Webinar: ADAPT SMART “Putting Stakeholders at the Centre”
19 April 2017, 14-15h CET
The first public webinar of ADAPT SMART highlighted how consortia members are collaborating with key stakeholder groups to incorporate their feedback into the project’s deliverables during the calendar year of 2017.
On April 19th, 2017, the AdaptSmart Consortia, comprising over 30 international partners including regulators, patients, academia and industry, held its first public webinar to give an update on the project’s progress and milestones, as well as its efforts to incorporate the feedback of key stakeholders groups during the calendar year of 2017.
The ADAPT SMART consortium (a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes) enables coordination of activities, supporting investigation of methodologies and dialogue to develop workable concepts for Medicines Adaptive Pathways to Patients, or MAPPs. According to the Journal The Pink Sheet, “Adaptive pathways would enable a drug to be approved earlier based on limited data for restricted populations where its benefit-risk balance could be favorable, and then real-world data would be used to support the product’s wider use. Discussions with HTA bodies, patients and other downstream stakeholders would have to take place early on during drug development so as to make sure their demands were also met.”
Whilst the MAPPs concept is being embraced internationally in Japan, Canada, and in the recent congressional testimony of newly appointed FDA Director Scott Gottlieb in the United States, in Europe, AdaptSmart has seen both enthusiastic support as well as criticisms from payers and stakeholder groups that MAPPs will lower the safety bar for patients.
Senior Medical Officer
Senior Director Regulatory Affairs & Policy, EU