Conference Program

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All Times EDT

Wednesday, September 21
Wed, Sep 21, 11:30 AM - 1:00 PM
Various Rooms
Roundtable Discussions

RL31: Integrating AI-Based Software as Medical Device (SaMD) in Drug Development (303600)

*Natalia Muhlemann, Cytel Inc. 

Keywords: AI, drug development, SaMD, precision medicine, digital biomarker

Rising pressure to increase R&D productivity and the changing environment with increasing opportunities for personalized medicine, digitalization and patient involvement in their disease management, call for continuous innovations in clinical development approaches. Traditional clinical trials are based on broad eligibility criteria and measure average outcome for all enrolled patients. Personalized medicine has already shifted the direction of drug development from traditional ways to biomarker-based approaches. In drug development, biomarkers can be used to define drug target selection, patient selection, enrichment, dose selection, safety assessment, and efficacy assessment. In oncology, predictive biomarkers have been associated with about 60% of new oncology drugs, and Companion Diagnostics is the topic of increasing interest in drugs development. Number of innovative adaptive methodologies has been already proposed and discussed for population enrichment especially in oncology trials. Current Companion Diagnostics and biomarkers are mainly based on IVD/molecular/genetic biomarkers. Recent advancement of IA in imaging, miniaturization of wearable devices and increasing quality of RWD enable the expansion of biomarker concept to Software as Medical Device (SaMD), such as AI-based imaging and ML-based population enrichment algorithms, and biomarkers based on wearables devices. However, the methodologies for optimal and efficient integration of these novel approaches into drugs trials have not yet been extensively discussed. The successful integration of SaMD into clinical development program requires close collaboration between biotech and medtech experts. I propose this topic for a round table session with a participation of biotech, medtech companies and clinicians from academic hospitals involved in integration AI-based imaging and AI-based algorithms into drug development, and experts from both CDRH and CDER/CBER.