Welcome to the latest issue of the Celerion Science Newsletter, designed to provide to our readers information on the latest technologies, trends and stories specifically focused on early clinical development activities and professionals in clinical pharmacology and associated sciences. We invite you to share our vision, techniques and experiences learned through our accomplishments in all aspects of early clinical development.
This issue brings you our metabolic experience, including NAFLD/NASH. Since 2007, Celerion has conducted over 100 studies for investigational products targeting metabolic diseases such as diabetes, obesity and nonalcoholic steatohepatitis (NASH). Our comprehensive NASH experience covers all aspects of drug development; from first-in-human to proof-of mechanism studies to biomarker development. Our capabilities also expand to proof-of-concept and NDA labeling studies, such as drug-drug interaction and ADME studies.
Not long ago, there was very little regulatory guidance or recommendations regarding a pathway for nonalcoholic steatohepatitis (NASH) drug approval. NASH is a chronic hepatic disease that can lead to cirrhosis, liver failure and need for transplant, and currently there is no FDA-approved treatment for NASH, creating a large unmet need for patients.
Sabina Paglialunga PhD, Scientfic Affairs presented "Leveraging Non-Invasive Approaches in NAFLD/NASH Clinical Research" at BioKorea. She spoke about the new FDA & EMA guidelines for the industry on NASH, advancements in non-invasive NASH biomarkers, and demonstrating efficacy in early phase clinical clinical studies.
Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are complex, chronic disorders associated with obesity, diabetes and metabolic syndrome. NASH is a more severe form of the disease, defined as excess fat infiltration within the liver combined with inflammation and injury. If left untreated, NASH can lead to cirrhosis, end-stage liver disease and liver cancer.
Assay Validation and Clinical Performance of Chronic Inflammatory and Chemokine Biomarkers of NASH Fibrosis
Nonalcoholic steatohepatitis (NASH) is a chronic liver disease that can lead to cirrhosis, liver transplant, and even hepatocellular carcinoma. While liver biopsy remains the reference standard for disease diagnosis, analytical and clinical development of non-invasive soluble biomarkers of NASH are of great importance to advance the field.
Optimizing I/E Criteria for Early NASH Clinical Studies with FibroScan® , ACCP 2019 - View Poster
Assay Validation and Clinical Performance of Chronic Inflammatory and Chemokine Biomarkers of NASH Fibrosis, Dutch Day 2019 - View Poster
Quantitation of Insulin Analogue Glargine and its two Metabolites M1 and M2 in Human Plasma Using a Hybrid IP-LC-MS/MS Approach, EBF 2019 - View Poster
Development of a New LC-MS/MS Assay to Determine 7α-hydroxy-4-cholesten-3-one (C4), a Bile Acid Synthesis Biomarker in Human Serum, EBF 2019 - View Poster
Biomarkers Challenges: SiMoA Makes the Tiny but Significant Difference, EBF 2019 - View Poster
Why Celerion for NAFLD/NASH Clinical Drug Development?
With focused expertise and experience, Celerion is ready to assist you in accelerating your metabolic disease clinical development. Since 2007, Celerion has conducted over 100 studies for investigational products targeting metabolic diseases such as diabetes, obesity and nonalcoholic steatohepatitis (NASH).
Do You Know Your ABCs? The ABCs of NASH
Nonalcoholic steatohepatitis (NASH) is a chronic liver disease characterized by steatosis, hepatic inflammation and injury. As a relatively new indication for disease treatment, the FDA and EMA have issued draft guidance for clinical drug development. The ABCs of NASH identifies key NASH terms related to inclusion criteria, clinical endpoints, biomarkers and outcome measures.
Sabina Paglialunga PhD, Director, Scientific Affairs
Sabina Paglialunga, PhD is the Director of Scientific Affairs at Celerion. In this key leadership position, she serves as both an internal and external subject matter expert for metabolic disease drug development programs including nonalcoholic steatohepatitis (NASH) and type 2 diabetes indications. She is responsible for providing scientific, operational and regulatory support for early clinical studies and supports a number of Celerion’s strategic initiatives. She also contributes to Celerion’s reputation for strong science through publications, presentations and webinars. Dr. Paglialunga joined Celerion in April 2015 and previously held the position of Metabolic and Pharmacodynamic Specialist and Associate Director, Scientific Affairs.
Her in-depth knowledge of metabolic pathologies was gained through over 10 years of research experience. Dr. Paglialunga received her PhD from McGill University, Canada in the department of Biochemistry. Her training also includes three Postdoctoral Fellowships (Maastricht University, the Netherlands; University of Guelph and University of Waterloo, Canada), where her research focused on lipid metabolism and glucose homeostasis with specialization in bioenergetics and oxidative stress in skeletal muscle, adipose tissue and the pancreas. She has also contributed to more than 40 publications in top tier diabetes and physiology journals. Dr. Paglialunga is a member of the American Diabetes Association and American Association for the Study of Liver Disease.