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13 Sep 2021 | 02:45 PM GMT

Standalone DTx: building clinical and economic evidence

Anchored by:

Ankita Deshpande
Global Marketing & Commmercial Lead
MODERNA THERAPEUTICS
Owen McCarthy
President, Co-Founder
MEDRHYTHMS

Participants:

Ankita Deshpande Global Marketing & Commmercial LeadModerna Therapeutics
Ankita Deshpande
Global Marketing & Commmercial LeadModerna Therapeutics
Owen McCarthy President, Co-FounderMedRhythms
Owen McCarthy
President, Co-FounderMedRhythms
AP
Acacia Parks Fractional Chief Science OfficerFound
AP
Acacia Parks
Fractional Chief Science OfficerFound
Jo Masterson CEO and Co-Founder2Morrow, Inc
Jo Masterson
CEO and Co-Founder2Morrow, Inc
JM
john mattison CMIOACP
JM
john mattison
CMIOACP
Jordan Silberman Dir of Clinical Analytics & ResearchElevance Health
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Kendal Dinsmore VP, Quality Assurance / Regulatory AffairsMahana Therapeutics
Kendal Dinsmore
VP, Quality Assurance / Regulatory AffairsMahana Therapeutics
Kristinn Gylfason Head of ComplianceSidekickHealth
Kristinn Gylfason
Head of ComplianceSidekickHealth
Maite Malet Investment & Corporate DevelopmentAsabys Partners
Maite Malet
Investment & Corporate DevelopmentAsabys Partners

About this Meeting

As DTx companies look for their place in the market, in order to convince the different healthcare stakeholders (payers, physicians, etc), they need to generate clinical and economic data that validates their products and services. The evidence requirements and challenges to generate it differ depending on the type of DTx; on this occasion we will focus on standalone DTx. Join this informal conversation with other senior leaders in the space where we will discuss the following: 

  •  Level of clinical and economic evidence required for standalone DTx compared to companion DTx - how does this change depending on the stakeholder, mode of action, risk of the product, etc? 
  •  Types of studies to generate clinical evidence (RCTs vs. RWE vs. others) and particularities of the study design for standalone DTx. 
  •  What is the most efficient way to generate economic evidence? What methods can be used to generate this data in the different stages of a product?