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 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
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About the Author
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.Dr. Weiner attended Johns Hopkins University and the State University of New York, and worked at Mount Sinai Hospital in New York (Resident), and Yale University (Fellow). After service in the US Air Force, in 1971 at the University of Wisconsin he was awarded a VA Research Associate at the Madison VA. Subsequently he was awarded a VA Clinical Investigatorship and relocated to the Palo Alto VA/Stanford University, where he subsequently received the Young Investigator Award of the American College of Cardiology in 1976. In 1980 he performed the first experiment using implanted coils to obtain 31P NMR spectra from the kidney of living rats, beginning his work using NMR/MRI for research. Since1980 he has been at the San Francisco VA/UCSF. He is currently Director of the Center for Imaging of Neurodegenerative Diseases. He is Professor of Radiology, Medicine, Psychiatry, and Neurology at UCSF. He has published over 600 peer reviewed scientific papers. His grants include studies of Alzheimer’s disease, vascular dementia, frontotemporal dementia, HIV/AIDS, gulf war illness, posttraumatic stress disorder, traumatic brain injury, amyotrophic lateral sclerosis, epilepsy, and other neurodegenerative conditions. He is the Principal Investigator of: the NIA funded Alzheimer’s Disease Neuroimaging Initiative (ADNI)/Grand Opportunities (GO) Grant, and the renewal of ADNI (total funding over $150 million for these 3 grants). Recently he was awarded a grant from the DOD entitled Effects of traumatic brain injury and post traumatic stress disorder on Alzheimer’s disease (AD) in Veterans using ADNI. In 2006 Dr. Weiner was awarded the Middleton Award, for outstanding research in the VA. In 2010 he was awarded the Gold Medal of Paul Sabatier University in Toulouse France, and the Gold Medal of the city of Toulouse, France. In 2011 he accepted the Ronald and Nancy Reagan Research Award from the Alzheimer’s Association on behalf of ADNI. In 2013, he is being awarded the Potamkin Prize for Research in Pick’s, Alzheimer’s, and Related Diseases from The American Academy of Neurology and The American Brain Foundation.
Table of Contents
Section I – Global Alzheimer’s Disease Clinical Trials
Ch 1 – Introduction and Overview of Global Clinical Trials
Ch 2 – Dementia and Neurodegenerative Diseases: Global and Local Public Health Burden
Section II – Challenges and Opportunities to conduct Alzheimer’s Disease Trials
Ch 3 – Global Issues in Drug Development
Ch 4 – Patient Populations and Evolution of Diagnostic and Therapeutic Standards
Ch 5 – Opportunities for Standardization of Diagnostic and Outcome Measures
Section III – Operationalization of Global Alzheimer’s Disease Trials
Ch 6 - The Increasing Competition for Clinical Trial Sites and Traditional Markets – Issues and Opportunities
Section IV – Enhancing Low and Middle Income Countries Capacities
Ch 7 – Strengthening/Building AD Global Clinical Trial Sites – Lessons Learned
Section V – Pharmacogenomics and Ethical Considerations
Ch 8 – Definitions
Ch 9 – Pharmacogenomics in Clinical Trials
Ch 10 – Pharmacogenomics in AD Clinical Trials
Ch 11 – Conduct of Global Clinical Trials in Vulnerable Populations (Ethical Considerations)
Ch 12 – Next Steps Towards Global Clinical Trials of CNS Disease
Section VI – Human Resources Planning
Ch 13 – Talent Management
Section VII – Appendices
Ch 14 – Useful Online Appendices