Helps sponsors apply medical imaging in trials to advance development of NAFLD/NASH therapeutics
PRINCETON, NJ – Bioclinica®, a leading provider of science and technology expertise to assist the life science industry in advancing the development of medical therapies, announced today that it has assembled a team of experts dedicated to nonalcoholic fatty liver disease (NAFLD) and its more advanced form, nonalcoholic steatohepatitis (NASH), to help sponsors develop therapeutics using medical imaging and other biomarkers in clinical trials.
NAFLD and NASH are increasing in prevalence, with nearly two billion people affected worldwide. "We've assembled a world-class team with a deep understanding of this disease space and the scientific, medical and regulatory intricacies of medical imaging endpoints for NAFLD and NASH trials to accelerate clinical development of effective treatments approved by international regulators," said Bioclinica President and CEO David Herron.
"Developing NAFLD and NASH therapeutics requires innovation in patient screening and monitoring in the clinical research setting," said Scientific Director Mark Tengowski, DVM, MS, PhD. "We're currently working with regulators and sponsors to successfully apply medical imaging as a reliable and non-invasive method of assessing liver fat and stiffness parameters. Our collective objective is to significantly reduce or replace the reliance on liver biopsies with non-invasive imaging methods to assess therapeutic response."
To date, Bioclinica has helped sponsors apply medical imaging to identify patients for inclusion in drug intervention trials and to monitor patient response at more than 225 investigator sites around the globe. "High-quality quantitative liver imaging is no easy task. Bioclinica MRI scientists and technologists work closely with the imaging facilities to qualify their equipment and train the staff on proper acquisition techniques," Tengowski explained adding, "These efforts combined with ongoing quality control ensure accurate, consistent, and reliable endpoints."
Bioclinica provides sponsors end-to-end NAFLD/NASH clinical trial support, beginning early in the protocol design process and extending through to regulatory submission. Services include infrastructure to submit, manage, analyze, report and transfer trial medical imaging data compliant with global data privacy and regulatory requirements using Bioclinica’s best-in-class SMART suite. Bioclinica drug safety experts are available to provide Risk Evaluation and Mitigation Strategies (REMS) as part of a comprehensive NAFLD/NASH offering.
Partnering with Bioclinica means sponsors can tap Bioclinica's extensive medical imaging capabilities employed on thousands of clinical trials, as well as the company’s experience supporting nearly 200 FDA regulatory approvals across a wide range of indications.
Bioclinica will be among the experts participating in and exhibiting at the third annual NASH Summit in Boston on April 22-25. Industry professionals involved in the conduct of NAFLD and NASH clinical trials are invited to join an informational webinar with Mark Tengowski on April 18, Detection and Monitoring in Fatty Liver Clinical Trials: The Role of Medical Imaging.