“Digital therapeutics has become a transformational part of any life science company. This program offers an introduction to the field, a survey of various technology sectors emerging in healthcare, and a detailed explanation of the regulatory and reimbursement pathways required to successfully launch a commercial digital therapeutic product.”
– Stan Kachnowski, Director of the Digital Health Program Series

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.

Please Contact Us

To learn more about this program, please contact Co-Director Stan Kachnowski at [email protected].

IMPACT

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.

PROGRAM STRUCTURE

The Program currently takes place in a live online format, using a combination of online tools, interactive lectures, online case studies, and online workshops for individuals and groups.

Sessions are taught by Columbia Business School professors, digital health practitioners, and business leaders and supplemented by sessions with colleagues from various fields and industries.

Sessions include:*

• Introduction to Managing DTx
• Digital Strategies for Operational Excellence
• The Pharma Value Creation Process Standard in Medical Technology and Innovation
• Healthcare Operations Integrations
• Digital Rx Approval Pathways
• Being a Leader with Digital Ethics
• Drivers of the Next Generation of Digital Medicine
• Designing a DTx Solution
• The Pharma Perspective: Digital Health Challenges and Opportunities in Medicine Development
• Digital Therapeutics Diffusion Case Studies: Approved and Used by Health Plans and Hospitals
• Designing and Running a Clinical Development Program for DTx
• An Overview of the Regulatory Landscape for Digital Therapeutics
• Importance of Data and Real- World-Evidence in Digital Therapeutic Development

*Sessions are subject to change.

For a complete program schedule download the agenda.

PARTICIPANT PROFILE

Managing Digital Therapeutic Approvals is designed for executives working in the rapidly evolving fields of life science innovation, pharmaceutical and device research, health tech investment, and other related industries. This program empowers participants to understand the complex digital health landscape and to both identify and capture meaningful opportunities to generate new value for both their organizations and customers.

Columbia Business School alumni and up to four of their colleagues are eligible for a 25 percent tuition benefit for this program. More on the Alumni Tuition Benefit.

FACULTY

Carri Chan
Associate Professor of Business, Columbia Business School

Carri Chan is an associate professor of Business in the Decision, Risk, and Operations division at Columbia Business School. Her research is in the area of healthcare operations management. Her primary focus is in data-driven modeling of complex stochastic systems, efficient algorithmic design for queuing systems, dynamic control of stochastic processing systems, and statistical and econometric analysis of healthcare systems. Chan’s research combines empirical and stochastic modeling to develop evidence-based approaches to improve patient flow through hospitals. She has worked with clinicians and administrators in numerous hospital systems including Northern California Kaiser Permanente, New York Presbyterian, and Montefiore Medical Center. She spent the 2019-2020 academic year on sabbatical at the Value Institute at NY Presbyterian Hospitals. Chan is the recipient of a 2014 National Science Foundation (NSF) Faculty Early Career Development Program (CAREER) award and the 2016 Production and Operations Management Society (POMS) Wickham Skinner Early Career Award. She received her BS in Electrical Engineering from MIT and MS and PhD in Electrical Engineering from Stanford University.
 

Stan Kachnowski
Chair
HITLAB

Stan Kachnowski is the Chair of the digital health organization HITLAB. He is an Oxford-trained researcher who has taught over 5,000 students from Columbia University, IIT-Delhi, and Quinnipiac College. His teaching and research over the past 25 years include educating graduate-level and executive students on four continents and conducting extensive studies on the efficacy and diffusion of digital health, including electronic data capture, ePRO, wearables, and predictive algorithms.
 

Frank Lichtenberg
Cain Brothers & Company Professor of Healthcare Management in the Faculty of Business
Columbia Business School

Frank Lichtenberg is Cain Brothers & Company Professor of Healthcare Management in the Faculty of Business at Columbia Business School, a research associate of the National Bureau of Economic Research, and a member of the CESifo Research Network. He previously taught at Harvard University, the University of Pennsylvania, and Ecole Polytechnique. He has served as an expert for the Federal Trade Commission, the U.S. Dept. of Justice, and state Attorneys General, and has testified before Congress. He has worked for several U.S. government agencies, including the Department of Justice, the Congressional Budget Office, and the Census Bureau, and been a visiting scholar at the Wissenschaftszentrum Berlin, the University of Munich, and elsewhere.
 

Along with the above, additional Columbia Business School faculty and industry experts contribute to and teach in the program.

FAQ

Do you have questions about our live online programs? Please review our commonly asked questions on our live online programs FAQs page.