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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 LeadsEmail
Vijay Pasapula (Cerus)VPasapula@cerus.com
Unnat Patel (AnalysisMate)unnat.patel@analysismate.com
Katie Warren (PHUSE Project Assistant)katie@phuse.global 


Objectives & DeliverablesTimelines
Draft White PaperQ42022

PHUSE Connect 2022 poster and presentation recording 

Q22022

Determination of sub-topics to expand further

Q32022

Draft of few sub-topics for White Paper

Q42022


Status
colourBlue
titleCurrent Status
Q12022

  • 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
  • Poster abstract approval for the PHUSE Connect 2022 
  • Sub-topics research expanded



Project MembersOrganisation
Erin ErginerPinnacle 21
Gianna HuangGilead Sciences
 Ippei AkiyaA2 Healthcare Corporation
Jing SuMerck
Kunal BanshingeSpringer Nature
Lavanya Sundaram

Sanofi

Manohara HalasiddappaAlgok Bio
Naseem Buckley Takeda
Neetu SangariPfizer
Sathish Kumar ChittaVeranex Solutions

Subhayan Das

Bristol Myers Squibb
Sudeepa DuttaICON DOCS
SungHo LimGenentech
Tao GuGilead Sciences
Teckla AkinyiGSK
Unnat Patel AnalysisMate

Zahra Karimaddini

Roche