The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Llicensing discussions.

Successfully advancing Adaptive Llicensing requires coordinated planning and action across multiple stakeholders. The Janus Initiative combines a safe haven multi-stakeholder process with an integrated, best-of-breed quantitative simulation toolset to facilitate biomedical eco-system innovation discussions grounded in case-based realities. The process engages stakeholders from academia, patient advocacy, providers, payers, heath technology assessment, regulators and product sponsors. The quantitative toolset reflects the critical relationships among the parameters, decision domains and metrics relevant to these stakeholders from clinical development through regulatory approval, reimbursement authorization and clinical adoption over the entire product life span. The Janus Initiative, as part of the NEWDIGS program at MIT is moving forward with its first case studies and will continue to develop across multiple therapeutic areas and global regions. [ABSTRACT FROM AUTHOR]