Pre-Conference Workshop - Tuesday, July 16

Bringing Prescription Digital Therapeutics Through Development to Clinical Validation: Focus on the Patient

13:00 - 16:00

Building best practices in development and clinical validation of clinician-prescribed digital therapeutics provides many opportunities for novel solutions to unprecedented challenges. This workshop will address rapidly-developing innovative clinical and regulatory efforts to address the fluid nuances inherent in reaching evolving clinical goals in the context of patient-centric approaches.

Key topics to be addressed include:

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Rethinking Clinical Trial Design

• Study design to support regulatory pathways for digital therapeutic success
• Active control/sham considerations including expectation testing
• Advantages to remote access to devices throughout the course of a study
• Outcome selection to test transfer of benefit from practice on intervention to recognized cognitive and functional improvements with emphasis on real world experience as well as clinical trial data

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Case Studies

• Development of control conditions with appropriate expectation and minimal efficacy outcomes
• Selective Stimulus Management Engine (SSME™) in ADHD: Targeted treatment development for different disease populations
• Development of a disease-specific PRO/COA directed at measuring improvement in cognitive issues inherent in patients with MDD
• Commitment to patient and provider experience: Companion Applications

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Future Possibilities

• Personalized Digital Therapeutics (patient-based)
• Expansion of application of digital treatments to healthy individuals and non-traditional therapeutic indications
• Digital therapeutics in the community

Join this interactive focused session that will bring practical insights from DTx pioneers Akili Interactive Labs, into the challenges, learnings and opportunities in digital therapeutics.

 

Workshop Leader

Deb Farlow

Deb Farlow
Clinical Operations & Research Manager
Akili Interactive Labs

 

 

Jason Trees

Jason Trees
Director, Product Management & Head, R&D
Akili Interactive Labs