
Global Clinical Trials for Alzheimer's Disease
Design, Implementation, and Standardization
- 1st Edition - August 28, 2013
- Imprint: Academic Press
- Editors: Menghis Bairu, Michael Weiner
- Language: English
- Hardback ISBN:9 7 8 - 0 - 1 2 - 4 1 1 4 6 4 - 7
- eBook ISBN:9 7 8 - 0 - 1 2 - 4 1 1 5 3 0 - 9
Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book… Read more

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Request a sales quoteGlobal Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease.
- Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials
- A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area
- Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries
Targets those individuals worldwide who are involved in clinical trials in AD, dementia and other neurodegenerative diseases, including scientists, physicians, regulators, safety officers, biostatisticians, data managers and more who plan and execute Alzheimer’s Disease clinical trials in and for developing companies.
- Edition: 1
- Published: August 28, 2013
- Imprint: Academic Press
- No. of pages: 432
- Language: English
- Hardback ISBN: 9780124114647
- eBook ISBN: 9780124115309
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Menghis Bairu
Menghis Bairu, M.D.—physician, editor, author, philanthropist and healthcare business executive—has more than two decades of international experience in the biotechnology, pharmaceutical, global health and non-profit arenas. Dr. Bairu serves as Executive Vice President, Chief Medical Officer and Head of Global Development at Elan. His responsibilities include, but are not limited to clinical development, biometrics, regulatory, CMC, QA, safety-and-risk management, clinical operations and medical affairs. Previously he served as head of Onclave Therapeutics, a wholly Elan-owned oncology biotech company.
He lectures extensively on global health and biopharmaceutical issues with particular focus on Emerging Markets (e.g. India, China, Latin America, Singapore, Middle East, South East Asia and Africa). He served as editor and co-author of Global Clinical Trials: Effective Implementation and Management (Elsevier, 2011), a textbook designed to help researchers develop and implement effective and ethical international clinical trials. Dr. Bairu is also editor/co-author of Global Clinical Trials Playbook: Management and Implementation (Elsevier, 2012), and Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization (Elsevier, 2013).
Prior to joining Elan, Dr. Bairu worked at Genentech for more than five years in a number of managed care, medical and commercial (Oncology, Immunology, and Cardiovascular) roles. He served as managed care Medical Director for Fremont Health Corporation/II before joining Genentech. He served on the board of directors for One World Health, a nonprofit drug development company funded by the Bill and Melinda Gates Foundation and A-Cube, a privately held pharma startup.
In 2013, Dr. Bairu was named to the boards of directors of Dubai-based NewBridge Pharmaceuticals (he also serves as chairman of NewBridge’s science and technology committee), and ADVentura Capital SL, a Barcelona, Spain-based venture capital firm focused on funding and mentoring promising healthcare, IT and GreenTech companies. In 2011, Dr. Bairu joined the advisory board of the China Trials 5, a global clinical trials development summit focusing on China and north Asia. He currently serves as Adjunct Faculty at the University of California San Francisco School of Medicine where he lectures on global clinical trials’ design, development and conduct.
MW