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Digital Biomarkers in Clinical Trials: Do’s & Don’ts in the Validation Process
Novel digital biomarkers have the potential to be part of clinical trials, but there are still a lot of questions regarding their reliability and validation process. Are you struggling with validating these digital biomarkers?
Join this meeting to share experiences and learn from others about:
- Technical vs. clinical validation: who are the stakeholders involved in each phase of the validation process? What are the regulatory bodies and payers asking for?
- Validation of software vs. hardware and the iterative nature of these technologies.
- While pharma companies are users of novel digital biomarkers and are willing to support their development, they are unlikely to take ownership. What is pharma’s responsibility in the validation process of digital biomarkers?
- How do the validation requirements change depending on the use case (e.g. digital biomarker as an endpoint vs. patient selection vs. tracking safety)?
- Some cross-industry bodies have created programs to help validate digital biomarkers, such as the Innovative Medicines Initiative (IMI), the Digital Biomarker Discovery Pipeline (DBDP) or the V3 framework from DiMe. Is this enough? What else does the industry need to make stakeholders use common standards?
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Digital Biomarkers in Clinical Trials: Do’s & Don’ts in the Validation Process
Digital Biomarkers in Clinical Trials: Do’s & Don’ts in the Validation Process
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Novel digital biomarkers have the potential to be part of clinical trials, but there are still a lot of questions regarding their reliability and validation process. Are you struggling with validating these digital biomarkers?
Join this meeting to share experiences and learn from others about:
- Technical vs. clinical validation: who are the stakeholders involved in each phase of the validation process? What are the regulatory bodies and payers asking for?
- Validation of software vs. hardware and the iterative nature of these technologies.
- While pharma companies are users of novel digital biomarkers and are willing to support their development, they are unlikely to take ownership. What is pharma’s responsibility in the validation process of digital biomarkers?
- How do the validation requirements change depending on the use case (e.g. digital biomarker as an endpoint vs. patient selection vs. tracking safety)?
- Some cross-industry bodies have created programs to help validate digital biomarkers, such as the Innovative Medicines Initiative (IMI), the Digital Biomarker Discovery Pipeline (DBDP) or the V3 framework from DiMe. Is this enough? What else does the industry need to make stakeholders use common standards?
Participants
Participants
Doina Sirbu
Medical Device Innovation Lead, UCB
Kevin Darcy
Director, Link Strategy at Veeva Systems
Randy Horton
Chief Solutions Officer, Orthogonal
Maria Ilia
Head of Implementation and Research, Imperial College Health Partners
Tim Ruckh
Digital Health Clinical Data Collection Lead at AstraZeneca
Maxime Champain
Lead, BDH External Innovation & Alliances, Search & Evaluation, Biogen
Doug Stover
Vice President, Global Head of Innovation at Alexion Pharmaceuticals
Emily Kunka
Digital Transformation Project Lead, UCB
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Tracy Lahey
Strategy & Business Development, Digital Health & Innovation at Amgen
Caroline Beaufour
Innovation Manager at WeHealth
Reginald Swift
Founder / CEO, Rubix LS
David Kiger
GVP, Digital Therapeutics, Biofourmis
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Mansa Shroff
Head of Partnerships at WKD.SMRT
Larry Liu
Strategy & Commercialization, Medable
Up to 12
Digital Biomarkers in Clinical Trials: Do’s & Don’ts in the Validation Process
Novel digital biomarkers have the potential to be part of clinical trials, but there are still a lot of questions regarding their reliability and validation process. Are you struggling with validating these digital biomarkers?
Join this meeting to share experiences and learn from others about:
- Technical vs. clinical validation: who are the stakeholders involved in each phase of the validation process? What are the regulatory bodies and payers asking for?
- Validation of software vs. hardware and the iterative nature of these technologies.
- While pharma companies are users of novel digital biomarkers and are willing to support their development, they are unlikely to take ownership. What is pharma’s responsibility in the validation process of digital biomarkers?
- How do the validation requirements change depending on the use case (e.g. digital biomarker as an endpoint vs. patient selection vs. tracking safety)?
- Some cross-industry bodies have created programs to help validate digital biomarkers, such as the Innovative Medicines Initiative (IMI), the Digital Biomarker Discovery Pipeline (DBDP) or the V3 framework from DiMe. Is this enough? What else does the industry need to make stakeholders use common standards?
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Digital Biomarkers in Clinical Trials: Do’s & Don’ts in the Validation Process
Digital Biomarkers in Clinical Trials: Do’s & Don’ts in the Validation Process
Digital Biomarkers in Clinical Trials: Do’s & Don’ts in the Validation Process
Novel digital biomarkers have the potential to be part of clinical trials, but there are still a lot of questions regarding their reliability and validation process. Are you struggling with validating these digital biomarkers?
Join this meeting to share experiences and learn from others about:
- Technical vs. clinical validation: who are the stakeholders involved in each phase of the validation process? What are the regulatory bodies and payers asking for?
- Validation of software vs. hardware and the iterative nature of these technologies.
- While pharma companies are users of novel digital biomarkers and are willing to support their development, they are unlikely to take ownership. What is pharma’s responsibility in the validation process of digital biomarkers?
- How do the validation requirements change depending on the use case (e.g. digital biomarker as an endpoint vs. patient selection vs. tracking safety)?
- Some cross-industry bodies have created programs to help validate digital biomarkers, such as the Innovative Medicines Initiative (IMI), the Digital Biomarker Discovery Pipeline (DBDP) or the V3 framework from DiMe. Is this enough? What else does the industry need to make stakeholders use common standards?
Join this group of peers and get a feel of what it's like to belong to a community of digital health gamechangers.
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Through focus groups, we bring together 6-10 thought leaders and industry stakeholders in a series of virtual meetings to collaborate around a defined topic. Each meeting gives the group the opportunity to examine, analyze and collaborate with one another around a digital health topic as well as produce a shareable result.
