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, 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 lead 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 of 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 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 from Gujarat University in India, and moved on to starting her career in United States. She has more than 15 years of experience in clinical and diagnostic research industry. Her expertise is in building a strong foundation of clinical operations and clinical research with 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 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.

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The coronavirus is not the first infectious disease that has forced clinical trials to adapt. Zika, Ebola and other diseases called for the world to adjust and collaborate global research efforts. With COVID-19, the rapid spread and impact on global healthcare systems forced us to change our trial management and accelerate our processes like never before. The global research community have already discovered and developed several tests and vaccines in record time through collaboration. Yet we are still working on predictive biomarker testing to identify people who are at the most risk of developing severe symptoms, epidemiological, vaccine and genetic studies.

To facilitate testing, research, and innovation and to ensure trials continued, Cerba Research and Cerba Healthcare adapted our capabilities and facilities to push research continuity.

Watch this webinar and discover the answers to these questions:

• Did we succeed, how fast did we adapt and are we ready to face a new pandemic crisis in the future?
• How did we maintain the high security and confidence of testing, and what did our reactivity and proactivity mean in the context of a health crisis?

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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.

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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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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.

Poster – Immune cell checkpoint profiling of solid tumors by multiplex immunofluorescence

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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

Autoimmune Diseases Clinical Trials- Enhance your success in tackling autoimmune diseases

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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

NASH Clinical Trials – Supporting the biggest phase 3 study in NASH

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Opportunities for finding proper treatments for both solid tumors and onco-hematological malignancies have never been better. Breakthroughs such as CAR-T cell therapies, checkpoint inhibitors, and combination therapies are rapidly earning FDA approval. With nearly infinite options in specificity and design, many more immune-based therapies are entering the clinical research funnel.

Nonetheless, clinical trial challenges remain. Key drivers include toxicity management, efficacy analysis, and follow-up. Parameters such as tissue distribution, tumor addiction, and surface density must be considered in predicting safety profiles.

The problem of finding proper resources to accomplish your studies compounds these hurdles. With over 35 years of experience, Cerba Research is a leader in oncology clinical trials. Our global solutions comprise a wide range of assays required at various stages of your trial.

Cerba Research Oncology Trials

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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.

Article – The Value of Biomarkers From Discovery Through Commercialization

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Cerba Research established its United States presence as a leading clinical diagnostics and clinical laboratory services provider when it opened a New York facility 20 years ago. To further support our global client base, Cerba Research recently expanded this facility — now our U.S. Immuno-Oncology Center of Excellence — which allows us to provide even more comprehensive, integrated central lab services, specialty lab and biomarker solutions, and diagnostic services worldwide.

Over one weekend in July, with no loss in activity, Cerba Research U.S. moved into a 30% larger facility, giving the lab 35,000 more square feet than before. To make best use of that space, the U.S. team brought in additional state-of-the-art equipment, expanded its testing, sample handling and logistics areas, and welcomed additional scientific and operational experts.

“It’s a new space with a lot of light and a lot of color,” says Chief Operating Officer Nele Langenaken, who founded Cerba Research U.S. in 1999. “Overall, it provides a clean, inviting, positive environment, which helps improve efficiency and motivation among staff, as well as helps us attract and retain top scientific talent.”

Cerba Research U.S. will maintain its close partnership with Northwell Health, the largest laboratory in the region. With more than 75 pathologists and a lab that processes more than 30,000 tests per day, its support allows Cerba Research U.S. to manage rapid turnaround and large-volume requests.

That said, its expert scientists and state-of-the-art equipment make Cerba Research U.S. a first choice for precision medicine clinical trials. “The industry is moving from quantity to quality and from routine to specialized,” says Cerba Research Chief Executive Officer Mario Papillon. “Nele created an ideal environment for customized assay development and validation for R&D projects.”

The most exciting updates to Cerba Research U.S. include:

Triple the flow cytometry capacity. The expansion allowed Cerba Research U.S. to more than triple its complex flow cytometry capacity. Equipment additions include automated flow cytometers and full spectrum machines that demonstrate up to 40 colors.

“We not only expanded our capabilities, we also optimized the process and created space for a new level of excellence in flow cytometry,” says Langenaken.

Quadruple the PBMC capacity. Peripheral blood mononuclear cells (PBMCs) are critical components of immunology, infectious disease, and oncology research. With the expansion, Cerba Research U.S. increased PBMC and cell isolation capacity to handle up to four times more sample volume than the previous location.

New histopathology immunohistochemistry (IHC) lab. For the first time, Cerba Research U.S. contains an in-house histopathology lab with tissue processing, cytology, and IHC solutions for biomarker discovery through to clinical validation. Our IHC capabilities include automated, multiplex, and specialized IHC.

Increased kit production. Cerba Research U.S. increased kit production by 40% in 2021 compared to this time last year. The expanded facility will allow it to expand that production even further.

Increased sample reception and storage. The expanded Cerba Research U.S. laboratory receives between 8,000 and 10,000 tubes per day. We expect that number to increase by 20 to 25% over the next few years. Additional storage capacity includes temperatures from ambient to -20°, -80° C, with available liquid nitrogen, all centrally monitored by a temperature monitoring system.

An even stronger team. With the expanded facility comes an expanded team. Additional scientists and operational experts give the U.S. team the depth to handle even the most complex projects.

The expanded flow cytometry, PBMC, and IHC capabilities give the U.S. CoE an even broader global footprint with which to serve immuno-oncology clinical trials. The expansion compliments CerbACT Asia, Cerba Research’s other immuno-oncology Center of Excellence, which offers cutting-edge technology in FCM, histopathology, IHC, and NGS sequencing from a purpose-built facility in Taiwan.

“We have a substantial team of flow cytometry scientists in the U.S., all with high international profiles,” says Papillon. “Combined with the clinical expertise of Northwell Health, our capabilities in North America are remarkable.”

As part of a network that includes seven offices and access to over 400 labs across five continents, you can be certain no matter how global your trial, Cerba Research has the capabilities and capacity to support your projects from early research through to commercialization.

Cerba Research, a strategic provider of diagnostic solutions, supports drug development by leveraging patient data and scientific insight to optimize R&D and commercialization globally. Providing early phase research, clinical development through central laboratory and diagnostic testing, assay and biomarker development and validation — through our global network of specialty laboratories. We partner with government agencies, non-government organizations, as well as pharma and biotech organizations to change the shape of clinical development, and advance healthcare.
Cerba Research is part of Cerba HealthCare, a leading player in medical diagnosis.

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