CHAPEL HILL, N.C. /PRNewswire/ -- TARGET PharmaSolutions, Inc., a company focused on real world evidence, is pleased to announce that it has entered into a strategic partnership with Gilead Sciences for TARGET-NASHand TARGET-HBV. Gilead is the sixth partner in TARGET-NASH, joining Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Intercept and Novartis, and the first partner to join TARGET-Hepatitis B.
TARGET-NASH is a robust, meticulously-documented, longitudinal observational study that evaluates adult and pediatric patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). TARGET-NASHhas enrolled over 4,250 patients to date and will enroll up to 15,000 patients in total 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 (Saint Louis University).
The academic steering committee co-chair, Dr. Arun Sanyal, MD stated, "TARGET-NASH is critical for the scientific and regulatory community as we prepare for the plethora of new agents for the treatment of NASH. In the immediate term, it will give us a critical understanding of NASH diagnosis and management in the real world across multiple populations. In the longer term, it is the perfect platform to have a deep understanding of the safety and effectiveness of these new agents across populations not included or underrepresented in Phase 3 clinical trials."
TARGET-HBV is an observational study that is evaluating patients with Hepatitis B. TARGET-HBV recently started enrolling patients and plans to enroll up to 5,000 patients across a diverse network of sites to advance our understanding of Hepatitis B.
Meg Powell, Pharm.D., CEO of TARGET PharmaSolutions, stated, "We are very excited to have Gilead join TARGET-NASHand TARGET-HBV. It is a privilege to partner with a company so focused on advancing the understanding of Liver Diseases."
TARGET PharmaSolutions provides regulatory grade data and analysis that can be used throughout the pharmaceutical development and commercialization process. The TARGET model organizes a community of stakeholders, including key scientific leaders, regulatory agencies, pharmaceutical manufacturers, 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. The TARGET model also provides its stakeholders access to a biorepository linked to validated clinical outcomes, including patient reported outcomes.
TARGET PharmaSolutions, Inc.