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18 Oct 2022 | 02:45 PM GMT

Masterclass: Clinical Trial Design Considerations for Prescription Digital Therapeutics and Therapeutic Digital Health Products

Anchored by:

Yuri Maricich
Venture Partner and Advisor
ANGELINI VENTURES

Participants:

Yuri Maricich Venture Partner and AdvisorAngelini Ventures
Yuri Maricich
Venture Partner and AdvisorAngelini Ventures
Chandana Fitzgerald President, CommunityHLTH
Chandana Fitzgerald
President, CommunityHLTH
Dr. Nick (Nemanja) Kovacev Head of Healthcare and Life Sciences PracticeHTEC Group
Dr. Nick (Nemanja) Kovacev
Head of Healthcare and Life Sciences PracticeHTEC Group
Lou Atkinson Research LeadEXi
Lou Atkinson
Research LeadEXi
Stacie Gutowski Program OfficerThe National Institutes of Drug Abuse (NIDA)
Stacie Gutowski
Program OfficerThe National Institutes of Drug Abuse (NIDA)
Thyago Ohana Digital Strategy & Capabilities LeadUCB Pharma
Thyago Ohana
Digital Strategy & Capabilities LeadUCB Pharma
Valentine Emmanuel Experience Design & Strategy LeadDaiichi Sankyo
Valentine Emmanuel
Experience Design & Strategy LeadDaiichi Sankyo

About this Meeting

Are you considering clinical validation for a SaMD or SaMD/PDT+drug combination product? Asking questions such as what type of evidence is needed? How to select the endpoints that will support your regulatory and commercial strategies? Why are digitally delivered clinical trials so important to have? Keep reading, this masterclass is for you!   

Join us in this masterclass led by Yuri Maricich (Chief Medical Officer and Head of Development at Pear Therapeutics) to learn more about navigating a new landscape of digitized trials and considerations when implementing trials for SaMD as well as SaMD/PDT + drug combination products. This masterclass will also cover: 

  • Level and quality of evidence and purpose of data. What types of studies or evidence can we use to achieve the quality of data needed for digital health solutions? What are the differences between software feasibility and upgrade studies vs robust traditional clinical trials? How do different stakeholders such as clinicians, professional societies (guidelines), payers, and policymakers think about evidence? 
  • Discuss the difference between digital clinical trials for drugs vs PDTs: factors to consider when approaching a clinical trial 
  • Approach to ensuring representativeness of the population, including from a health equity perspective.  
  • Selecting endpoints to align with regulatory and commercial strategies, while addressing unmet needs in a disease area. 
  • Real-world evidence (RWE) is an area of great potential for DTx. How can we harness RWE to show effectiveness, safety or new indications to the different stakeholders? How should we think about demonstrating value for payers?