GLOBAL CLINICAL TRIALS PLAYBOOK

Menghis Bairu, M.D., EVP and General Manager, has primary responsibility for overseeing strategic opportunities for Elan. With more than two decades of international experience in the biopharmaceutical, global health, and non-profit arenas, his skills span the commercial, research and development, and managed-care sectors of the pharmaceutical industry. Dr Bairu's particular emphasis is the clinical development and global implementation of important and cost-effective new therapies.

Named Executive Vice President in 2007, Dr. Bairu served as Elan's Chief Medical Officer and Head of Global Development through 2010. In this capacity, his responsibilities included Clinical Development, Biometrics, Regulatory, CMC, Quality/Compliance, Safety and Risk Management, Clinical Operations, and Medical Affairs.

In May 2006, Dr. Bairu was appointed Senior Vice President and Head of Elan International for Biopharmaceutical activities. Since joining Elan in 2004, he has served as Vice President and Head of Global Medical Affairs and Senior Director in charge of the Regional Medical Scientists.
Dr. Bairu worked at Genentech for five years in various commercial, clinical and managed care roles, and served as Medical Director for Fremont Health Corporation before joining Elan. He received his undergraduate degree in Business Administration from Instituto VII Tecnico Commerciale in Milan, Italy, and earned his M.D. at the Universita Statale, Facolta' di Medicina e Chirurgia (Faculty of Medicine & Surgery) in Milan.
Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a dozen drug registrations. His previous roles include CEO of a NASDAQ listed company, Senior Vice President of Global Development at Elan, and Head of Clinical Research for the Biotherapeutics Unit at Genentech. He was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned an M.D. from Harvard and the equivalent of a J.D. from Oxford, where he studied as a Rhodes Scholar.

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium.

Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries.  This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. 

* Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world

* Provides real world international examples which illustrate the practical translation of principles 

* Includes forms, templates, and additional references for standardization in a number of global scenarios

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials.