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8:50 am Chair’s Opening Remarks

Clinical Integration of Digital Therapeutics to Deliver for Patients Worldwide

9:00 am Reimagining Medicine

Synopsis

• Opportunities and expectations for digital therapeutics
• Arming patients and doctors with DTx-enabled data
• The patient experience of the future

9:30 am “Are We There Yet?”: Lessons Learned from a Decade of Clinical Experience with DTx

  • Matthias Zenker Senior Vice President & Head, Business Development DTx, GAIA AG

Synopsis

• Products, pitfalls and perception: Health care professionals and their understanding of DTx
• Outpatient vs inpatient: How DTx can create meaningful impact
• Product vs component: DTx as one part of complex interventions
• Science does matter: RCTs and their impact on dissemintation in routine care

10:00 am Unpicking the Tricky Question of “How To Prescribe a DTx?”

  • Guarav Narang VP, Strategic Partnerships & Operations, Rx.Health

Synopsis

• Discuss what we’ve learnt on our journey from developing the first enterprisewide app prescription platform and how that informs our current outlook
• Review some of the barriers preventing clinicians from prescribing DTx and how we can overcome these hurdles
• If prescribing one DTx was complicated enough, how should we approach prescribing two or more at the same time?

10:30 am Morning Refreshments & Networking

11:00 am Digital Therapeutics Engagement Chain: Key Success Factors

Synopsis

• What is the digital therapeutics engagement chain?
• Understand how it varies by deployment and operating environment
• Determine key performance indicators to prove efficacy

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

Synopsis

Key topics to be discussed include:

• Understanding the current approach of clinicians to digital therapeutics and the current limitations faced in DTx applications
• Discussing the differing privacy and cybersecurity levels across healthcare organizations
• Integrating digital therapeutics to the complex workflows existing in healthcare systems, from clinical dashboards and patient activation to prescription and reimbursement workflows

12:15 pm Networking Lunch

Clarifying the Regulatory Guidelines for Digital Therapeutics

Synopsis

Despite placement within the SaMD framework, questions still remain across the regulatory approach for digital therapeutics. This session provides insight into the latest regulatory developments and leading internal strategies to maximise commercial success of digital therapeutics.

1:15 pm Regulatory “Must Haves” When Developing Software as a Medical Device (SaMD) That Uses Machine Learning & Artificial Intelligence

  • Mary Dixon Chief Executive Officer & Founder, Innovenn

Synopsis

• From data to development; creating clinically meaningful software
• Navigating developing US and International regulatory testing requirement and standards
• The importance of Usability, Human Factors and User Interface testing in the development process

1:30 pm Regulatory & Reimbursement Implications of FDA Breakthrough Device Designation

  • Martin Culjat Senior Vice President, Scientific & Regulatory Affairs, Dthera Sciences

Synopsis

• Overview of the FDA Breakthrough Devices program and eligibility criteria
• Discussion on what Breakthrough Device designation might mean for digital therapeutics companies
• Exploring emerging CMS reimbursement opportunities for Breakthrough devices

Safety & Privacy Requirements for Data Collection & Storage

Synopsis

Data is at the centre of digital therapeutics, but are we ensuring we respect patient privacy and collect information in accordance to safety laws? This session explores this all-important question to ensure digital therapeutics benefit patients in need while adhering to guidelines to protect patient privacy.

2:00 pm Healthcare in the Age of the Consumer: Drawing on the Parallels of Consumer & Healthcare Industries

Synopsis

• Agile methods in product delivery in digital therapeutics
• Tension between traditional consumer approach and clinical prudence
• Creating engaging experiences to improve outcomes

2:30 pm Creating a Digital Therapeutic Platform to Treat Multiple Therapeutic Areas

Synopsis

• Digital platforms in other industries provide the blueprint for digital therapeutics
• Behavioral health is the meta-condition that is the basis for a digital therapeutic platform
• Comorbid conditions with behavioral health and other diseases enable treating the mind and body

3:00 pm Afternoon Refreshments

3:30 pm Roundtable Session: Exploring the Impact of International Guidelines & Laws on DTx Development & Adoption

  • Zina Manji Senior Director, Global Regulatory Affairs, Innovation, GlaxoSmithKline Consumer Healthcare

Synopsis

• HIPPA, CCPA and GDPR: How do these geographical laws impact the national and international use of your digital therapeutic, and how do you develop systems with these in mind?
• How can we develop the frameworks to ensure patients fully understand their given consent?
• Ensuring collected patient information is truly required, and that unnecessary information is safely excluded from databases
• Ensuring safe and effective data exchange between systems for improved interoperability

4:30 pm End of Day Two & Close of 2nd Clinically Validated DTx Summit 2019