Gene-Genie! A web-based artificial intelligence platform supporting site preparedness for gene therapy

BACKGROUND: Recombinant Adeno-Associated Virus (rAAV) gene therapies are now approved for the treatment of certain rare diseases and require specialized knowledge for clinical implementation. OBJECTIVES: Our objective was to develop and evaluate an artificial intelligence (AI) chatbot called 'Gene-Genie' with domain expertise in the implementation of rAAV gene therapies. METHODS: The study was conducted in two phases. The first phase, Gene-Genie development, involved technical scoping, proof-of-concept, and technical testing by a team of pharmacists, medical practitioners, regulatory specialists, and laboratory scientists. In the second phase, Gene-Genie was evaluated using an exploratory pilot pre-post study design, based on feedback from hospital pharmacy leaders before and after using Gene-Genie. The total score on the questionnaire ranged from 0 to 28, with a higher score indicating better perceived knowledge of gene therapy. RESULTS: The AI chatbot was successfully developed in phase 1 to deliver accurate, reliable, and context-aware interactions, aligned with the scope of the intended use case. The chatbot successfully referenced a curated and linked set of resources and avoided off-topic questions and responses. In the second phase, 8 pharmacy leaders tested Gene-Genie and provided feedback on its utility to further improve the chatbot. The mean ± standard deviation score on the perceived knowledge questionnaire was 17.0 ± 5.5 pre and 20.0 ± 2.2 post using Gene-Genie. The majority of participants agreed or strongly agreed (n = 5, 62.5%) that they would recommend Gene-Genie to other hospital Directors of Pharmacy (or similar) to help them with gene therapy implementation. CONCLUSION: We have developed Gene-Genie, which is an AI conversational chatbot that is domain-specific to gene therapy. Exploratory findings suggest that a domain-specific chatbot like Gene-Genie may be useful to those in hospital pharmacy leadership positions to implement gene therapy programs.