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07 Sep 2022 | 02:45 PM GMT

Masterclass: Regulation of DTx in the US - Experience from a Real Company

Anchored by:

Andrew Norden
Chief Medical Officer
ONCOHEALTH
Michelle Rubin-Onur
Director of Regulatory
ENZYME

Participants:

Andrew Norden Chief Medical OfficerOncoHealth
Andrew Norden
Chief Medical OfficerOncoHealth
Michelle Rubin-Onur Director of RegulatoryEnzyme
Michelle Rubin-Onur
Director of RegulatoryEnzyme
Anneleen Vyncke Digital Care Transformation Program LeadUCB
Anneleen Vyncke
Digital Care Transformation Program LeadUCB
Emma Carr Co-Founder and Chief Scientific OfficerAmara Therapeutics
Emma Carr
Co-Founder and Chief Scientific OfficerAmara Therapeutics
Jordan Silberman Dir of Clinical Analytics & ResearchElevance Health
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Maxime Champain Search & Evaluation lead, External InnovationBiogen
Maxime Champain
Search & Evaluation lead, External InnovationBiogen
Richard Bunney DirectorDeviceology
Richard Bunney
DirectorDeviceology

About this Meeting

Are you trying to get your DTx solution regulated in the US? Would you like to learn from the experiences of a real company? Keep reading, this masterclass is for you! 

Having regulatory clearance is absolutely essential for many DTx companies to successfully bring their solution to market. Most times, knowing what is on the books is not enough to understand how you should navigate the regulatory landscape in practice. In this masterclass, we will hear about the experience from a real company; Michelle Rubin-Onur, Director of Regulatory at Blue Note Therapeutics, will walk us through the following:  

  • Regulatory pathways for SaMD in the US and how to approach the discussions with the FDA 
  • Enforcement discretion in place during the public health emergency: what should companies do when it goes away? How to plan for that? 
  • Clinical studies: how can you evaluate or consider endpoints for your solution and incorporate FDA's feedback into clinical studies?  
  • SaMD continuous improvement: what are the regulatory implications? How can companies deal with that efficiently?