mars excite info deck
TRANSCRIPT
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Visit us at marsddcom
MaRS HealthB E C A U S E T H E F U T U R E M A T T E R S
J A N U A R Y 2 0 1 5
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Our Future MattersJanuary
2015
MaRS works with partners to catalyze accelerate scale and diffuse innovation
We help entrepreneurs start and grow successful global companies
Together we help Canada prosper
MaRS Because Our Future MattersBuild the new economy Improve society
Health Energy Work amp Learning Tech
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EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
MaRS Programs amp Services span the innovation continuum
Talent
Individuals Inventions
Ideas
Ventures
High Impact
Companies amp
Initiatives
Systems
Health Systems
and Markets
MaRSrsquo Network Investors Industry Health orgs Policymakers Advisors Prof Services
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
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NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
MaRS Excellence in Clinical Innovation and Technology
Evaluation program
DE
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EN
T bull
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OW
ING
VE
NT
UR
ES
bullO
PE
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AR
KE
TS
Our Future Matters
Ontariorsquos Evidence Revolution Commitment to Evidence in Healthcare
January2015
Ontario Excellent Care for All Act (2010)
The people of Ontario and their Government
bull Will ensure that healthcare providers are supported to plan for and improve the quality of care they deliver based on the best available scientific evidence(HQO formed to promulgate quality-based evidence)
Drummond Report (2012)
bull (Healthcare) Policies should be based on evidence that provides guidance on what services procedures devices and drugs are effective efficient and eligible for public funding
Ontario Government Budget (2012)
bull Evidence will drive decisions on funding new and existing procedures The government is committed to funding only those services that are supported by medical evidence
bull The government will accelerate the evidence-based approach to care by building on the mandate of Health Quality Ontario (HQO)
DE
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AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Dealing with Uncertainty ndash Field Evaluation
January2015
bull Post-market assessment of technology performance in the real world
through primary data gathering
bull Improves decision making prior to long-term commitment through
appropriate adoption
bull Designed to inform policy and funded by government
bull Alternative is passive diffusion and intuitive decision making
bull Completed 19 and 19 ongoing Ten CEDs significantly impacted policy
decision making and published in peer reviewed journals
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Whatrsquos Wrong with the Status Quo
January2015
bull Evidence based analysis (EBA) is used to police the adoption of health
technologies -when it is too late to address relevance or make changes
bull High rejection rates (OHTAC at 48) reflects poor quality research in the
pre-market space
bull Patents for non-drug technologies allow market dominance for only plusmn 18
months ndash need to evaluate and get to market quickly Compounds the
problem
bull Increasing focus on post market comparative effectiveness will continue to
grow
bull We are stifling innovation by increasing risk to investors and innovators
bull Why use evidence to criticize rather than to drive innovation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
bull 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 randomization
concealment ITT ndash leading to low quality evidence
bull Policy including non-affordability
competing pressures
bull Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
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PIN
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AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
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PIN
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AL
EN
T bull
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OW
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ES
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Our Future MattersJanuary
2015
The Application Process
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Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
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Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
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Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
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Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
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Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
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bullO
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G M
AR
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Our Future MattersJanuary
2015
MaRS works with partners to catalyze accelerate scale and diffuse innovation
We help entrepreneurs start and grow successful global companies
Together we help Canada prosper
MaRS Because Our Future MattersBuild the new economy Improve society
Health Energy Work amp Learning Tech
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
MaRS Programs amp Services span the innovation continuum
Talent
Individuals Inventions
Ideas
Ventures
High Impact
Companies amp
Initiatives
Systems
Health Systems
and Markets
MaRSrsquo Network Investors Industry Health orgs Policymakers Advisors Prof Services
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
MaRS Excellence in Clinical Innovation and Technology
Evaluation program
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Ontariorsquos Evidence Revolution Commitment to Evidence in Healthcare
January2015
Ontario Excellent Care for All Act (2010)
The people of Ontario and their Government
bull Will ensure that healthcare providers are supported to plan for and improve the quality of care they deliver based on the best available scientific evidence(HQO formed to promulgate quality-based evidence)
Drummond Report (2012)
bull (Healthcare) Policies should be based on evidence that provides guidance on what services procedures devices and drugs are effective efficient and eligible for public funding
Ontario Government Budget (2012)
bull Evidence will drive decisions on funding new and existing procedures The government is committed to funding only those services that are supported by medical evidence
bull The government will accelerate the evidence-based approach to care by building on the mandate of Health Quality Ontario (HQO)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Dealing with Uncertainty ndash Field Evaluation
January2015
bull Post-market assessment of technology performance in the real world
through primary data gathering
bull Improves decision making prior to long-term commitment through
appropriate adoption
bull Designed to inform policy and funded by government
bull Alternative is passive diffusion and intuitive decision making
bull Completed 19 and 19 ongoing Ten CEDs significantly impacted policy
decision making and published in peer reviewed journals
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Whatrsquos Wrong with the Status Quo
January2015
bull Evidence based analysis (EBA) is used to police the adoption of health
technologies -when it is too late to address relevance or make changes
bull High rejection rates (OHTAC at 48) reflects poor quality research in the
pre-market space
bull Patents for non-drug technologies allow market dominance for only plusmn 18
months ndash need to evaluate and get to market quickly Compounds the
problem
bull Increasing focus on post market comparative effectiveness will continue to
grow
bull We are stifling innovation by increasing risk to investors and innovators
bull Why use evidence to criticize rather than to drive innovation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
bull 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 randomization
concealment ITT ndash leading to low quality evidence
bull Policy including non-affordability
competing pressures
bull Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
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AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
MaRS Programs amp Services span the innovation continuum
Talent
Individuals Inventions
Ideas
Ventures
High Impact
Companies amp
Initiatives
Systems
Health Systems
and Markets
MaRSrsquo Network Investors Industry Health orgs Policymakers Advisors Prof Services
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
MaRS Excellence in Clinical Innovation and Technology
Evaluation program
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Ontariorsquos Evidence Revolution Commitment to Evidence in Healthcare
January2015
Ontario Excellent Care for All Act (2010)
The people of Ontario and their Government
bull Will ensure that healthcare providers are supported to plan for and improve the quality of care they deliver based on the best available scientific evidence(HQO formed to promulgate quality-based evidence)
Drummond Report (2012)
bull (Healthcare) Policies should be based on evidence that provides guidance on what services procedures devices and drugs are effective efficient and eligible for public funding
Ontario Government Budget (2012)
bull Evidence will drive decisions on funding new and existing procedures The government is committed to funding only those services that are supported by medical evidence
bull The government will accelerate the evidence-based approach to care by building on the mandate of Health Quality Ontario (HQO)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Dealing with Uncertainty ndash Field Evaluation
January2015
bull Post-market assessment of technology performance in the real world
through primary data gathering
bull Improves decision making prior to long-term commitment through
appropriate adoption
bull Designed to inform policy and funded by government
bull Alternative is passive diffusion and intuitive decision making
bull Completed 19 and 19 ongoing Ten CEDs significantly impacted policy
decision making and published in peer reviewed journals
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Whatrsquos Wrong with the Status Quo
January2015
bull Evidence based analysis (EBA) is used to police the adoption of health
technologies -when it is too late to address relevance or make changes
bull High rejection rates (OHTAC at 48) reflects poor quality research in the
pre-market space
bull Patents for non-drug technologies allow market dominance for only plusmn 18
months ndash need to evaluate and get to market quickly Compounds the
problem
bull Increasing focus on post market comparative effectiveness will continue to
grow
bull We are stifling innovation by increasing risk to investors and innovators
bull Why use evidence to criticize rather than to drive innovation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
bull 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 randomization
concealment ITT ndash leading to low quality evidence
bull Policy including non-affordability
competing pressures
bull Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
MaRS Excellence in Clinical Innovation and Technology
Evaluation program
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Ontariorsquos Evidence Revolution Commitment to Evidence in Healthcare
January2015
Ontario Excellent Care for All Act (2010)
The people of Ontario and their Government
bull Will ensure that healthcare providers are supported to plan for and improve the quality of care they deliver based on the best available scientific evidence(HQO formed to promulgate quality-based evidence)
Drummond Report (2012)
bull (Healthcare) Policies should be based on evidence that provides guidance on what services procedures devices and drugs are effective efficient and eligible for public funding
Ontario Government Budget (2012)
bull Evidence will drive decisions on funding new and existing procedures The government is committed to funding only those services that are supported by medical evidence
bull The government will accelerate the evidence-based approach to care by building on the mandate of Health Quality Ontario (HQO)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Dealing with Uncertainty ndash Field Evaluation
January2015
bull Post-market assessment of technology performance in the real world
through primary data gathering
bull Improves decision making prior to long-term commitment through
appropriate adoption
bull Designed to inform policy and funded by government
bull Alternative is passive diffusion and intuitive decision making
bull Completed 19 and 19 ongoing Ten CEDs significantly impacted policy
decision making and published in peer reviewed journals
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Whatrsquos Wrong with the Status Quo
January2015
bull Evidence based analysis (EBA) is used to police the adoption of health
technologies -when it is too late to address relevance or make changes
bull High rejection rates (OHTAC at 48) reflects poor quality research in the
pre-market space
bull Patents for non-drug technologies allow market dominance for only plusmn 18
months ndash need to evaluate and get to market quickly Compounds the
problem
bull Increasing focus on post market comparative effectiveness will continue to
grow
bull We are stifling innovation by increasing risk to investors and innovators
bull Why use evidence to criticize rather than to drive innovation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
bull 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 randomization
concealment ITT ndash leading to low quality evidence
bull Policy including non-affordability
competing pressures
bull Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Ontariorsquos Evidence Revolution Commitment to Evidence in Healthcare
January2015
Ontario Excellent Care for All Act (2010)
The people of Ontario and their Government
bull Will ensure that healthcare providers are supported to plan for and improve the quality of care they deliver based on the best available scientific evidence(HQO formed to promulgate quality-based evidence)
Drummond Report (2012)
bull (Healthcare) Policies should be based on evidence that provides guidance on what services procedures devices and drugs are effective efficient and eligible for public funding
Ontario Government Budget (2012)
bull Evidence will drive decisions on funding new and existing procedures The government is committed to funding only those services that are supported by medical evidence
bull The government will accelerate the evidence-based approach to care by building on the mandate of Health Quality Ontario (HQO)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Dealing with Uncertainty ndash Field Evaluation
January2015
bull Post-market assessment of technology performance in the real world
through primary data gathering
bull Improves decision making prior to long-term commitment through
appropriate adoption
bull Designed to inform policy and funded by government
bull Alternative is passive diffusion and intuitive decision making
bull Completed 19 and 19 ongoing Ten CEDs significantly impacted policy
decision making and published in peer reviewed journals
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Whatrsquos Wrong with the Status Quo
January2015
bull Evidence based analysis (EBA) is used to police the adoption of health
technologies -when it is too late to address relevance or make changes
bull High rejection rates (OHTAC at 48) reflects poor quality research in the
pre-market space
bull Patents for non-drug technologies allow market dominance for only plusmn 18
months ndash need to evaluate and get to market quickly Compounds the
problem
bull Increasing focus on post market comparative effectiveness will continue to
grow
bull We are stifling innovation by increasing risk to investors and innovators
bull Why use evidence to criticize rather than to drive innovation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
bull 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 randomization
concealment ITT ndash leading to low quality evidence
bull Policy including non-affordability
competing pressures
bull Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Dealing with Uncertainty ndash Field Evaluation
January2015
bull Post-market assessment of technology performance in the real world
through primary data gathering
bull Improves decision making prior to long-term commitment through
appropriate adoption
bull Designed to inform policy and funded by government
bull Alternative is passive diffusion and intuitive decision making
bull Completed 19 and 19 ongoing Ten CEDs significantly impacted policy
decision making and published in peer reviewed journals
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Whatrsquos Wrong with the Status Quo
January2015
bull Evidence based analysis (EBA) is used to police the adoption of health
technologies -when it is too late to address relevance or make changes
bull High rejection rates (OHTAC at 48) reflects poor quality research in the
pre-market space
bull Patents for non-drug technologies allow market dominance for only plusmn 18
months ndash need to evaluate and get to market quickly Compounds the
problem
bull Increasing focus on post market comparative effectiveness will continue to
grow
bull We are stifling innovation by increasing risk to investors and innovators
bull Why use evidence to criticize rather than to drive innovation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
bull 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 randomization
concealment ITT ndash leading to low quality evidence
bull Policy including non-affordability
competing pressures
bull Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Whatrsquos Wrong with the Status Quo
January2015
bull Evidence based analysis (EBA) is used to police the adoption of health
technologies -when it is too late to address relevance or make changes
bull High rejection rates (OHTAC at 48) reflects poor quality research in the
pre-market space
bull Patents for non-drug technologies allow market dominance for only plusmn 18
months ndash need to evaluate and get to market quickly Compounds the
problem
bull Increasing focus on post market comparative effectiveness will continue to
grow
bull We are stifling innovation by increasing risk to investors and innovators
bull Why use evidence to criticize rather than to drive innovation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
bull 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 randomization
concealment ITT ndash leading to low quality evidence
bull Policy including non-affordability
competing pressures
bull Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
bull 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 randomization
concealment ITT ndash leading to low quality evidence
bull Policy including non-affordability
competing pressures
bull Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Can We Better Streamline the Path to Market
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
bull Design
bull Prototyping
bull Effectiveness
and safety
testing in
models
Clinical
bull Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
bull Application to
Health
Canada for
Licenses
approving
saleuse
Patients have
access to device
Adoptionlisting
bull Health
technology
appraisal for
reimbursement
and adoption
decision-
making
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Pull model for innovation
EXCITE is a world first partnership between government the healthcare system academia clinicians and industry launched in late 2011
At the end of the program technology innovators receive a high quality EXCITE core evidentiary bundle they can use for both regulatory (Health Canada) licensing and an application to the payer [Ontario Health Technology Advisory Committee (OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term Care and other reimbursement and purchasing reviewers
As a result relevant disruptive effective health technologies can get to market faster for improved health outcomes ndash in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator
For more information see httpexcitemarsddcom
Excellence in Clinical Innovation and Technology Evaluation
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Value of EXCITE
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 ofadoption pre-launch
Academic CROs
PayerHTA Bodies
EXCITE
Regulator
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Concept
RegulationTIME
U
Pre-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
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The EXCITE Collaboration Model
bullDr Les Levin CSObullDr Zayna Khayat DirectorbullAdel Aziziyeh Project Managerbull Lily Lo Coordinator
bullAdvice on science methodologybullAllocation of projectsbullHeads of 6 methodology centresbullDr Les Levin CSO
bullAdvise prioritization of technologiesbullAdvice on clinical study designbull Support in conditions of adoptionbull Comprised of implementation sub-
committee of OHTAC
Management Board
bullAdvice oversight directionbullApprove technologies protocol budgetbull Senior reps health economic development
HTA AHSCs industry
bullReview 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
bullDesign study with industry Execute and publish the study
bull Early advice on design of the evidence package and study
Methodology Centres
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
TORONTO
OTTAWA
METHODS CENTRE
TORONTO
HAMILTON
TORONTO
bull MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology
health technology
assessment and in
conducting complex multi-
centre trials with proven
capacity for data collection
synthesis and reporting
bull 6 MCs are engaged by
EXCITE
bull They are responsible for
overseeing the design and
execution of EXCITE
studies sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilitiesexperience to
complete evaluations
successfully
In process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE analysis packages
Assess usabilityhuman factors Develop education system for training
end users Investigate patient preferences Analyze factors influencing of uptake Develop a registry for tracking post-
adoption effectiveness + long-term safety
Knowledge transfer
Field evaluation Systematic Review Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
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OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
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AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
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PIN
G T
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T bull
GR
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bullO
PE
NIN
G M
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Our Future MattersJanuary
2015
Good
Fit
Robust Study
Design
Strong
Evidence
Evaluation
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators- Multinational
- Small and
Medium
enterprises
Regulatory
LicensingReimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board decision
Exploratory Meeting
Proposal Approval Contract
Execution
First Patient Enrollment
Apply
DE
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UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
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PIN
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EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
EXCITE Selection Criteria
bull Applicants must submit an executive summary and all
relevant reports articles and materials related to the
technology
bull Health technologies are prioritized for participation in
EXCITE based on the following criteria
o Relevance to the needs of the health system
o Disruptive potential (ie the promise of substantially better
clinical outcomes including safety andor substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario Canada (if relevant)
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
The Application Process
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
The Contract Framework and Money Flow Process
January2015
MaRS EXCITE
Methodological Centre
Technology Innovator
A B
C
D-X
Participating Sites
A Participation Agreement MaRS EXCITE and MC
B Participation Agreement MaRS and Company
C Research Agreement MC and Company
D-X Subcontracts MC and participating or sub-contracted sites
Secretariat
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Conditions of Adoption
Projected Adoption Rates
Infrastructure Readiness
Reimbursement Considerations
Economic Projections
Knowledge Translation
Procurement
Projected volumes incidence rates and target population
consequences of optimal or minimal adoption
End-user training requirements
Human resource requirements
Facilities requirements
OHIP Fee code adjustments
MOHLTC + OMA
Downstream costs avoided Impact on health system
costs in optimal and min adoption
Cost Effective analysis
KT toolkits specific to each technology
Informing healthcare professionals
Consider non-price factors
Collaboration between industry and hospitals
EXCITE team helps define and negotiate
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
Examples of Participating Companies
January2015
Pg 10
Apnea Dx Rna Diagnostics and MyndTec are currently being evaluated in the field in Ontario Results will be available for a reimbursement decision in 2016
Home sleep apnea diagnosis device
Rna Disruption Assay (RDA) for early prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device for hypertension
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the Ontario Health Innovation Council proposed a four-year $20 million Health Technology Innovation Evaluation Fund to support pre-market evaluations and early adoption of home ndashgrown innovative health technologies
The fund will be managed by a the Office of the Chief Innovation Strategist and will collaborate with Innovation Brokers like EXCITE that will be a single point of access to health system decision makers test sites and funding for development and commercialization of innovative health technologies
To read the full report visit wwwohicca
November 2014
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
KE
TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at
DE
VE
LO
PIN
G T
AL
EN
T bull
GR
OW
ING
VE
NT
UR
ES
bullO
PE
NIN
G M
AR
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TS
Our Future MattersJanuary
2015
Zayna Khayat
Program Director
zkhayatmarsddcom
Lily Lo
Associate
llomarsddcom
Adel Aziziyeh
Project Manager
aaziziyehmarsddcom
Les Levin
Chief Scientific Officer
llevinmarsddcom
For more information visit wwwexcitemarsddcomTwitter marsexcite
Or contact us at