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What Label Claims can you make about your DTx?
As the Digital Therapeutics (DTx) industry matures, regulation is becoming increasingly important. New models are emerging, but the approach remains open to interpretation depending on the therapeutic type, geography, and user group. In this meeting we want to focus on a key question that impacts the regulatory and market access strategies of DTx companies: what label claims can you make about your DTx? More specifically, we will discuss the following questions:
- What label claims can DTx companies make about their solution? How tightly regulated is the industry? Does it depend on the specific solution?
- How can DTx companies use label claims that ease their regulatory and market access strategies? For example, using ‘it helps have a better quality of sleep instead of ‘it treats insomnia’. What are the implications of using one or the other?
- DTx label claims become important for pharma companies when they want to launch a DTx - drug combo. Do the label claims change depending on the drug being paired with the DTx solution? What are the claims that will make the DTx-drug combo promotion and adoption strategies more effective?
- Regional regulatory differences may lead to different claims depending on the country. How does this affect the scaling strategy of the DTx?
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What Label Claims can you make about your DTx?
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As the Digital Therapeutics (DTx) industry matures, regulation is becoming increasingly important. New models are emerging, but the approach remains open to interpretation depending on the therapeutic type, geography, and user group. In this meeting we want to focus on a key question that impacts the regulatory and market access strategies of DTx companies: what label claims can you make about your DTx? More specifically, we will discuss the following questions:
- What label claims can DTx companies make about their solution? How tightly regulated is the industry? Does it depend on the specific solution?
- How can DTx companies use label claims that ease their regulatory and market access strategies? For example, using ‘it helps have a better quality of sleep instead of ‘it treats insomnia’. What are the implications of using one or the other?
- DTx label claims become important for pharma companies when they want to launch a DTx - drug combo. Do the label claims change depending on the drug being paired with the DTx solution? What are the claims that will make the DTx-drug combo promotion and adoption strategies more effective?
- Regional regulatory differences may lead to different claims depending on the country. How does this affect the scaling strategy of the DTx?
Participants
Participants
Anish Shindore
Founder & Managing Partner, GSD Health
Brian Mahony
Medical Device & Digital Medicine Researcher, BioInnovate
Arthur Bretonnet, MBA
Global digital innovation immunology at UCB
Chris Wasden
Chief Strategy Officer, Twill
Bert Hartog
Senior Director Clinical Innovation, Janssen
Nik Vassev
Co-Founder, Rocket VR Health
Chris Cera
CEO, Arcweb Technologies
Amanda Woodward
Insights Manager, Strategy, Twill
Louise O Mahony
Head of Healthcare Partnerships at EXi
Brian Binkowski
Director of Quality, Twill
Jo Masterson
Chief Executive Officer, 2Morrow, Inc.
Christopher Hall
VP, Pharma at Mobio Interactive
Shrawan Patel
Founder & MD, Strategy Health
Aman H. Bhatti, MD
Senior Vice President, Global BioPharma, AliveCor Inc.
Adriano Garcez
Director, Evidence Generation & Outcomes Research, ZS Associates
Up to 12
What Label Claims can you make about your DTx?
As the Digital Therapeutics (DTx) industry matures, regulation is becoming increasingly important. New models are emerging, but the approach remains open to interpretation depending on the therapeutic type, geography, and user group. In this meeting we want to focus on a key question that impacts the regulatory and market access strategies of DTx companies: what label claims can you make about your DTx? More specifically, we will discuss the following questions:
- What label claims can DTx companies make about their solution? How tightly regulated is the industry? Does it depend on the specific solution?
- How can DTx companies use label claims that ease their regulatory and market access strategies? For example, using ‘it helps have a better quality of sleep instead of ‘it treats insomnia’. What are the implications of using one or the other?
- DTx label claims become important for pharma companies when they want to launch a DTx - drug combo. Do the label claims change depending on the drug being paired with the DTx solution? What are the claims that will make the DTx-drug combo promotion and adoption strategies more effective?
- Regional regulatory differences may lead to different claims depending on the country. How does this affect the scaling strategy of the DTx?
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Set up a free HealthXL platform account for a taste of what the community has to offer. Or talk to us about upgrading to a premium account:
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Set up a free HealthXL platform account for a taste of what the community has to offer. Or talk to us about upgrading to a premium account:
- Join any virtual and in-person events
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- Get personalised recommendations
- Join specialised communities in areas like DTx, AI, Clinical Trials Innovation and more
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What Label Claims can you make about your DTx?
What Label Claims can you make about your DTx?
What Label Claims can you make about your DTx?
As the Digital Therapeutics (DTx) industry matures, regulation is becoming increasingly important. New models are emerging, but the approach remains open to interpretation depending on the therapeutic type, geography, and user group. In this meeting we want to focus on a key question that impacts the regulatory and market access strategies of DTx companies: what label claims can you make about your DTx? More specifically, we will discuss the following questions:
- What label claims can DTx companies make about their solution? How tightly regulated is the industry? Does it depend on the specific solution?
- How can DTx companies use label claims that ease their regulatory and market access strategies? For example, using ‘it helps have a better quality of sleep instead of ‘it treats insomnia’. What are the implications of using one or the other?
- DTx label claims become important for pharma companies when they want to launch a DTx - drug combo. Do the label claims change depending on the drug being paired with the DTx solution? What are the claims that will make the DTx-drug combo promotion and adoption strategies more effective?
- Regional regulatory differences may lead to different claims depending on the country. How does this affect the scaling strategy of the DTx?
Join this group of peers and get a feel of what it's like to belong to a community of digital health gamechangers.
All meetings are limited to 10 people to allow for honest discussions, so apply fast or become a HealthXL member and get priority access to all meetings, latest industry reports and and much more.
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What are HealthXL Virtual Meetings?
HealthXL Virtual Meetings are private group meetings limited to 10 people across different demographic and stakeholder groups. For 75 minutes, you take a deep dive into your chosen topic and explore it from different angles. Virtual Meetings are not webinars: There is no audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And through our Community Hub, you stay up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.
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HealthXL brings together gamechangers of digital health to support honest discussions in small, private groups. In our Community Hub, for which you can register for free, you can follow a wide range of communities across telehealth, digital therapeutics, patient engagement and more. As a full HealthXL member, you also get access to curated news, the latest insights and an expert network to connect with. Join exclusive virtual meetings to exchange strategies, viewpoints and learnings with members from like-minded yet diverse stakeholder groups.
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As member of HealthXL, you join a community of digital health thought leaders, innovators and game changers around the world. With your membership, you get access to hundreds of insights, reports and resources. You can browse a database with over 90k healthcare organizations and view their active strategic partnerships, commercial relationships, latest funding rounds and research. Through our in-house curated digital health newsfeed, you stay informed on the most impactful news and you can regularly meet with members to share learnings, discuss the latest developments and connect with peers of different demographical stakeholder groups. Contact us today to find out about pricing options.
Through focus groups, we bring together 6-10 thought leaders and industry stakeholders in a series of virtual meetings to collaborate around a defined topic. Each meeting gives the group the opportunity to examine, analyze and collaborate with one another around a digital health topic as well as produce a shareable result.
