Global Clinical Trials Playbook (ePub)

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,

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"This is indeed a valuable resource with a broad range of regional experiences in clinical trials and touching a wide array of topics increasing the potential of target readers. I have truly found it quite informative."

Dr. Michael Makanga, Director South-South Cooperation and Head of Africa Office, European & Developing Countries Clinical Trials Partnership (EDCTP), South Africa

"Global Clinical Trials Playbook is a treatise in self-learning, and a must read for researchers in academia, CROs, and NGOs involved in funding and conducting clinical trials. It is a vital reference for those interested in capacity building in clinical research, especially in developing countries."

Professor S. D. Seth, MD, FAMS, FNASc, FIPS, FCAI, FISCD, Advisor of Clinical Trials Registry – India, National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India

"This is an important book that comprehensively addresses capacity building across the globe. The breadth of the book and the broad array of geographies covered are impressive. This is a major publication that will push the field forward."

Dr. Dan Zhang, MD, PhD, Chairman & CEO of Fountain Medical Group, Shanghai, China

"Dr. Bairu and colleagues have produced the definitive reference guide to undertaking clinical trials around the world. I am sure that the Global Clinical Trials Playbook will instantly become an indispensable resource for funders and organisers of clinical trials who wish to stay up to date with the latest thinking in this fast moving field."

Dr. Rubin Minhas, M.B.Ch.B, Editor-in-Chief: ‘Clinical Evidence’, ‘Best Practice’ & Clinical Director, BMJ Evidence Centre