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[V4-S5] Development of Disease-Modifying Drugs for Alzheimer’s Disease (AD); Utilizing the Use of Biomarkers
Session Chair(s)
Yoshiko Komuro, PhD
Inspection Director, Office of Non-Clinical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Developing a treatment for Alzheimer’s disease (AD) is an extremely critical issue as the world continues to age. Development of a disease-modifying drug that differs from the existing symptomatic drugs, by slowing or stopping disease progression is highly desired. For more than ten years, such disease-modifying drugs have been actively developed, but none have been approved. Difficulties in selecting appropriate patients and evaluating efficacy are considered the major reasons for this lack of approval. Recent studies utilized biomarkers that reflect the pathophysiological changes of AD to overcome some of these issues. This session will discuss the issues surrounding the development of disease-modifying drugs for AD, and points to consider while utilizing these biomarkers.
Speaker(s)
Treatments of Alzheimer’s Disease: Current Therapy and Future Direction
Haruhiko Akiyama, MD, PhD
Yokohama Brain and Spine Center, Japan
Director, Department of Clinical Research
Biomarkers of Alzheimer's Disease - Based on Imaging Technology
Yoichi Inoue, JD, MD
GE Healthcare Japan, Japan
Medical Affair, Japan
Opportunities and Challenges of Biomarker in Development of Disease-Modifying Drugs for AD
Ichiro Arano, PhD
MSD K.K., Japan
Director, Primary Care, Clinical Operation
Takaaki Suzuki, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug II
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