Sema4 has limited experience with the development or commercialization of clinical or research products in connection with the databases it manages and to which it has access, and its Centrellis and Traversa platforms. Sema4’s partners’ usage of an advanced machine learning engine for therapeutic decision-making are at an early
stage of development and usage under current and proposed collaborations, and Sema4 is continuing to develop new processes that may support the development of new therapeutics applications such as the delivery of personalized clinically actional insights into clinical reports, clinical trial matching, real-world evidence trials, and clinical decision support, via an advanced programmable interface layer. Although Sema4’s partners have invested significant financial resources to develop and utilize new technologies to support preclinical studies and other early research and development activities, and provide general and administrative support for these operations, Sema4’s future success is dependent on its current and future partners’ ability to successfully derive actionable insights from the database and its platform, and its partners’ ability, where applicable, to obtain regulatory approval for new therapeutic solutions based off existing models or to obtain regulatory approval and marketing for, and to successfully commercialize, new therapeutics. The use of Sema4’s platform and the databases it manages and to which it has access for these purposes will require additional regulatory investments for Centrellis, such as “good practice” quality guidelines and regulations, or GxP, and data quality and integrity controls.
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