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Location: Virtual Event

Co-Sponsor: Drug Information Association (DIA) https://www.diaglobal.org/en/conference-listing/meetings/2021/04/biostatistics-industry-and-regulator-forum

Background: Growing out of the DIA Annual Workshop on Statistical Methodologies in the Biopharmaceutical Sciences and the FDA/DIA Stat Forum, the FDA/DIA Biostatistics Industry and Regulator Forum 2021 will be designed by a program committee including members from the Office of Biostatistics (FDA/CDER), the DIA’s Statistics Community (Special Area Interest Community), and industry to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians, and clinical trialists who develop new drugs and biologics. A primary focus for this meeting will be to establish an on-going dialogue between industry and regulatory agencies -- emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress being made in designing and implementing innovative solutions.

Meeting Goals and Objectives: 1) Explore and implement innovative statistical solutions to issues associated with the evidence and regulatory review of therapeutic drugs and biologics. 2) Describe the application of statistical methodologies and thinking to the development of new therapeutic biologics and drugs. 3) Assess the impact of regulations and guidance on statistical practice. 4) Discuss ideas for improving the communication between industry statisticians and reviewers.

Who Should Attend? The workshop will appeal to statisticians in, or consulting for, the biopharmaceutical industry, clinicians, epidemiologists, drug safety professionals, regulatory and medical scientists, and other stakeholders interested in recent statistical issues in clinical research.

Contacts: Yuan-Li Shen, Deputy Division Director, Division of Biometrics V, Yuan.Li.Shen@fda.hhs.gov, 301-796-1753, or Scott Goldie, Special Assistant, scott.goldie@fda.hhs.gov, 301-796-2055, Office of Biostatistics, Office of Translational Sciences, CDER.