SAN DIEGO, October 28, 2015 – Profil Institute for Clinical Research, a clinical research organization (CRO) focused on diabetes, obesity and NALFD/NASH, today announced a collaboration with Rohit Loomba, M.D., a leading clinical and academic researcher in NAFLD and NASH.
Dr. Loomba’s research focuses on all aspects of NAFLD, including non-invasive biomarkers, genetics, epidemiology, clinical trial design, imaging end-points, and integrated OMICs using microbiome, metabolome and lipidome. His research at UC San Diego has contributed to a number of important milestones, including the establishment of MRI-PDFF as a non-invasive biomarker of treatment response in early phase trials in NASH; the first prospective study of MRE in patients with biopsy-proven NAFLD; and the first trial in NASH with comprehensive MRI and 2D and 3D MRE assessment paired with liver biopsies in NASH. His research is widely published in peer reviewed journals. He is Director of UC San Diego’s NAFLD Research Center and is the founder and principal investigator of the San Diego Integrated NAFLD Research Consortium (SINC).
“Dr. Loomba is recognized internationally as a leading expert in NAFLD and NASH research. His team at UCSD has helped pioneer a number of imaging modalities and noninvasive biomarker discoveries, often referred to as ‘virtual biopsies’ for NAFLD/NASH diagnosis, prognosis and disease progression monitoring,” said Dr. Marcus Hompesch, Profil Institute’s President and CEO. “This consulting agreement between Dr. Loomba and Profil Institute represents the bridging of groundbreaking independent academic science with Profil Institute’s expertise and experience in designing and executing complex clinical research and development planning for the biopharmaceutical industry.”
“There’s a tremendous need to find clinical solutions for NAFLD and NASH. Given the comorbidities that exist, Profil Institute’s previous work in diabetes, obesity and metabolic disease have allowed its team to develop the clinical research and development expertise to respond to the growing unmet medical need for diagnostics, treatments and monitoring tools,” said Dr. Loomba.
About non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)
Non-alcoholic fatty liver disease (NAFLD) is a condition indicated by excess fat deposition in the liver and is a comorbidity of metabolic syndrome, obesity and diabetes. NAFLD is rapidly becoming the most common liver disease globally with population-based estimates ranging from 20 to 30%.1, 2 Among patients with type 2 diabetes, the reported prevalence of NAFLD is 65%.3 In patients with severe obesity, the prevalence of NAFLD can exceed 90%.1, 2
Approximately 10–22% of patients with NAFLD have the progressive subtype non-alcoholic steatohepatitis (NASH), which can result in cirrhosis, hepatocellular carcinoma, and liver failure, often necessitating liver transplantation. 4
About Profil Institute for Clinical Research, Inc.
Profil Institute is an early engagement clinical research organization (CRO) exclusively focused on metabolic diseases, including diabetes, obesity and NAFLD/NASH. The company is recognized globally for its scientific expertise, expanded scope of research methodologies, and experience with every clinically relevant drug class in diabetes. Profil Institute provides a full scope of CRO services from consulting for strategic clinical development and regulatory planning through design and completion of complex clinical trials, including the reporting and publication of final study results.
Profil Institute has completed more than 230 clinical trials focused on metabolism, including diabetes, obesity and NAFLD/NASH. Profil Institute is leveraging that deep expertise in metabolic disease to become the leading CRO pursuing solutions for the unmet medical needs of NAFLD/NASH patients.
Profil Institute’s expertise and experience encompasses small and large molecule therapies, biologics and biosimilars through all routes of administration, as well as devices. The company’s clients range from large pharma and drug discovery companies to small virtual companies throughout the Americas, Europe and Asia.
Profil Institute is also widely recognized as an innovator of methodologies, including its Automated Glucose Clamp technology, and for driving new, higher standards in metabolic clinical research through collaborative science with key academic and industry partners. For more information, please visit www.profilinstitute.com.
For further information, please contact:
Profil Institute for Clinical Research, Inc.
+1 (858) 663-6148
- Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The Diagnosis and Management of Non-Alcoholic Fatty Liver Disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. 2012 Jun;55(6):2005-23.
- Ahmed M. Non-alcoholic fatty liver disease in 2015. World Journal of Hepatology. 2015;7:1450-9.
- Doycheva I, Cui J, Nguyen P, Costa EA, Hooker J, Hofflich H, Bettencourt R, Brouha S, Sirlin CB, Loomba R. Non-invasive screening of diabetics in primary care for NAFLD and advanced fibrosis by MRI and MRE. Aliment Pharmacol Ther. 2015 Sep 15. doi: 10.1111/apt.13405.
- Bazick J, Donithan M, Neuschwander-Tetri B, Kleiner D, Brunt E, Wilson L, Doo E, Lavine J, Tonascia J, Loomba R. Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD. Diabetes Care. 2015 Apr;10.2337/dc14-1239.