TARGET PharmaSolutions, a clinical data company based in Durham, has enrolled the first patient in a new observational study of how asthma patients are faring with various treatments for the disease.

“This will not only aid in mapping the natural history of asthma but will also provide insights into the impact of different treatment paradigms on patient populations over time and collect real-world data as new agents are proceeding to market,” said Michael Wechsler, M.D., professor of medicine and director of the National Jewish Health Cohen Family Asthma Institute.  Wechsler is the chair of a steering committee that will guide the study on behalf of the asthma community.

The study, called TARGET-ASTHMA, is a longitudinal analysis that will extend three years retrospectively prior to patient consent and 10 years going forward, the company said in a news release.

Screen shot from TARGET PharmaSolutions

The study will draw from a database of medical record data received from community and academic sites and will include patient-reported outcome measures and biorepository samples. Partners will use the data to inform optimal treatment approaches and potential solutions as they develop and commercialize drugs.

In addition to asthma, the study will capture data on additional respiratory diseases in the future.

“In working with partners and investigative sites, there has been significant interest in a reliable, longitudinal view of patients with respiratory complications, like asthma, to better understand the challenges of this chronic disease,” said Neal Bibeau, chief executive officer of TARGET PharmaSolutions. “We look forward to working with Dr. Wechsler and other key leaders in this area.”

TARGET-ASTHMA is the company’s seventh “real-world” observational cohort study launched since 2016. The other ongoing TARGET studies are focused on nonalcoholic steatohepatitis, hepatocellular carcinoma, inflammatory bowel disease, primary biliary cholangitis, immune-mediated inflammatory skin conditions and chronic hepatitis B.

The TARGET study model organizes groups of stakeholders around a specific disease to produce regulatory-grade data and analysis about the disease’s natural history, current treatment paradigms and patient outcomes. Stakeholders include key scientific leaders, regulatory agencies, pharmaceutical manufacturers, and patient advocacy groups who provide direction for the study aims and structure.

New CEO, senior advisor appointed

Bibeau was appointed CEO of TARGET PharmaSolutions in February, succeeding Meg Powell, Pharm. D., the company’s co-founder and board chair.

“Neal Bibeau is a seasoned health care technology executive who has delivered innovative, real-world data solutions for the life sciences industry, driving growth and value for all stakeholders,” Powell said.  “His background in data management and healthcare will accelerate our development of real-world data that answer pressing questions in healthcare and drug development.”

Before joining TARGET, Bibeau was president and CEO of Symphony Health Solutions, a real-world health data, analytics and software business based in, Conshohocken, Penn. He led the transformation of Symphony’s business from health data publishing and consulting to a technology and data analytics platform with over $200 million in annual revenue.

In 2017 the company was sold to PRA Health Sciences, a Raleigh-based contract research organization, for $530 million.

TARGET also appointed Franz Humer, the former CEO and board chairman of Roche Holding, as a senior advisor. He will advise the company on building strategic business relationships, help develop strategically aligned innovations and provide guidance on emerging market developments.

“In my years of working in the pharma industry, never have high-quality evidence and data been more important than today,” Humer said. “TARGET has built a truly innovative platform and a world-class team whose solution stands to revolutionize the drug-discovery and -development process.”

(c) North Carolina Biotechnology Center