TARGET PharmaSolutions, Inc., a real-world clinical data company, is pleased to announce that Intercept (Nasdaq: ICPT) has extended its strategic partnership for TARGET-NASH to a multi-year agreement.
TARGET-NASH is a longitudinal observational study that evaluates patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). TARGET-NASH is collecting retrospective and prospective data on its enrolled patients and is developing a biorepository which its stakeholders can access for translational studies (including those of genomics and biomarkers). To date, TARGET-NASH has enrolled 2,364 patients at 55 sites. There have been multiple presentations on TARGET-NASH at leading academic conferences and a methodology publication is currently in press. TARGET-NASH plans to enroll up to 15,000 patients over the coming years. TARGET-NASH is led by an academic steering committee chaired by Drs. Arun Sanyal, MD (Virginia Commonwealth University); Ken Cusi, MD (University of Florida), and Brent Tetri (St. Louis University).
Meg Powell, CEO of TARGET PharmaSolutions, stated "We are pleased to extend our partnership with Intercept for TARGET-NASH. We are developing valuable real-world data and insight on the NASHpatient population. Our industry partners are benefitting from their participation in TARGET-NASH as each company works to enhance its understanding of this increasingly prevalent disease and to progress its NASH development program. We are excited to have the opportunity to assist our industry partners in these critical efforts."
TARGET PharmaSolutions provides insights and actions to improve clinical, medical, and commercial outcomes throughout the pharmaceutical development and commercialization process. The TARGET model organizes a community of stakeholders, including pharmaceutical manufacturers, key opinion leaders, regulatory agencies, and patient advocacy groups, around a specific disease to generate real world evidence about the natural history of the given disease, current treatment paradigm, and patient outcomes. This model enables TARGET's stakeholders to answer critical strategic and planning questions and to prepare for regulatory and payer requests. The TARGET model also provides access to a biorepository linked to validated clinical outcomes, including patient reported outcomes (PROs).
TARGET PharmaSolutions was formed in February, 2015 and has four disease communities: TARGET-NASH (nonalcoholic steatohepatitis), TARGET-PBC (primary biliary cholangitis), TARGET-HCC (hepatocellular carcinoma), and TARGET-IBD (inflammatory bowel disease). The TARGET model is based on the success of HCV-TARGET, a case study in Hepatitis C. Formed in 2011 by Drs. Michael Fried, MD (University of North Carolina) and David Nelson, MD (University of Florida), HCV-TARGET has enrolled over 11,000 patients and has generated data that has been used by physicians, payers, and regulatory agencies around the world.
About TARGET PharmaSolutions
TARGET PharmaSolutions is a privately held real-world clinical data company that provides pharmaceutical and biotechnology partners a more efficient way to generate data that can be used to better understand the natural history of diseases, current treatment paradigms, and patient outcomes in the real-world setting. TARGET PharmaSolutions is based in Chapel Hill, N.C. For more information, visit www.targetpharmasolutions.com.