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Measuring Efficacy and Safety of DTx

24th August @ 9:45AM EDT

There are a broad number of DTx solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, it is essential to prove their efficacy and safety. How can we measure DTx efficacy and safety so that they are validated with uniform rigor across settings? Considering the challenges DTx companies are facing when it comes to performing RCTs (cost, time and constantly evolving softwares/devices), is RWE the best choice or is it a variation of gold standard RCTs? Although regulatory frameworks are going to evolve to adapt to new technologies, the inherent conservatism of regulatory processes will probably make this a long and tedious journey; what can the industry do to accelerate the changes needed? 

Join this meeting with other senior leaders to discuss: 

  • Best practices to measure efficacy and safety of DTx
  • How do the requirements change depending on the stakeholder and the characteristics of the DTx product?
  • What is the role of regulatory bodies in DTx validation?

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Measuring Efficacy and Safety of DTx

Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
Michael Pace
CEO & Founder at PalmHealth.co
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Measuring Efficacy and Safety of DTx

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24th August @ 9:45AM EDT

There are a broad number of DTx solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, it is essential to prove their efficacy and safety. How can we measure DTx efficacy and safety so that they are validated with uniform rigor across settings? Considering the challenges DTx companies are facing when it comes to performing RCTs (cost, time and constantly evolving softwares/devices), is RWE the best choice or is it a variation of gold standard RCTs? Although regulatory frameworks are going to evolve to adapt to new technologies, the inherent conservatism of regulatory processes will probably make this a long and tedious journey; what can the industry do to accelerate the changes needed? 

Join this meeting with other senior leaders to discuss: 

  • Best practices to measure efficacy and safety of DTx
  • How do the requirements change depending on the stakeholder and the characteristics of the DTx product?
  • What is the role of regulatory bodies in DTx validation?
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Participants

Participants

Jordan Silberman, MD, PhD

Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.

Michael Pace

CEO & Founder at PalmHealth.co

Nemanja (Nick) Kovačev

MedTech Expert, HTEC Group

Kendal Dinsmore

Senior Director, Global RA/QA at Mahana Therapeutics

Chris Wasden

Chief Strategy Officer, Twill

Doina Sirbu

Medical Device Innovation Lead, UCB

Todd Greenwood

Director, Evidence Generation and Outcomes Research, ZS

Emily Kunka

Digital Transformation Project Lead, UCB

John Mattison

Operating Partner and CMIO, Arsenal Capital Partners

Krys Zaluski

Director Of Business Development, Digital Health at Sumitomo Dainippon Pharma

Koichi Iwata

Vice President, Technology and Advanced Analytics at Symphony Health

Number of Participants


Up to 12
Date  
August 24, 2021
Community

Measuring Efficacy and Safety of DTx

There are a broad number of DTx solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, it is essential to prove their efficacy and safety. How can we measure DTx efficacy and safety so that they are validated with uniform rigor across settings? Considering the challenges DTx companies are facing when it comes to performing RCTs (cost, time and constantly evolving softwares/devices), is RWE the best choice or is it a variation of gold standard RCTs? Although regulatory frameworks are going to evolve to adapt to new technologies, the inherent conservatism of regulatory processes will probably make this a long and tedious journey; what can the industry do to accelerate the changes needed? 

Join this meeting with other senior leaders to discuss: 

  • Best practices to measure efficacy and safety of DTx
  • How do the requirements change depending on the stakeholder and the characteristics of the DTx product?
  • What is the role of regulatory bodies in DTx validation?
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Measuring Efficacy and Safety of DTx

24th August @ 9:45AM EDT
Digital Therapeutics (DTx)

Measuring Efficacy and Safety of DTx

24th August @ 9:45AM EDT
Digital Therapeutics (DTx)
Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
LinkedIn Profile
Michael Pace
CEO & Founder at PalmHealth.co
LinkedIn Profile
Nemanja (Nick) Kovačev
MedTech Expert, HTEC Group
LinkedIn Profile
Kendal Dinsmore
Senior Director, Global RA/QA at Mahana Therapeutics
LinkedIn Profile
Chris Wasden
Chief Strategy Officer, Twill
LinkedIn Profile
Doina Sirbu
Medical Device Innovation Lead, UCB
LinkedIn Profile
Todd Greenwood
Director, Evidence Generation and Outcomes Research, ZS
LinkedIn Profile
Emily Kunka
Digital Transformation Project Lead, UCB
LinkedIn Profile
John Mattison
Operating Partner and CMIO, Arsenal Capital Partners
LinkedIn Profile
Krys Zaluski
Director Of Business Development, Digital Health at Sumitomo Dainippon Pharma
LinkedIn Profile
Koichi Iwata
Vice President, Technology and Advanced Analytics at Symphony Health
LinkedIn Profile

Measuring Efficacy and Safety of DTx

There are a broad number of DTx solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, it is essential to prove their efficacy and safety. How can we measure DTx efficacy and safety so that they are validated with uniform rigor across settings? Considering the challenges DTx companies are facing when it comes to performing RCTs (cost, time and constantly evolving softwares/devices), is RWE the best choice or is it a variation of gold standard RCTs? Although regulatory frameworks are going to evolve to adapt to new technologies, the inherent conservatism of regulatory processes will probably make this a long and tedious journey; what can the industry do to accelerate the changes needed? 

Join this meeting with other senior leaders to discuss: 

  • Best practices to measure efficacy and safety of DTx
  • How do the requirements change depending on the stakeholder and the characteristics of the DTx product?
  • What is the role of regulatory bodies in DTx validation?
When:
24th August @ 9:45AM EDT
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