Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives.
Advances in therapeutic strategies for Alzheimer's disease that lead to even small delays in onset and progression of the condition would significantly reduce the global burden of the disease. To effectively test compounds for Alzheimer's disease and bring therapy to individuals as early as possible there is an urgent need for collaboration between academic institutions, industry and regulatory organizations for the establishment of standards and networks for the identification and qualification of biological marker candidates. Biomarkers are needed to monitor drug safety, to identify individuals who are most likely to respond to specific treatments, to stratify presymptomatic patients and to quantify the benefits of treatments. Biomarkers that achieve these characteristics should enable objective business decisions in portfolio management and facilitate regulatory approval of new therapies.
Hampel
Harald
H
Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Johann Wolfgang Goethe-University, Heinrich-Hoffmann-Str. 10, 60528 Frankfurt/Main, Germany. harald.hampel@med.uni-frankfurt.de
Frank
Richard
R
Broich
Karl
K
Teipel
Stefan J
SJ
Katz
Russell G
RG
Hardy
John
J
Herholz
Karl
K
Bokde
Arun L W
AL
Jessen
Frank
F
Hoessler
Yvonne C
YC
Sanhai
Wendy R
WR
Zetterberg
Henrik
H
Woodcock
Janet
J
Blennow
Kaj
K
D000544:Alzheimer Disease / Q000175:diagnosis* / Q000235:genetics; D000818:Animals; D015415:Biomarkers; D002986:Clinical Trials as Topic; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000639:trends*; D004345:Drug Industry / Q000639:trends*; D023381:Endpoint Determination; D006801:Humans; D008279:Magnetic Resonance Imaging; D008967:Molecular Biology; D049268:Positron-Emission Tomography; D018570:Risk Assessment
D015415:Biomarkers