Chapel Hill-based TARGET PharmaSolutions, a clinical data company focused on real-world evidence in disease studies, has formed a strategic partnership with Gilead Sciences to better understand two major liver disorders.

Gilead is the sixth major pharmaceutical partner to join in TARGET-NASH, a study of nonalcoholic fatty liver disease, or nonalcoholic steatohepatitis (NASH), and the first to join in TARGET-HBV, a study of hepatitis B.

“It is a privilege to partner with a company so focused on advancing the understanding of liver diseases,” said Meg Powell, Pharm.D., chief executive officer of TARGET PharmaSolutions.

The other TARGET-NASH partners are Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Intercept and Novartis.

TARGET-NASH is a longitudinal observational study that evaluates adult and pediatric patients with nonalcoholic fatty liver disease or nonalcoholic steatohepatitis. The study has enrolled over 4,250 patients to date and will have up to 15,000 patients in total over the coming years.

“TARGET-NASH is critical for the scientific and regulatory community as we prepare for the plethora of new agents for the treatment of NASH,” said Arun Sanyal, M.D., of Virginia Commonwealth University, who co-chairs an academic steering committee for the study. “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.”

NASH is a disease of abnormal fat accumulation in the liver that can inflame the organ, leading to scarring and sometimes liver cirrhosis or cancer. It is heavily influenced by lifestyle habits such as chronic over-eating and lack of exercise and is different than other fatty liver diseases caused by alcohol abuse or medication side effects.

TARGET-HBV is an observational study that is evaluating patients with hepatitis B, a viral infection of the liver that is the most common serious liver infection in the world. The study recently started enrolling patients and plans to enroll up to 5,000 patients across a diverse network of sites to advance the understanding of Hepatitis B.

Disease community model

TARGET PharmaSolutions provides regulatory grade data and analysis that can be used throughout the pharmaceutical development and commercialization process.

The company’s TARGET model organizes a community of stakeholders, including scientific investigators, pharmaceutical manufacturers, opinion leaders, regulatory agencies, and patient advocacy groups, around a specific disease to generate real-world evidence about the natural history of the disease, current treatment paradigms and patient outcomes.

The model allows stakeholders to answer critical strategic and planning questions and gain access to a biorepository of patient tissues linked to validated clinical outcomes, including patient-reported outcomes.

In addition to TARGET-NASH and TARGET-HBV, the company leads four other disease communities for studies of primary biliary cholangitis, hepatocellular carcinoma, inflammatory bowel disease and immune mediated skin conditions.

TARGET PharmaSolutions was formed in February 2015 and is backed by a Series A funding round completed in 2016 and led by Raleigh-based REX Health Ventures, the venture capital arm of UNC REX Healthcare, with participation by VentureSouth of Greenville, S.C., and local angel investors.

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