Stimulating knowledge, research, and impactful interactions related to Translational Digital Biomarkers (TBD) in North America and beyond.
Connecting technology providers, industry, academics, and regulatory stakeholders to increase adoption of TBD technologies.
Trans Dig Biom medium

The Translational Digital Biomarkers Initiative will connect early stage and commercially available digital biomarker providers, industry, academics and regulatory stakeholders to increase adoption of these technologies. The initiative 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
  • 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)

Click here to see draft working group scope.

Planned deliverables:

  • Create a virtual knowledge exchange where scientists & regulatory bodies can access information about translational digital biomarkers
  • Create a database 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
  • Promote & coordinate interactions and discussions among end-users and technology providers to share learnings, discuss and identify opportunities for animal welfare refinements
  • Organize a translational digital biomarkers conference to bring technology providers & end-users together

Who should join?

Anyone interested in collaborating to facilitate new development and speed adoption of translational digital biomarkers.

  • Technology providers
  • Scientists & basic researchers
  • Drug discovery & development agents
  • Internal/regulatory decision-makers
  • Animal welfare evaluators
  • Other stakeholders

How can I join?

Submit a Working Group Application

  • Name and contact information
  • Curriculum vitae, biography, or company descriptor
  • Statement of interest detailing why you would like to join
  • Cost: $1000/institution/year (beginning April 15, 2020) to participate in one of both working groups.

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

Membership Expectations

  • $1000/institution/year (beginning April 1, 2020) to participate in one or both working groups.
  • Approximately 1 hour per month attendance at teleconferences. (The frequency/duration of meetings will be revisited once membership is established.)
  • 4-10 hours of work annually outside of meetings (e.g., creating/reviewing deliverables)

Working Group Leadership Contact Information

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

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