CHAPEL HillBristol-Myers Squibb is the latest pharmaceutical heavyweight to enter a strategic partnership with Chapel Hill’s TARGET PharmaSolutions to study a major disease.

The two companies will team up on TARGET-IBD, a longitudinal observational study that evaluates patients with inflammatory bowel disease, including adult and pediatric patients with ulcerative colitis, Crohn’s disease and indeterminate colitis. The study has enrolled over 1,850 patients to date at 30 investigative sites.

“TARGET-IBD continues to collect valuable real-world data which enhances our understanding of the natural history of inflammatory bowel disease and the impact of different treatment paradigms on patient populations over time,” said Millie Long, M.D., of the University of North Carolina, who is co-chair of an academic steering committee leading TARGET-IBD.

“The outcomes from real-world evidence can help doctors as they work to provide treatments to individual patients in real-life settings,” Long said. “This is particularly important given the ongoing innovation in the treatment of inflammatory bowel disease.”

The other committee co-chairs are Bruce Sands, M.D., of Mount Sinai and David Rubin, M.D., of the University of Chicago.

The TARGET-IBD study design is disease focused, not treatment-specific, allowing for continuous acquisition of natural history and outcomes data, including patient-reported outcomes, as new treatments continue to enter the market and clinical programs evolve.  It also includes a biorepository that its stakeholders can access for translational studies of viral resistance, genomics and biomarkers to further their research of inflammatory bowel disease.

Gilead Sciences teams with TARGET PharmaSolutions on liver studies

“TARGET-IBD continues to make tremendous progress by enrolling a diverse patient cohort – including adult and pediatric patients – from a network of academic and community sites,” said Meg Powell, MBA, Pharm.D., chief executive officer of TARGET.  “The meticulously detailed real-world data it is collecting from these patients, such as severity of disease, is valuable for TARGET-IBD industry partners like Bristol Myers Squibb as they work to develop treatments to enhance patient outcomes.”

Powell said the partnership builds on TARGET’s current partnership with Bristol-Myers Squibb for studies of two liver diseases, nonalcoholic steatohepatitis and hepatocellular carcinoma.

Other pharmaceutical companies joining various TARGET studies include Gilead Sciences, Allergan, Boehringer Ingelheim, Intercept and Novartis.

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.

TARGET leads studies of six diseases: irritable bowel syndrome, nonalcoholic steatohepatitis, primary biliary cholangitis, hepatocellular carcinoma, hepatitis B and immune mediated skin conditions.

TARGET 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.