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11 May 2022 | 02:45 PM GMT

Proving DTx efficacy and safety

Participants:

Chandana Fitzgerald President, CommunityHLTH
Chandana Fitzgerald
President, CommunityHLTH
Anish Shindore Founder & Managing PartnerGSD Health
Anish Shindore
Founder & Managing PartnerGSD Health
BB
Brian Binkowski Director of QualityTwill
BB
Brian Binkowski
Director of QualityTwill
Chris Cera CEOArcweb Technologies
Chris Cera
CEOArcweb Technologies
Jordan Abdi GovernorGuy's and St Thomas'? NHS Foundation Trust
Jordan Abdi
GovernorGuy's and St Thomas'? NHS Foundation Trust
Karine Soulat Marketing Consultant on health and e healthKe-Health
Karine Soulat
Marketing Consultant on health and e healthKe-Health
Maxime Champain Search & Evaluation lead, External InnovationBiogen
Maxime Champain
Search & Evaluation lead, External InnovationBiogen
Myles Furnace Chief Commercial OfficerEolas Medical
Myles Furnace
Chief Commercial OfficerEolas Medical
Randy Horton VP of Solutions and PartnershipsOrthogonal
Randy Horton
VP of Solutions and PartnershipsOrthogonal
Shaheen Lakhan Chief Medical OfficerClick Therapeutics
Shaheen Lakhan
Chief Medical OfficerClick Therapeutics
SE
Stephen Egan DirectorRediCare
SE
Stephen Egan
DirectorRediCare

About this Meeting

What is the most efficient way for DTx companies to generate evidence?  DTx companies often struggle with proving efficacy and safety, especially small companies with limited resources. Often, DTx are asked to follow the same standards as traditional drugs. As DTx solutions are ever-evolving, this is difficult to achieve. Join the HealthXL DTx community in this meeting to discuss:  

  • How to successfully build an evidence generation strategy aligned with a commercial strategy?  
  • Best practices to measure efficacy and safety of DTx: Randomized Controlled Trial (RCT) design (sham DTx, comparators, participants diversity, etc) and the role of other types of clinical studies. 
  • The iterative nature of DTx products: how is the testing cycle different in digital products compared to drugs and how do we deal with that? How can the industry work towards new standards/guidelines for DTx that are used across the industry? 
  • Evidence requirements and how they depend on the stakeholders and characteristics of the DTx product (e.g. Prescription Digital Therapeutics (PDT) vs. non-PDT, standalone vs. drug-DTx combination)?