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Digital measures in Clinical Trials: Development & Validation assessment

21st February @ 10:45AM EDT

Do you work in the development and/or validation of digital measures for clinical trials? Are you struggling to include these new measures in a clinical trial? This meeting is for you!


Digital measures (both digital-enabled measures and novel digital biomarkers) have the potential to form part of clinical development programs, but there are still a lot of questions to be addressed before this becomes a reality. In this meeting we will focus on:


  • What does the development process look like (both for software/algorithms and hardware)? What is the role of third parties like Apple?
  • Who are the stakeholders involved in the development process (e.g clinicians, patients, engineers, etc)?
  • Technical and clinical validation of digital measures: who is responsible for this validation, requirements of the different stakeholders, validation of software vs. hardware and how to deal with software updates/iterations.
  • Standardization of understanding/interpretation across the field: what is the role of initiativeslike the DATAcc, EVIDENCE and the V3 Framework from DiMe or the Digital Biomarker Discovery Pipeline?

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Digital measures in Clinical Trials: Development & Validation assessment

George Platings
Market Development Specialist at uMotif
Andy Coravos
CEO/Co-Founder, Elektra Labs
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Digital measures in Clinical Trials: Development & Validation assessment

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21st February @ 10:45AM EDT

Do you work in the development and/or validation of digital measures for clinical trials? Are you struggling to include these new measures in a clinical trial? This meeting is for you!


Digital measures (both digital-enabled measures and novel digital biomarkers) have the potential to form part of clinical development programs, but there are still a lot of questions to be addressed before this becomes a reality. In this meeting we will focus on:


  • What does the development process look like (both for software/algorithms and hardware)? What is the role of third parties like Apple?
  • Who are the stakeholders involved in the development process (e.g clinicians, patients, engineers, etc)?
  • Technical and clinical validation of digital measures: who is responsible for this validation, requirements of the different stakeholders, validation of software vs. hardware and how to deal with software updates/iterations.
  • Standardization of understanding/interpretation across the field: what is the role of initiativeslike the DATAcc, EVIDENCE and the V3 Framework from DiMe or the Digital Biomarker Discovery Pipeline?
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Participants

Participants

George Platings

Market Development Specialist at uMotif

Andy Coravos

CEO/Co-Founder, Elektra Labs

Stefanie Kolbe

Vice President Business Development & Strategy, Data4Life

Minhaz Morshed

Business Development Manager at Data4Life

Doina Sirbu

Medical Device Innovation Lead, UCB

Emily Kunka

Digital Transformation Project Lead, UCB

Joseph Rubinsztain

CEO & Co-Founder, ChronWell

Erwin De beuckelaer

Director Innovative Capabilities, The Janssen Pharmaceutical Companies of Johnson & Johnson

Tanja Dowe

CEO, Debiopharm Innovation Fund

Zina Manji

Sr Director of Regulatory Affairs at GSK

Lauren Bataille

Head of Digital Patient Health & Innovation - Cardiovascular, Renal & Metabolism at AstraZeneca

Number of Participants


Up to 12
Date  
February 21, 2022
Community

Digital measures in Clinical Trials: Development & Validation assessment

Do you work in the development and/or validation of digital measures for clinical trials? Are you struggling to include these new measures in a clinical trial? This meeting is for you!


Digital measures (both digital-enabled measures and novel digital biomarkers) have the potential to form part of clinical development programs, but there are still a lot of questions to be addressed before this becomes a reality. In this meeting we will focus on:


  • What does the development process look like (both for software/algorithms and hardware)? What is the role of third parties like Apple?
  • Who are the stakeholders involved in the development process (e.g clinicians, patients, engineers, etc)?
  • Technical and clinical validation of digital measures: who is responsible for this validation, requirements of the different stakeholders, validation of software vs. hardware and how to deal with software updates/iterations.
  • Standardization of understanding/interpretation across the field: what is the role of initiativeslike the DATAcc, EVIDENCE and the V3 Framework from DiMe or the Digital Biomarker Discovery Pipeline?
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  • Join specialised communities in areas like DTx, AI, Clinical Trials Innovation and more
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Digital measures in Clinical Trials: Development & Validation assessment

21st February @ 10:45AM EDT
Clinical Trials Innovation

Digital measures in Clinical Trials: Development & Validation assessment

21st February @ 10:45AM EDT
Clinical Trials Innovation
George Platings
Market Development Specialist at uMotif
LinkedIn Profile
Andy Coravos
CEO/Co-Founder, Elektra Labs
LinkedIn Profile
Stefanie Kolbe
Vice President Business Development & Strategy, Data4Life
LinkedIn Profile
Minhaz Morshed
Business Development Manager at Data4Life
LinkedIn Profile
Doina Sirbu
Medical Device Innovation Lead, UCB
LinkedIn Profile
Emily Kunka
Digital Transformation Project Lead, UCB
LinkedIn Profile
Joseph Rubinsztain
CEO & Co-Founder, ChronWell
LinkedIn Profile
Erwin De beuckelaer
Director Innovative Capabilities, The Janssen Pharmaceutical Companies of Johnson & Johnson
LinkedIn Profile
Tanja Dowe
CEO, Debiopharm Innovation Fund
LinkedIn Profile
Zina Manji
Sr Director of Regulatory Affairs at GSK
LinkedIn Profile
Lauren Bataille
Head of Digital Patient Health & Innovation - Cardiovascular, Renal & Metabolism at AstraZeneca
LinkedIn Profile

Digital measures in Clinical Trials: Development & Validation assessment

Do you work in the development and/or validation of digital measures for clinical trials? Are you struggling to include these new measures in a clinical trial? This meeting is for you!


Digital measures (both digital-enabled measures and novel digital biomarkers) have the potential to form part of clinical development programs, but there are still a lot of questions to be addressed before this becomes a reality. In this meeting we will focus on:


  • What does the development process look like (both for software/algorithms and hardware)? What is the role of third parties like Apple?
  • Who are the stakeholders involved in the development process (e.g clinicians, patients, engineers, etc)?
  • Technical and clinical validation of digital measures: who is responsible for this validation, requirements of the different stakeholders, validation of software vs. hardware and how to deal with software updates/iterations.
  • Standardization of understanding/interpretation across the field: what is the role of initiativeslike the DATAcc, EVIDENCE and the V3 Framework from DiMe or the Digital Biomarker Discovery Pipeline?
When:
21st February @ 10:45AM EDT
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