Global prevalence of non-alcoholic fatty liver disease (NAFLD) is 25.24% in 2016, a percentage that has rapidly increased over the past decade.

There exist two types of NAFLD, non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). Both Masson’s Trichrome Analysis CD45/ CD138/ Adipophilin IHC subtypes are associated with lipid accumulation in the liver, the latter being more severe with inflammatory cell infiltration, fibrosis and subsequent hepatocyte damage and impaired organ function.

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

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

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.

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. 

Discover the art of histopathology through the eyes of our most skilled scientists.

Immunohistochemistry biomarkers are key players in clinical development success. Tissue biomarkers can aid in the confirmation of diagnosis, patient selection, and/or for mechanistic evaluation.

If you would like to know more about how Cerba Research can help you, our IHC expert scientific team will consult with you on your specific needs. Flexible in our approach and delivery to provide timely and cost effective solutions to meet your clinical and commercial objectives.

Download our digital book to see the art of histopathology for yourself.

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.