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DIA/FDA Biostatistics Industry and Regulator Forum


Session 3: Challenges and Opportunities with Drug Development in Alzheimer’s Disease

    Session Chair(s)
      Karen Lynn Price, PhD, MA

      Karen Lynn Price, PhD, MA

      • Senior Research Advisor
      • Eli Lilly and Company, United States
      Kun  Jin, PhD

      Kun Jin, PhD

      • Statistical Team Leader, OB, OTS, CDER
      • FDA, United States
    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.
    Learning Objective : At the conclusion of the session, participants should be able to:
    • Gain awareness of the challenges associated with drug development in Alzheimer’s Disease (AD)
    • Describe opportunities for statistical methods to improve and impact drug development in AD
    • Gain awareness of ways to get engaged in cross-functional partnerships to help improve design and analysis of AD studies
    Speaker(s)
      Jamie A. Mullen, MD

      Alzheimer’s Disease: Challenges in Clinical Trial Design, Conduct, and Interpretation

      Jamie A. Mullen, MD

      • Global Clinical Leader
      • AstraZeneca, United States
      Hong  Liu-Seifert, PhD

      Brief Overview of ASA Biopharmaceutical Section AD Scientific Working Group

      Hong Liu-Seifert, PhD

      • Sr. Research Advisor
      • Eli Lilly, United States
      Kun  Jin, PhD

      Speaker

      Kun Jin, PhD

      • Statistical Team Leader, OB, OTS, CDER
      • FDA, United States
      Robert  Lenz, MD, PhD

      Panelist

      Robert Lenz, MD, PhD

      • Vice President, Head of Center for Design and Innovation
      • Amgen, United States
      Stephen E. Wilson, DrPH, MPH

      Panelist

      Stephen E. Wilson, DrPH, MPH

      • Statistical Consultant, United States