Value of Data Sharing to Advance Drug Development: A Regulatory Perspective

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-021-00275-y ◽

2021 ◽

Author(s):

Aliza Thompson ◽

Ameeta Parekh

Keyword(s):

Drug Development ◽

Data Sharing ◽

Regulatory Perspective

Download Full-text

African Americans, Kidney Disease, and Drug Development: A Regulatory Perspective

American Journal of Kidney Diseases ◽

10.1053/j.ajkd.2018.06.023 ◽

2018 ◽

Vol 72 (5) ◽

pp. S33-S36 ◽

Author(s):

Carolina Panico ◽

Aliza Thompson

Keyword(s):

African Americans ◽

Kidney Disease ◽

Drug Development ◽

Regulatory Perspective

Download Full-text

Regulatory perspective of biomarker bioanalysis during drug development

Bioanalysis ◽

10.4155/bio-2019-0029 ◽

2019 ◽

Vol 11 (7) ◽

pp. 607-610 ◽

Author(s):

Chongwoo Yu ◽

E Dennis Bashaw

Keyword(s):

Drug Development ◽

Regulatory Perspective

Download Full-text

The Critical Path for Alzheimer’s Disease (CPAD): Pre‐competitive data sharing and generation of innovative high‐impact quantitative tools to support Alzheimer’s disease drug development

Alzheimer s & Dementia ◽

10.1002/alz.043919 ◽

2020 ◽

Vol 16 (S9) ◽

Author(s):

Sudhir Sivakumaran ◽

Klaus Romero ◽

Nathan J Hanan ◽

Vikram Sinha ◽

Samantha Budd Haeberlein ◽

...

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Drug Development ◽

Data Sharing ◽

Critical Path ◽

Download Full-text

Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective

Biomarkers in Medicine ◽

10.2217/17520363.2.3.305 ◽

2008 ◽

Vol 2 (3) ◽

pp. 305-311 ◽

Author(s):

Shashi Amur ◽

Felix W Frueh ◽

Lawrence J Lesko ◽

Shiew-Mei Huang

Keyword(s):

Clinical Practice ◽

Drug Development ◽

Regulatory Perspective ◽

Development Regulation

Download Full-text

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective

Annals of Oncology ◽

10.1093/annonc/mdz037 ◽

2019 ◽

Vol 30 (4) ◽

pp. 644-651 ◽

Author(s):

Y. Bi ◽

J. Liu ◽

B. Furmanski ◽

H. Zhao ◽

J. Yu ◽

...

Keyword(s):

Drug Development ◽

Dosing Schedule ◽

Regulatory Perspective ◽

Development Approach

Download Full-text

Albuminuria as a surrogate marker for drug development: A European Regulatory perspective

Kidney International ◽

10.1111/j.1523-1755.2004.09232.x ◽

2004 ◽

Vol 66 ◽

pp. S126-S127 ◽

Author(s):

Gonzalo Calvo ◽

Fernando De Andres-Trelles

Keyword(s):

Drug Development ◽

Surrogate Marker ◽

Regulatory Perspective ◽

European Regulatory

Download Full-text

Pharmacogenomic-guided drug development: regulatory perspective

The Pharmacogenomics Journal ◽

10.1038/sj.tpj.6500046 ◽

2002 ◽

Vol 2 (1) ◽

pp. 20-24 ◽

Author(s):

L J Lesko ◽

J Woodcock

Keyword(s):

Drug Development ◽

Regulatory Perspective

Download Full-text

Radiopharmaceuticals for Drug Development: United States Regulatory Perspective

Current Radiopharmaceuticals ◽

10.2174/1874471010801010002 ◽

2008 ◽

Vol 1 (1) ◽

pp. 2-6 ◽

Author(s):

Henry VanBrocklin

Keyword(s):

United States ◽

Drug Development ◽

Regulatory Perspective

Download Full-text

The Critical Path for Alzheimer’s Disease (CPAD) Consortium: A platform for pre‐competitive data sharing, standardization, and analysis to support quantitative tools for AD drug development

Alzheimer s & Dementia ◽

10.1002/alz.051903 ◽

2021 ◽

Vol 17 (S9) ◽

Author(s):

Sudhir Sivakumaran ◽

Nathan J Hanan ◽

Zihan Cui ◽

Jackson Burton ◽

Patrick Lang ◽

...

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Drug Development ◽

Data Sharing ◽

Download Full-text

P4-253: THE CRITICAL PATH FOR ALZHEIMER'S DISEASE (CPAD) CONSORTIUM - A PRE-COMPETITIVE, GLOBAL, INTEGRATED, AND STANDARDIZED ALZHEIMER DISEASE CLINICAL TRIAL DATA SHARING REPOSITORY TO SUPPORT AD DRUG DEVELOPMENT

Alzheimer s & Dementia ◽

10.1016/j.jalz.2019.06.3922 ◽

2019 ◽

Vol 15 ◽

pp. P1376-P1377

Author(s):

Stephen P. Arnerić ◽

Samantha Budd Haeberlein ◽

Billy Dunn ◽

Michael Gold ◽

Volker D. Kern ◽

...

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Clinical Trial ◽

Alzheimer Disease ◽

Drug Development ◽

Data Sharing ◽

Critical Path ◽

Clinical Trial Data ◽

Download Full-text