digital health: clinical evidence and patient impact · defining digital health –fda definition...
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ANDHealth and Novartis Present
Digital Health:
Clinical Evidence and Patient Impact
ANDHealth Members::
#ANDHealthSummit |@ANDHealthAU | @Novartis
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STRENGTHENING AUSTRALIA’S
DIGITAL HEALTH SECTOR
BRONWYN LE GRICE
CO-FOUNDER | CEO | MANAGING DIRECTOR,
ANDHEALTH
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DE-RISKING DIGITAL HEALTH
An Industry Led Model Supporting the Commercialisation of
Evidence-Based Digital Health ProductsBronwyn Le Grice
Managing Director | Co-Founder
ANDHealth
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ABOUT DIGITAL HEALTH
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DEFINING DIGITAL HEALTH – FDA DEFINITION
The use of technologies such as smart phones,
social networks and internet applications is not
only changing the way we communicate, but is
also providing innovative ways for us to monitor
our health and well-being and giving us greater
access to information.
Together these advancements are leading to a
convergence of people, information,
technology and connectivity to improve health
care and health outcomes.
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Source: http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm
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DEFINING DIGITAL HEALTH II
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Mobile health (mHealth)
Health information technology (IT)
Wearable & connected devices
Telehealth and telemedicine
Personalised & precision medicine
Technology
Reduce inefficiencies
Improve access
Reduce costs
Increase quality
Make medicine more
personalized for patients
Providers
Monitor Health &
Wellbeing
Track activities,
symptoms, actions
Improve adherence
Communicate with
physicians
Data-based healthcare
conversation
Patients
Source: http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm
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DEFINING DIGITAL HEALTH- TECHNOLOGY EXAMPLES
Source: https://medium.com/@sebastianhrw/pharma-should-make-some-bold-moves-in-digital-health-54561c3bf9eb© ANDHEALTH LIMITED | ALL RIGHTS RESERVED 7
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A COMPLEX STAKEHOLDER LANDSCAPE
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Pharmaceutical Companies- Compliance
- Dosing
- Delivery
- Interaction between drug
effects and device therapy
Regulators- Healthcare policy
- Medical research
- Regulatory compliance
- Consumer rights
Multinational Medtech- Data Connectivity
- Diagnosis
- Clinical Decision Support
- Big Data
- Proprietary platforms
- Patient & provider interfaces
- Consumer reach
Public and Private Payers- Patient education
- Disease management
- Fraud prevention
- Risk management
- Social media data
Employers- Benefit Plan Design
- Health and Wellness Programs
Transaction Services- Claims processing
- Banks: health savings
- Accounts and payments
Adapted from: Fraser, H., Jayadewa, C., Goodwyn, J., Mooiweer, P., Gordon, D., Piccone, J., Analytics across the ecosystem: A prescription for optimising healthcare outcomes (2013) IBM Global Business Services, Life Sciences & Healthcare, NY, USA.
Government Policy- Health programs
- Health data for decision
making
- Reimbursement
Life Sciences- Clinical Development
- Clinical Trials
- Medication Compliance
- Medical Devices
- Consumer relationships
- Wellness and Care services
Public Health- Pandemic Readiness
- Vaccine inventory and
distribution
- Sanitation and public safety
- Healthy lifestyles and diet
- Living with chronic disease
Healthcare Providers- Electronic Medical Records
- Health information exchange
- Patient ID and eHealth
- Social Media data
- Telehealth
- Hospital in the Home
Medical Research Centres- Clinical Research
- Cohort Studies
- Clinical Trials
Retail Clinics- Consumer Services
Pharmacies- E- prescribing
- New Services
Health clubs- Health and wellness programs
Patient &Consumers- Social media data
- Personal Health
records
- Medical device
tracking data
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DIGITAL HEALTH SECTOR
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Digital Health is one of the fastest growing investment classes globally. In 2017, US$11.5 Billion was
invested across 10 sub sectors. (Source: StartUp Health Insights End of Year 2017 Report)
Total Invested In Digital Health Year on Year Top 10 Most Active Sub-Sectors 2017
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ABOUT ANDHEALTH
10© ANDHEALTH LIMITED | ALL RIGHTS RESERVED
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ANDHEALTH| AN INDUSTRY LED SOLUTION
VISION
To create a world leading, national, integrated ecosystem for the development, commercialisation and
implementation of evidence-based digital health technologies.
MISSION
ANDHealth’s mission is to create an integrated and connected ecosystem for the development &
commercialisation of evidence-based digital health products by bringing together participants from the
medtech and pharmaceutical sectors with a broader
stakeholder group drawn from a wide range of sectors involved in the evolution of digital health technologies, and by putting in place the key elements required to create a
cohesive and collaborative digital health industry.
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ANDHEALTH CONSORTIUM MEMBERS
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ANDHEALTH ECOSYSTEM PARTNERS
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WHY ARE WE UNIQUE?
Australia’s only industry-led, mid-stage accelerator
Dedicated solely to digital health & informed by industry leaders with proven backgrounds
Non-Profit – no downside to companies participating – utilisation of taxpayer support and industry
contributions to build capabilities within Australia
No transfer of equity into offshore hands or overlay of complex legal arrangements by micro-VC funds
(Conscious of the cost of capital in subsequent rounds)
Partners, key staff & advisors meet strict criteria – Must demonstrate hands-on experience in:
Product development of a market ready product which is evidenced based and has a sustainable
business model;
Negotiation of a significant (preferably international) commercial agreement between two or
more parties, where at least one party is from industry; and/ or
Raising of a significant amount of capital for one or more companies.
Australia’s only female founded, female led and majority female governed accelerator program
International connectivity through HealthXL, and significant international networks of member
organisations
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ABOUT THE ECOSYSTEM
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CHALLENGES FOR INVESTORS
Early-mid-stage Venture Capitalists and professional (institutional) investors have internal processes & skill-sets designed to assess and minimise risk.
Digital health technologies pose a unique set of challenges for investors as traditional frameworks and assessment criteria don’t necessarily fit.
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Technology Investors
Typically Invest in:
- Agile, fast to market companies
- In revenue with exponential revenue growth forecasts
- Large markets, rapid globalization
- Discounted Cash Flow or MRR driven Valuation
- Often B2C business models
Struggle with:
- Long development timelines
- Complex Regulatory Landscape
- Limited Product Iteration
- Long Sales Timelines
- Slow Revenue Growth
- Complex Business Models - Who Pays?
Healthcare Investors
Typically Invest in:
- Strong Intellectual Property Position
- Strong Clinical Data
- Known Development/ Regulatory Path
- Value Inflection Points driven by Milestones
- Comparable Exit driven Valuation
- Usually B2B Business Models
- Often no revenues for life of investment
Struggle with:
- Minimal or partial patent protection
- Unclear & shifting regulatory landscape
- Lack of clinical data
- Understanding of IT based offerings
- Lack of significant number of comparable exits for valuation
- Identification & validation of a clear business model – who will pay?
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ANDHEALTH FILLS A CRITICAL GAP IN THE ECOSYSTEM
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Early Stage Industry
Agnostic Accelerators &
Pitch Contests
Ideation|ConceptCreation|Lean Canvas
Product Market Fit| Voice of Customer
Clinical Validation | Evidence | Commercial Validation| Investment/ partnership readiness
Investment
International Commercialisation
Commercial Partnerships
International Commercialisation & expansion
Industry Specific Accelerators
Product Definition| Early Product Market Fit | MVP
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ANDHEALTH
Australia’s only industry-led accelerator program dedicated to digital
health
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ABOUT ANDHEALTH+
19
•Eligible: Mid-stage evidence
based digital health
technologies which have
achieved proof-of-principle
•ANDHealth supports a project
to progress the technology
towards investment
5 Projects
each round
•Experienced Advisory & Support team
•$60k of funding for project expenses,
plus significant in-kind support
•Potential additional project funding
where Partners & Collaborators are
interested in investing
ANDHealth+
provides•NO equity allocation required.
•NO ownership rights to project
IP
•Access to advice from people
with proven track record in
digital health
commercialisation
•NO catch!ANDHealth+
advantage
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ENABLING VALUE CREATION THROUGH COLLABORATION
Multi-Disciplinary team of proven expertise around
each cohort company
Focus is on tailored support to create value/ enable
a step change in outcomes
Projects are company driven – but informed by
expertise
Objective is to enhance operations, not dictate
activities
Seek projects where involvement will have a
definitive impact (help where help is needed)
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Attraction Connectivity
PurposeLeverage
Relationship
CapitalHuman Capital
Synergistic
CapitalStructural
Capital
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TYPES OF PROJECTS
Types of projects might include:
Product Verification and Validation
Clinical Evidence and Outcomes
➢ Efficacy in a clinical or industry setting and
voice of customer
Commercial Strategy, Evidence and Outcomes
➢ Health Economics and Business Validation
in the Health Setting
➢ Regulatory Certification or roadmap to
certification (eg, TGA, FDA)
➢ Reimbursement and Pricing Strategy
Examples of previously funded projects:
Strategy work for international market entry
Health economics report
Reimbursement strategy
Regulatory advice
Direct costs of a pivotal pilot study
Third party expert validation of product
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ANDHEALTH | 2017 COHORT
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ANDHealth 2017
at a glance
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55 applications
10 companies short listed
6 cohort companies selected
Applications from every state + the ACT
Selection Panel of 12 industry leaders
20 hours of applicant support calls
33% female applicants
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2017 COHORT COMPANIES
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DoseMe is precision dosing software specifically developed for
clinical use at the point-of-care. The DoseMe platform significantly
improves dosing accuracy and patient outcomes by providing real-
time dose-related decision support to enable precision medicine
using readily available patient data.
COHORT COMPANY
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• 2 new employees• 2018, 12 to 82 live sites• 7x increase in patient numbers
from Jan to March• Successfully launched into infusion
centre market in United States
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COHORT COMPANY
Atmo Biosciences’ connected electronic pill sensor provides
real time gas information for gut health diagnosis and
management.
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• Industry CEO• Established external clinical advisory board• Human trial outcomes published in Nature• Capital raising strategy finalised with early
engagement with Investors for seed round funding
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COHORT COMPANY
Perx is changing the way people and healthcare
organisations approach medication – forming positive
habits through fun games and memorable rewards.
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• Closed seed round of $780,000 • Launched 2 commercial pilots across
pharmaceuticals and public health• Hired 3 new full-time employees and 1
new part-time employee
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Seer Medical transfers epilepsy diagnosis from the hospital to the
home, using wearable devices and cloud computing.
COHORT COMPANY
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• Expanded services into TAS and NSW• Hired 8 new employees• Released a secondary product in
wearable epilepsy event logging to assist with long term monitoring and management.
• Entered into 3 clinical trial service agreements
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SkinView provides a point of care solution for diagnosis
of skin cancer and skin lesions which transforms a
smartphone into a diagnostic dermatoscope.
COHORT COMPANY
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• Market Voice of Customer study complete• Business strategy workshops with sector
leaders• Third Party review of hardware complete• Third Party review of Software and AI
complete
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MCRI AllergyPal is a digital management tool for
parents and carers of children with food allergies. It
is changing the way allergy information is shared to
reduce anxiety and improve care in the event of an
allergic reaction.
COHORT COMPANY
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• Hired an industry CEO• Beta roll out complete• Product launching next week as
part of national food allergy week