Managing Digital Therapeutic Approvals
Requirements
This program is suitable for attendees at all executive levels who are working in the rapidly evolving fields of life science innovation, pharmaceutical and device research, health tech investment and other related industries.
Requirements
This program is suitable for attendees at all executive levels who are working in the rapidly evolving fields of life science innovation, pharmaceutical and device research, health tech investment and other related industries.
Managing Digital Therapeutic Approvals
Requirements
This program is suitable for attendees at all executive levels who are working in the rapidly evolving fields of life science innovation, pharmaceutical and device research, health tech investment and other related industries.
Overview
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.
“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
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.
“Tremendous networking and learnings. By going through this program, you will get a flavor of all the areas that you need to know about when considering a DTx approval. This training will allow me to help us guide our way through the digital health and DTx space more efficiently and with higher impact.”
Ellen Krijnen
Medical Business Development Director at Neurocast“Very relevant content and excellent subject focus. A must-do program for all digital healthcare professionals.”
Veneeth Purushotaman
CHCIO, Group Chief Information Officer at Aster Dm Healthcare“The Columbia professors to the industry leaders who teach and present in the program drove home the economics, data, and RWE trends that we need to be aware of in the post-COVID era. The faculty have an open-door policy, and there is the added benefit of meeting a global network of digital health professionals who will the trailblazers of tomorrow.”
Johnson Hor
Director at Shoebox Ventures“Coming from a developing nation, where digital therapeutics are just starting to get implemented, learning how DTx is replacing the traditional methods of treating, diagnosing, and monitoring diseases was very exciting. I was also thrilled to be in the group of participants with a rich network in DTx that we can link up with from my organization and introduce the many products into our untapped market in Africa.”
Nyasha Mutetwa
Sales and Marketing Manager at Axis Solutions Africa“This extraordinary program is a platform for transformational learning for digital therapeutics in the dramatic and quickly changing healthcare landscape. A must to understand how to navigate the new world of digital therapeutics in healthcare.”
Andrea Diamond
CEO of Diamond Nutrition Counseling, Inc.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.
Faculty
Carri Chan
Professor of Business and Faculty Director, Healthcare and Pharmaceutical Management Program
Columbia Business School
Carri Chan
Professor of Business and Faculty Director, Healthcare and Pharmaceutical Management Program
Columbia Business School
Carri Chan is a 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
Professor of Health Information Management in the division of Policy and Management at the Mailman School of Public Health at Columbia University
Stan Kachnowski
Professor of Health Information Management in the division of Policy and Management at the Mailman School of Public Health at Columbia University
Professor Stan Kachnowski, PhD MPA CSEP, an Oxford-trained researcher, 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.
Kachnowski has authored over 200 peer-reviewed papers and presentations for national and international journals and societies in digital health development, management, and diffusion. He was selected as a fellow to CHIME in 1998. In 2003, he received a letter of commendation for teaching excellence from the dean of the School of Public Health at Columbia University. Professor Kachnowski was named a fellow to England’s Royal Society of Medicine for his research demonstrating the outcomes effectiveness of using the Palm Pilot in managing haemophilia patients in 2005. Professor Kachnowski has received grant funding from a wide-ranging groups of sponsors, including over a dozen nations, AARP, WHO, USAID, Gates and Dell Foundations, and most of the top 20 global life science companies. Over the past 25 years, he has also served as interim CTO for life science organizations, including Eyetech and Oncology.com. He currently serves on the board of directors for Oursmedicina, The Hudson Center for Health Equity, and Aptus Health.
Professor Kachnowski holds Bachelor's and Master’s Degrees from the University of Vermont and a Doctorate from the University of Oxford and is an alumnus of Columbia Business School's Advanced Management Program.
Frank Lichtenberg
Cain Brothers & Company Professor of Healthcare Management in the Faculty of Business
Columbia Business School
Frank Lichtenberg
Cain Brothers & Company Professor of Healthcare Management in the Faculty of Business
Columbia Business School
Frank Lichtenberg is the 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. Department 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.
FAQ
Certification
I’m interested in the Certificate in Business Excellence (CIBE), how do I get started?
At Columbia Business School Executive Education, you’ll be able to customize a unique learning experience by selecting programs that best interest you and are most suited for your needs. Any completed program, regardless of format (live online, in-person, or online), will count towards the Certificate in Business Excellence.
Which programs qualify for the CIBE?
Any completed executive education program, regardless of format (live-online, in-person, or online), will count towards the Certificate in Business Excellence. Partner programs will also count towards the certificate.
What programs are considered partner programs?
Executive education programs developed and administered with our educational partners, bring the best of our combined knowledge, thought leadership, resources, and expertise. Kindly find a list of our partners here on our partnership page.
What are the costs of the certificate?
There’s no set cost associated with the certificate path since you’re able to customize your learning journey with in-person and online programs (price will vary depending on the program type and length).
Are there any tuition assistance or scholarships?
At Columbia Business School Executive Education, we offer non-degree and non-credit-based professional development programs to the global business community. As our programs are non-degree and non-credit, they do not qualify for financial aid.
How are CIBE credits determined?
Credits for a program are determined by the program duration and total learning hours.
Where do I find information on the credit value for a program?
You will find this information on each program page. Credits range from 0.5 credits – 26 credits per program.
How do I get enrolled in the CIBE?
Your certificate journey will start with your first program, and you have 4 years to complete your CIBE. You may register for any of our executive education programs on each program page. You may enroll using the “Enroll Now” button, and the application process should take 5-10 minutes.
How do I receive credits?
You are required to fully attend a program and complete all necessary coursework in order to receive CIBE credits. Credits are only awarded after you complete a program.
How do I check the status of my Certificate completion?
Kindly reach out to a Learning Solutions representative for any questions on the status of your CIBE credit count.
Do CIBE credits expire?
Credits are only valid for four years (Please note: While we are not able to offer in-person programming due to the COVID-19 pandemic, the duration to complete the programming has been extended to five years.). If you have not completed your CIBE within four years, we will only count non-expired credits towards your CIBE credit total.
Does the Certificate in Business Excellence expire?
Your Certificate in Business Excellence does not expire. Once you become a certificate recipient, you will join the greater alumni community at Columbia Business School.
I’ve reached 18 CIBE credits, what’s next?
Congratulations! You should receive a digital copy of your certificate at the end of your program. If you do not receive a copy from your program manager, kindly contact your Learning Solutions representative or your program manager for next steps.
Will I receive a physical certificate?
Yes, all certificate recipients will receive a physical plaque. If you completed your last CIBE credits through an online or live online program, you will receive a plaque in the mail. We will ask for you to provide us with your preferred mailing address and our vendor will ship the plaque directly to you. We kindly ask for your patience as the processing time takes a few weeks. Please contact your program manager for the status of your plaque. If you completed your last CIBE credits through an in-person program, you will receive a plaque at the end of the program.
How do I get access to my alumni benefits?
Once you complete your CIBE, we kindly ask for your patience as we process your alumni credentials. The processing time can take anywhere from 8 to 10 weeks long.
Can I refer colleagues to the Certificate in Business Excellence?
If you are a certificate holder, you may sponsor up to four colleagues each year for full-price in-person programs lasting up to seven days and all full-price online programs.
Can I add the Certificate in Business Excellence to LinkedIn?
Yes! We will provide you with instructions on how to add your certificate to your LinkedIn profile after you become a Certificate recipient.
Preferred Pricing and Tuition Benefits for Alumni
Are there preferred pricing options available for live online programs?
Yes, preferred pricing is available for groups of two or more. To inquire, email execed@gsb.columbia.edu.
As a Columbia Business School alumni am I eligible for tuition benefit?
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.
Assignments
Will there be any homework or assignments?
For select programs, there will be some assignments to complete after the end of select program sessions. Assignments will typically consist of readings, self-reflections, and brief assessments. This approach is designed to help you practice your learnings.
How long will assignments take?
We do not expect that homework assignments will take up a large amount of time to complete.
Will there be any examinations or grades?
There will be no examinations or grades for our live online programs.
Access
When will I receive information on how to log in?
You will receive your login information immediately before the program start date. Kindly reach out to your Program Manager for further instructions on how to prepare and log in for the program.
What platform do you use to deliver live online programs?
We use the Zoom platform.
Recordings
Will sessions be recorded?
Most live online sessions (depending on the faculty and program) will be recorded and will be available for you upon request. In-person programs are not recorded.
How long will they be available for?
Recordings will be available for the duration of the program. Depending on the program, some recordings may have additional availability post-program.
How do I gain access to the recordings?
Your Program Manager will provide you with further instructions on how to gain access to recorded sessions.
Experience
How do participants network during the live online programs? Will I participate in group work?
Our live online programs are fully virtual and highly interactive. Most programs also feature small group work for a high-touch learning experience. The virtual program experience allows participants to feel comfortable and productive learning at home while preserving the interconnectivity of an in-person program.
What are the networking opportunities during the live online sessions?
Yes. Examples of this may include: virtual lunches, virtual receptions, use of the chat function, and virtual office hours for you to connect with participants and faculty. Please refer to the agenda of the specific live online program you are interested in for details.
Live Online Format
What are live online programs?
Now, more than ever, executives need the knowledge and insights to help them adapt to change and solve complex problems. As the business world has evolved, we have applied new best practices to continuously improve your learning experience. With our live online programs, we are taking select in-person programs and are translating them to a fully live and virtual format, delivering the same interactive sessions with faculty and real-time application of the knowledge you would experience in person.
What is the difference between live online and online programs?
Compare our two formats for distance learning here.
What does “live online” mean?
Live online programs are fully virtual, highly interactive programs taking place in real-time, often featuring small group work for a high-touch learning experience. Our Columbia Business School faculty stream to you live and virtually, no matter where you are located.
Are all live online programs the same in terms of format and length?
No. Please refer to the agenda of the specific live online program you are interested in. For any questions, please reach out to the Contact person listed on the program's web page.
Do I have to attend all live sessions?
Participants are expected to attend all sessions. However, we understand that participants may have scheduling conflicts. Kindly let us know in advance whenever possible and your Program Manager would be happy to discuss how we can help you get up to speed. We will also record most faculty sessions, which you can review upon request.
Will I need to attend the live sessions even if I’m based in a different time zone?
You are required to attend all live sessions even if you are based in a different time zone. (Kindly reach out to the Learning Solutions team to learn more about our asynchronous program offerings, which consist predominantly of pre-recorded videos that you can watch on your own time).
COVID-19 Safety Plans
Please review the latest COVID-19 related protocols at Columbia Business School.
Sign Up for Email Alerts
Sign up for program updates and content relevant to today's business leaders from Columbia Business School Executive Education.