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Supporting the Next Major Health Epidemic

Supporting the Next Major Health Epidemic

Non-alcoholic fatty liver disease (NAFLD)/Non-alcoholic steatohepatitis (NASH) is viewed as the next major health epidemic and with no current anti-NASH medication on the market to treat this chronic disease; it is expected to place a heavy burden on our healthcare systems.

NAFLD is considered to be a hepatic manifestation of metabolic syndrome, associated with obesity and insulin resistance. The incidence of NAFLD/NASH is rapidly increasing worldwide, currently affecting over 1 billion people, and the prevalence of NAFLD/NASH is not limited to adults as the rise of this disease is also observed in children. Presently, the standard of care for NAFLD/NASH includes invasive liver biopsy procedures for diagnosis and management. Therefore, NASH is expected to become the most common indication for liver transplantation in the United States by 2020, surpassing viral diseases like hepatitis C.

This month, Thomas Jefferson University Hospital in Philadelphia reported its 1,000th liver transplant surgery. This milestone calls out to our industry the importance of our work in support of patients with end-stage liver disease.

Non-invasive diagnostic and prognostic techniques to identify NASH patients and those who will positively response to a given treatment regimen is overwhelmingly needed. Recent advancements in medical imaging, such as magnetic resonance elastography and FibroScan, are contributing to achieving these goals. In addition, an emerging trend in early clinical research is to examine pharmacodynamic effects in patient populations. In this respect, imaging tools as well as soluble biomarkers found in bodily fluids such as blood, urine, saliva, etc. are extremely useful to evaluate NAFLD/NASH drug efficacy.

A number of pharmaceutical companies are currently involved in NAFLD/NASH research. This list includes, but is not limited to Intercept, Genfit, Galmed, Gilead, Genentech, Pfizer, Merck, and Novartis.

An experienced contract research organization (CRO) will have NAFLD/NASH capabilities and experience in hepatic lipid metabolism and fibrosis biomarkers to incorporate into drug development Single Ascending Dose (SAD), Multi-Ascending Dose (MAD), Drug Interaction (DDI), Phase 1b, Proof-of-Concept (POC) studies. The scientific and clinical operational staff will have experience and thorough understanding of the disease as well as bioanalytical and non-invasive measurements of hepatic lipid metabolism, inflammation and fibrosis. In addition, the CRO will have a strong recruitment track-record to support special-population studies like diabetes, obesity, NAFLD programs.

Celerion’s experienced and knowledgeable scientific and clinical operational team can help navigate NAFLD/NASH drug development programs through this emerging market.

Science leading to medicine, done well, helps saves patients’ lives and provides for a healthy standard of living.

Celerion was recognized by Biopharmaceutical Clients in May 2016 as a Leader in Contract Research Quality Benchmarking Survey.