EXCITE International is a collaboration of key stakeholders working together in the premarket space to expedite access to innovative health technologies globally.
Our unique approach helps innovators of breakthrough technologies achieve accelerated adoption with greater certainty, at a lower cost. Faster market adoption improves patient outcomes and drives health system efficiencies.
Our scope of expertise draws on thought leaders and organizations working in the innovation space from around the world, including Canada, the United States, the United Kingdom and the Netherlands. Our collaboration is growing rapidly as we include other jurisdictions.
Our Executive Board is drawn from the worldwide community of healthcare thought leaders, corporate executives and innovators.
EXCITE International's operations are led by Dr. Les Levin, CEO and Chief Scientific Officer; Shahira Bhimani, Vice President, Business Development and Operations; and Keelin Mayer, Director, Business Operations and Secretary/Treasurer.
Three critical Committees support our work at EXCITE International: the Payers’ Advisory
Committee, the International Scientific Collaboration and the Advisory Council.
EXCITE International was formed in part to address the discontinuous nature of regulatory and coverage decision-making and to address these through single harmonized studies that meet the needs and expectations of both. While the EI process does not expect pre-market approval of health technologies that might be effective, by including the perspectives of Payers in protocol design, it hopes to mitigate the risk of rejection downstream recognizing that the final coverage decisions rests with individual Payers alone.
Given the pivotal nature of the Payer perspective, the Payers’ Advisory Committee (PAC) provides a generic framework for addressing the interests of Payers specifically as these relate to protocol development. In addition, the PAC will provide Payers an opportunity to share any perspectives between each other regarding implementation or adoption once the results of EI clinical evaluations are available. The PAC cannot and will not provide any advice or undertake steps to influence adoption decision making by any of its members’ host organizations, respecting the independent policy and legislative realities of all jurisdictions represented.
The EXCITE International Advisory Council includes leading global scientists, innovators, corporate leaders and healthcare specialists who provide input on conditions for adoption and verify alignment with health system priorities.
In partnership with EXCITE International, the REshape Center is fashioning a Charter to determine the process for how EXCITE International can work to most effectively to include patients. Following the Patients’ Charter, the evolving Patients Included Committee (#patientsincluded) will provide ongoing advice to EXCITE International to ensure that meaningful patient input occurs throughout each of its offerings, discussions, publications, and conferences. This international initiative is being led by Lucien Engelen, founder of #patientsincluded, which has gained rapid global recognition.
Commencing with a focus on the Netherlands, EXCITE International’s Patients Included Committee will rapidly grow to include all EXCITE International’s member countries, based on existing and new initiatives in this area.
EXCITE International (EI) aims to develop high quality multinational studies amongst member countries according to an inclusive approach to protocol designs that:
* mitigates the risk of rejection by being acceptable to regulators, industry, payers, health systems, patients and end-users
* provide the best evidence of efficacy and safety
* are most efficient
* maximize external validity
The EI Scientific Collaboration (SC) is comprised of international experts from within the scientific community who will guide the development of protocols that will allow EI to fulfill its mandate as set out above. The SC is advisory to the Global Methodology Resource Centre (GMRC) selected to assemble the protocol for each approved technology. Detailed protocol development will be undertaken by the GMRC working closely with Key International Opinion Leaders (KOLs) and EI committees that express the interests of payers and patients. The GMRC will also be responsible for ensuring input by Regulators into protocol development. The SC will provide ongoing advice to the GMRC and advice to the EI Board regarding approval or the final protocol. Terms of reference for the SC are attached as Appendix 1. Membership of the Scientific Collaboration is attached as Appendix 2.
It is important to point out that industry is expected to be very much involved in protocol development and has to sign off on the final protocol
Our International Scientific Collaboration members provide thought leadership and direction on innovative trial design and methodologies to guide technologies into the market more effectively.