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, …

SEND test submission with Covance. Photo of binary code

The Tale of a Real-life SEND Test Submission

What to Expect When Submitting Your First SEND Dataset to the FDA With the December 17, 2016* requirement for the FDA Standard for the Exchange of Nonclinical Data (SEND*) fast-approaching, our Covance SEND action team prepared a dataset for test submission to the FDA. This helped us to better understand …

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 …

Covance Drug Development China 4

The Shift Toward More-Personalized Medicine in China

Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape. An emerging focus on biomarkers …

Advancing Rare Disease Drug Development: Four Key Considerations for Market Access

Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study …

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 …

Covance Labs Rare and Orphan Drug Development DNA Strand

Accelerating Rare Disease and Orphan Drug Development: Opportunities for Biomarkers, Diagnostics & Patient Engagement

Rare diseases affect more than 350 million people worldwide but patients often face limited options for approved therapies. As a result, many patients have joined advocacy groups first and foremost to connect with others struggling with their rare disease, but also to promote research, unite multiple stakeholders and stimulate new possibilities …

Capitalizing on Global Drug Development Opportunities from China

The Chinese pharmaceutical market continues to grow steadily, but drug developers in China face similar challenges as their global counterparts: Development times are increasing and success rates are declining. Xiaoning Guo, PhD, PMP, clinical development program director of Covance Asia Pacific, recently discussed potential strategies to improve investment returns and …