CONFERENCE DAY ONE - TUESDAY, FEBRUARY 11
8:00 am Morning Check-In & Coffee
8:50 am Chair’s Opening Remarks & Start of Day One
Accelerating Commercialization Roadmaps for Robust Market Strategies
9:00 am Case Study: Effective Commercialization & Market Access Through Pharma Partnerships
Synopsis
- Learnings on the successes and challenges of DTx-pharma collaborations
- Understand the data required to demonstrate value as part of the PDURS or Software-Drug combination frameworks
- Explore the role of pharma partnerships in the post-COVID digital therapeutics landscape for sustainable commercialization avenues
9:30 am Unlocking Commercial Value Through Product & Regulatory Strategies
Synopsis
- Leverage multiple regulatory pathways to accelerate market entry and enhance credibility with stakeholders
- Explore non-conventional commercialization routes, to increase exposure and drive ROI
- Demonstrate the benefits of combining regulatory innovation with non-traditional strategies to generate sustainable revenue
10:00 am Fireside Chat: Dtx-Pharma Partnerships & Understanding Viable Commercial Avenues for Providing Multi-Modality Health
Synopsis
- Engage in a cross functional expert-led panel discussion into the viability of the new Prescription Drug Use Related Software (PDURS) framework
- Understand the regulatory, technical, and commercial differences between PDURS and Drug-Software combinations
- Consider potential changes that could shape the future Pharma-Digital health partnerships
10:45 am Speed Networking & Morning Break
Synopsis
Make the most of this morning networking session to reconnect with your industry and meet fellow pioneers. Use this opportunity effectively connect with cross-industry stakeholders and form important connections for expediting your product development & commercialization
11:45 am Incorporating AI & Achieving Healthcare Integration for Sustainable Digital Therapeutics
Synopsis
- Explore how AI can be integrated into SAAMD products to enhance personalization, efficiency, and regulatory compliance in healthcare
- Address failures in digital therapeutics by driving integration across the broader healthcare continuum, avoiding siloed solutions
- Understand regulatory expectations surrounding AI integration and how agencies want AI features incorporated into digital health products
12:15 pm Increasing Demand & Adoption by Building Physician Trust in DTx Products
Synopsis
- Increasing physician buy-in to boost demand for your products
- Effectively communicate with prescribers, payers, and patients to foster trust and support
- Balancing physician engagement with payer requirements to ensure smoother product adoption and reimbursement pathways
12:45 pm Bridging the Gap: Successfully Integrating Digital Therapeutics into Healthcare Systems
Synopsis
- Insight into how healthcare providers assess and adopt digital therapeutics, including balancing innovation with clinical and operational realities
- Why economic analysis, implementation risk, and system integration should be considered early in the development process to avoid delays and barriers to adoption
- Discuss how digital therapeutics companies can preemptively address the needs of payers, providers, and caregivers to ensure successful product deployment, including insights into reimbursement strategies
1:15 pm Lunch & Networking
Understanding the Data Required to Demonstrate Value to Regulators, Investors, Payors, Clinicians, & Patients
2:15 pm Navigating Clinical Trials & Commercial Strategy for Digital Therapeutics Targeting Fatal Outcomes
Synopsis
- Challenges in designing suicide prevention trials that ensure safety while gathering data on both short- and long-term patient outcomes
- Unique considerations for commercial strategies for DTx’s to treat life-threatening conditions
- Understanding the more stringent regulatory standards for treatments aimed at fatal outcomes
2:45 pm Integrating Human Coaching to Improve Patient Outcomes Founder & CEO Prove Increased Value to Payors
Synopsis
- Understand how the integration of human coaching into Prosoma’s products improved patient outcomes and justified increased reimbursement from payors
- Explore the specific data and metrics used to demonstrate the value of human intervention, including patient outcomes and DTx program completion rates
- Learn how outcome-driven insights helped secure higher reimbursement rates by proving long-term cost-effectiveness and a significant benefit to patients
3:15 pm Structured Networking Break
3:45 pm Designing Clinical Trials & Leveraging Funding for Digital Therapeutics in Addiction
Synopsis
- Clinical trials focus on safety, efficacy, and relapse prevention using validated addiction endpoints
- NIDA supports digital therapeutic projects addressing opiates, smoking, vaping, and withdrawal-related insomnia
- Flagship funding opportunities to support projects aimed to scale and sustain innovative addiction treatments
4:15 pm The Value and Impact of Medical Affairs in the Lifecycle of a Digital Therapeutic
Synopsis
- Increase clinician familiarity with digital therapeutics, ensuring their confident adoption in patient care
- Implement a Medical Science Liaison strategy to bridge gaps between DTx companies and healthcare providers, facilitating knowledge transfer and open dialogues about their place in holistic healthcare
- Provide ongoing, data-driven education to reinforce DTx product efficacy, enabling clinicians to effectively communicate therapeutic benefits to patients and improve outcomes