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28 Jul 2022 | 02:45 PM GMT

Evidence Generation for Standalone DTx

Anchored by:

Eugene Borukhovich
Co-Founder & COO
YOURCOACH HEALTH
Ciara Clancy
Chief Executive Officer
BEATS MEDICAL LTD

Participants:

Ciara Clancy Chief Executive OfficerBeats Medical Ltd
Ciara Clancy
Chief Executive OfficerBeats Medical Ltd
Eugene Borukhovich Co-Founder & COOYourCoach Health
Eugene Borukhovich
Co-Founder & COOYourCoach Health
Adriano Garcez Director, DTx/SaMD Evidence GenerationZS Associates
Adriano Garcez
Director, DTx/SaMD Evidence GenerationZS Associates
Chris Cera CEOArcweb Technologies
Chris Cera
CEOArcweb Technologies
Dr. Nick (Nemanja) Kovacev Head of Healthcare and Life Sciences PracticeHTEC Group
Dr. Nick (Nemanja) Kovacev
Head of Healthcare and Life Sciences PracticeHTEC Group
Francesca Wuttke Founder & CEOnen Health
Francesca Wuttke
Founder & CEOnen Health
Jordan Silberman Dir of Clinical Analytics & ResearchElevance Health
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Thomas Sutton Global Head of Design, Digital Health R&DAstraZeneca
Thomas Sutton
Global Head of Design, Digital Health R&DAstraZeneca

About this Meeting

Standalone digital therapeutics (DTx) solutions are not comparable to drugs or standard treatment protocols. However, since they claim to treat medical conditions and there are no DTx standardized frameworks, the evidence requirements for standalone DTx are often the same as traditional medical treatments. This is challenging for small companies that don’t have the financial resources, and it doesn’t make much sense considering the iterative nature of these treatments. So, what are the best evidence generation strategies for standalone DTx manufacturers?  

Join this meeting to share your experiences and learn from others about: 

  • How do we align the evidence generation plan with the commercial and regulation strategies from the early days? What are the differences in evidence requirements between prescription and non-prescription standalone DTx? How does this determine whether or not the company takes the prescription route? 
  • What internal capabilities and/or partnerships does a standalone DTx manufacturer need to build an efficient and effective evidence generation strategy?  
  • Most companies struggle to show long-term evidence when payers ask for it. Are there any techniques or studies that can help address this? How can we use extrapolation correctly to show long-term evidence without waiting for the product to be in the market for five years? 
  • NICE (the National Institute for Health and Care Excellence) recently recommended offering Sleepio as an effective alternative to sleeping pills. What level of evidence is needed to meet goals like this? What can we learn from this example from an evidence generation perspective? Is Big Health the example to follow?