Managing Digital Therapeutic Approvals

Digital therapeutics (DTx), a growing trend across life sciences, is emerging as a popular form of assisting physicians to transform patient behavior and improve clinical outcomes. It is defined as the use of any technology that is capturing, storing, and transmitting data for a therapeutically proven outcome and today is the fastest-growing part of life sciences.

Digital therapeutics is part of the broader digital-health landscape, but to be called DTx, a product has to be software-driven, evidence-based, and confirm a claim to prevent, manage, or treat a medical disease or disorder.

The increasingly dominant role of mobile technology and artificial intelligence in our everyday lives has broadened the role of DTx in healthcare. Although historically, interest in developing DTx was mainly confined to academia and technology companies, the potential to use DTx in conjunction with medicines to improve health outcomes has sparked the interest of big pharma, who have started to venture into the DTx space through investments and strategic partnerships with tech companies.

The Managing Digital Therapeutic Approvals program is designed to provide an intensive dive into the regulatory and legal landscape for the successful management of digital therapeutic approvals. Participants will learn the necessary strategies and features to ensure regulatory compliance for their digital therapeutics.

To learn more about this program, please contact Co-Director Stan Kachnowski at swk16@gsb.columbia.edu.

The Managing Digital Therapeutic Approvals program equips you with the insights you need for how to use new DTx technologies in order to improve patient awareness.

With the help of case studies, you’ll be able to identify how DTx products offer both smart solutions and ways to integrate those ideas into the healthcare system.

During the program, you will learn:

• How to catalyze the translation of science and technology into valuable solutions for patients and consumers in a post-COVID world
• Which stakeholders are accelerating the demands for digital health solutions in a post-COVID environment
• What the barriers of the digital approval process are and how company products have been able to integrate into the healthcare system
• How the diffusion of any technology — health technology or others — greatly hinges on user-centered product design and why digital therapeutics are no exception
• About opportunities for digital to impact the development of new medicines, including a better understanding of the challenges in identifying and adopting novel solutions in pharma
• Practical aspects in the design of a clinical development program for digital therapeutics
• FDA regulatory oversight of medical devices, product development lifecycle regulatory considerations, and the intersection of innovation and regulatory planning
• About opportunities and challenges in applying data science and real-world-evidence to digital therapeutics.

Upon completion of this program, you will earn three credits towards a Certificate with select alumni and tuition benefits. Learn more.