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12
DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Visit us at marsdd.com MaRS Health Innovation Platform APRIL 11, 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation Lead, Director, MaRS EXCITE MaRS Discovery District [email protected] @ZaynaKhayat

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Page 1: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Visit us at marsddcom

MaRS Health Innovation Platform

A P R I L 1 1 2 0 1 6

Zayna Khayat PhD Sr Advisor Health System Innovation Lead Director MaRS EXCITE MaRS Discovery District zkhayatmarsddcom ZaynaKhayat

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Hurdles to full value capture from med tech

6 Adoption

Patients accessing

technology

Time

1 Evidence

2 Licensing

3 HTA Coverage decision

4 Funding fee codes hellip

5 Procurement

(+ Obsolescence of old)

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Impact Potential

Gravity of unmet need

Degree of

ldquoNewnessrdquo

Vs Std of Care

MaRS Health Innovation Platform

helping improve med tech value proof

Pay-for-performance vehicles in healthcare

Liberating health data flow to

enhance med tech value

Pull model for health technology adoption and diffusion

Building a competitive global med tech industry

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

A new paradigm for Evidence-to-Policy-to-Practice

Reframe Innovationindustry - part of the health system not apart from it

Shortfalls of how breakthrough tech gets to patients today

ndash Regulation and reimbursement processes discrete sequential

ndash Evidence used to ldquopolicerdquo adoption following regulation ndash too late expensive inefficient

ndash Even if positive funding decision lowslowno uptake

ndash Canadian technology originators bypassing home market

EXCITE Harmonized pre-market process addresses regulatory coverage amp adoption concerns hellip efficiently

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The Big Idea Start HTA Earlier hellip

In Collaboration with Payers amp Regulators

Netherlands

NHS

Ontario + UK + US

bull Qualitative research ndash patients clinicians hellip bull Quantiative ndash theoretical HTA

bull Review of clinical trial design data

~10 US payers

bull Review of clinical trial design bull Review of market access plan

bull Design + execute pivotal study that reflects hellip bull hellip Needs of payers amp regulators lsquocuz they are involved at front end

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The EXCITE Model A new Paradigm

Regulator TIME

U

Pre-Launch Post-Launch

RampD

Obsolescence

Yes -Diffusion

Payer

No

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Health System

Academic HTA

Regulators

Industry

+ 24 research hospitals

+ gt30 community health orgs + 15 others

EXCITE A Collaboration on Steroids

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

Examples of Projects in the Program

P U B L I C LY D I S C L O S A B L E P R O J E C T S A R E hellip

bull Bresotec ndash Home sleep apnea diagnostic test

bull Medtronic ndash Renal denervation for hypertension (discontinued)

bull Rna Diagnostics ndash Rna disruption for early prediction of response to chemo in breast cancer

bull MyndTec ndash Electrical stimulation to restore voluntary upper limb movements post stroke

bull Aegis ndash Left atrial appendage closure device for stroke reduction in patients with atrial fibrillation

bull AssureRx Health- primary care pharmacogenomics test for schizophrenia and major depressive disorder

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 2: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Hurdles to full value capture from med tech

6 Adoption

Patients accessing

technology

Time

1 Evidence

2 Licensing

3 HTA Coverage decision

4 Funding fee codes hellip

5 Procurement

(+ Obsolescence of old)

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Impact Potential

Gravity of unmet need

Degree of

ldquoNewnessrdquo

Vs Std of Care

MaRS Health Innovation Platform

helping improve med tech value proof

Pay-for-performance vehicles in healthcare

Liberating health data flow to

enhance med tech value

Pull model for health technology adoption and diffusion

Building a competitive global med tech industry

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

A new paradigm for Evidence-to-Policy-to-Practice

Reframe Innovationindustry - part of the health system not apart from it

Shortfalls of how breakthrough tech gets to patients today

ndash Regulation and reimbursement processes discrete sequential

ndash Evidence used to ldquopolicerdquo adoption following regulation ndash too late expensive inefficient

ndash Even if positive funding decision lowslowno uptake

ndash Canadian technology originators bypassing home market

EXCITE Harmonized pre-market process addresses regulatory coverage amp adoption concerns hellip efficiently

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The Big Idea Start HTA Earlier hellip

In Collaboration with Payers amp Regulators

Netherlands

NHS

Ontario + UK + US

bull Qualitative research ndash patients clinicians hellip bull Quantiative ndash theoretical HTA

bull Review of clinical trial design data

~10 US payers

bull Review of clinical trial design bull Review of market access plan

bull Design + execute pivotal study that reflects hellip bull hellip Needs of payers amp regulators lsquocuz they are involved at front end

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The EXCITE Model A new Paradigm

Regulator TIME

U

Pre-Launch Post-Launch

RampD

Obsolescence

Yes -Diffusion

Payer

No

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Health System

Academic HTA

Regulators

Industry

+ 24 research hospitals

+ gt30 community health orgs + 15 others

EXCITE A Collaboration on Steroids

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

Examples of Projects in the Program

P U B L I C LY D I S C L O S A B L E P R O J E C T S A R E hellip

bull Bresotec ndash Home sleep apnea diagnostic test

bull Medtronic ndash Renal denervation for hypertension (discontinued)

bull Rna Diagnostics ndash Rna disruption for early prediction of response to chemo in breast cancer

bull MyndTec ndash Electrical stimulation to restore voluntary upper limb movements post stroke

bull Aegis ndash Left atrial appendage closure device for stroke reduction in patients with atrial fibrillation

bull AssureRx Health- primary care pharmacogenomics test for schizophrenia and major depressive disorder

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 3: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Impact Potential

Gravity of unmet need

Degree of

ldquoNewnessrdquo

Vs Std of Care

MaRS Health Innovation Platform

helping improve med tech value proof

Pay-for-performance vehicles in healthcare

Liberating health data flow to

enhance med tech value

Pull model for health technology adoption and diffusion

Building a competitive global med tech industry

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

A new paradigm for Evidence-to-Policy-to-Practice

Reframe Innovationindustry - part of the health system not apart from it

Shortfalls of how breakthrough tech gets to patients today

ndash Regulation and reimbursement processes discrete sequential

ndash Evidence used to ldquopolicerdquo adoption following regulation ndash too late expensive inefficient

ndash Even if positive funding decision lowslowno uptake

ndash Canadian technology originators bypassing home market

EXCITE Harmonized pre-market process addresses regulatory coverage amp adoption concerns hellip efficiently

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The Big Idea Start HTA Earlier hellip

In Collaboration with Payers amp Regulators

Netherlands

NHS

Ontario + UK + US

bull Qualitative research ndash patients clinicians hellip bull Quantiative ndash theoretical HTA

bull Review of clinical trial design data

~10 US payers

bull Review of clinical trial design bull Review of market access plan

bull Design + execute pivotal study that reflects hellip bull hellip Needs of payers amp regulators lsquocuz they are involved at front end

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The EXCITE Model A new Paradigm

Regulator TIME

U

Pre-Launch Post-Launch

RampD

Obsolescence

Yes -Diffusion

Payer

No

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Health System

Academic HTA

Regulators

Industry

+ 24 research hospitals

+ gt30 community health orgs + 15 others

EXCITE A Collaboration on Steroids

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

Examples of Projects in the Program

P U B L I C LY D I S C L O S A B L E P R O J E C T S A R E hellip

bull Bresotec ndash Home sleep apnea diagnostic test

bull Medtronic ndash Renal denervation for hypertension (discontinued)

bull Rna Diagnostics ndash Rna disruption for early prediction of response to chemo in breast cancer

bull MyndTec ndash Electrical stimulation to restore voluntary upper limb movements post stroke

bull Aegis ndash Left atrial appendage closure device for stroke reduction in patients with atrial fibrillation

bull AssureRx Health- primary care pharmacogenomics test for schizophrenia and major depressive disorder

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 4: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

A new paradigm for Evidence-to-Policy-to-Practice

Reframe Innovationindustry - part of the health system not apart from it

Shortfalls of how breakthrough tech gets to patients today

ndash Regulation and reimbursement processes discrete sequential

ndash Evidence used to ldquopolicerdquo adoption following regulation ndash too late expensive inefficient

ndash Even if positive funding decision lowslowno uptake

ndash Canadian technology originators bypassing home market

EXCITE Harmonized pre-market process addresses regulatory coverage amp adoption concerns hellip efficiently

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The Big Idea Start HTA Earlier hellip

In Collaboration with Payers amp Regulators

Netherlands

NHS

Ontario + UK + US

bull Qualitative research ndash patients clinicians hellip bull Quantiative ndash theoretical HTA

bull Review of clinical trial design data

~10 US payers

bull Review of clinical trial design bull Review of market access plan

bull Design + execute pivotal study that reflects hellip bull hellip Needs of payers amp regulators lsquocuz they are involved at front end

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The EXCITE Model A new Paradigm

Regulator TIME

U

Pre-Launch Post-Launch

RampD

Obsolescence

Yes -Diffusion

Payer

No

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Health System

Academic HTA

Regulators

Industry

+ 24 research hospitals

+ gt30 community health orgs + 15 others

EXCITE A Collaboration on Steroids

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

Examples of Projects in the Program

P U B L I C LY D I S C L O S A B L E P R O J E C T S A R E hellip

bull Bresotec ndash Home sleep apnea diagnostic test

bull Medtronic ndash Renal denervation for hypertension (discontinued)

bull Rna Diagnostics ndash Rna disruption for early prediction of response to chemo in breast cancer

bull MyndTec ndash Electrical stimulation to restore voluntary upper limb movements post stroke

bull Aegis ndash Left atrial appendage closure device for stroke reduction in patients with atrial fibrillation

bull AssureRx Health- primary care pharmacogenomics test for schizophrenia and major depressive disorder

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 5: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The Big Idea Start HTA Earlier hellip

In Collaboration with Payers amp Regulators

Netherlands

NHS

Ontario + UK + US

bull Qualitative research ndash patients clinicians hellip bull Quantiative ndash theoretical HTA

bull Review of clinical trial design data

~10 US payers

bull Review of clinical trial design bull Review of market access plan

bull Design + execute pivotal study that reflects hellip bull hellip Needs of payers amp regulators lsquocuz they are involved at front end

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The EXCITE Model A new Paradigm

Regulator TIME

U

Pre-Launch Post-Launch

RampD

Obsolescence

Yes -Diffusion

Payer

No

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Health System

Academic HTA

Regulators

Industry

+ 24 research hospitals

+ gt30 community health orgs + 15 others

EXCITE A Collaboration on Steroids

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

Examples of Projects in the Program

P U B L I C LY D I S C L O S A B L E P R O J E C T S A R E hellip

bull Bresotec ndash Home sleep apnea diagnostic test

bull Medtronic ndash Renal denervation for hypertension (discontinued)

bull Rna Diagnostics ndash Rna disruption for early prediction of response to chemo in breast cancer

bull MyndTec ndash Electrical stimulation to restore voluntary upper limb movements post stroke

bull Aegis ndash Left atrial appendage closure device for stroke reduction in patients with atrial fibrillation

bull AssureRx Health- primary care pharmacogenomics test for schizophrenia and major depressive disorder

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 6: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

The EXCITE Model A new Paradigm

Regulator TIME

U

Pre-Launch Post-Launch

RampD

Obsolescence

Yes -Diffusion

Payer

No

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Health System

Academic HTA

Regulators

Industry

+ 24 research hospitals

+ gt30 community health orgs + 15 others

EXCITE A Collaboration on Steroids

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

Examples of Projects in the Program

P U B L I C LY D I S C L O S A B L E P R O J E C T S A R E hellip

bull Bresotec ndash Home sleep apnea diagnostic test

bull Medtronic ndash Renal denervation for hypertension (discontinued)

bull Rna Diagnostics ndash Rna disruption for early prediction of response to chemo in breast cancer

bull MyndTec ndash Electrical stimulation to restore voluntary upper limb movements post stroke

bull Aegis ndash Left atrial appendage closure device for stroke reduction in patients with atrial fibrillation

bull AssureRx Health- primary care pharmacogenomics test for schizophrenia and major depressive disorder

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 7: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Health System

Academic HTA

Regulators

Industry

+ 24 research hospitals

+ gt30 community health orgs + 15 others

EXCITE A Collaboration on Steroids

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

Examples of Projects in the Program

P U B L I C LY D I S C L O S A B L E P R O J E C T S A R E hellip

bull Bresotec ndash Home sleep apnea diagnostic test

bull Medtronic ndash Renal denervation for hypertension (discontinued)

bull Rna Diagnostics ndash Rna disruption for early prediction of response to chemo in breast cancer

bull MyndTec ndash Electrical stimulation to restore voluntary upper limb movements post stroke

bull Aegis ndash Left atrial appendage closure device for stroke reduction in patients with atrial fibrillation

bull AssureRx Health- primary care pharmacogenomics test for schizophrenia and major depressive disorder

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 8: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

Examples of Projects in the Program

P U B L I C LY D I S C L O S A B L E P R O J E C T S A R E hellip

bull Bresotec ndash Home sleep apnea diagnostic test

bull Medtronic ndash Renal denervation for hypertension (discontinued)

bull Rna Diagnostics ndash Rna disruption for early prediction of response to chemo in breast cancer

bull MyndTec ndash Electrical stimulation to restore voluntary upper limb movements post stroke

bull Aegis ndash Left atrial appendage closure device for stroke reduction in patients with atrial fibrillation

bull AssureRx Health- primary care pharmacogenomics test for schizophrenia and major depressive disorder

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 9: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

February 2016

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Ontario Office of Chief Health Innovation Strategist work collaboratively to prepare the system infrastructure for adoption bull 1st completed EXCITE evidence package June lsquo16 Home apnea Dx

Factors Affecting Successful Adoption

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 10: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

Whatrsquos next 2 EXCITE International

February 2016

bull Incorporated separate entity (February 2016)

bull Single platform for companies to conduct multi-jurisdictional harmonized clinical trials amp early HTA

bull Starting with UK US Canada NZ

bull Next summit June 23 MaRS

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 11: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters

EXCITE INTERNATIONAL

SECRETARIAT

bull Coordinates multinational evaluations for MNEs amp SMEs

bull Facilitates methodologist centre quality frameworks

bull Advisesassists members in setting up local EXCITE ndash like operations

February 2016

International Board

International Scientific Collab

International Leadership Centres

EXCITE International Affiliates

V E R Y P R E L I M I N A R Y

C A N A D A ( M A R S )

Develop accepted frameworks to assist EXCITE International affiliates in their work

U S U K E U R O P E hellip N Z

EXCITE International Working Model

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E

Page 12: MaRS Health Innovation Platform - CADTH.ca · S Visit us at marsdd.com MaRS Health Innovation Platform A P R I L 1 1 , 2016 Zayna Khayat, Ph.D. Sr. Advisor, Health System Innovation

DE

VE

LO

PIN

G T

AL

EN

T bull

GR

OW

ING

VE

NT

UR

ES

bull O

PE

NIN

G M

AR

KE

TS

Our Future Matters February 2016

ZAYNA KHAYAT Director

zkhayatmarsddcom

KAROL KAMECKA Coordinator

kkameckamarsddcom

LIANA DI MARCO Project Manager ldimarcomarsddcom

LES LEVIN Chief Scientific Officer llevinmarsddcom

LILY LO Senior Associate llomarsddcom

F O R M O R E I N F O R M A T I O N V I S I T W W W E X C I T E M A R S D D C O M

T W I T T E R M A R S E X C I T E