Biomarkers & Diagnostics: Growing Influence on Drug Development for NAFLD/NASH

Biomarkers and diagnostics are playing an ever-increasing role in drug development. Personalized medicines, defined as drug therapies used alongside specific diagnostic tests, topped 40% of all FDA approvals in 2018. Across biopharma, drug developers increased their utilization of selection biomarkers, significantly improving the probability of success for their clinical programs.1, …

NASH NAFLD Blog

Challenges in the Diagnosis of NAFLD, NASH and Comorbidities in the Pediatric Population

Nonalcoholic fatty liver disease (NAFLD) is the accumulation of fat or lipids in the liver in the absence of significant alcohol uptake or viral infection. Within NAFLD there is a spectrum of disease ranging from excess storage of fat in the liver (NAFL) to fat plus inflammation (called nonalcoholic steatohepatitis …

Clinical Outcomes in NASH

Clinical Outcomes in NASH: Choosing the Right Endpoints

Non-alcoholic steatohepatitis (NASH) can lead to serious conditions such as cirrhosis and its complications, liver cancer and hepatic transplantation. Many patients eventually die from liver-related problems or cardiovascular disease. The challenge in developing drugs for NASH is to demonstrate an improvement in clinical outcomes. Cirrhosis takes several years to develop, …

What Are the Emerging Noninvasive Biomarkers in NASH?

Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical procedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those …

Pre-Clinical Issues in NASH Development Covance Blog

How to Navigate Pre-Clinical Issues in NASH Development

The pre-clinical phase of development for non-alcoholic steatohepatitis (NASH) drugs faces many challenges. Biopharmaceutical companies have several options for rodent models, but they must weigh factors such as customization versus speed before deciding on the best approach. Some of the challenges include: Diet: There is no prevailing wisdom in the …