The biopharma industry has come to realize that data from controlled clinical studies may testify to a drug’s efficacy but might not be enough to prove its value. In its most recent move to keep up with the latest trend, Parexel has set up a team committed to providing real-world data insights.
Seas of real-world data do exist in the healthcare system but are just not readily available for research purposes, said Joshua Schultz, SVP and head of Parexel’s Access unit, to which the new team belongs. “Our new service will allow clients to more seamlessly collect and communicate the specific data that payers, physicians, and patients require to establish that a new product offers greater benefits than the existing standard of care.”
This is not a sudden change of direction for Parexel, Schultz said, since the CRO uses real-world data every day to inform its consulting. It is, however, a reflection of some recent changes going on in the industry, namely the impact of the 21st Century Cures Act, advances in technology through which data can be extracted from unstructured fields and securely stored at volume, normalization automated, and advanced analytics applied to address needs across all phases of development, he said.
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The company is doubling down on the real-world evidence realm amid a round of planned layoffs that involves 1,100 to 1,200 employees as it prepares for a buyout by private equity firm Pamplona Capital.
Parexel is definitely not the only one trying to jump-start the quickly evolving field. INC Research, for example, just recently strengthened its offerings by hiring several experienced executives to its dedicated real-world and late-phase team established in 2011.
The Parexel team will include talents with expertise in epidemiology, health economics and outcomes research, market access, analytics, medical sciences, and safety, the CRO said. It will leverage data collected from different resources like electronic medical records and patient-reported outcomes as evidence that supports a drug’s commercial value. The goal is to accelerate market access and mitigate commercial risk.
Moreover, services the new team offers are not restricted to sales and marketing, but also include regulatory support in a more cost- and time-effective manner. This can be a particularly promising field, given that the Cures Act is allowing more real-world evidence into approval of indication expansion and postmarketing surveillance.
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The new offering is the latest addition to Parexel’s Connected Journey, an ecosystem of more than 40 data-driven services designed to provide stakeholders access to high-quality data in real time, to help biopharma researchers make sense of the data more quickly.
Schultz considers the new establishment “a specific investment that allows Parexel to be at the forefront of using real-world data beyond identifying sites and patients for a study or for the development of health economic models.” It enables Parexel to “integrate these data to bring value to the full product-development spectrum using the specialized data-agnostic approach, technology and expertise that comes with a dedicated delivery unit.”