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.

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.

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.

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Our Histoprofile®- T-reg light panel is ready for use in your clinical trials

Accurate characterization of the tumor micro-environment when tissue sample access is limited can be an important challenge in the field of immuno-oncology. The balance and tumor infiltration of T cell subpopulations are of particular interest and its importance has been repeatedly demonstrated in the literature. T cells are important immune effector cells and are therefore preferred targets for immuno-modulation.

Conventional T cells can be broadly classified as helper (Th), cytotoxic (Tcyto), memory or regulatory (Treg) cells. Tcyto cells ensure optimal immune responses against invading microbes and tumor antigens. Under homeostatic conditions, Tregs promote peripheral tolerance. However, within tumors, Tregs can supress Tcyto cell functions. The multiplex protocol, Histoprofile®- T-reg light panel, developed at Cerba Research on the Discovery ULTRA (Ventana) platform is designed to stain specific sub-populations of T cells on a single slide, avoiding the need of serial sections from precious patient’s FFPE samples in clinical trials while still providing an indepth analysis of the tumor microenvironment.

Our in-depth analytical validation ensures the quality of this robust protocol on solid tumor tissues. Evaluate T-cell subpopulations and their spatial distribution in the tumor microenvironment.

Immune checkpoint proteins are important regulators in self-tolerance but also allow cancer cells to evade immune destruction. Checkpoint inhibitor (CKI) blockade therapies can help restore antitumoral immunity. Combination blockade has demonstrated the potential to result in greater tumor growth inhibition than monotherapies in preclinical studies.

Multiplex immunofluorescence offers a technical advantage by allowing for the detection of co-expression and spatial organization of multiple targets within a preserved tissue architecture on a single slide. We have developed the HISTOPROFILE®-CKI multiplex immunohistochemistry panel to offer personalized immune cell checkpoint profiling.

In a meta-analysis of several studies using various methodologies, worldwide prevalence of NAFLD (Non-alcoholic fatty liver disease) is 25.2% and 6.45% for NASH (Non-Alcoholic SteatoHepatitis). NASH prevalence is expected to increase by 63% between 2015 and 2030, yet the condition is still poorly understood and there is no known treatment. The need for therapeutic agents is urgent.

At Cerba Research, we are committed to improving the diagnosis and treatment for NASH. In 2016, after we successfully supported their Phase II NASH study, a midsize biotech engaged our services for Phase III. Gratified to have gained their trust and eager to continue our productive collaboration with this meticulous client, we rolled up our sleeves and took on the challenge of supporting the largest NASH Phase III study to date.

Discover how Cerba Research was able to support one of the biggest Phase 3 studies in NASH