The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Seeks Industry Partners for Clinical Research Collaborations on Therapeutics, Diagnostics or Devices for Childhood Cholestatic Liver Diseases

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is seeking industry partners for clinical research collaborations on therapeutics, diagnostics, or devices for childhood cholestatic liver diseases. The collaboration will focus on evaluating the natural history, pathogenesis, diagnosis, genetic factors, genomics, proteomics, metabolomics, lipidomics, epigenomics, imaging studies, and determinants of progression and severity of these diseases. The research will also explore the use of serum markers for fibrosis and disease activity, and the utility of these markers as surrogate markers of therapeutic response. Some of the key areas of focus include: • Evaluating the natural history, pathogenesis, diagnosis, genetic factors, genomics, proteomics, metabolomics, lipidomics, epigenomics, imaging studies, and determinants of progression and severity of biliary atresia, alpha-one antitrypsin deficiency, cystic fibrosis liver disease, Alagille syndrome, PFIC, bile acid synthesis defects, mitochondrial respiratory chain and fatty acid oxidation defects, primary sclerosing cholangitis, or idiopathic neonatal hepatitis. • Exploring the use of serum markers for fibrosis and serum markers for disease activity to predict hepatic histology. • Investigating proprietary drugs, reagents, or devices in controlled randomized clinical trials as potential diagnostics or therapies for these diseases. • Evaluating novel newborn or infant screening techniques or devices for biliary atresia or cholestasis. • Evaluating noninvasive imaging methods for assessing fibrosis, biliary disease, and parenchymal pathology in these diseases.