1st Edition

Digital Therapeutics Strategic, Scientific, Developmental, and Regulatory Aspects

Edited By Oleksandr Sverdlov, Joris van Dam Copyright 2023
    462 Pages 105 Color Illustrations
    by Chapman & Hall

    462 Pages 105 Color Illustrations
    by Chapman & Hall

    One of the hallmarks of the 21st century medicine is the emergence of digital therapeutics (DTx)—evidence-based, clinically validated digital technologies to prevent, diagnose, treat, and manage various diseases and medical conditions. DTx solutions have been gaining interest from patients, investors, healthcare providers, health authorities, and other stakeholders because of the potential of DTx to deliver equitable, massively scalable, personalized and transformative treatments for different unmet medical needs.

    Digital Therapeutics: Scientific, Statistical, Clinical, and Regulatory Aspects is an unparalleled summary of the current scientific, statistical, developmental, and regulatory aspects of DTx which is poised to become the fastest growing area of the biopharmaceutical and digital medicine product development. This edited volume intends to provide a systematic exposition to digital therapeutics through 19 peer-reviewed chapters written by subject matter experts in this emerging field.

    This edited volume is an invaluable resource for business leaders and researchers working in public health, healthcare, digital health, information technology, and biopharmaceutical industries. It will be also useful for regulatory scientists involved in the review of DTx products, and for faculty and students involved in an interdisciplinary research on digital health and digital medicine.

    Key Features:

    • Provides the taxonomy of the concepts and a navigation tool for the field of DTx.
    • Covers important strategic aspects of the DTx industry, thereby helping investors, developers, and regulators gain a better appreciation of the potential value of DTx.
    • Expounds on many existing and emerging state-of-the art scientific and technological tools, as well as data privacy, ethical and regulatory considerations for DTx product development.
    • Presents several case studies of successful development of some of the most remarkable DTx products.
    • Provides some perspectives and forward-looking statements on the future of digital medicine.

    1. Digital Therapeutics within the Digital Health Landscape: Foundational Aspects. 2. Sector Perspective: Digital Therapeutics in Behavioral Health. 3. Navigating the Code to Commercial Lifecycle of Digital Health Apps: Defining and Defending Your Strategy for Success. 4. Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel. 5. Statistical Designs for Developing Personalized Mobile Treatment Interventions. 6. Statistical Approaches in the Development of Digital Therapeutics. 7. Health Economics Aspects of Digital Therapeutics. 8. Healthcare Data Ownership and Privacy: A Perspective for Digital Therapeutics. 9. Building the Story of Scientific Evidence for Digital Therapeutics: Trials, Meta-Analysis, and Real-World Data. 10. U.S. Regulatory Pathways for Digital Therapeutics. 11. Building Digital Health and Therapeutic Solutions for the Future: What's Required for Success? 12. Digital Therapeutics for Sleep and Mental Health. 13. DTx for the NEXT Three Billion! 14. Akili: A Novel Approach to Clinical Intervention with Digital Therapeutics. 15. SilverCloud Health: Online Mental Health and Wellbeing Platform. 16. Digitally Augmenting Therapies: A DTx Opportunity for Pharma Portfolio Development. 17. The Converegence of Digital Health Technologies: The Role of Digital Therapeutics in the Future Healthcare System. 18. Decentralized Clinical Trials: A New Paradigm for New Medical Product Development and Digital Therapeutics. 19. The Past, Present, and Future of Digital Therapeutics. Index.


    Dr. Oleksandr Sverdlov is Neuroscience Disease Area Lead Statistician in early clinical development at Novartis. He received B.Sc. in Applied Mathematics from V.N. Karazin Kharkiv National University, Ukraine, M.Sc. in Statistics from University of Maryland, Baltimore County (UMBC), and Ph.D. in Information Technology with Concentration in Statistical Science from George Mason University. He has been actively involved in methodological research and applications of innovative statistical approaches in drug development. He is the editor of a monograph "Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects" (CRC Press/Chapman & Hall, 2015) and a co-author of a book "Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach" (CRC Press/Chapman & Hall, 2019). His most recent work involves design and analysis of proof-of-endpoint clinical studies evaluating novel digital technologies.

    Joris van Dam is a Digital Health Intrapreneur, helping organizations deliver upon the promise of digital health technologies to transform the experience and treatment outcomes of the patients we collectively serve. For the past several years, Joris has led the Digital Therapeutics research program at the Novartis Institutes of Biomedical Research in Cambridge, MA. In the 10+ years before that, Joris worked on a wide variety of Digital Health solutions improving the clinical treatment and the clinical research experience of patients and providers in the U.S., Europe, India, and Africa. Joris received a Ph.D. in Computer Science / Artificial Intelligence from the University of Amsterdam in 1998, after which he spent several years in consulting and program management before recognizing the promise and the urgency of digital health solutions to improve the health of our nations.