TL47: Organizing a Therapeutic Area Scientific Working group for Alzheimer's
*Hong Liu-Seifert, Lilly  Stephen Wilson, FDA/CDER/OTS/OB/DBIII 

Keywords: Alzheimer's, working group, collaboration, research

Alzheimer's Disease (AD) is an extremely important disease with a huge unmet medical need. It is the sixth-leading cause of death in the United States and is the only leading cause of death without a way to prevent, cure or even slow its progression. More than 5 million Americans are living with Alzheimer's disease. Without the development of medical breakthroughs that prevent, slow or stop the disease, by 2050, the number of people with Alzheimer's disease could reach 13.8 million. The human suffering by both the patients and caregivers, and the economic burden on the nation's health care system and government programs is enormous.

Under this backdrop of urgency, many innovative statistical methodologies and trial designs are being proposed and implemented. This roundtable will describe and discuss these efforts and think about how we can create a working group to pull these activities together. The focus is on research collaboration to develop analytical approaches in relevant areas of AD, with the goal to advance the understanding of the disease state and enable the next generation of breakthrough treatment.

There is no doubt that AD is one of the most significant health crises facing the United States in the upcoming decades. Many of us either have had loved ones passed away from the disease or currently fighting the courageous battle with the disease. So the passion all of us feel is real and personal. We must act now to find the next generation treatment for AD that will slow and hopefully prevent the disease someday.

This roundtable discussion is co-organized by Hong Liu-Seifert(Lilly) and Steve Wilson (FDA). We envision a cross regulatory/industry/academia collaboration in the Alzheimer's area to improve the science and lead the field to better solutions.