Expert Insights into Novel Evidence


Panel at SCOPE discusses applying novel evidence in regulatory decision-making.

In the discussion: “Novel Evidence for Regulatory Decisions: The Key Factors for Success,” held at the 14th Annual Summit for Clinical Ops Executives (SCOPE) meeting in Orlando, panel members offered suggestions on how to successfully implement novel evidence—defined as RWE, digital biomarkers and novel digital endpoints—in the life cycle of drug development. The panel, moderated by Michelle Crouthamel, D.BA, head of digital sciences for AbbVie Inc., consisted of Jennifer Goldsack, CEO of Digital Medicine Society (DiMe); Christopher Boone, VP, global head of health economics of AbbVie Inc., and Amy Abernethy, president of Verily Life Sciences.

Boone kicked off the discussion, explaining what he’s noticed across the industry and suggested preliminary steps to take. “We’re seeing an awakening in the pharmaceutical industry,” he said. “It’s not just about R&D and regulatory approval but thinking about our evidence plans and the continuous evidence generation across the life cycle of an asset is very important.”

Boone also noted Crouthamel leads AbbVie’s digital science team, which “accesses the landscape of these novel technologies and certifies their usefulness before we put our hands on them.”

Abernethy described her own experiences using novel evidence through Project Baseline, a study that enrolled 2,500 individuals in order to create a 360-degree view of health.

“Reflected across time, this view of health included clinical data, echocardiograms, and visits with clinicians,” she said. “It also included wearing sensors on the wrist in order to understand movement and sleep across time. The sensor was also able to alert participants to answer questions, helping understand their story over time.”

Abernethy stressed that in the end, the science matters. “We have to do the hard work of understanding performance, reliability, and the correct context for intended use.”

Goldsack agreed: “When we think about a digital health model, we aren’t thinking about a single proprietary product, but about a high performing sensor technology, coupled with a trustworthy algorithm that works in every single person,” she explained.

Crouthamel asked the panelists for key takeaways.
“The number one thing to think about is building scalable infrastructure at which we can do this science,” said Abernethy. “Longitudinal infrastructure that sets up the mechanism to continuously validate all of the endpoints that we are talking about. We need to set a scale so that we don’t have to do this over 40 years, but only a few.”

Boone continued by stating, “The data infrastructure piece is very important. The upscaling and rescaling in addition to building longitudinal data points is key.”

Goldsack agreed. “I think that what the infrastructure affords us to do is have a more thoughtful digital strategy that transcends these individual slings shots. That allows us to think about how we capture return on investment for our business and for the patients through the development of these new tools. We need appropriately trained colleagues to make this happen. Pathways to ROI need to exist.”

Crouthamel M, Goldsack J, Boone C, Abernethy A. Novel Evidence for Regulatory Decisions: The Key Factors for Success. Presented at: SCOPE; Feb. 6-8, 2022; Orlando, Fla.

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