8.00 – 17.00 EST | 5.00 – 14.00 PST

All Times Listed in EST

8:00 am Morning Coffee Room

Outlining Market Access, Pricing & Reimbursement Clarity to Expedite Commercialization & Patient Accessibility

8:50 am Chair’s Opening Remarks

9:00 am Opening Address: Demonstrating Value to Payers in the DTx Industry


• Understanding how to demonstrate value to a payer – addressing the challenges of going from payer to payer with the hope of understanding a better model for payer satisfaction
• Improving patient outcomes: what payers are looking for and using this to implement into strategic payer approach
• Demonstrating cost savings and assessing the health economic value of a DTx to payers to get implementation of a DTx
• Leveraging real world evidence and exploring novel value-based pricing structures to define pricing strategy for clarity

9:30 am Fireside Chat


Hear from industry leaders to clarify the definition of DTx as evidence-based medical interventions. This deep dive session will cover how DTx differentiates from health and wellness segments of the industry, and address your burning question: are the current regulatory frameworks optimal for the DTx industry.

10:00 am Break & Speed Networking


Join our virtual speed networking room to break the ice with your fellow colleagues. Our platform will pair you up with a fellow attendee for a 5mins chat to expand your network, reconnect and engage with your global DTx colleagues!

10:45 am The Evolution of DTx Reimbursement in the U.S.


• Navigating and clarifying the current DTx US payment pathways to elevate understanding of how it fits in with your DTx
• Evaluation and payment of new DTx solutions from a payer’s perspective to better position your DTx
• Leveraging RWE to drive payment and adoption

11:15 am The Straw that Stirs the Drink-Digital Treatment of Tobacco Addiction


• DTx and the biochemical measurement of tobacco consumption, allows tobacco addiction to be treated like every other chronic disease
• Treatment of tobacco dependent patients generates significant insurance reimbursement to medical centers, hospitals and clinicians
• DTx of tobacco addiction can increase quit rates, dramatically improving individual and population health, saving medical institutions
millions of dollars
• Tobacco dependent patients are medical “frequent flyers”. As such, the opportunities for effective digital interventions is practically limitless

11:45 am Why Centralize Data for Decentralized Trials? Safe & Private Federated Data Makes for Better DTx


  • Learn how a federated approach to data analytics in decentralized clinical trials is possible while leaving the data safely at rest
  • Learn how federated machine learning, decentralized data and audit layers can accelerate research that is free from potential bias
  • Learn how new privacy tools can allow decentralized data to be analyzed without ever exposing or revealing the data

12:15 pm Networking Lunch

Navigating through the Fast-Evolving Regulatory Frameworks

1:15 pm Communicating KPIs to Different Stakeholders -The Importance of Standardized Rating Metrics

  • Renae Beaumont Assistant Professor of Psychology in Clinical Psychiatry, Weill Cornell Medicine


• Clarifying and reviewing KPIs for payors, providers and patients – what outcomes REALLY matter?
• Discussing the need for standardized metrics that provide meaningful and user-friendly information to different DTx stakeholders
• Considerations and implications of such metrics for the DTx industry – next steps and future directions

1:45 pm Panel Discussion


Frameworks across the globe & pathway clarity. Discuss the variations, requirements, and FDA resources
for pathways clarity in DTx frameworks and delve into the first national dedicated reimbursement
pathway in Germany that has allowed DTx companies to thrive

Embracing RWE to Optimize Clinically Validated DTx Development Program

2:30 pm Afternoon Break

3:00 pm Fireside Chat: Importance of Strategic Partnerships in DTx Trial Execution


● What does it take to plan and run a DTx clinical trial?
● What are the benefits to leveraging partners for study execution?
● What considerations are there in selection what to partner on, and with who?

3:30 pm Evidence Generation for DTx: Gaps, Challenges & Opportunities

  • Dario Motti Global Principal Scientist, Digital Health Technologies, Roche


• The importance of continuous evidence generation in support of DTx regulatory clearance, commercialization and adoption
• DTx evidence requirements, what we are missing and what we are doing well: challenges and opportunities in DTx clinical investigations
• New evolved data generation techniques and strategies to fit the nature of the healthcare-tech hybrid that is the DTx industry
• A path forward: leveraging the full arsenal of clinical research in DTx programs

4:00 pm Executing Efficient Clinical Trials That Optimize Evidence Generation


• Successfully overcoming clinical trial challenges as a DTx company
• Discussing frontline experiences and forging partnerships for running effective and efficient studies
• Addressing the critical issues of usability, efficacy, and cost effectiveness using multi-faceted evidence generation

4:30 pm Panel Discussion


In this panel discussion, we will hear from DTx experts on digital therapeutics’ value propositions, and how we should challenge traditional guidelines, as well as product development to ensure patient centricity and maximize adoption.
We will delve into how the future healthcare system need to evolve to support a fast growing DTx industry, and the roadmap to achieve this.

5:15 pm Chair’s Closing Remarks, End of Day One & Networking


We look forward to welcoming you back for Day Two to address the major topics surrounding patient
adherence and the challenges encountered when commercializing a DTx