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07 Mar 2022 | 03:45 PM GMT
Past Meeting

Measuring efficacy and safety for DTx

Anchored by:

Jin Lee
Director of Digital Health
ASTELLAS PHARMA, INC
Ravi Janapureddy
Co-founder & CEO
RESONY

Participants:

Jin Lee Director of Digital HealthAstellas Pharma, IncOther
Other
Jin Lee
Director of Digital HealthAstellas Pharma, Inc
Ravi Janapureddy Co-founder & CEOResony
Ravi Janapureddy
Co-founder & CEOResony
Chris Wasden Chief Strategy OfficerTwillOther
Other
Chris Wasden
Chief Strategy OfficerTwill
Eleonora Lippolis Digital Health and Therapeutics Business LeadMerck KGaA
Eleonora Lippolis
Digital Health and Therapeutics Business LeadMerck KGaA
Francesca Wuttke Founder & CEOnen HealthStartup
Startup
Francesca Wuttke
Founder & CEOnen Health
Jordan Silberman Dir of Clinical Analytics & ResearchElevance HealthOther
Other
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Malika bouazzaoui Head of Clinical Validationieso
Malika bouazzaoui
Head of Clinical Validationieso
Malika BOUAZZAOUI Head of Clinical Validationieso
Malika BOUAZZAOUI
Head of Clinical Validationieso
Myles Furnace Chief Commercial OfficerEolas MedicalStartup
Startup
Myles Furnace
Chief Commercial OfficerEolas Medical
Nicole Baker CEObiologit
Nicole Baker
CEObiologit
Oded Kraft Co-founder, CEO and PresidentGray Matters Health
Oded Kraft
Co-founder, CEO and PresidentGray Matters Health
SE
Stephen Egan DirectorRediCare
SE
Stephen Egan
DirectorRediCare
Zina Manji Founder/Principal, Regulatory StrategistInnopathwayz, LLCLife Sciences, Pharma & Biotech
Life Sciences, Pharma & Biotech
Zina Manji
Founder/Principal, Regulatory StrategistInnopathwayz, LLC

About this Meeting

DTx companies struggle with measuring efficacy and safety, especially small companies with limited resources. Often, DTx are asked to follow the same standards as traditional drugs, but with DTx solutions ever evolving - this is difficult to achieve. If you are working in this space, read on!  

 In this session you will hear about the challenges and best practices when measuring DTx efficacy and safety and what levels of evidence the different stakeholders require. Join your fellow senior leaders to discuss the following: 

-Best practices to measure efficacy and safety of DTx: RCTs design (sham DTx,  comparators, participants diversity, etc) and the role of Real-World Evidence (RWE). 
 Strategic partnerships to generate DTx evidence. 
-How do the requirements change depending on the stakeholder and the characteristics of the DTx product? 
-What is the role of regulatory bodies in DTx validation?

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