics. Among the techniques of biomarker analysis, there is Flowcytometry, which allows for precise analysis of liquid samples, but not only.

Validation test development for specific biomarkers is a prerequisite for a successful application in translational research, preclinical and clinical phases. The advantages and disadvantages of this technique, the samples, and the conditions of use: Cerba Research will open the doors of its worldwide laboratories for an hour. To answer all your questions about one of the leading techniques of analysis for the development of innovative treatments, our experts will share their knowledge and experience.

Learning Objectives

• What is Flow Cytometry?
• What is the benefit of this technique?
• How is it implemented in clinical trials?
• Assays management details

Speakers

Nithianandan Selliah, Ph.D., Global Head of Flow Cytometry at Cerba Research

Nithianandan obtained his PhD in Immunology and started to work on HIV research. After more than 10 years of HIV research, he joined a biotech company to work on biomarker discovery for autoimmune diseases. His interest in Flow cytometry at the biotech company led him to join global CRO to work on assay development and validation in Flow cytometry for global clinical trials. He joined Cerba Research to continue to work on his passion for Flow cytometry in clinical trial and takes on new challenges to build the best Flow cytometry service to the clients.

He is working with exceptional scientific teams in the US and Belgium to bring on new assays for various therapeutic indications, including Immuno-oncology and autoimmune diseases.

Ishita Modi, Director, Scientific Customer Solutions at Cerba Research

A microbiologist by education, Ishita finished her studies at Gujarat University in India and moved on to start her career in the United States. She has more than 15 years of experience in the clinical and diagnostic research industry. Her expertise is in building a strong foundation of clinical operations and clinical research with a commitment to meeting client’s scientific needs to help advance medicine. Ishita has worked at CRO/Central Lab as well as at some of the leading clinical diagnostic labs in the region. Her scientific expertise includes infectious diseases and genetics, and gained extensive experience in microbiology, virology, and molecular biology. Ishita is a New York State-certified Medical Technologist and also a certified IRB (Institutional Review Board) professional. Her experience over the years has made her very strong in all aspects of clinical research and regulatory requirements. She has a passion for advancing science and making a difference in the future of healthcare.

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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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.

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.

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.

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.