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 | |
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Vijay Pasapula (Cerus) | VPasapula@cerus.com |
Unnat Patel (AnalysisMate) | unnat.patel@analysismate.com |
Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
Objectives & Deliverables | Timelines |
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Determination of sub-topics to expand further | Q3 2022 |
PHUSE CSS and PHUSE Connect 2023 project update | Q3/Q4 2022 |
Draft of few sub-topics for White Paper | Q4 2022 |
CURRENT STATUSQ3/4 2022 |
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Project Members | Organisation |
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Erin Erginer | Pinnacle 21 |
Gaurav A Singh | ZS |
Gianna Huang | Gilead Sciences |
Ippei Akiya | A2 Healthcare Corporation |
Jing Su | Merck |
Kunal Banshinge | Springer Nature |
Lavanya Sundaram | Sanofi |
Manohara Halasiddappa | Algok Bio |
Naseem Buckley | Takeda |
Neetu Sangari | Pfizer |
Nimita Limaye | IDC |
Sathish Kumar Chitta | Veranex Solutions |
Subhayan Das | Bristol Myers Squibb |
Sudeepa Dutta | ICON DOCS |
SungHo Lim | Genentech |
Tao Gu | Gilead Sciences |
Teckla Akinyi | GSK |
Unnat Patel | AnalysisMate |
Zahra Karimaddini | Roche |