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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters April 2015 MaRS Excellence in Clinical Innovation and Technology Evaluation program CADTH Symposium April 14, 2015 Zayna Khayat I zkhayat@marsdd.com I @ZaynaKhayatzkhayat@marsdd.com

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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters April 2015 Poor pre-market quality clinical trial produces uncertainty Accuracy versus clinical utility for diagnostic tests No prospective economic analysis Research failed to address health system perspectives Me-too technologies Lack of generalizability Inadequate trial design e.g. randomization, concealment, ITT leading to low quality evidence Policy including non-affordability, competing pressures Evidence used to police adoption in isolation from originators of innovation Is HTAs placement too late?

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Pre-Market Partnership formed April 2012 between government, OHTAC, the health system, regulators, academia, clinicians and industry in selection by the health system and protocol design by all Studies funded by industry Streamlines path to adoption of disruptive technologies through a single harmonized process that meets regulatory and reimbursement requirements Process includes evaluation, systematic review, economic analysis and conditions of adoption analysis Housed at MaRS, a neutral innovation space (MaRS) which provides flow- through of funds, secretariat, coordinating and quality support Executed by 4 academic Methodology Centres working with 24 Research Hospitals EXCITE Overview Excellence in Clinical Innovation and Technical Evaluation

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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters January 2015 Concept Regulation TIME U Pre-MarketPost-Market Cost Effectiveness (CE) Systematic review Effectiveness Obsolescence Diffusion Yes Unconditional No Efficacy Safety Value (CE) Affordability Ethical & societal Post-market conditions E f f e c t i v e n e s s Cost Effectiveness Systematic review Efficacy Safety Value (CE) Affordability Ethical & societal Post-market conditions Reimbursement

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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters April 2015 EXCITE: Parallel value propositions Industry Efficient HTA & decision- making Early engagement prepare infrastructure for adoption Alignment with regulator & 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 policy impacts, publications New methodological challenges Maintain independence Single, harmonized process for regulatory and reimbursement More efficient, economical and mitigates investment risk Earlier feedback on technology Negotiate conditions of adoption pre-launch Academic Centres Payer/HTA Bodies Regulator Citizens: Faster access to health technologies with a strong value proof

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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters April 2015 The EXCITE Collaboration Model Dr. Les Levin, CSO Dr. Zayna Khayat, Director Adel Aziziyeh, Project Manager Lily Lo, Coordinator Advice on science, methodology Allocation of projects Heads of 5 methodology centres Dr. Les Levin, CSO Advise prioritization of technologies Advice on clinical study design Support in conditions of adoption Comprised of implementation sub- committee of OHTAC Management Board Advice, oversight, direction Approve technologies, protocol, budget Senior reps: health, economic development, HTA, AHSCs, industry Review protocols for safety Chair Tony Easty Excellence in complex clinical trial design and execution in collaboration with 24 Research Hospitals Contracted in by EXCITE Design study with industry; Execute and publish the study Early advice on design of the evidence package and study Methodology Centres

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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters Since April 2012, 49 companies applied in 7 Calls for Innovation Technologies selected: 9 currently active (1 multinational, 2 US, 1 BC, 5 Ont) 6 under review (to be approved at April 23 board) Publicly discloseable projects are: Home sleep apnea test Renal denervation for hypertension (discontinued) Rna disruption for early prediction of clinical response to chemo in breast cancer Electrical stimulation for voluntary upper limb movements in stroke Current state of the EXCITE program November 2014

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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters Whats next? 1. Conditions of Adoption To read the full report visit www.ohic..cawww.ohic..ca April 2015 Projected Adoption Rates Infrastructure Readiness Reimbursement Considerations Economic Projections Knowledge Translation Procurement EXCITE + Office of Health Innovation to work collaboratively to prepare the system

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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters Whats next? 2. Geographic expansion April 2015 EXCITE International Planning Summit (March 27 2015) UK NICE, NHS, regulators, AHSN US FDA, BCBS, Kaiser, Mayo Canada Industry Canada, Health Canada, Federal Innov. Panel Ontario MoHLTC, CAHO Industry small and multinational (Canada, US, UK, NZ)

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DEVELOPING TALENT GROWING VENTURES OPENING MARKETS Our Future Matters April 2015 Zayna Khayat Director zkhayat@marsdd.com Lily Lo Associate llo@marsdd.com Adel Aziziyeh Project Manager aaziziyeh@marsdd.com Les Levin Chief Scientific Officer llevin@marsdd.com For more information visit www.excite.marsdd.comwww.excite.marsdd.com Twitter: #MaRSEXCITE Or contact us at: