Subteam: Expedited Approvals Chairs: Bob Campbell, Larry Gould Subteam Objectives Develop and publish on statistical approaches for evidence generation relevant to Expedited Approvals and other novel development approaches across product life cycles. Establish and promote the role for Bayesian statistics and Adaptive Design as key drivers of Expedited Approvals Engage in the subteam patient advocacy, payer, and medical reviewer perspectives Facilitate visibility and networking among teams and initiatives working on different aspects of efficient and ethical drug development challenge Leadership/Participants Co-Leaders: ADSWG: Bob Campbell robert_campbell@brown.edu BSWG: Larry Gould Members: Zoran Antonijevic Sandeep Menon Matt Austin Eva Miller Bob Beckman David Norris Carl-Frederick Burman Nitin Patel Cong Chen Martin Posch Jennifer Clark Jiang Qi Vladimir Draglin Sammi Tang Weili He Kiichiro Toyoizumi John Lowey Zoeyy Zhao Subteam Deliverables Plan 3Q2017 – Complete Strategy Document for further research of statistical properties of Expedited Approvals. 4Q2017 - Actively recruit new members to add missing perspectives needed to implement strategy 4Q2018 – Publication of next set of papers outlined in the strategy document. Resource Needs: Notes / Issues Recruitment of members from payer and patient organizations. Identify accessible data sources for analysis of expedited approval impact Meeting Schedule Monthly: September - May DIA: Adaptive Design Scientific Working Group 11 August 2017 draft update - BC