1. 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
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.
4Q 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