Alzheimer's Disease Drug Development: Research and Development Ecosystem

doi:10.1017/9781108975759

Alzheimer's Disease (AD) is a growing global public health challenge. The development of new therapies is urgently needed, and a complex ecosystem of organizations has grown to facilitate AD drug discovery and development. Masterfully collating information on the drug development ecosystem, this book emphasizes the contributions of each aspect in the pipeline with a uniform approach to chapters, enabling readers to access relevant information quickly. Topics covered include the use of non-clinical laboratory studies, biomarker development, artificial intelligence, design and management of clinical trials, and funding and financing models. Also discussed is the critical role of advocacy fundraising for drug development. With the approval of aducanumab, the function of the ecosystem has become apparent. This is a definitive overview of how the ecosystem works in transferring an AD drug from its discovery in the laboratory through clinical trial testing to regulatory review and eventual marketing.

'The book occupies a unique niche among similar titles in the area, presenting the state-of-the-art in Alzheimer's disease drug development from a drug discovery perspective, a clinical perspective, and a financial perspective.'

Marc A. Ilies Source: Doody's Review

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Contents

Alzheimer’s Disease Drug Development
pp i-ii
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Alzheimer’s Disease Drug Development - Title page
pp iii-iii
Research and Development Ecosystem
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Copyright page
pp iv-iv
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Dedication
pp v-vi
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Contents
pp vii-x
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Contributors
pp xi-xviii
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Foreword
pp xix-xix
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Acknowledgments
pp xx-xx
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Section 1 - Advancing Alzheimer’s Disease Therapies in a Collaborative Science Ecosystem
pp 1-72
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1 - Alzheimer’s Disease Drug Development: A Research and Development Ecosystem
pp 1-24
- By Jeffrey Cummings, Jefferson Kinney, Howard Fillit
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2 - Drug Development for Alzheimer’s Disease: An Historical Perspective
pp 25-33
- By Howard Fillit, Jeffrey Cummings
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3 - Alzheimer’s Disease Drug Discovery in Academia: From High-Throughput Screening to In Vivo Testing
pp 34-44
- By Kurt R. Brunden, Goodwell Nzou, Carlo Ballatore
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4 - The Harrington Discovery Institute and Alzheimer’s Disease Drug Development
pp 45-53
- By Andrew A. Pieper, J. Simon Mazza-Lunn, Diana R. Wetmore
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5 - Repurposed Agents in Alzheimer’s Disease Drug Development
pp 54-61
- By Clive Ballard, Janet Sultana
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6 - Artificial Intelligence in Alzheimer’s Drug Discovery
pp 62-72
- By Feixiong Cheng, Jeffrey Cummings
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Section 2 - Non-clinical Assessment of Alzheimer’s Disease Candidate Drugs
pp 73-134
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7 - Role of Animal Models in Alzheimer’s Disease Drug Development
pp 73-94
- By Jefferson Kinney, Amanda M. Leisgang Osse, Bruce Lamb, Adrian Oblack, Alan D. Palkowitz, Frank J. Belas
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8 - Use of Induced Pluripotent Stem Cell-Derived Neuronal Disease Models from Patients with Familial Early-Onset Alzheimer’s Disease in Drug Discovery
pp 95-105
- By Brenda Hug, Rudolph E. Tanzi, Steven L. Wagner
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9 - Preclinical Longitudinal In Vivo Biomarker Platform for Alzheimer’s Disease Drug Discovery
pp 106-122
- By Min Su Kang, Eduardo R. Zimmer, Julie Ottoy, Monica Shin, Marcel Seungsu Woo, Arturo Aliaga, Gassan Massarweh, A. Claudio Cuello, Serge Gauthier, Pedro Rosa-Neto
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10 - Biobanking and Biomarkers in the Alzheimer’s Disease Drug-Development Ecosystem
pp 123-134
- By Jefferson Kinney, Arnold Salazar
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Section 3 - Alzheimer’s Disease Clinical Trials
pp 135-360
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11 - Phase 1 Trials in Alzheimer’s Disease Drug Development
pp 135-149
- By Manfred Windisch
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12 - The Importance of Phase 2 in Drug Development for Alzheimer’s Disease
pp 150-161
- By Philip Scheltens, Willem de Haan, Roos J. Jutten, Everhard Vijverberg, Arno de Wilde, Niels Prins
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13 - Alzheimer’s Disease Drug Development in Pharmaceutical Companies
pp 162-169
- By Eric Siemers, Robert A. Dean, James E. Senetar, Janice M. Hitchcock, Russell L. Barton
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14 - Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development
pp 170-176
- By Marwan Sabbagh, Jiong Shi, Philip Scheltens, Niels Prins
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15 - ATRI and ACTC: Academic Programs to Accelerate Alzheimer’s Disease Drug Development
pp 177-189
- By Paul S. Aisen, Rema Raman, Michael S. Rafii, Reisa A. Sperling, Ronald C. Petersen
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16 - The European Prevention of Alzheimer’s Disease Program: A Public–Private Partnership to Facilitate the Secondary Prevention of Alzheimer’s Disease Dementia
pp 190-206
- By Craig W. Ritchie
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17 - The Global Alzheimer’s Platform Foundation®: Delivering New Medicines Faster by Accelerating Clinical Trials
pp 207-215
- By Jason Bork, Cyndy Cordell, John Dwyer, Gabe Goldfeder, Debra R. Lappin, Richard Mohs, Julie Neild, Rona Schillinger, Jill Smith, Katy Smith, Leigh Zisko, George Vradenburg
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18 - Clinical Trial Development in Frontotemporal Lobar Degeneration
pp 216-231
- By Peter A. Ljubenkov, Adam Boxer
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19 - Statistical Considerations in the Design and Analysis of Alzheimer’s Disease Clinical Trials
pp 232-248
- By Suzanne B. Hendrix, Jessie Nicodemus-Johnson, Logan Kowallis, Newman Knowlton, Sean Hennessey, Samuel P. Dickson
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