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13 Jul 2022 | 02:45 PM GMT

Masterclass: Clinical Trial Design for Digital Health Products

Anchored by:

Vandana Menon
VP, Value, Evidence & Strategy
ALNYLAM PHARMACEUTICALS

Participants:

Vandana Menon VP, Value, Evidence & StrategyAlnylam Pharmaceuticals
Vandana Menon
VP, Value, Evidence & StrategyAlnylam Pharmaceuticals
Chandana Fitzgerald President, CommunityHLTH
Chandana Fitzgerald
President, CommunityHLTH
Adriano Garcez Director, DTx/SaMD Evidence GenerationZS Associates
Adriano Garcez
Director, DTx/SaMD Evidence GenerationZS Associates
Ary Deleray Digital Health Business LeaderRoche
Ary Deleray
Digital Health Business LeaderRoche
Bernhard Kappe Founder & CEOOrthogonal
Bernhard Kappe
Founder & CEOOrthogonal
Bert Hartog R&D OperationsThe Janssen Pharmaceutical Companies of Johnson & Johnson
Bert Hartog
R&D OperationsThe Janssen Pharmaceutical Companies of Johnson & Johnson
Caroline Beaufour Innovation LeadServier
Caroline Beaufour
Innovation LeadServier
Fatima Perez Sastre Digital Health Solutions Business PartnerNovartis
Fatima Perez Sastre
Digital Health Solutions Business PartnerNovartis
Fiona Clemente Digital Health Scouting OfficerWeHealth
Fiona Clemente
Digital Health Scouting OfficerWeHealth
Jo Masterson CEO and Co-Founder2Morrow, Inc
Jo Masterson
CEO and Co-Founder2Morrow, Inc
Mansa Shroff Director of Business Dev & Chief of StaffWKD.SMRT
Mansa Shroff
Director of Business Dev & Chief of StaffWKD.SMRT
Rebecca Parsons Senior Director, Digital HealthAstraZeneca
Rebecca Parsons
Senior Director, Digital HealthAstraZeneca
Todd Greenwood Director Evidence GenerationZS Associates
Todd Greenwood
Director Evidence GenerationZS Associates
Wen Dombrowski MD MBA Chief Convergence OfficerCATALAIZE
Wen Dombrowski MD MBA
Chief Convergence OfficerCATALAIZE

About this Meeting

How can we design trials for our digital health tools so they are rigorously validated and regulated? Should we use the same approach pharma companies use for drug trials? What comparator should we select? How do we deal with product iterations? What is the best evidence generation strategy for our product?  

HealthXL members often ask these questions in our meetings, seeking advice and best practices in trial design for digital health solutions. However, finding the answers can be difficult. For this reason, we are organizing this masterclass led by Akili Interactive; they will share some of their learnings about:   

  • Types of studies we can use for digital health products (descriptive vs. analytical trials vs. others) and selecting the comparator.  
  • How do we ensure the representativeness of the population? How to wisely pick the participants of the study? What tools do we have to enrich the population (for example, predicting who will be responders and non-compliers)? 
  • Endpoints selection alignment with your regulation and commercial strategies. How do you select the right endpoints for your trial?  
  • Real-world evidence (RWE) is an area of great potential for DTx. How can you harness RWE to show effectiveness, safety or new indications to the different stakeholders?