Research output: Contribution to journal › Article › peer-review
Bringing regenerative medicines to the clinic: the future for regulation and reimbursement. / Bubela, Tania; McCabe, Christopher; Archibald, Peter; Atkins, Harold; Bradshaw, Steven; Kefalas, Panos; Mujoomdar, Michelle; Packer, Claire; Piret, James; Raxworthy, Mike; Soares, Marta; Viswanathan, Sowmya.
In: REGENERATIVE MEDICINE, 13.11.2015.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Bringing regenerative medicines to the clinic:
T2 - the future for regulation and reimbursement
AU - Bubela, Tania
AU - McCabe, Christopher
AU - Archibald, Peter
AU - Atkins, Harold
AU - Bradshaw, Steven
AU - Kefalas, Panos
AU - Mujoomdar, Michelle
AU - Packer, Claire
AU - Piret, James
AU - Raxworthy, Mike
AU - Soares, Marta
AU - Viswanathan, Sowmya
PY - 2015/11/13
Y1 - 2015/11/13
N2 - Significant investments in regenerative medicine necessitate discussion to align evidentiary requirements and decision-making considerations from regulatory, health system payer and developer perspectives. Only with coordinated efforts will the potential of regenerative medicine be realized. We report on discussions from two workshops sponsored by NICE, University of Alberta, Cell Therapy Catapult and Centre for Commercialization of Regenerative Medicine. We discuss methods to support the assessment of value for regenerative medicine products and services and the synergies that exist between market authorization and reimbursement regulations and practices. We discuss the convergence in novel adaptive licensing practices that may promote the development and adoption of novel therapeutics that meet the needs of healthcare payers.
AB - Significant investments in regenerative medicine necessitate discussion to align evidentiary requirements and decision-making considerations from regulatory, health system payer and developer perspectives. Only with coordinated efforts will the potential of regenerative medicine be realized. We report on discussions from two workshops sponsored by NICE, University of Alberta, Cell Therapy Catapult and Centre for Commercialization of Regenerative Medicine. We discuss methods to support the assessment of value for regenerative medicine products and services and the synergies that exist between market authorization and reimbursement regulations and practices. We discuss the convergence in novel adaptive licensing practices that may promote the development and adoption of novel therapeutics that meet the needs of healthcare payers.
U2 - 10.2217/rme.15.51
DO - 10.2217/rme.15.51
M3 - Article
C2 - 26565607
JO - REGENERATIVE MEDICINE
JF - REGENERATIVE MEDICINE
SN - 1746-0751
ER -