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Masterclass: FDA Breakthrough Designation: How Can DTx Companies Navigate it?

25th January @ 10:45AM EDT

Getting regulatory clearance/approval for DTx can be challenging, and it requires a learning curve to define the best regulatory strategy for a specific solution. Beyond the regulatory pathways (like the 510k or the de novo), DTx companies can also join voluntary programs that may help make these therapies available as rapidly as possible. In this masterclass led by Tim Marjenin (Vice President of Neurology Regulatory Affairs at MCRA, and former Assistant Director at the FDA), we will focus on the FDA Breakthrough Designation and how DTx companies can successfully navigate it. In more detail, Tim will walk us through:

  • How does the breakthrough designation differ from the other types of evaluations reviewed by the FDA’s CDRH (Center for Devices and Radiological Health)? 
  • How can we carefully consider the proposed indications to align them with the future reimbursement strategies?
  • A demonstration of a reasonable expectation of technical and clinical success are the key elements of the submission. How can we clearly articulate them?
  • What does the threshold for achieving the breakthrough designation depend on?

We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.

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Masterclass: FDA Breakthrough Designation: How Can DTx Companies Navigate it?

Tim Marjenin
Vice President of Neurology Regulatory Affairs, MCRA
Daphne Petrich
Senior Business Development Manager at HelloBetter

Join this HealthXL Event today:

Participate in this Digital Health Sprint in order to:
- Deep dive into a topic over 2 focused sessions.
- Engage with a small group of 10 global thought-leaders throughout.
- This sprint is outcome-focused: HealthXL and participants create exclusive outputs.
- Grow your network with our break out sessions.


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.

25th January @ 10:45AM EDT

Getting regulatory clearance/approval for DTx can be challenging, and it requires a learning curve to define the best regulatory strategy for a specific solution. Beyond the regulatory pathways (like the 510k or the de novo), DTx companies can also join voluntary programs that may help make these therapies available as rapidly as possible. In this masterclass led by Tim Marjenin (Vice President of Neurology Regulatory Affairs at MCRA, and former Assistant Director at the FDA), we will focus on the FDA Breakthrough Designation and how DTx companies can successfully navigate it. In more detail, Tim will walk us through:

  • How does the breakthrough designation differ from the other types of evaluations reviewed by the FDA’s CDRH (Center for Devices and Radiological Health)? 
  • How can we carefully consider the proposed indications to align them with the future reimbursement strategies?
  • A demonstration of a reasonable expectation of technical and clinical success are the key elements of the submission. How can we clearly articulate them?
  • What does the threshold for achieving the breakthrough designation depend on?

We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.

Participants

Participants

Tim Marjenin

Vice President of Neurology Regulatory Affairs, MCRA

Daphne Petrich

Senior Business Development Manager at HelloBetter

Nita Thingalaya

US Digital Health Care Medical Director, Sanofi

Maxime Champain

Lead, BDH External Innovation & Alliances, Search & Evaluation, Biogen

Smit Patel

Director of Digital Medicine at DiMe

Carman Ho

Vice President, L1 Health

Angelie Singh

Digital Project Manager, Pfizer

Cathy Zaremba

Director of Product Marketing, BrightInsight

Jorge Juan Fernández García

Director of Innovation, EIT Health

Shaun Patel

Cofounder & CEO, React Neuro

Serdar Gemici

Co-Founder, Albert Health

Patrick Leyseele

Founder and CEO, 3.life

Ofer Waks

Director, Corporate Strategy and Innovation at Pfizer

Alba Zurriaga Carda, PhD

Director of Digital Investments, Sanofi Ventures

Number of Participants


Up to 12
Date  
January 25, 2023
Community

Masterclass: FDA Breakthrough Designation: How Can DTx Companies Navigate it?

Getting regulatory clearance/approval for DTx can be challenging, and it requires a learning curve to define the best regulatory strategy for a specific solution. Beyond the regulatory pathways (like the 510k or the de novo), DTx companies can also join voluntary programs that may help make these therapies available as rapidly as possible. In this masterclass led by Tim Marjenin (Vice President of Neurology Regulatory Affairs at MCRA, and former Assistant Director at the FDA), we will focus on the FDA Breakthrough Designation and how DTx companies can successfully navigate it. In more detail, Tim will walk us through:

  • How does the breakthrough designation differ from the other types of evaluations reviewed by the FDA’s CDRH (Center for Devices and Radiological Health)? 
  • How can we carefully consider the proposed indications to align them with the future reimbursement strategies?
  • A demonstration of a reasonable expectation of technical and clinical success are the key elements of the submission. How can we clearly articulate them?
  • What does the threshold for achieving the breakthrough designation depend on?

We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.

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Frequently Asked Questions

What is a HealthXL Digital Health Meeting?

HealthXL Digital Health Meetings are private group meetings limited to a maximum of 10 people across different demographic and stakeholder groups. They are not webinars, but participant-led group meetings to allow you to explore every facet of digital health with peers.

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I am participating in this meeting, but can't attend anymore. Can I cancel it?

It can always happen that you cannot attend meetings due to unforeseen reasons. Due to the small group size, even missing one person can be disruptive. We'd like to ask all participants to inform us with at least 48 hours notice or suggest a suitable replacement for themselves.

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Masterclass: FDA Breakthrough Designation: How Can DTx Companies Navigate it?

25th January @ 10:45AM EDT
Digital Therapeutics (DTx)

Masterclass: FDA Breakthrough Designation: How Can DTx Companies Navigate it?

25th January @ 10:45AM EDT
Digital Therapeutics (DTx)
Tim Marjenin
Vice President of Neurology Regulatory Affairs, MCRA
LinkedIn Profile
Daphne Petrich
Senior Business Development Manager at HelloBetter
LinkedIn Profile
Nita Thingalaya
US Digital Health Care Medical Director, Sanofi
LinkedIn Profile
Maxime Champain
Lead, BDH External Innovation & Alliances, Search & Evaluation, Biogen
LinkedIn Profile
Smit Patel
Director of Digital Medicine at DiMe
LinkedIn Profile
Carman Ho
Vice President, L1 Health
LinkedIn Profile
Angelie Singh
Digital Project Manager, Pfizer
LinkedIn Profile
Cathy Zaremba
Director of Product Marketing, BrightInsight
LinkedIn Profile
Jorge Juan Fernández García
Director of Innovation, EIT Health
LinkedIn Profile
Shaun Patel
Cofounder & CEO, React Neuro
LinkedIn Profile
Serdar Gemici
Co-Founder, Albert Health
LinkedIn Profile
Patrick Leyseele
Founder and CEO, 3.life
LinkedIn Profile
Ofer Waks
Director, Corporate Strategy and Innovation at Pfizer
LinkedIn Profile
Alba Zurriaga Carda, PhD
Director of Digital Investments, Sanofi Ventures
LinkedIn Profile

Masterclass: FDA Breakthrough Designation: How Can DTx Companies Navigate it?

Getting regulatory clearance/approval for DTx can be challenging, and it requires a learning curve to define the best regulatory strategy for a specific solution. Beyond the regulatory pathways (like the 510k or the de novo), DTx companies can also join voluntary programs that may help make these therapies available as rapidly as possible. In this masterclass led by Tim Marjenin (Vice President of Neurology Regulatory Affairs at MCRA, and former Assistant Director at the FDA), we will focus on the FDA Breakthrough Designation and how DTx companies can successfully navigate it. In more detail, Tim will walk us through:

  • How does the breakthrough designation differ from the other types of evaluations reviewed by the FDA’s CDRH (Center for Devices and Radiological Health)? 
  • How can we carefully consider the proposed indications to align them with the future reimbursement strategies?
  • A demonstration of a reasonable expectation of technical and clinical success are the key elements of the submission. How can we clearly articulate them?
  • What does the threshold for achieving the breakthrough designation depend on?

We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.

When:
25th January @ 10:45AM EDT
Apply to attend
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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.