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Evidence Generation for Standalone DTx
Standalone digital therapeutics (DTx) solutions are not comparable to drugs or standard treatment protocols. However, since they claim to treat medical conditions and there are no DTx standardized frameworks, the evidence requirements for standalone DTx are often the same as traditional medical treatments. This is challenging for small companies that don’t have the financial resources, and it doesn’t make much sense considering the iterative nature of these treatments. So, what are the best evidence generation strategies for standalone DTx manufacturers?
Join this meeting to share your experiences and learn from others about:
- How do we align the evidence generation plan with the commercial and regulation strategies from the early days? What are the differences in evidence requirements between prescription and non-prescription standalone DTx? How does this determine whether or not the company takes the prescription route?
- What internal capabilities and/or partnerships does a standalone DTx manufacturer need to build an efficient and effective evidence generation strategy?
- Most companies struggle to show long-term evidence when payers ask for it. Are there any techniques or studies that can help address this? How can we use extrapolation correctly to show long-term evidence without waiting for the product to be in the market for five years?
- NICE (the National Institute for Health and Care Excellence) recently recommended offering Sleepio as an effective alternative to sleeping pills. What level of evidence is needed to meet goals like this? What can we learn from this example from an evidence generation perspective? Is Big Health the example to follow?
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Evidence Generation for Standalone DTx
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Participate in this Digital Health Sprint in order to:
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You actively participate in this discussion. Spaces are limited to 8 - 12 people, allowing you to focus on quality in-depth conversations.
Don't miss your opportunity to connect with senior leaders to shape the future of digital health. Because only if you are prepared now can you lead the future.
Standalone digital therapeutics (DTx) solutions are not comparable to drugs or standard treatment protocols. However, since they claim to treat medical conditions and there are no DTx standardized frameworks, the evidence requirements for standalone DTx are often the same as traditional medical treatments. This is challenging for small companies that don’t have the financial resources, and it doesn’t make much sense considering the iterative nature of these treatments. So, what are the best evidence generation strategies for standalone DTx manufacturers?
Join this meeting to share your experiences and learn from others about:
- How do we align the evidence generation plan with the commercial and regulation strategies from the early days? What are the differences in evidence requirements between prescription and non-prescription standalone DTx? How does this determine whether or not the company takes the prescription route?
- What internal capabilities and/or partnerships does a standalone DTx manufacturer need to build an efficient and effective evidence generation strategy?
- Most companies struggle to show long-term evidence when payers ask for it. Are there any techniques or studies that can help address this? How can we use extrapolation correctly to show long-term evidence without waiting for the product to be in the market for five years?
- NICE (the National Institute for Health and Care Excellence) recently recommended offering Sleepio as an effective alternative to sleeping pills. What level of evidence is needed to meet goals like this? What can we learn from this example from an evidence generation perspective? Is Big Health the example to follow?
Participants
Participants
Ciara Clancy
Founder & CEO, Beats Medical Ltd
Eugene Borukhovich
COO & Co-Founder of YourCoach.Health
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Thomas Sutton
Global Head of Design, Digital Health R&D at AstraZeneca
Maxime Champain
Lead, BDH External Innovation & Alliances, Search & Evaluation, Biogen
Adriano Garcez
Director, Evidence Generation & Outcomes Research, ZS Associates
Nemanja (Nick) Kovačev
MedTech Expert, HTEC Group
Chris Cera
CEO, Arcweb Technologies
Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
Francesca Wuttke
CEO and Founder, nen Health
Up to 12
Evidence Generation for Standalone DTx
Standalone digital therapeutics (DTx) solutions are not comparable to drugs or standard treatment protocols. However, since they claim to treat medical conditions and there are no DTx standardized frameworks, the evidence requirements for standalone DTx are often the same as traditional medical treatments. This is challenging for small companies that don’t have the financial resources, and it doesn’t make much sense considering the iterative nature of these treatments. So, what are the best evidence generation strategies for standalone DTx manufacturers?
Join this meeting to share your experiences and learn from others about:
- How do we align the evidence generation plan with the commercial and regulation strategies from the early days? What are the differences in evidence requirements between prescription and non-prescription standalone DTx? How does this determine whether or not the company takes the prescription route?
- What internal capabilities and/or partnerships does a standalone DTx manufacturer need to build an efficient and effective evidence generation strategy?
- Most companies struggle to show long-term evidence when payers ask for it. Are there any techniques or studies that can help address this? How can we use extrapolation correctly to show long-term evidence without waiting for the product to be in the market for five years?
- NICE (the National Institute for Health and Care Excellence) recently recommended offering Sleepio as an effective alternative to sleeping pills. What level of evidence is needed to meet goals like this? What can we learn from this example from an evidence generation perspective? Is Big Health the example to follow?
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HealthXL community members lead discussion on a defined topic among a maximum of 12 participants. There is no audience and no recordings, just an interactive space to reflect and share learnings.
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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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- Gain full access to all articles and HealthXL reports
- Get personalised recommendations
- Join specialised communities in areas like DTx, AI, Clinical Trials Innovation and more
- Full access to community insights and meeting takeaway reports
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Evidence Generation for Standalone DTx
Evidence Generation for Standalone DTx
Evidence Generation for Standalone DTx
Standalone digital therapeutics (DTx) solutions are not comparable to drugs or standard treatment protocols. However, since they claim to treat medical conditions and there are no DTx standardized frameworks, the evidence requirements for standalone DTx are often the same as traditional medical treatments. This is challenging for small companies that don’t have the financial resources, and it doesn’t make much sense considering the iterative nature of these treatments. So, what are the best evidence generation strategies for standalone DTx manufacturers?
Join this meeting to share your experiences and learn from others about:
- How do we align the evidence generation plan with the commercial and regulation strategies from the early days? What are the differences in evidence requirements between prescription and non-prescription standalone DTx? How does this determine whether or not the company takes the prescription route?
- What internal capabilities and/or partnerships does a standalone DTx manufacturer need to build an efficient and effective evidence generation strategy?
- Most companies struggle to show long-term evidence when payers ask for it. Are there any techniques or studies that can help address this? How can we use extrapolation correctly to show long-term evidence without waiting for the product to be in the market for five years?
- NICE (the National Institute for Health and Care Excellence) recently recommended offering Sleepio as an effective alternative to sleeping pills. What level of evidence is needed to meet goals like this? What can we learn from this example from an evidence generation perspective? Is Big Health the example to follow?
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.
Frequently asked questions:
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.
