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8:50 am Chair’s Opening Remarks

  • Megan Coder Executive Director, Digital Therapeutics Alliance

Robust Clinical Trial Design & Execution

Synopsis

The digital therapeutics space is full with confusion on true validation levels of various digital therapeutics, making it more important than ever to ensure trials are designed correctly and robustly. Through interactive discussion, this session tackles the critical steps for clinically evaluated digital therapeutics, highlighting the importance of robust trial methods in representing the evidence-driven route for external approval.

9:00 am The Future of Digital Therapeutics: The Pharma Perspective

Synopsis

• Digital therapeutics in the future
• How are large organisations looking at new modalities?
• It’s beyond innovation, but do organisations understand and are they structured to deliver?

9:30 am DTx Clinical Imperatives

  • Anil Jina Chief Medical Officer, Akili Interactive

Synopsis

• Setting a high bar for clinical validation
• DTx trial design and methodology
• Leveraging digital for real-world data

10:00 am Improving User Experience to Ensure Rich Data & Reduce Attrition

  • Olivier Jarry Chief Commercial Officer & President, DarioHealth

Synopsis

• The trap of believing “build it (digitally) and they will come”
• Consistent and intense participation of the patient is required to run clinical trials, enact lifestyle changes and deliver outcomes
• Techniques for robust engagement (e.g. attention capture, rewards, gamification)

10:30 am Speed Networking

10:45 am Morning Refreshments

11:00 am Running a Pharma Study with a Digital Therapeutic: Our Experiences

Synopsis

• In this talk we’ll share our experiences, the good the bad and the ugly
• Running our first proof-of-concept clinical trial at Novartis with the use of a digital therapeutic

11:30 am Q&A Session with the Expert Speakers

Synopsis

Key topics to be discussed include:

• Incorporating reliable placebos and blinding to trials, building validity for later stage approval from reimbursement and regulatory systems
• Asking the right questions to find the ‘active ingredient’: What is truly influencing our results?
• System development for improving user experience for a range of therapeutic modalities

Reimbursement & Commercial Considerations for Informed Development Decisions & Successful Market Access & Adoption

Synopsis

As the digital therapeutics space evolves, an understanding of the reimbursement landscape is critical for informed development decisions. This session will tackle the widespread lack of understanding surrounding the payer approach and reimbursement pathways, as well as critical commercial strategies to prepare for streamlined financial success.

1:30 pm Digital Therapeutics: Software as Prescription Medical Treatments

Synopsis

• Hear what healthcare executives need to know and what is being missed
• Learn how prescription digital therapeutics (PDTs) will be integrated in to care protocols
• Understand how reimbursement, medical policies, and drug formularies will change as PDTs enter the market

2:00 pm Taking Digital Therapeutics to the Market: Key Considerations in Partnerships & Beyond

Synopsis

• Exploring the strategies for partnership decisions to launch a commercially viable therapeutic
• Taking partner challenges into consideration to ensure mutual benefit and establish a “fair deal”
• Key commercial strategies to build internally, from sales force to scaling, and the effective execution of these in real practice

2:30 pm Overcoming Barriers to Scale in Digital Therapeutics

  • Chris Hogg Chief Commercial Officer, Propeller Health

Synopsis

• The barriers we’ve overcome so far, and what’s next for the industry
• Understanding the current reimbursement path for digital therapeutics
• Overcoming infrastructure issues related to distribution
• Determining the best path to scale: B2C, B2B, B2B2C and everything in between

3:00 pm Afternoon Refreshments

3:30 pm The Role of Clinical Evidence in Adoption by Payers, Providers & Patients

Synopsis

• Learn how evidence influences customers in different ways and is a critical component of your brand story to drive adoption
• Learn how clinical evidence was used with these groups through real world case studies
• Uncovering the secrets of the medical policy: Understanding the process to validate technologies

4:00 pm Digital Therapeutics Reimbursement: Charting New Territory

  • Mark Bini Vice President, Innovation & Member Experience, Express Scripts

Synopsis

• Understanding payer incentives
• Focusing on value
• Preventing data overload for providers
• Integrating digital and traditional therapies

4:30 pm Q&A Session with the Expert Speakers

  • Megan Coder Executive Director, Digital Therapeutics Alliance
  • Aaron Gani Founder & Chief Executive Officer, BehaVR
  • Joel Sangerman Chief Commercial Officer, Click Therapeutics
  • Mark Bini Vice President, Innovation & Member Experience, Express Scripts

Synopsis

• Understanding evidence requirements of public vs private insurers
• Clarifying the reimbursement categories within the US market, from drug to psychosocial services, and their impact on DTx development and commercialization
• Developing direct to consumer models: Comparing prescribable to over-the-counter routes for consumer accessibility
• Exploring recent guidelines issued by NICE and Germany, and what these mean for international growth

5:15 pm End of Day One