A recent survey shows that 90 percent of biopharma companies are making significant investments in real-world evidence capabilities to support multiple annual objectives that include driving drug development and meeting regulatory requirements.

The findings of Deloitte’s second annual life sciences industry’s real-world evidence (RWE) capabilities show how the importance of how the use of RWE has evolved across the industry and how has impacted the application of real-world data. Real world evidence, as defined by the U.S. Food and Drug Administration is “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. The survey was conducted to shed light on how biopharmaceutical companies’ approach to optimize the use of RWE across the enterprise is changing through investments, functional applications and technology," Deloitte said.

Since Deloitte conducted its first study last year, multiple companies in the industry have been investing in the RWE space. Deloitte pointed to Roche’s $1.98 billion acquisition of Flatiron Health earlier this year to gain its Health OncologyCloud platform that includes the industry-leading electronic medical record for oncology, advanced analytics, patient portal and integrated billing management. Flatiron’s tech is an aggregating data resource that enables researchers to develop real-world insights into the ever-changing oncology landscape.

In the 2018 Real-World Evidence Benchmark Survey, Deloitte found that 90 percent of the companies surveyed are investing significantly in bringing RWE capabilities in-house. Additionally, those companies are applying RWE across their entire product lifecycle, including new applications. Those top RWE applications include supporting value-based contracting arrangements, regulatory submissions, and improving clinical trial design and execution, Deloitte’s survey revealed. However, the survey also notes that only 45 percent of companies actually have current capabilities to leverage the real-world evidence in order to achieve those goals today.

“The study confirms that insights from real-world healthcare data are central to biopharma companies’ future success as the industry shifts towards a value-based, personalized paradigm,” Brett Davis, ConvergeHEALTH general manager and principal at Deloitte Consulting LLP said in a statement. “This has significant implications for their operating models, external partnering strategies and enterprise technology platforms.”

Deloitte’s survey included executives from 20 global biopharma companies who shared information on applying RWE in real-world scenarios. The survey showed that two of the biggest increases in investment among companies in the industry will be for talent and technology platforms. The survey showed that companies will increase budgets for talent by about 30 percent and new technology budgets by about 25 percent. AI and machine learning, in particular, were identified as critical for capitalizing on the data to derive insights such as identifying patients with undiagnosed or underdiagnosed diseases, the research showed. A majority of the companies, about 60 percent, have made headway into adapting AI and machine learning. Almost all of the companies surveyed anticipate harnessing AI for RWE in the next few years, the survey said.


Dan Housman, managing director of Deloitte Consulting and chief technical officer of ConvergeHEALTH, said the pace of technological innovation, in big data and AI, is accelerating and life science companies are just beginning to apply these approaches to health care.

“We are seeing exciting new applications of AI/ML approaches on RWD to derive novel insights into health and disease. As healthcare data continues to explode, and companies’ access to larger and more diverse sets of RWD increases, these models will only get better and impactful,” Housman said.

The survey also found that companies are acquiring real-world data from a number of non-traditional means, including wearable devices, mobile apps, and clinical data linked to molecular data. Deloitte said evidence discovered from these sources could provide greater insights on disease progression, treatments, and patient benefits.

The survey noted that there were several barriers for companies adopting real-world data. The barriers include lack of receptivity by healthcare providers and payers and lack of support from executive leadership and other internal stakeholders. The third most cited reason was a lack of access to external data, the report showed. Of all three barriers included, Davis said buy-in from executives is the most “critical driver of broader adoption of real-world data.”

“External stakeholders will become more receptive through transparent communication and new collaborative models for engagement. Strategic partnerships will help solve data access issues. The key for biopharma companies is to establish end-to-end RWE management strategies supported by the right talent, platforms, partnerships, and operating models,” Davis said.

Sourced from Biospace - written by Alex Keown