DIA/FDA Biostatistics Industry and Regulator Forum

Alzheimer’s disease (AD) represents a huge unmet medical need, and currently there are no therapies for prevention, cure, or to slow progression of disease. The disease is slow to progress and difficult to measure, yielding challenging clinical trial designs that are resource-intensive and have a high risk of failure. Statisticians have an opportunity to be leaders in the improvement of the design and analysis of AD clinical trials and we need to take action now. This session will focus on an open discussion and idea generation regarding what statisticians can do to help address key challenges with AD drug development, to ultimately help bring much needed treatments to patients and their families. Discussion will include an overview from the ASA Biopharmaceutical Section AD Scientific Working Group (SWG), which has been formed for the advancement of AD treatments and is led by statisticians from industry, academic, and government sectors. The session will also provide a clinician’s perspective regarding the role of statistical methods toward development of effective therapies. In addition, we will have a robust panel discussion, which will incorporate FDA representatives to hear the regulatory perspective on challenges and opportunities. The session will include ample time for open discussion of ideas, experiences from practice, and key opportunities, to better enable statistics to play a key role in moving forward the development of effective therapies for AD.