This recent conference in Zürich, sponsored by the Foundation for the National Institutes of Health (FNIH), the Wellcome Trust (UK) and the Swiss Federal Institute of Technology in Zürich (ETH Zürich), was entitled “Reverse Engineering of Digital Measures: A Conference on Patient-Centric Digital Evidence”.

Reverse translation is the process of gathering data from interventional studies, observational studies, samples, and data repositories to understand how to improve the efficiency of clinical trials. It is, at its heart, patient-centric.

And this meeting delivered on all points in its name. Multiple stakeholders, including regulators, members of pre-competitive consortia, representatives from life-sciences and technology companies, and patients, gathered to discuss what we can learn from patients to create better pharmaceutical products and drug-development tools.

  • This conference provided very compelling examples of digital tool development with patient-centricity in mind. Four case studies were presented:
    Mobilise-D: a project aimed at developing digital mobility assessments to augment our understanding of diseases including COPD, MS, PD, and PFF. The team presented tremendous progress over several years and shared regulatory feedback.
  • IDEA FAST: aimed at assessing fatigue, sleep, and activities of daily living across several neurodegenerative disorders and immune mediated inflammatory diseases to identify biomarkers of fatigue in an indication-agnostic fashion.
  • DHTs for SMA: presented by the Roche team about the challenges of developing better outcome measures in research on spinal muscular atrophy.
  • Schizophrenia: an academic partnership program to develop novel digital biomarkers to improve care delivery for patients with mental health disorders.

Each panel presentation was followed up by a Q&A panel discussion that showed different perspectives from multiple stakeholders – including patients – highlighting both the challenges ahead of us, as well as the opportunities to learn from each other and collaborate to make a difference for patients.
The meeting highlighted that digital monitoring is making inroads into clinical trials and care delivery, displacing hype. We are anticipating more regulatory approvals of novel tools that we can learn from. Future dialogue will be incomplete without payers and ethicists, who both need to have a stronger voice in this conversation. And, of course, we always need to listen to patients.

At Koneksa, we are committed to developing and validating existing and noble digital biomarkers and facilitating deployment of these new tools by providing a device-agnostic sensor and data integration platform to get novel insights about disease features and properties of medicines under development. Our CSO, Elena Izmailova, presented at this meeting as both a scientist and a patient. She shared her patient journey after receiving a diagnosis of suspected cancer, and explained how she self-monitored before and after treatment. The title of her talk was “We Are All Patients,” which reverberated in many follow-up discussions, reflecting that the field needs to learn more from patient insights and data scientists at the same time.

This conference also confirmed many findings and conclusions from the previous meeting, held in February 2020 in Bethesda as they were pressure tested by the pandemic. Digital medicine and digital tools have progressed tremendously in the last 2.5 years and are here to stay, providing better patient care and better medicines to those who need them.