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Bethesda North Marriott Hotel and Conference Center

23 abr 2018 1:00 p.m. - 25 abr 2018 4:15 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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

Karen Lynn Price, PhD

Senior Research Fellow, Statistical Innovation Center/Design Hub

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

AstraZeneca, United States

Global Clinical Leader

Hong  Liu-Seifert, PhD

Brief Overview of ASA Biopharmaceutical Section AD Scientific Working Group

Hong Liu-Seifert, PhD

Eli Lilly, United States

Sr. Research Advisor

Kun  Jin, PhD

Speaker

Kun Jin, PhD

FDA, United States

Statistical Team Leader, OB, OTS, CDER

Robert  Lenz, MD, PhD

Panelist

Robert Lenz, MD, PhD

Amgen, United States

Vice President, Head of Center for Design and Innovation

Steve  Wilson, PhD

Panelist

Steve Wilson, PhD

FDA, United States

Senior Staff Fellow, OB, OTS, CDER

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