Book contents
- Alzheimer’s Disease Drug Development
- Alzheimer’s Disease Drug Development
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Acknowledgments
- Section 1 Advancing Alzheimer’s Disease Therapies in a Collaborative Science Ecosystem
- Section 2 Non-clinical Assessment of Alzheimer’s Disease Candidate Drugs
- Section 3 Alzheimer’s Disease Clinical Trials
- 11 Phase 1 Trials in Alzheimer’s Disease Drug Development
- 12 The Importance of Phase 2 in Drug Development for Alzheimer’s Disease
- 13 Alzheimer’s Disease Drug Development in Pharmaceutical Companies
- 14 Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development
- 15 ATRI and ACTC: Academic Programs to Accelerate Alzheimer’s Disease Drug Development
- 16 The European Prevention of Alzheimer’s Disease Program: A Public–Private Partnership to Facilitate the Secondary Prevention of Alzheimer’s Disease Dementia
- 17 The Global Alzheimer’s Platform Foundation®: Delivering New Medicines Faster by Accelerating Clinical Trials
- 18 Clinical Trial Development in Frontotemporal Lobar Degeneration
- 19 Statistical Considerations in the Design and Analysis of Alzheimer’s Disease Clinical Trials
- 20 Alzheimer’s Disease Trial Recruitment and Diversifying Trial Populations
- 21 The Role of Online Registries in Accelerating Alzheimer’s Disease Drug Development
- 22 Data Safety Monitoring Boards in Alzheimer’s Disease Trials
- 23 Globalization of Alzheimer’s Disease Clinical Trials
- 24 The Use and Development of Clinical Measures of Alzheimer’s Disease Trials
- 25 Tele-Trials, Remote Monitoring, and Trial Technology for Alzheimer’s Disease Clinical Trials
- 26 Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development
- 27 The Role of the Contract Research Organization in Alzheimer’s Disease: The Vital Link in the Clinical Drug-Development Program
- 28 The Role of Regulatory Agencies in Alzheimer’s Disease Drug Development
- 29 Alzheimer’s Disease Clinical Trial Study Partners
- 30 From Trials to Practice: Are We Ready for a Disease-Modifying Treatment?
- 31 Best Practices for Clinical Trials during COVID-19
- Section 4 Imaging and Biomarker Development in Alzheimer’s Disease Drug Discovery
- Section 5 Academic Drug-Development Programs
- Section 6 Public–Private Partnerships in Alzheimer’s Disease Drug Development
- Section 7 Funding and Financing Alzheimer’s Disease Drug Development
- Index
- References
13 - Alzheimer’s Disease Drug Development in Pharmaceutical Companies
from Section 3 - Alzheimer’s Disease Clinical Trials
Published online by Cambridge University Press: 03 March 2022
Book contents
- Alzheimer’s Disease Drug Development
- Alzheimer’s Disease Drug Development
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Acknowledgments
- Section 1 Advancing Alzheimer’s Disease Therapies in a Collaborative Science Ecosystem
- Section 2 Non-clinical Assessment of Alzheimer’s Disease Candidate Drugs
- Section 3 Alzheimer’s Disease Clinical Trials
- 11 Phase 1 Trials in Alzheimer’s Disease Drug Development
- 12 The Importance of Phase 2 in Drug Development for Alzheimer’s Disease
- 13 Alzheimer’s Disease Drug Development in Pharmaceutical Companies
- 14 Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development
- 15 ATRI and ACTC: Academic Programs to Accelerate Alzheimer’s Disease Drug Development
- 16 The European Prevention of Alzheimer’s Disease Program: A Public–Private Partnership to Facilitate the Secondary Prevention of Alzheimer’s Disease Dementia
- 17 The Global Alzheimer’s Platform Foundation®: Delivering New Medicines Faster by Accelerating Clinical Trials
- 18 Clinical Trial Development in Frontotemporal Lobar Degeneration
- 19 Statistical Considerations in the Design and Analysis of Alzheimer’s Disease Clinical Trials
- 20 Alzheimer’s Disease Trial Recruitment and Diversifying Trial Populations
- 21 The Role of Online Registries in Accelerating Alzheimer’s Disease Drug Development
- 22 Data Safety Monitoring Boards in Alzheimer’s Disease Trials
- 23 Globalization of Alzheimer’s Disease Clinical Trials
- 24 The Use and Development of Clinical Measures of Alzheimer’s Disease Trials
- 25 Tele-Trials, Remote Monitoring, and Trial Technology for Alzheimer’s Disease Clinical Trials
- 26 Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development
- 27 The Role of the Contract Research Organization in Alzheimer’s Disease: The Vital Link in the Clinical Drug-Development Program
- 28 The Role of Regulatory Agencies in Alzheimer’s Disease Drug Development
- 29 Alzheimer’s Disease Clinical Trial Study Partners
- 30 From Trials to Practice: Are We Ready for a Disease-Modifying Treatment?
- 31 Best Practices for Clinical Trials during COVID-19
- Section 4 Imaging and Biomarker Development in Alzheimer’s Disease Drug Discovery
- Section 5 Academic Drug-Development Programs
- Section 6 Public–Private Partnerships in Alzheimer’s Disease Drug Development
- Section 7 Funding and Financing Alzheimer’s Disease Drug Development
- Index
- References
Summary
Drug development is a long and arduous process that requires many researchers at different types of institutions. These include researchers in university settings, researchers in government settings, researchers in non-profit organizations and researchers in the pharmaceutical industry. The pharmaceutical industry itself is heterogeneous, ranging from tiny biotech companies to large multi-national organizations. This chapte emphasizes drug development efforts by the pharmaceutical industry but will also make note of the many collaborations between pharma and researchers at other types of institutions.
Keywords
- Type
- Chapter
- Information
- Alzheimer's Disease Drug DevelopmentResearch and Development Ecosystem, pp. 162 - 169Publisher: Cambridge University PressPrint publication year: 2022
References
Siemers, E. Drug development in AD: point of view from the industry. J Prev Alzheimers Dis 2015; 2: 216–18.Google Scholar
Cummings, J, Ritter, A, Zhong, K. Clinical trials for disease-modifying therapies in Alzheimer’s disease: a primer, lessons learned, and a blueprint for the future. J Alzheimers Dis 2018; 64: S3–22.CrossRefGoogle Scholar
Rinaldi, A. Setbacks and promises for drugs against Alzheimer’s disease: as pharmaceutical companies are retreating from drug development for Alzheimer’s, new approaches are being tested in academia and biotech companies. EMBO Rep 2018; 19: e46714.CrossRefGoogle ScholarPubMed
Biogen. Biogen plans regulatory filing for aducanumab in Alzheimer’s disease based on new analysis of larger dataset from Phase 3 studies. Investor Relations 2019; Oct. 22. Available at: https://investors.biogen.com/news-releases/news-release-details/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease (accessed January 2021).Google Scholar
Food and Drug Administration. FDA’s decision to approve new treatment for Alzheimer’s disease. Available at: www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease (accessed June 2021).Google Scholar
Food and Drug Administration. Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER); 2018.Google Scholar
European Medicines Agency. Clinical investigation of medicines for the treatment of Alzheimer’s disease: CPMP/EWP/553/1995. Available at: www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicines-treatment-alzheimers-disease-revision-2_en.pdf (accessed January 2021).Google Scholar
Pharmaceuticals and Medical Devices Agency (PMDA). Project to promote the development of innovative pharmaceuticals, medical devices, and regenerative medical products (Ministry of Health, Labour, and Welfare) regulatory science research for the establishment of criteria for clinical evaluation of drugs for Alzheimer’s disease. Available at: www.pmda.go.jp/files/000221585.pdf (accessed January 2021).Google Scholar
Morant, AV, Vestergaard, HT, Lassen, AB, Navikas, V. US, EU, and Japanese regulatory guidelines for development of drugs for treatment of Alzheimer’s disease: implications for global drug development. Clin Transl Sci 2020; 13: 652–64.Google Scholar
Food and Drug Administration. Expedited programs for serious conditions: drugs and biologics, May 2014. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics (accessed June 2021).Google Scholar
Food and Drug Administration. Summary memorandum. Available at: www.accessdata.fda.gov/drugsatfda_docs/nda/2021/Aducanumab_BLA761178_Dunn_2021_06_07.pdf (accessed June 2021).Google Scholar
Centers for Medicare and Medicaid Services. Decision memo for beta amyloid positron emission tomography in dementia and neurodegenerative disease (CAG-00431N). Available at: www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=265 (accessed January 2021).Google Scholar