This endeavor would not have been possible had we not met as classmates (and dormitory mates) at Harvard Medical School. This book is dedicated to our families, whose support and encouragement made the endeavor possible. We also would like to thank everyone at Elsevier for their hard work and invaluable help and making the process an exciting and enjoyable one.
Dr. Chin is a Harvard trained, Board Certi\ufb01 ed internist with drug development across a wide range of specialties, includ- ing oncology, immunology, ophthalmology, neurology, endocrinology, and cardiovascular medicine, among others. He has been responsible for over 40 Investigational New Drug (IND) Applications and 8 New Drug Applications (NDAs)/ Biologic License Applications (BLAs). Some of the drugs Dr. Chin has overseen include ranibizumab, natalizumab, ten- ecteplase, bapineuzumab, ziconotide, and omalizumab. He has both US and international experience, and has overseen a wide variety of functions, including Clinical Development, Regulatory, Biostatistics, Quality Assurance/Compliance, Chemistry Manufacturing, and Control, Safety and Medical Affairs.
Dr. Chin is currently President and CEO of a NASDAQ-listed a biotechnology company. Previously, he was Senior Vice President and Head of Global Development for Elan Corporation, and before that served as the Head of Clinical Research for the Biotherapeutics Unit at Genentech. Dr. Chin holds a Medical Degree from Harvard Medical School. He received the equivalent of a J.D. with honors from Oxford University, England under a Rhodes Scholarship. He graduated with a Bachelor of Arts in Biology, magna cum laude, from Harvard University. He previously served on the adjunct clini- cal faculty at Stanford Medical School.
Dr. Lee is currently an Assistant Professor of Medicine and Biomedical Informatics, and Epidemiology at the University of Pittsburgh. He is also Core Faculty in the Section for Decision Sciences and Clinical Systems Modeling, the Center for Research in Health Care, and the RAND-University of Pittsburgh Health Institute. He is a Co-Investigator for the National Institutes of Health (NIH) Modeling of Infectious Diseases Agent Study (MIDAS) research and informatics network, and a Co-Investigator for a Bill & Melinda Gates Foundations Grant on the evaluation of candidate vaccine technologies using computational models.
His previous positions include serving as Senior Manager at Quintiles Transnational, working in biotechnology equity research at Montgomery Securities, and co-founding Integrigen, a biotechnology company. His consulting experi- ence includes a large variety of clients, ranging from large and small pharmaceutical, biotechnology, and medical device companies.
Dr. Lee received his B.A. from Harvard University, M.D. from Harvard Medical School, and M.B.A. from the Stanford Graduate School of Business. He is board-certi\ufb01 ed in Internal Medicine, having completed his residency training at the University of California, San Diego.
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Hi Vinay I am doing a course of Principles and practice of clinical research - Harvard web-learning and I kindly ask you if you coulde send me those books. thank you joanadiasdasilva@gmail.com
Hi Vinay, I am Dr Soumya doing Diploma in Clinical Research and Regulatory Affairs at Manipal University. I needed to download the clinical research books for my study. Can you please make those books available for me to download? Its my request to u... Thank you.