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.
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.Message Presenter
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.Message Presenter
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.Message Presenter
Who Should Attend?
- Translational Medicine
- Clinical Operation Leaders
- Research and Early Clinical Development
- Biomarker & Experimental Medicine Leaders
What You Will Learn
- How to make optimal use of liver biopsies
- Which methods of analysis are available
- The role of non-invasive imaging methods and analysis
- How the placebo effect can impact trial results
Headquartered in Ghent, Belgium, Cerba Research is a Global Central & Specialist Laboratory.
Our footprint includes 6 harmonised central lab locations in Ghent, New York, Johannesburg, Shanghai, Taipei & Sydney.
Complimentary to these central labs, our network of Cerba specialty labs support our core therapy expertise in three distinct areas – Oncology, Liver Indications & Infectious Disease. APH, Flow Cytometry, Genomics, Metabolomics, Microbiology + Virology and Molecular Biology permit our clients to discern and select correct instruments, appropriate sensitivities / detection and techniques for true full service delivery.
Worthy of note too is our unique presence in Africa. Complimentary to our Central Lab operation in Johannesburg, Cerba has the largest network of Labs, Staff Pathologists and supporting Logistics in Africa.
From preclinical transition to the clinic, and on to commercialisation, supporting emerging and established biotechs through to large global pharma clients, we are known and proud of our close partnering, higher frequency of contact and all round availability at your demand.
Our subject matter experts enjoy open collaboration at the pace our clients require to optimise their therapeutic development and draw those pivotal insights earlier. We partner with these clients to speed up their research and development whether it be in the area of discussing, agreeing and then delivery of specialized custom assays and panels, assay transfer, or perhaps overcoming operational peculiarities baked in to studies by way of challenges regarding stability of samples for testing. Every synopsis, protocol and study is unique and new challenges arise time after time. We are adept at meeting and overcoming those challenges and enjoying long standing and fruitful relationships with our sponsors.
We are ISO 15189 accredited, CAP CLIA accredited with no deficiencies cited to date, and with significant capabilities for testing under BSL3.
Cerba Research is the pharmaceutical development arm of Cerba Healthcare. Cerba Healthcare is Headquartered in Paris, France and employs >7,000 staff, including over 130 staff pathologists and conducting 40 million tests annually.