Experience the unparalleled activity of Cerba Research’s Infectious Diseases (ID) therapy sector, boasting a remarkable track record of over 600 executed trials in just the last 5 years.

Experience the unparalleled activity of Cerba Research’s Infectious Diseases (ID) therapy sector, boasting a remarkable track record of over 600 executed trials in just the last 5 years.

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.

Of all types of cancer, lung cancer caused more deaths worldwide than any other type of cancer. It also causes more deaths than breast and colorectal cancers combined. Patients with the most common lung cancer, non-small cell lung cancer (NSCLC), have higher survival rates than patients with small-cell lung cancer (SCLC), but the outcomes for both remain bleak. According to the National Cancer Institute, the five-year survival rate for NSCLC between 2004 and 2010 was 20.7% compared to only 6.3% for SCLC.2

NSCLC patients also have more promising and more precise, treatment options today compared to even 10 years ago. Advances in biomarker and precision medicine have led to the development of immunotherapies and targeted novel treatments that have the potential to improve patient outcomes. In the United States, the FDA has approved dozens of biomarker-driven therapies for NSCLC, including ALK, EGFR, and ROS1 inhibitors. Meanwhile, more than 1,200 treatments are in development.

Discover the latest trends in precision medicine for NSCLC in this white paper

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.

Liver biopsies are the gold standard for Non-Alcoholic Steatohepatitis diagnosis and thus essential to NASH clinical trials, yet obtaining them is invasive, can be painful and comes with risk of complications. Making optimal use of these valuable samples is therefore critical.

In this webinar, our experts will highlight possible ways to get the most out of liver biopsies and moreover, provide an overview of alternative methodologies.

The presenters will discuss available stainings of liver biopsies for diagnosing NASH, how alternative and innovative imaging can facilitate pathologists’ reading of the samples and how the placebo effect can impact study results. Together, they will lead the discussion on how to determine the best process for trials and boost the optimal use of liver biopsies for studies.

Speakers

Fanny Estermann, PhD, Biomarker Study Team Leader, Cerba Research Montpellier

Fanny Estermann holds a PhD in Biology. She conducted successfully her work on oncolytic viruses at Salk Institute for Biological Studies (La Jolla, CA, USA), paving the way for a new type of targeted cancer therapy. As a specialist in cancer research, she then worked on senescence, cancer and metabolism at the Cancer Institute of Montpellier (ICM, France). She focused her work on metabolism dysfunctions and its consequences in the global health and cancers. She then joined the Montpellier’s University Hospital center (IRMB, France) to develop cutting-edge stem cell, cancer and senescence techniques. After gathering extensive experience in cancer research, stem cells and metabolism, she received a degree in Clinical Trials from the University of Medicine of Montpellier before joining Cerba Research, as Biomarker Study Team Leader and Regional Head of Project Management. Her main goal with her team is to deliver high quality results to clients by designing and conducting custom scientific projects to fit clients’ needs in preclinical and clinical trials. She has been closely involved in the management and development of Cerba Research biopsy processing and new stainings. She is a direct interlocutor of many NASH KOL.

Manon Motte, Head of Image Analysis, Cerba Research Montpellier

Graduated as Master in Skin Biology at the University of Lyon, Manon worked for more than 7 years in the pharmaceutical industry in a Morphology Histologic team (R&D department) for Dermatological projects. She has a strong experience in the implementation of transverse Histology/Omics technology as well as in the validation of Image analysis applications (Pre-clinical and clinical Studies). Manon is also a specialist in histological techniques and related processes. Today, Manon has chosen to extend her experience in the histology and immunohistochemistry department of Cerba Research as an imaging manager and ensures compliance with GLP and ISO17025 standards in order to ensure maximum reliability in the results delivered to our customers. Manon leads the team advancing NASH associated imaging solutions to assist in the pathologist’s evaluation at Cerba Research. This development includes the evolution of digital pathology and software assisted analyses specific for NASH histological stains and their associated scores.

Pablo Ortiz, MD, PhD, Chief Scientific Officer, OWL Metabolomics

Pablo Ortiz became MD by Universidad Autónoma of Madrid (1972-1978) where he also achieved his PhD (1984-1990, Cum Laude) and Postgraduate with Honors in the Autonomous of Barcelona University about “Biostatistics in Medicine” (1980-1981). Pablo Ortiz graduated as an MD from Universidad Autónoma in Madrid (‘72-’78), after which he continued to a Postgraduate with Honors in Biostatistics in Medicine at the Barcelona University (‘80-’81). He also holds a PhD in Biostatistics in Medicine, obtained from Universidad Autónoma.
Pablo has extensive training in managing R&D projects and clinical trials, and over 25 years of experience (1979-2004) within the Medical Department of Boehringer Ingelheim. He was named Honorary Professor at the Faculty of Medicine of Málaga University in 2000 and from 2008 to 2011, and currently teaches in the Master’s in Biotechnology program at the University Pompeu Fabra of Barcelona.  From June 2004 until November 2012, he was CEO at Digna Biotech, a company created as a spin-off of University of Navarra, which he left with 4 clinical-Stage Products (1 small peptide, 2 proteins and 1 viral vector). He was member of the Board of Trustees in Fundación Moderna (Goverment of Navarra) and 2 Biotechs companies (Bionure and ProRetina) from 2010 to 2011. From January 2013 to date, Pablo is head of the Biotech division at Pivotal (Clinical CRO). He joined OWL in January 2013 as a senior consultant, in June 2014 as Chief Executive Officer and is currently its Chief Scientific Officer. He has published more than 30 papers in international peer-reviewed journals.