DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

MaRS Excellence in Clinical Innovation and Technology Evaluation program

CADTH Symposium April 14 2015

Zayna Khayat I zkhayatmarsddcom I ZaynaKhayat

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

Poor pre-market quality clinical trial produces uncertainty

bull Accuracy versus clinical utility for diagnostic tests

bull No prospective economic analysis

bull Research failed to address health system perspectives

bull Me-too technologies

bull Lack of generalizability

bull Inadequate trial design eg randomizationconcealment ITT ndash leading to low quality evidence

Policy including non-affordability competing pressures

Evidence used to police adoption in isolation from originators of innovation

Is HTArsquos placement too late

Pre-Market Partnership formed April 2012 between government OHTAC the health system regulators academia clinicians and industry in selection by the health system and protocol design by all

Studies funded by industry

Streamlines path to adoption of disruptive technologies through a single harmonized process that meets regulatory and reimbursement requirements

Process includes evaluation systematic review economic analysis and ldquoconditions of adoptionrdquo analysis

Housed at MaRS a neutral innovation space (MaRS) which provides flow-through of funds secretariat coordinating and quality support

Executed by 4 academic Methodology Centres working with 24 Research Hospitals

EXCITE OverviewExcellence in Clinical Innovation and Technical Evaluation

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersJanuary2015

Concept

RegulationTIME

UPre-Market

Post-Market

Cost Effectiveness (CE)

Systematic review

Effectiveness

Obsolescence

Diffusion

Yes

Unconditional No

bull Efficacy Safety

bull Value (CE) Affordability

bull Ethical amp societal

bull Post-market conditions

E f f e c t i v e n e s s

Cost Effectiveness

Systematic review

bull Efficacy Safetybull Value (CE)

Affordabilitybull Ethical amp societalbull Post-market

conditions

Reimbursement

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

EXCITE Parallel value propositions

Industry Efficient HTA amp decision-

making Early engagement ndash prepare

infrastructure for adoption Alignment with regulator amp

broader innovation agenda Could decrease costs

Relevant issues addressed early

Mitigates re-submissions Alignment with health system

and broader innovation agenda

Access to new disruptive technologies ndash policy impacts publications

New methodological challenges Maintain independence

Single harmonized process for regulatory and reimbursement

More efficient economical and mitigates investment risk

Earlier feedback on technology Negotiate conditions of

adoption pre-launch

Academic Centres

PayerHTA Bodies

Regulator

Citizens Faster access to health technologies with a strong value proof

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

The EXCITE Collaboration Model

bull Dr Les Levin CSObull Dr Zayna Khayat Directorbull Adel Aziziyeh Project Managerbull Lily Lo Coordinator

bull Advice on science methodologybull Allocation of projectsbull Heads of 5 methodology centresbull Dr Les Levin CSO

bull Advise prioritization of technologiesbull Advice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-

committee of OHTAC

Management Board

bull Advice oversight directionbull Approve technologies protocol budgetbull Senior reps health economic development

HTA AHSCs industry

bull Review protocols for safetybull Chair Tony Easty

bull Excellence in complex clinical trial design and execution in collaboration with 24 Research Hospitalsbull Contracted in by EXCITE

bull Design study with industry bull Execute and publish the study

bull Early advice on design of the evidence package and study

Methodology Centres

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

bull Since April 2012 49 companies applied in 7 Calls for Innovation

bull Technologies selected

- 9 currently active (1 multinational 2 US 1 BC 5 Ont)

- 6 under review (to be approved at April 23 board)

bull Publicly discloseable projects are

- Home sleep apnea test- Renal denervation for hypertension (discontinued)- Rna disruption for early prediction of clinical

response to chemo in breast cancer- Electrical stimulation for voluntary upper limb

movements in stroke

Current state of the EXCITE program

November 2014

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

April2015

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Office of Health Innovation to work collaboratively to prepare the system

Pre-Market Partnership formed April 2012 between government OHTAC the health system regulators academia clinicians and industry in selection by the health system and protocol design by all

Studies funded by industry

Streamlines path to adoption of disruptive technologies through a single harmonized process that meets regulatory and reimbursement requirements

Process includes evaluation systematic review economic analysis and ldquoconditions of adoptionrdquo analysis

Housed at MaRS a neutral innovation space (MaRS) which provides flow-through of funds secretariat coordinating and quality support

Executed by 4 academic Methodology Centres working with 24 Research Hospitals

EXCITE OverviewExcellence in Clinical Innovation and Technical Evaluation

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersJanuary2015

Concept

RegulationTIME

UPre-Market

Post-Market

Cost Effectiveness (CE)

Systematic review

Effectiveness

Obsolescence

Diffusion

Yes

Unconditional No

bull Efficacy Safety

bull Value (CE) Affordability

bull Ethical amp societal

bull Post-market conditions

E f f e c t i v e n e s s

Cost Effectiveness

Systematic review

bull Efficacy Safetybull Value (CE)

Affordabilitybull Ethical amp societalbull Post-market

conditions

Reimbursement

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

EXCITE Parallel value propositions

Industry Efficient HTA amp decision-

making Early engagement ndash prepare

infrastructure for adoption Alignment with regulator amp

broader innovation agenda Could decrease costs

Relevant issues addressed early

Mitigates re-submissions Alignment with health system

and broader innovation agenda

Access to new disruptive technologies ndash policy impacts publications

New methodological challenges Maintain independence

Single harmonized process for regulatory and reimbursement

More efficient economical and mitigates investment risk

Earlier feedback on technology Negotiate conditions of

adoption pre-launch

Academic Centres

PayerHTA Bodies

Regulator

Citizens Faster access to health technologies with a strong value proof

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

The EXCITE Collaboration Model

bull Dr Les Levin CSObull Dr Zayna Khayat Directorbull Adel Aziziyeh Project Managerbull Lily Lo Coordinator

bull Advice on science methodologybull Allocation of projectsbull Heads of 5 methodology centresbull Dr Les Levin CSO

bull Advise prioritization of technologiesbull Advice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-

committee of OHTAC

Management Board

bull Advice oversight directionbull Approve technologies protocol budgetbull Senior reps health economic development

HTA AHSCs industry

bull Review protocols for safetybull Chair Tony Easty

bull Excellence in complex clinical trial design and execution in collaboration with 24 Research Hospitalsbull Contracted in by EXCITE

bull Design study with industry bull Execute and publish the study

bull Early advice on design of the evidence package and study

Methodology Centres

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

bull Since April 2012 49 companies applied in 7 Calls for Innovation

bull Technologies selected

- 9 currently active (1 multinational 2 US 1 BC 5 Ont)

- 6 under review (to be approved at April 23 board)

bull Publicly discloseable projects are

- Home sleep apnea test- Renal denervation for hypertension (discontinued)- Rna disruption for early prediction of clinical

response to chemo in breast cancer- Electrical stimulation for voluntary upper limb

movements in stroke

Current state of the EXCITE program

November 2014

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

April2015

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Office of Health Innovation to work collaboratively to prepare the system

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersJanuary2015

Concept

RegulationTIME

UPre-Market

Post-Market

Cost Effectiveness (CE)

Systematic review

Effectiveness

Obsolescence

Diffusion

Yes

Unconditional No

bull Efficacy Safety

bull Value (CE) Affordability

bull Ethical amp societal

bull Post-market conditions

E f f e c t i v e n e s s

Cost Effectiveness

Systematic review

bull Efficacy Safetybull Value (CE)

Affordabilitybull Ethical amp societalbull Post-market

conditions

Reimbursement

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

EXCITE Parallel value propositions

Industry Efficient HTA amp decision-

making Early engagement ndash prepare

infrastructure for adoption Alignment with regulator amp

broader innovation agenda Could decrease costs

Relevant issues addressed early

Mitigates re-submissions Alignment with health system

and broader innovation agenda

Access to new disruptive technologies ndash policy impacts publications

New methodological challenges Maintain independence

Single harmonized process for regulatory and reimbursement

More efficient economical and mitigates investment risk

Earlier feedback on technology Negotiate conditions of

adoption pre-launch

Academic Centres

PayerHTA Bodies

Regulator

Citizens Faster access to health technologies with a strong value proof

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

The EXCITE Collaboration Model

bull Dr Les Levin CSObull Dr Zayna Khayat Directorbull Adel Aziziyeh Project Managerbull Lily Lo Coordinator

bull Advice on science methodologybull Allocation of projectsbull Heads of 5 methodology centresbull Dr Les Levin CSO

bull Advise prioritization of technologiesbull Advice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-

committee of OHTAC

Management Board

bull Advice oversight directionbull Approve technologies protocol budgetbull Senior reps health economic development

HTA AHSCs industry

bull Review protocols for safetybull Chair Tony Easty

bull Excellence in complex clinical trial design and execution in collaboration with 24 Research Hospitalsbull Contracted in by EXCITE

bull Design study with industry bull Execute and publish the study

bull Early advice on design of the evidence package and study

Methodology Centres

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

bull Since April 2012 49 companies applied in 7 Calls for Innovation

bull Technologies selected

- 9 currently active (1 multinational 2 US 1 BC 5 Ont)

- 6 under review (to be approved at April 23 board)

bull Publicly discloseable projects are

- Home sleep apnea test- Renal denervation for hypertension (discontinued)- Rna disruption for early prediction of clinical

response to chemo in breast cancer- Electrical stimulation for voluntary upper limb

movements in stroke

Current state of the EXCITE program

November 2014

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

April2015

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Office of Health Innovation to work collaboratively to prepare the system

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

EXCITE Parallel value propositions

Industry Efficient HTA amp decision-

making Early engagement ndash prepare

infrastructure for adoption Alignment with regulator amp

broader innovation agenda Could decrease costs

Relevant issues addressed early

Mitigates re-submissions Alignment with health system

and broader innovation agenda

Access to new disruptive technologies ndash policy impacts publications

New methodological challenges Maintain independence

Single harmonized process for regulatory and reimbursement

More efficient economical and mitigates investment risk

Earlier feedback on technology Negotiate conditions of

adoption pre-launch

Academic Centres

PayerHTA Bodies

Regulator

Citizens Faster access to health technologies with a strong value proof

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

The EXCITE Collaboration Model

bull Dr Les Levin CSObull Dr Zayna Khayat Directorbull Adel Aziziyeh Project Managerbull Lily Lo Coordinator

bull Advice on science methodologybull Allocation of projectsbull Heads of 5 methodology centresbull Dr Les Levin CSO

bull Advise prioritization of technologiesbull Advice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-

committee of OHTAC

Management Board

bull Advice oversight directionbull Approve technologies protocol budgetbull Senior reps health economic development

HTA AHSCs industry

bull Review protocols for safetybull Chair Tony Easty

bull Excellence in complex clinical trial design and execution in collaboration with 24 Research Hospitalsbull Contracted in by EXCITE

bull Design study with industry bull Execute and publish the study

bull Early advice on design of the evidence package and study

Methodology Centres

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

bull Since April 2012 49 companies applied in 7 Calls for Innovation

bull Technologies selected

- 9 currently active (1 multinational 2 US 1 BC 5 Ont)

- 6 under review (to be approved at April 23 board)

bull Publicly discloseable projects are

- Home sleep apnea test- Renal denervation for hypertension (discontinued)- Rna disruption for early prediction of clinical

response to chemo in breast cancer- Electrical stimulation for voluntary upper limb

movements in stroke

Current state of the EXCITE program

November 2014

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

April2015

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Office of Health Innovation to work collaboratively to prepare the system

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future MattersApril2015

The EXCITE Collaboration Model

bull Dr Les Levin CSObull Dr Zayna Khayat Directorbull Adel Aziziyeh Project Managerbull Lily Lo Coordinator

bull Advice on science methodologybull Allocation of projectsbull Heads of 5 methodology centresbull Dr Les Levin CSO

bull Advise prioritization of technologiesbull Advice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-

committee of OHTAC

Management Board

bull Advice oversight directionbull Approve technologies protocol budgetbull Senior reps health economic development

HTA AHSCs industry

bull Review protocols for safetybull Chair Tony Easty

bull Excellence in complex clinical trial design and execution in collaboration with 24 Research Hospitalsbull Contracted in by EXCITE

bull Design study with industry bull Execute and publish the study

bull Early advice on design of the evidence package and study

Methodology Centres

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

bull Since April 2012 49 companies applied in 7 Calls for Innovation

bull Technologies selected

- 9 currently active (1 multinational 2 US 1 BC 5 Ont)

- 6 under review (to be approved at April 23 board)

bull Publicly discloseable projects are

- Home sleep apnea test- Renal denervation for hypertension (discontinued)- Rna disruption for early prediction of clinical

response to chemo in breast cancer- Electrical stimulation for voluntary upper limb

movements in stroke

Current state of the EXCITE program

November 2014

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

April2015

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Office of Health Innovation to work collaboratively to prepare the system

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

bull Since April 2012 49 companies applied in 7 Calls for Innovation

bull Technologies selected

- 9 currently active (1 multinational 2 US 1 BC 5 Ont)

- 6 under review (to be approved at April 23 board)

bull Publicly discloseable projects are

- Home sleep apnea test- Renal denervation for hypertension (discontinued)- Rna disruption for early prediction of clinical

response to chemo in breast cancer- Electrical stimulation for voluntary upper limb

movements in stroke

Current state of the EXCITE program

November 2014

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

April2015

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Office of Health Innovation to work collaboratively to prepare the system

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

Whatrsquos next 1 Conditions of Adoption

To read the full report visit wwwohicca

April2015

Projected Adoption Rates

Infrastructure Readiness

Reimbursement Considerations

Economic Projections

Knowledge Translation

Procurement

EXCITE + Office of Health Innovation to work collaboratively to prepare the system

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters

Whatrsquos next 2 Geographic expansion

April 2015

EXCITE International Planning Summit (March 27 2015)

bull UK ndash NICE NHS regulators AHSN

bull US ndash FDA BCBS Kaiser Mayohellipbull Canada ndash Industry Canada

Health Canada Federal Innov Panel

bull Ontario ndash MoHLTC CAHObull Industry ndash small and

multinational (Canada US UK NZ)

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters April2015

Zayna KhayatDirectorzkhayatmarsddcom

Lily LoAssociatellomarsddcom

Adel AziziyehProject Manageraaziziyehmarsddcom

Les LevinChief Scientific Officerllevinmarsddcom

For more information visit wwwexcitemarsddcomTwitter MaRSEXCITE

Or contact us at

DE

VE

LO

PI

NG

T

AL

EN

T

bull

GR

OW

IN

G

VE

NT

UR

ES

bull

OP

EN

IN

G

MA

RK

ET

S

Our Future Matters April2015

Zayna KhayatDirectorzkhayatmarsddcom

Lily LoAssociatellomarsddcom

Adel AziziyehProject Manageraaziziyehmarsddcom

Les LevinChief Scientific Officerllevinmarsddcom

For more information visit wwwexcitemarsddcomTwitter MaRSEXCITE

Or contact us at