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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 


Q22022
Objectives & DeliverablesTimelines
Draft White PaperQ42022

PHUSE Connect 2022 poster and presentation recording 

Determination of sub-topics to expand further

Q32022

further 

Q3 2022

PHUSE CSS and PHUSE Connect 2023 project update

Q3/Q4 2022

Draft of few sub-topics for White Paper

Q42022

Q4 2022


  • 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

    Status
    colourBlue
    titleCurrent Status
    Q12022

    Q3/4 2022

    • Sub-topics streamlining is progressing.
    • Considering expanding of scope to Digital Health Technologies  



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

    Sanofi

    Manohara HalasiddappaAlgok Bio
    Naseem Buckley Takeda
    Neetu SangariPfizer
    Nimita LimayeIDC
    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