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The translation phase transforms a lead candidate from DTx Discovery into a real-world software product by refining the DTx’s mechanism of action (MOA) into a clinically applicable solution. This process includes two key components: Formulation and Optional Preclinical Validation. Together, they ensure the DTx is effective, user-friendly, and ready for clinical testing.
In Digital Therapeutics (DTx), formulation is analogous to drug formulation in the pharmaceutical industry. While drug formulation focuses on the properties of an active pharmaceutical ingredient (API), DTx formulation requires integrating various digital components (e.g., algorithms, user interfaces, and engagement strategies) into a cohesive therapeutic experience. The formulation stage ensures that these elements work harmoniously to deliver consistent clinical benefits while engaging patients and fitting into healthcare workflows.
Depending on the risk profile, preclinical validation may involve in silico simulations or early usability testing to assess the feasibility and acceptability of the DTx. This phase, which can overlap with early clinical development, provides a proof-of-mechanism (POM) by evaluating whether the DTx can achieve its intended effects. Early signals of clinical efficacy (proof-of-concept) can be obtained during this stage, providing a foundation for more extensive clinical trials.
Throughout translation, iterative feedback loops refine the DTx, ensuring alignment with configuration baselines in the value stream, continuously improving before reaching patients and providers.
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