Biomarkers for alzheimer's disease: Academic, industry and regulatory perspectives

Harald Hampel; Richard Frank; Karl Broich; Stefan J. Teipel; Russell G. Katz; John Hardy; Karl Herholz; Arun L W Bokde; Frank Jessen; Yvonne C. Hoessler; Wendy R. Sanhai; Henrik Zetterberg; Janet Woodcock; Kaj Blennow

doi:10.1038/nrd3115

Biomarkers for alzheimer's disease: Academic, industry and regulatory perspectives

Harald Hampel, Richard Frank, Karl Broich, Stefan J. Teipel, Russell G. Katz, John Hardy, Karl Herholz, Arun L W Bokde, Frank Jessen, Yvonne C. Hoessler, Wendy R. Sanhai, Henrik Zetterberg, Janet Woodcock, Kaj Blennow

Research output: Contribution to journal › Article › peer-review

Abstract

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. © 2010 Macmillan Publishers Limited. All rights reserved.

Original language	English
Pages (from-to)	560-574
Number of pages	14
Journal	Nature Reviews Drug Discovery
Volume	9
Issue number	7
DOIs	https://doi.org/10.1038/nrd3115
Publication status	Published - Jul 2010

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title = "Biomarkers for alzheimer's disease: Academic, industry and regulatory perspectives",

abstract = "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. {\textcopyright} 2010 Macmillan Publishers Limited. All rights reserved.",

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year = "2010",

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doi = "10.1038/nrd3115",

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T1 - Biomarkers for alzheimer's disease: Academic, industry and regulatory perspectives

AU - Hampel, Harald

AU - Frank, Richard

AU - Broich, Karl

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AU - Katz, Russell G.

AU - Hardy, John

AU - Herholz, Karl

AU - Bokde, Arun L W

AU - Jessen, Frank

AU - Hoessler, Yvonne C.

AU - Sanhai, Wendy R.

AU - Zetterberg, Henrik

AU - Woodcock, Janet

AU - Blennow, Kaj

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AB - 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. © 2010 Macmillan Publishers Limited. All rights reserved.

U2 - 10.1038/nrd3115

DO - 10.1038/nrd3115

M3 - Article

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EP - 574

JO - Nature Reviews Drug Discovery

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Biomarkers for alzheimer's disease: Academic, industry and regulatory perspectives

Abstract

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