digital health: clinical evidence and patient...

ANDHealth and Novartis Present

Digital Health:

Clinical Evidence and Patient Impact

ANDHealth Members::

#ANDHealthSummit |@ANDHealthAU | @Novartis

STRENGTHENING AUSTRALIA’S

DIGITAL HEALTH SECTOR

BRONWYN LE GRICE

CO-FOUNDER | CEO | MANAGING DIRECTOR,

ANDHEALTH

DE-RISKING DIGITAL HEALTH

An Industry Led Model Supporting the Commercialisation of

Evidence-Based Digital Health ProductsBronwyn Le Grice

Managing Director | Co-Founder

ANDHealth

© ANDHEALTH LIMITED | ALL RIGHTS RESERVED

ABOUT DIGITAL HEALTH

4© ANDHEALTH LIMITED | ALL RIGHTS RESERVED

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.

© ANDHEALTH LIMITED | ALL RIGHTS RESERVED 5

Source: http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm

http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm

DEFINING DIGITAL HEALTH II


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

http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm

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

https://medium.com/@sebastianhrw/pharma-should-make-some-bold-moves-in-digital-health-54561c3bf9eb

A COMPLEX STAKEHOLDER LANDSCAPE


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

DIGITAL HEALTH SECTOR


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

https://www.startuphealth.com/insights/

ABOUT ANDHEALTH


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.


ANDHEALTH CONSORTIUM MEMBERS


ANDHEALTH ECOSYSTEM PARTNERS


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


ABOUT THE ECOSYSTEM


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.


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?

ANDHEALTH FILLS A CRITICAL GAP IN THE ECOSYSTEM

© ANDHEALTH LIMITED | ALL RIGHTS RESERVED17

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

ANDHEALTH

Australia’s only industry-led accelerator program dedicated to digital

health


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


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)


Attraction Connectivity

PurposeLeverage

Relationship

CapitalHuman Capital

Synergistic

CapitalStructural

Capital

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


ANDHEALTH | 2017 COHORT


ANDHealth 2017

at a glance


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

2017 COHORT COMPANIES


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

© ANDHEALTH LIMITED | COMMERCIAL IN CONFIDENCE 25

• 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

COHORT COMPANY

Atmo Biosciences’ connected electronic pill sensor provides

real time gas information for gut health diagnosis and

management.


• 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

COHORT COMPANY

Perx is changing the way people and healthcare

organisations approach medication – forming positive

habits through fun games and memorable rewards.


• 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

Seer Medical transfers epilepsy diagnosis from the hospital to the

home, using wearable devices and cloud computing.

COHORT COMPANY


• 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

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


• 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

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


• Hired an industry CEO• Beta roll out complete• Product launching next week as

part of national food allergy week

Thank [email protected]

@ANDHealthAU


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