The Translational Digital Biomarkers Hub will include early stage and commercially available digital biomarker technologies and will engage end-users and those interested in learning more about how these technologies can be used to promote the 3Rs.

Objectives:

  • Showcase digital technologies & capabilities
  • Promote & support collaboration, sharing and opportunities for interactions within and between end-users
  • Create a data base by sharing summarized scientific data (precompetitive or blinded) collected from these technologies that can be used in practice to support data-driven refinements to animal welfare
  • Engage regulatory bodies (FDA & EMA) to identify a path for how to characterize and qualify digital biomarkers within the regulatory environment (i.e. path of acceptance of data from new technologies)

Planned deliverables:

  • Create a virtual knowledge exchange (on NA3RsC.org) where scientists and regulatory bodies can access information about translational digital biomarkers.
  • Promote &, coordinate interactions and discussions among end-users (and potential end-users) of digital technologies to share learnings, discuss and identify opportunities for animal welfare refinements and determine the idea platform for discussions to promote collaboration between scientists and technology providers.
  • Organize a digital biomarkers conference to bring technology providers and end-users together.

Please click here to see draft working group scope (to be finalized once group is formed).

Membership:

  • $1000/institution/year (beginning April 1, 2020) to participate in one or both working groups.
  • Initially, members are anticipated to commit approximately 1 hour per month to teleconferences with end-users and quarterly teleconferences with technology providers. The frequency/duration of meetings will be revisited once membership is established.
  • Outside of these scheduled meetings, members are expected to dedicate approximately 4-10 hours of work annually to this working group in some capacity (e.g., additional engagement, creating/reviewing deliverables, etc.).

We’re specifically looking for technology providers, scientists and other stakeholders interested in collaborating to facilitate new development and speed adoption of translational digital biomarker and microphysiologic systems technologies into the research market. This includes basic research, drug discovery and development, internal/regulatory decision makers and animal welfare evaluation.

Working Group Hub Application Link

You will be asked to submit:

  • Name and contact information
  • Curriculum vitae, biography, or company descriptor
  • Statement of interest detailing why you would like to join

 

If you would like to participate but the membership dues cause financial hardship, please contact us.

 

Translational Digital Biomarkers Leadership Information

Szczepan Baran       (617) 871-8255                  szczpan.baran@novartis.com

Laura Schaevitz       (650) 797-2000 x118        laura@vium.com