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The Coming Era
of Digital Therapeutics
NRC Live - Zorgtech
September 2018
Chris Hogg
Chief Commercial Officer, Propeller
@cwhogg
Digital transformation
is coming to healthcare
Digital is fundamentally affecting all industries
– with varying speed and scope
Industries higher on the
adoption curve were completely transformed
People now expect solutions that just work.
They want solutions that solve their problems
and fit into their daily lives.
We are just beginning to see the
digitization of healthcare
Physicians: Office Visit → Telemedicine or Virtual Primary Care
We are just beginning to see the
digitization of healthcare
Pharmacist: In Pharmacy → Mobile / Home Delivery
We are just beginning to see the
digitization of healthcare
Pharmaceuticals: Traditional medicines → Digital therapeutics
...represent the next generation of healthcare
...use software and technology to improve
clinically-meaningful endpoints
...are clinically-validated in rigorous clinical trials
...can be used alone or in combination with
existing treatments
Digital therapeutics...
What is a digital therapeutic?
Digital therapeutics represent the next
era of development in medicine
Small molecule
medicines
Large molecule
biologic medicines
Technology, data,
behavior, content
Digital therapeutics typically have
two core mechanisms of action
Individual Care Team
Goal:
Mechanisms:
Improve individual’s clinical status
● Behavior change
● Improved adherence
● Personalized content and
coaching
● Data driven user experiences
● New data + data science
Identify patients most in need of added
attention, services or treatment changes
● Data on non-adherence
● Data on clinical status
● Data on progress or worsening
● Prediction of exacerbation or
hospitalization
Just like traditional medicines, digital therapeutics are
clinically validated, regulated and prescribed by physicians
Just like traditional medicines, digital therapeutics will be
used alone and in combination with existing medicines
Similar to pharma and biotech development, digital
therapeutics developers are mostly disease specific
A look at 5 leading digital therapeutics companies
WellDoc
FDA-cleared in 2013
Target indication:
Type 2 diabetes
1 Quinn CC, et al. Diabetes Technol Ther. 2008;10(3):160-168. Quinn CC, et al.
Diabetes Care. 2011:34(9):1934-1942.. Richard Katz, MD; George Washington
University Medical Center; Journal of Health Communication, December 2011.
Quinn, CC, et al. Glycemic Control: Impact on Physician Prescribing Behavior,
Presentation ADA 72nd Scientific Sessions, 2012. Tang PY, et al. eHealth-Assisted
Lay Health Coaching for Diabetes Self-Management Support American Diabetes
Association 76th Scientific Sessions Poster Presentation 2016.
Propeller
FDA-cleared in 2012
Reduced Acute Care Utilization 1
(150%)
Hospitalizations
(100%)
(50%)
0%
50%
100%
150%
(77%)
10%
(86%)
1%
(70%)
(17%)
53%
(1%)
Hosp.
Days
ED Visits Clinic
Visits
Asthma Non-Asthma
Improved Adherence 2
0
2
0
4
0
6
0
Control Intervention
Medicationadherence%
+58%
1 Merchant et al (under review). “Impact of a Digital Health Intervention on Asthma Resource Utilization”
2 Van Sickle D, Humblet O, Barrett M, Henderson K, and Hogg C. 2016. Randomized, controlled study of the impact of a mobile health tool on asthma SABA use, control
and adherence. European Respiratory Journal:48: PA1018. http://erj.ersjournals.com/content/48/suppl_60/PA1018
Target indications:
Asthma and COPD
Akili Interactive
FDA-clearance - submitted
Children with Sensory Processing Dysfunction (SPD)
Anguera JA, et al., (2017) A pilot study to determine the feasibility of enhancing cognitive
abilities in children with sensory processing dysfunction. PLoS ONE 12(4): e0172616.
https://doi.org/10.1371/journal.pone.0172616
Target indications:
ADHD, Autism Spectrum Disorder, Major
Depressive Disorder, Parkinson’s
Pear Therapeutics
FDA-cleared in 2017
1. Campbell et al. Am J Psychiatry. 2014.
2. Hubbard et al. Psychol Addict Behav. 1997.
3. Simpson. Am J Psychiatry. 1979.
4. Zhang et al. Addiction. 2003
Target indications:
Substance abuse disorders, PTSD, major
depression, schizophrenia, multiple sclerosis
Proteus Digital Health
FDA-cleared in 2012
FDA-approved drug combination in 2017
Frias J, et al., “Effectiveness of Digital Medicines to Improve Clinical
Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes:
Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial”; J Med
Internet Res 2017;19(7):e246
Target indications:
Schizophrenia, high blood pressure, high
cholesterol, orphan diseases
The Future
of Digital Therapeutics
9,400
517457
Today there is a vibrant, but still early,
digital therapeutics market
We will see a proliferation new digital therapeutics
companies, with increased development of digital
therapeutics across all therapeutic areas
We will see increasing partnerships between digital
therapeutics companies and big pharma, who see DTx as a
new source of innovation they can commercialize
.
Biopharma Digital News
Novartis Pear Therapeutics 2/28/18: Announce collaboration to develop digital therapeutics for Schizophrenia and
Multiple Sclerosis
Otsuka Proteus 11/15/17: Received FDA approval (NDA) of digital medicine (pill with embedded sensor)
Novo Nordisk Glooko 7/17/17: Announce partnership to develop and market app for diabetes management
Roche MySugr 6/30/17: Roche acquires MySugr (popular app for diabetes self management)
Bayer BetaConnect
5/30/17: Beyer gets FDA approval (sBLA) for BetaConnect (connected betaseron pen
injector for MS)
Sonofi Verily 9/12/16: Jointly create OnDuo joint venture with $500M investment
Teva CareTRx 9/27/15: Teva acquires Gecko Health for its respiratory CareTRx platform and apps
AZ Adherium 8/19/15: AstraZeneca invests $3M in Adherium and signs commercial agreement
GSK / BI / Novartis Propeller
Development and commercial deals signed in 2014 (Boehringer Ingelheim), 2016 (GSK)
and 2017 (Novartis)
Alternative:
Connected medium-
dose ICS+LABA
Alternative:
Connected high- dose
ICS+LABA
Use connected
high-dose ICS+LABA
+ SABA to determine
appropriateness of
omazlizumab
Alternative:
Connected high- dose
ICS+LABA
Use connected
high-dose ICS+LABA
+ SABA to determine
appropriateness of
omazlizumab
We will see digital therapeutics find their place in
treatment algorithms and guidelines
Patient journey with digital therapeutics
A patient meets with her doctor,
who evaluates her.
Her doctor selects the appropriate therapy,
and she leaves with a prescription.
Patient journey with digital therapeutics
The patient goes to the pharmacy
and picks up her Rx.
Her doctor selected a digital therapeutic, so
her connected medicine comes with an app.
Patient journey with digital therapeutics
As she goes about her normal life, she
uses her medicines as she normally does.
She also receives a software-based
intervention, and starts to improve.
Patient journey with digital therapeutics
Meanwhile….
Many patients have been prescribed digital therapeutics that are delivering
data back to physicians and hospital systems
Patient journey with digital therapeutics
Healthcare providers and care managers use the data from digital therapeutics
to risk stratify patients and prioritize outreach.
Patient journey with digital therapeutics
Patient returns to her doctor and they
review data on adherence and disease
status from her digital therapeutic.
Her physician uses the data from her digital
therapeutic to get her to the right therapy regimen.
Disease severity and
level of control
Digital therapeutics present new opportunities
for patients, healthcare providers and payers
Patients will have more therapy options, will get to the best
therapy regimen faster, and have better control of their health.
Care teams will have better data on how patients are doing,
and be able to offer better solutions to their patients.
Payers and hospitals will lower utilization and costs, and have data
on which therapies are most useful in which patient groups.
With digital therapeutics, we will finally be
able to deliver on the main promise
of digital health
The ability to deliver...
...the right intervention
...to the right patient
...at the right time.
The Coming Era of Digital Therapeutics

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The coming era of digital therapeutics nrc live - sept 2018

  • 1. The Coming Era of Digital Therapeutics NRC Live - Zorgtech September 2018 Chris Hogg Chief Commercial Officer, Propeller @cwhogg
  • 3. Digital is fundamentally affecting all industries – with varying speed and scope
  • 4. Industries higher on the adoption curve were completely transformed
  • 5. People now expect solutions that just work. They want solutions that solve their problems and fit into their daily lives.
  • 6. We are just beginning to see the digitization of healthcare Physicians: Office Visit → Telemedicine or Virtual Primary Care
  • 7. We are just beginning to see the digitization of healthcare Pharmacist: In Pharmacy → Mobile / Home Delivery
  • 8. We are just beginning to see the digitization of healthcare Pharmaceuticals: Traditional medicines → Digital therapeutics
  • 9. ...represent the next generation of healthcare ...use software and technology to improve clinically-meaningful endpoints ...are clinically-validated in rigorous clinical trials ...can be used alone or in combination with existing treatments Digital therapeutics... What is a digital therapeutic?
  • 10. Digital therapeutics represent the next era of development in medicine Small molecule medicines Large molecule biologic medicines Technology, data, behavior, content
  • 11. Digital therapeutics typically have two core mechanisms of action Individual Care Team Goal: Mechanisms: Improve individual’s clinical status ● Behavior change ● Improved adherence ● Personalized content and coaching ● Data driven user experiences ● New data + data science Identify patients most in need of added attention, services or treatment changes ● Data on non-adherence ● Data on clinical status ● Data on progress or worsening ● Prediction of exacerbation or hospitalization
  • 12. Just like traditional medicines, digital therapeutics are clinically validated, regulated and prescribed by physicians
  • 13. Just like traditional medicines, digital therapeutics will be used alone and in combination with existing medicines
  • 14. Similar to pharma and biotech development, digital therapeutics developers are mostly disease specific
  • 15. A look at 5 leading digital therapeutics companies
  • 16. WellDoc FDA-cleared in 2013 Target indication: Type 2 diabetes 1 Quinn CC, et al. Diabetes Technol Ther. 2008;10(3):160-168. Quinn CC, et al. Diabetes Care. 2011:34(9):1934-1942.. Richard Katz, MD; George Washington University Medical Center; Journal of Health Communication, December 2011. Quinn, CC, et al. Glycemic Control: Impact on Physician Prescribing Behavior, Presentation ADA 72nd Scientific Sessions, 2012. Tang PY, et al. eHealth-Assisted Lay Health Coaching for Diabetes Self-Management Support American Diabetes Association 76th Scientific Sessions Poster Presentation 2016.
  • 17. Propeller FDA-cleared in 2012 Reduced Acute Care Utilization 1 (150%) Hospitalizations (100%) (50%) 0% 50% 100% 150% (77%) 10% (86%) 1% (70%) (17%) 53% (1%) Hosp. Days ED Visits Clinic Visits Asthma Non-Asthma Improved Adherence 2 0 2 0 4 0 6 0 Control Intervention Medicationadherence% +58% 1 Merchant et al (under review). “Impact of a Digital Health Intervention on Asthma Resource Utilization” 2 Van Sickle D, Humblet O, Barrett M, Henderson K, and Hogg C. 2016. Randomized, controlled study of the impact of a mobile health tool on asthma SABA use, control and adherence. European Respiratory Journal:48: PA1018. http://erj.ersjournals.com/content/48/suppl_60/PA1018 Target indications: Asthma and COPD
  • 18. Akili Interactive FDA-clearance - submitted Children with Sensory Processing Dysfunction (SPD) Anguera JA, et al., (2017) A pilot study to determine the feasibility of enhancing cognitive abilities in children with sensory processing dysfunction. PLoS ONE 12(4): e0172616. https://doi.org/10.1371/journal.pone.0172616 Target indications: ADHD, Autism Spectrum Disorder, Major Depressive Disorder, Parkinson’s
  • 19. Pear Therapeutics FDA-cleared in 2017 1. Campbell et al. Am J Psychiatry. 2014. 2. Hubbard et al. Psychol Addict Behav. 1997. 3. Simpson. Am J Psychiatry. 1979. 4. Zhang et al. Addiction. 2003 Target indications: Substance abuse disorders, PTSD, major depression, schizophrenia, multiple sclerosis
  • 20. Proteus Digital Health FDA-cleared in 2012 FDA-approved drug combination in 2017 Frias J, et al., “Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial”; J Med Internet Res 2017;19(7):e246 Target indications: Schizophrenia, high blood pressure, high cholesterol, orphan diseases
  • 21. The Future of Digital Therapeutics
  • 22. 9,400 517457 Today there is a vibrant, but still early, digital therapeutics market
  • 23. We will see a proliferation new digital therapeutics companies, with increased development of digital therapeutics across all therapeutic areas
  • 24. We will see increasing partnerships between digital therapeutics companies and big pharma, who see DTx as a new source of innovation they can commercialize . Biopharma Digital News Novartis Pear Therapeutics 2/28/18: Announce collaboration to develop digital therapeutics for Schizophrenia and Multiple Sclerosis Otsuka Proteus 11/15/17: Received FDA approval (NDA) of digital medicine (pill with embedded sensor) Novo Nordisk Glooko 7/17/17: Announce partnership to develop and market app for diabetes management Roche MySugr 6/30/17: Roche acquires MySugr (popular app for diabetes self management) Bayer BetaConnect 5/30/17: Beyer gets FDA approval (sBLA) for BetaConnect (connected betaseron pen injector for MS) Sonofi Verily 9/12/16: Jointly create OnDuo joint venture with $500M investment Teva CareTRx 9/27/15: Teva acquires Gecko Health for its respiratory CareTRx platform and apps AZ Adherium 8/19/15: AstraZeneca invests $3M in Adherium and signs commercial agreement GSK / BI / Novartis Propeller Development and commercial deals signed in 2014 (Boehringer Ingelheim), 2016 (GSK) and 2017 (Novartis)
  • 25. Alternative: Connected medium- dose ICS+LABA Alternative: Connected high- dose ICS+LABA Use connected high-dose ICS+LABA + SABA to determine appropriateness of omazlizumab Alternative: Connected high- dose ICS+LABA Use connected high-dose ICS+LABA + SABA to determine appropriateness of omazlizumab We will see digital therapeutics find their place in treatment algorithms and guidelines
  • 26. Patient journey with digital therapeutics A patient meets with her doctor, who evaluates her. Her doctor selects the appropriate therapy, and she leaves with a prescription.
  • 27. Patient journey with digital therapeutics The patient goes to the pharmacy and picks up her Rx. Her doctor selected a digital therapeutic, so her connected medicine comes with an app.
  • 28. Patient journey with digital therapeutics As she goes about her normal life, she uses her medicines as she normally does. She also receives a software-based intervention, and starts to improve.
  • 29. Patient journey with digital therapeutics Meanwhile…. Many patients have been prescribed digital therapeutics that are delivering data back to physicians and hospital systems
  • 30. Patient journey with digital therapeutics Healthcare providers and care managers use the data from digital therapeutics to risk stratify patients and prioritize outreach.
  • 31. Patient journey with digital therapeutics Patient returns to her doctor and they review data on adherence and disease status from her digital therapeutic. Her physician uses the data from her digital therapeutic to get her to the right therapy regimen. Disease severity and level of control
  • 32. Digital therapeutics present new opportunities for patients, healthcare providers and payers Patients will have more therapy options, will get to the best therapy regimen faster, and have better control of their health. Care teams will have better data on how patients are doing, and be able to offer better solutions to their patients. Payers and hospitals will lower utilization and costs, and have data on which therapies are most useful in which patient groups.
  • 33. With digital therapeutics, we will finally be able to deliver on the main promise of digital health The ability to deliver... ...the right intervention ...to the right patient ...at the right time.
  • 34. The Coming Era of Digital Therapeutics