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20 Jun 2022 | 02:45 PM GMT

Digital Biomarkers in Clinical Trials: Do’s & Don’ts in the Validation Process

Anchored by:

Tim Ruckh
Digital Health Clinical Data Collection Lead
ASTRAZENECA
Doina Sirbu
Medical Device Innovation Lead
UCB PHARMA

Participants:

Doina Sirbu Medical Device Innovation LeadUCB Pharma
Doina Sirbu
Medical Device Innovation LeadUCB Pharma
Tim Ruckh Digital Health Clinical Data Collection LeadAstraZeneca
Tim Ruckh
Digital Health Clinical Data Collection LeadAstraZeneca
Chandana Fitzgerald President, CommunityHLTH
Chandana Fitzgerald
President, CommunityHLTH
Doug Stover AdvisorDecimal Health
Doug Stover
AdvisorDecimal Health
Kevin Darcy Director, Link StrategyVeeva
Kevin Darcy
Director, Link StrategyVeeva
Larry Liu Sr. Director, DigMedable
Larry Liu
Sr. Director, DigMedable
Mansa Shroff Director of Business Dev & Chief of StaffWKD.SMRT
Mansa Shroff
Director of Business Dev & Chief of StaffWKD.SMRT
Maria Ilia Associate Director RWE, ConsultancyOPEN Health
Maria Ilia
Associate Director RWE, ConsultancyOPEN Health
Maxime Champain Search & Evaluation lead, External InnovationBiogen
Maxime Champain
Search & Evaluation lead, External InnovationBiogen
Tracy Lahey Strategy & Business Development ManagerAmgen
Tracy Lahey
Strategy & Business Development ManagerAmgen

About this Meeting

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?