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MaRS EXCITE Info Deck
- 1. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Visit us at marsdd.com MaRS Health B 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
- 2. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 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 Matters Build the new economy. Improve society. Health Energy Work & Learning Tech
- 3. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 MaRS Programs & Services span the innovation continuum Talent Individuals, Inventions, Ideas Ventures High Impact Companies & Initiatives Systems Health Systems and Markets MaRS’ Network: Investors Industry Health orgs Policymakers Advisors Prof. Services
- 4. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 MaRS Excellence in Clinical Innovation and Technology Evaluation program
- 5. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters Ontario’s Evidence Revolution Commitment to Evidence in Healthcare January 2015 Ontario Excellent Care for All Act (2010) The people of Ontario and their Government: • 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) • (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) • 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. • The government will accelerate the evidence-based approach to care by building on the mandate of Health Quality Ontario (HQO)
- 6. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters Dealing with Uncertainty – Field Evaluation January 2015 • Post-market assessment of technology performance in the real world through primary data gathering • Improves decision making prior to long-term commitment through appropriate adoption • Designed to inform policy and funded by government • Alternative is passive diffusion and intuitive decision making • Completed 19 and 19 ongoing. Ten CEDs significantly impacted policy decision making and published in peer reviewed journals
- 7. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters What’s Wrong with the Status Quo? January 2015 • Evidence based analysis (EBA) is used to police the adoption of health technologies -when it is too late to address relevance or make changes • High rejection rates (OHTAC at 48%) reflects poor quality research in the pre-market space • Patents for non-drug technologies allow market dominance for only ± 18 months – need to evaluate and get to market quickly. Compounds the problem • Increasing focus on post market comparative effectiveness will continue to grow • We are stifling innovation by increasing risk to investors and innovators • Why use evidence to criticize rather than to drive innovation?
- 8. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 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 innovators Barriers to Adoption
- 9. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 Can We Better Streamline the Path to Market? PRE-MARKET POST-MARKET Device Development Device Manufacturing and Testing Device Licensing Pre-clinical • Design • Prototyping • Effectiveness and safety testing in models Clinical • Effectiveness and safety testing in patients or using patient samples Government licensing • Application to Health Canada for Licenses approving sale/use Patients have access to device Adoption/listing • Health technology appraisal for reimbursement and adoption decision- making
- 10. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 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 – in Ontario and globally through a single harmonized study that was designed collaboratively with the payer and regulator. For more information, see: http://excite.marsdd.com Excellence in Clinical Innovation and Technology Evaluation
- 11. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 The Value of EXCITE 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 CROs Payer/HTA Bodies EXCITE Regulator
- 12. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 Concept RegulationTIME U Pre-Market Post-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
- 13. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 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 6 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 * In process
- 14. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 TORONTO OTTAWA METHODS CENTRE TORONTO HAMILTON TORONTO • 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 • 6 MCs are engaged by EXCITE • 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 capabilities/experience to complete evaluations successfully. * In process
- 15. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 EXCITE analysis packages Assess usability/human 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
- 16. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 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 Licensing Reimbursement Patient and Clinician Use 16 The EXCITE Process Board decision Exploratory Meeting Proposal Approval Contract Execution First Patient Enrollment Apply
- 17. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 EXCITE Selection Criteria • Applicants must submit an executive summary and all relevant reports, articles and materials related to the technology • 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 (i.e., the promise of substantially better clinical outcomes, including safety, and/or 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)
- 18. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 The Application Process
- 19. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters The Contract Framework and Money Flow Process January 2015 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
- 20. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 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
- 21. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters Examples of Participating Companies January 2015 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
- 22. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS 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 –grown 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 www.ohic..ca November 2014
- 23. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS Our Future Matters January 2015 Zayna Khayat Program 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.com Twitter: #marsexcite Or contact us at:
Editor's Notes
- MaRS EXCITE ( Excellence in Clinical Innovation and Technology Evaluation ) is one of many services and programs that MaRS offers to entrepreneurs and ventures in the health industry. For more information on the MaRS Health portfolio please visit www.marsdd.com
- Since 2010, the Ontario Government has focused on making decisions on health care funding based on strong high quality evidence.
- To support evidence based decision making regarding the adoption of new health technologies, the Ontario government and many other jurisdictions worldwide rely on data from field evaluations. These field evaluations are conducted after the technologies have been licensed by Health Canada and are fully funded by the government.
- It has been observed that many health technologies lack the sufficient data needed to warrant a government funded field evaluation and therefore do not get recommended or introduced into the healthcare system.
- Additionally, innovators often fail to prove the clinical utility or value of the device to the end user ( physicians, hospitals, patients) and do not demonstrate adequate cost savings to the health system to justify the cost of the technology.