Koneksa at the CNS Summit With Chief Scientific Officer Dr. Elena Izmailova

The digital field has been greatly transformed during the 18 months of the pandemic. The timid pre-pandemic attempts to test and explore digital health technologies (DHT) were swiftly replaced by real studies with tons of data from using DHTs in real life. This year’s CNS Summit—an annual gathering of R&D life science leaders that has taken place since 2009—reflected that reality, with speakers sharing their experiences and forecasting future directions. The plenary sessions brought a constellation of outstanding speakers, followed by presentations from industry leaders on technological innovation and use cases. Progress was reported in several directions: decentralized clinical trials, novel digital measures, and endpoints, along with digital therapeutics. Everyone agreed that forming productive partnerships will be the future of DHTs, in both clinical research and care delivery. However, how these partnerships and collaborations will be formed and developed remains to be seen as the field becomes increasingly competitive due to increased demand in both tools and services. A pragmatic approach to pre-competitive collaboration was the main topic of discussion at the spotlight session hosted by Koneksa. Our session brought together representatives from biotech, pharma, and precompetitive consortia and sought to address three critical questions:

• What should clinical teams consider when selecting devices for biomarker-based mobile measures?

• What validation experiments need to be designed and completed before these tools can be deployed in interventional studies?

• Which aspects of device selection and validation can be done via pre-competitive consortia collaboration efforts, and which should be kept internally?

Aaron Kithcart and James Donohue

from Regeneron Pharmaceuticals presented an interesting case of repositioning a 510(K) cleared device for use in clinical trials to enable objective continuous monitoring for advanced hemodynamic variables in healthy volunteers.

Derek Buhl

from Takeda Pharmaceuticals talked about the importance and considerations of measuring people’s sleep remotely in a natural environment, which provides an opportunity to derive sleep measures longitudinally and avoid the white coat effect.

Diane Stephenson

from the Critical Path Institute gave an update on the progress of the Critical Path for Parkinson’s Consortium and reported the achievements of the WATCH-PD study. The session openly discussed the challenges of implementing digital technologies in clinical development, including obtaining internal buy-in within sponsor organizations, managing critical aspects of partnering with the technology sector, and determining which aspects of this work make sense to be shared in a pre-competitive space. The bottom line is: Digital technologies are valuable tools for data collection in clinical trials. Their use case is very different from drug development candidates and provides the perfect opportunity for precompetitive collaborations and data sharing. However, sometimes these tools are perceived as sponsors’ intellectual property, potentially having a competitive advantage. More examples, like the case studies presented at the Koneksa spotlight session, may help clarify the nature of these tools and convince the digital community that it will be safe to share the tools to accelerate the field—as was done for laboratory biomarker assays and imaging technologies that are widely used in drug development today. To learn more about patient-centric digital biomarker solutions for remotely collected clinical data, contact Koneksa.