Project Scope Scope is limited to digital biomarkers usage in Clinical Trials Problem Statement Digital biomarkers are defined as objective, quantifiable physiological and behavioural data that are collected and measured by means of digital devices such as portables, wearables, implantables, or digestibles. As an emerging technology, Digital Biomarkers ability in addressing medical challenges is enormous. Project “DB360”, to focus on all areas surrounding Digital Biomarkers and its usage in clinical trials. You can find further information here. Problem Impact This project identifies current state of digital biomarkers in clinical sector and its future impact. It will cover the topics: Classification of existing digital biomarkers, Clinical Therapeutic areas where digital biomarkers usage is progressing, limitations, etc., Stakeholders impacted are Pharma, CROs, tech companies, regulators and SDOs. “DB360” will be built on the paper DH08 submitted in PHUSE US Connect 2020 with final outcome of White Paper and presentations at PHUSE conferences in 2022 |
| Project Leads | |
|---|---|
| Vijay Pasapula | VPasapula@cerus.com |
| Paula Rowley (PHUSE Project Assistant) | paula@phuse.global |
CURRENT STATUSQ22021 |
|---|
'NEW Project'. This project has just been launched and is currently calling for volunteers. We now have a project lead Vijay Pasapula but are looking for a Project Co-Lead . If this is of interest to you please email: workinggroups@phuse.global |
| Project Members | Organisation |
|---|---|
| Ippei Akiya | A2 Healthcare |
| Gianna Huang | Gilead Sciences |
| Neetu Sangari | Pfizer |
| SungHo Lim | Genentech |
| Tao Gu | Gilead Sciences |
| Teckla Akinyi | GSK |
| Unnat Patel | AnalysisMate |
| Lavanya Sundaram | Sanofi |
| Naseem Buckley | Takeda |
| Zahra Karimaddini | Roche |
| Teckla Akinyi | GSK |
| Manohara Halasiddappa | Algok Bio |
| Jing Su | MSD |
| Objectives & Deliverables | Timelines |
|---|---|
Existing digital biomarkers classification (Q3/Q4) | Q3-Q42021 |
| Identifying Clinical Trials Therapeutic Areas where DBs are using DB's | Q3-Q42021 |
| Identify the limitations of usage of digital biomarker in clinical trials | Q42021/Q12022 |
| Deep dive into the areas identified during learning process and possible white paper, conference presentation during | PHUSE CONNECT/CSS, 2022 |