Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team

Author:

Arnerić Stephen P.1,Batrla-Utermann Richard2,Beckett Laurel3,Bittner Tobias2,Blennow Kaj4,Carter Leslie5,Dean Robert6,Engelborghs Sebastiaan7,Genius Just5,Gordon Mark Forrest8,Hitchcock Janice6,Kaplow June9,Luthman Johan9,Meibach Richard10,Raunig David11,Romero Klaus1,Samtani Mahesh N.12,Savage Mary13,Shaw Leslie14,Stephenson Diane1,Umek Robert M.15,Vanderstichele Hugo16,Willis Brian6,Yule Susan17

Affiliation:

1. Critical Path Institute, Coalition Against Major Diseases, Tucson, AZ, USA

2. Roche Diagnostics, Basel, Switzerland

3. University of California, Davis, CA, USA

4. Clinical Neurochemistry Lab, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Mölndal, Sweden

5. AbbVie, Abbott Park, IL, USA

6. Eli Lilly and Company, Indianapolis, IN, USA

7. Reference Center for Biological Markers of Dementia (BIODEM), University of Antwerp, Antwerp, Belgium

8. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA

9. Eisai, Woodcliff Lake, NJ, USA

10. Novartis, East Hanover, NJ, USA

11. Icon, Warrington, PA, USA

12. Janssen R&D, Raritan, NJ, USA

13. Merck, Rahway, NJ, USA

14. University of Pennsylvania, Philadelphia, PA, USA

15. Meso Scale Diagnostics, LLC, Rockville, MD, USA

16. Biomarkable, Gent, Belgium

17. Genentech/Roche, San Francisco, CA, USA

Publisher

IOS Press

Subject

Psychiatry and Mental health,Geriatrics and Gerontology,Clinical Psychology,General Medicine,General Neuroscience

Reference74 articles.

1. Qualifying biomarkers for use in drug development: A US Food and Drug Administration overview;Woodcock;Expert Opin Med Diagn,2011

2. Biomarker qualification: Toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization;Amur;Clin Pharmacol Ther,2015

3. Building a roadmap to biomarker qualification: Challenges and opportunities;Amur;Biomark Med,2015

4. The Coalition Against Major Diseases: Developing tools for an integrated drug development process for Alzheimer’s and Parkinson’s diseases;Romero;Clin Pharmacol Ther,2009

5. Alzheimer’s and Parkinson’s diseases face common challenges in therapeutic development: Role of the Precompetitive Consortium, Coalition Against Major Diseases;Stephenson;J Alzheimers Dis Parkinsonism,2015

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