Discover the extraordinary world of rare diseases, where uniqueness defines the landscape. While these conditions may lack a singular definition, they encompass a myriad of fascinating conditions waiting to be understood and treated.

This presentation was given by Marie Gerus-Durand, Principal Scientist & Validation Engineer at Cerba Research Montpellier at the JMP Discovery Summit Europe.

Cerba Research is a global company providing high-quality, specialized analytical and diagnostic solutions for clinical trials. Cerba Research Montpellier develops customized immunohistochemistry protocols to detect the expression of selected targets on patients’ tissue sections.

To be used in clinical trials, these protocols must meet the regulatory agencies’ criteria to ensure that the protocol will allow consistent results on precious patients’ samples. With the diversity of parameters evaluated and the types of evaluation possible in implementing these custom protocols, automating data analysis became a need.

Thanks to various JMP® tools, we have developed an automated analysis that saves time and homogenizes protocol performance reports by including statistical and graphical data in a Dashboard. This process, submitted as JMP Add-in, has been incorporated into our user workflows, thus facilitating our procedures.

Watch the full presentation here

Watch Cerba Research’s latest webinar, ‘The Added Value of Flow Cytometry in CAR T-Cell Clinical Trials’.

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

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.

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.