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

A late-stage biopharmaceutical company dedicated to metabolic and chronic liver diseases is developing an in vitro diagnostic (IVD) test for NASH at-risk patients. The test integrates four independent biomarkers – miR-34a-5p, A2M, YKL-40, and HbA1c. The output is a 0-10 score with threshold values, identifying patients with low risk or high risk of developing NASH.

The main objective of this study is to evaluate the physiological stability of these biomarkers between the fed and fasting state in patients with the target condition (NAFLD) over a 30-day period.

Discover how our team of experts helped this biopharmaceutical company to reach its goals

In immuno-oncology (I/O), meeting budget and timeline expectations in the journey from translational research to commercialization is a challenge. You need expert, integrated central laboratory and diagnostic solutions delivered by top scientists who will help you assess needs and generate early insights that optimize your protocol.

What else should you look for in a clinical laboratory partner? Along with access to a sizable patient database, impeccable performance across the globe, and I/O experience, three main testing capabilities are mandatory for success in this field: immunohistochemistry, flow cytometry, and next-generation sequencing.

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 originally held on October 4 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

Despite the growing prevalence of NASH, there are currently no approved treatments for the disease beyond liver transplant. The constellation of risk factors for NASH has generated a multitude of targets and there is an obvious need to bring promising treatments through clinical trials and to patients quickly. 

With Cerba’s network spanning five continents, team up with our experienced scientists to generate early insights and direct the course of your complex trial.

Our locations consist of cutting-edge laboratories that provide a full portfolio of specialty laboratory testing, anchored by seven centers in the Americas, Europe, Africa, and Asia-Pacific regions. With consistent, high-quality data and a road map to the patients you need, we empower you to develop personalized medicines and diagnostic solutions that will change lives worldwide.

Discover our Australia capabilities