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14 Jul 2022 | 02:45 PM GMT

What label claims can you make about your DTx?

Anchored by:

Anish Shindore
Founder & Managing Partner
GSD HEALTH

Participants:

Anish Shindore Founder & Managing PartnerGSD Health
Anish Shindore
Founder & Managing PartnerGSD Health
Adriano Garcez Director, DTx/SaMD Evidence GenerationZS Associates
Adriano Garcez
Director, DTx/SaMD Evidence GenerationZS Associates
Brian Mahony Medical Research FellowBioinnovate
Brian Mahony
Medical Research FellowBioinnovate
Brian Mahony Chief Commercial OfficerOutput Sports
Brian Mahony
Chief Commercial OfficerOutput Sports
Chris Cera CEOArcweb Technologies
Chris Cera
CEOArcweb Technologies
Chris Wasden Chief Strategy OfficerTwill
Chris Wasden
Chief Strategy OfficerTwill
Christopher Hall Commercial Director, APACMarula Health
Christopher Hall
Commercial Director, APACMarula Health
Jo Masterson CEO and Co-Founder2Morrow, Inc
Jo Masterson
CEO and Co-Founder2Morrow, Inc
Louise O'Mahony Head of Customer SuccessEXi
Louise O'Mahony
Head of Customer SuccessEXi
Nik Vassev Co-Founder & COONovobeing
Nik Vassev
Co-Founder & COONovobeing
Shrawan Patel Co-Founder & General PartnerPharmStars
Shrawan Patel
Co-Founder & General PartnerPharmStars

About this Meeting

As the Digital Therapeutics (DTx) industry matures, regulation is becoming increasingly important. New models are emerging, but the approach remains open to interpretation depending on the therapeutic type, geography, and user group. In this meeting we want to focus on a key question that impacts the regulatory and market access strategies of DTx companies: what label claims can you make about your DTx? More specifically, we will discuss the following questions: 

  • What label claims can DTx companies make about their solution? How tightly regulated is the industry? Does it depend on the specific solution? 
  • How can DTx companies use label claims that ease their regulatory and market access strategies? For example, using ‘it helps have a better quality of sleep instead of ‘it treats insomnia’. What are the implications of using one or the other?  
  • DTx label claims become important for pharma companies when they want to launch a DTx - drug combo. Do the label claims change depending on the drug being paired with the DTx solution? What are the claims that will make the DTx-drug combo promotion and adoption strategies more effective? 
  • Regional regulatory differences may lead to different claims depending on the country. How does this affect the scaling strategy of the DTx?