Strong & Sustainable Partnership

Learn how Cerba Research and Fulgent are enhancing genomic data in clinical trials for better patient outcomes across all phases through their NGS services. In this presentation, you’ll learn how we’re accelerating precision medicine with next generation biomarker discovery through our partnership and specific expertise in oncology, rare disease, CNS, metabolic, and infectious diseases.

Hematological malignancies originate from the uncontrolled growth of hematopoietic and lymphoid tissues. These biologically and clinically heterogeneous disorders account for 6.5% of all cancers worldwide, and for approximately 9.5% of newly diagnosed cancers every year.

Due to the high level of heterogeneity in cytogenetic, genetic, epigenetic, transcriptional, post-transcriptional, and metabolic alterations of hematological diseases, integrated multi-omics analyses are needed to improve clinical outcomes.

At Cerba Research, we aim to bring a multi-modal approach to precision medicine to disease. From discovery to clinical development, we provide world-class teams and capabilities worldwide to help you in your quest for novel treatment against hematological malignancies.

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

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.

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.

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

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 the 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°, and -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 complements 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.