TARGET PharmaSolutions Adds Partnership with Novartis to Study Liver Disease

Clinical data company TARGET PharmaSolutions of Chapel Hill has expanded its stable of major pharmaceutical company strategic alliances by adding Novartis to its study of liver disease.

The long-term partnership is for TARGET’s study of patients with nonalcoholic fatty liver disease (NAFLD) or a more serious form of the disease, nonalcoholic steatohepatitis (NASH). Novartis joins a growing list of large pharmaceutical companies developing therapies for NASH that are involved in the study, called TARGET-NASH.

“We are very excited to have Novartis join TARGET-NASH,” said TARGET CEO, president and co-founder Meg Powell, Pharm.D., in a news release. “TARGET-NASH has enrolled a large, diverse patient population and is generating valuable real-world data and insight on NASH, including the natural history of the disease and current treatment patterns.”

Data from the study, combined with tissue biorepository and patient-reported outcomes, “will enable our collaborators to continue to increase their understanding of this growing disease,” Powell said. TARGET will enroll up to 15,000 patients over the coming years.

TARGET Partnerships Strengthen Study

In October 2017, TARGET announced a multi-year partnership with Boehringer Ingelheim International of Ingelheim, Germany. At the same time, the company extended its partnerships with Bristol-Myers Squibb and Intercept Pharmaceuticals to multi-year agreements.

TARGET began 2017 with about 20 employees but has more than doubled its workforce to about 50 and expects to have 70 employees by the end of 2018, Powell said.

“Real-world evidence continues to be so critical in advancing drug development and ultimate patient outcomes,” said Powell. “TARGET is pleased that its real-world collaborative platform is providing a way to facilitate drug development and ultimately move the entire field forward.”

TARGET said limited information about the epidemiology of NASH complicates the development of new medications. TARGET-NASH aims to provide an improved baseline for measuring the impact of new therapies on medical co-morbidities, natural history, and hepatic, cardiovascular, and endocrine-associated outcomes, ultimately enabling the development of better treatments for NASH patients, the company said.

In addition to TARGET-NASH, the company has three other disease communities for the study of primary biliary cholangitis, hepatocellular carcinoma and inflammatory bowel disease.

TARGET connects stakeholders with real-world evidence

The TARGET model organizes a community of stakeholders, including pharmaceutical manufacturers, key opinion leaders, regulatory agencies, investigators 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 is based on HCV-TARGET, a case study in hepatitis C. Formed in 2011 by Michael Fried, M.D., of the University of North Carolina at Chapel Hill, and David Nelson, M.D., of the University of Florida, HCV-TARGET has enrolled over 11,000 patients and generated data used by physicians, payers and regulatory agencies around the world.

TARGET was formed in February 2015. The North Carolina Biotechnology Center awarded the company a $500,000 Strategic Growth Loan in 2016, but “we have been fortunate to not have to draw on this line of credit to date,” Powell said.

TARGET 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.