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 |
| Unnat Patel | unnat.patel@analysismate.com |
| Paula Rowley (PHUSE Project Assistant) | paula@phuse.global |
| ||||||
|---|---|---|---|---|---|---|
Developing sub-topics for a White Paper presentation which will be focused on identifying issues such as data sources, RWE technologies, data privacy and related issues, and standards. |
| Project Members | Organisation | ||
|---|---|---|---|
| Erin Erginer | Pinnacle 21 | Ippei Akiya | A2 Healthcare Corporation |
| Gianna Huang | Gilead Sciences | ||
| Neetu Sangari | Pfizer | ||
| SungHo Lim | Genentech | ||
| Tao Gu | Gilead Sciences | ||
| Teckla Akinyi | GSK | ||
| Unnat Patel | AnalysisMate | ||
| Ippei Akiya | A2 Healthcare Corporation | ||
| Jing Su | Merck | ||
| Kunal Banshinge | Springer Nature | ||
| Lavanya Sundaram | Sanofi | ||
| Manohara Halasiddappa | Algok Bio | ||
| Naseem Buckley | TakedaZahra Karimaddini | ||
| Neetu Sangari | RochePfizer | ||
| Teckla Akinyi | GSK | ||
| Manohara Halasiddappa | Algok Bio | ||
| Jing Su | MSD | ||
| Kunal Banshinge | Springer Nature | ||
| Erin Erginer | Pinnacle 21 | ||
| Jing Su | Merck | ||
| Naseem Buckley | Takeda | ||
| Zahra Karimaddini | Roche | ||
Subhayan Das | Bristol Myers Squibb | ||
| SungHo Lim | Genentech | ||
| Tao Gu | Gilead Sciences | ||
| Teckla Akinyi | GSK | ||
| Unnat Patel | AnalysisMate | ||
Zahra Karimaddini | Roche | Subhayan Das | Bristol Myers Squibb |
| 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 |