DR. CHARLES THEUER has been CEO and President and a Director of TRACON Pharmaceuticals since 2006. Dr. Theuer has been instrumental in bringing novel blockbuster oncology drugs to market, including Sutent® to treat advanced kidney cancer, while working as Director of Clinical Oncology at Pfizer. Dr. Theuer has held senior management positions at notable biotechnology firms, including TargeGen, Inc., and IDEC Pharmaceutical Corp. He has worked at the National Cancer Institute and held academic positions at the University of California, Irvine. He completed a general surgery residency program at Harbor-UCLA Medical Center and was board certified in general surgery in 1997. Dr. Theuer’s previous research involved immunotoxin and cancer vaccine development, translational work in cancer patients, and gastrointestinal cancer epidemiology. He is married with two adult children and enjoys hiking, coaching basketball, and sculling.

“This book by Dr. Charles Theuer and his colleagues offers an innovative approach to drug development. The core of the new approach, an independent CRO model, promises to enable life science companies to develop new medicines faster, with less expense, and without sacrificing quality. The book is a must-read for anyone in the industry interested in bringing new medicines to market.” —JOHN COGAN, PHD Former Lead Independent Director, Gilead Sciences, Inc.; Senior Fellow, Hoover Institution, Stanford University

• FOREWORD INTRODUCTION THE BILLION-DOLLAR DRUG PROBLEM JOURNEY FROM ONCOLOGY SURGEON TO BIOTECHNOLOGY EXECUTIVE BIOTECHNOLOGY LESSONS BIG PHARMA LESSONS CROS—THE PITFALLS OF BUSINESS AS USUAL IN DRUG DEVELOPMENT UNDERSTANDING AND NAVIGATING THE FDA THE TRACON PRODUCT DEVELOPMENT PLATFORM HARNESSING GLOBAL INNOVATION FOR US PATIENTS INTEGRATING TECHNOLOGY AS PART OF THE TRACON PDP THE FINER POINTS OF COMMERCIALIZING AN ONCOLOGY DRUG SUMMARY ACKNOWLEDGMENTS GLOSSARY ABOUT THE LEAD AUTHOR OUR SERVICES

DR. CHARLES THEUER has been CEO and President and a Director of TRACON Pharmaceuticals since 2006. Dr. Theuer has been instrumental in bringing novel blockbuster oncology drugs to market, including Sutent® to treat advanced kidney cancer, while working as Director of Clinical Oncology at Pfizer. Dr. Theuer has held senior management positions at notable biotechnology firms, including TargeGen, Inc., and IDEC Pharmaceutical Corp. He has worked at the National Cancer Institute and held academic positions at the University of California, Irvine. He completed a general surgery residency program at Harbor-UCLA Medical Center and was board certified in general surgery in 1997. Dr. Theuer’s previous research involved immunotoxin and cancer vaccine development, translational work in cancer patients, and gastrointestinal cancer epidemiology. He is married with two adult children and enjoys hiking, coaching basketball, and sculling.

“This book by Dr. Charles Theuer and his colleagues offers an innovative approach to drug development. The core of the new approach, an independent CRO model, promises to enable life science companies to develop new medicines faster, with less expense, and without sacrificing quality. The book is a must-read for anyone in the industry interested in bringing new medicines to market.” —JOHN COGAN, PHD Former Lead Independent Director, Gilead Sciences, Inc.; Senior Fellow, Hoover Institution, Stanford University

• FOREWORD INTRODUCTION THE BILLION-DOLLAR DRUG PROBLEM JOURNEY FROM ONCOLOGY SURGEON TO BIOTECHNOLOGY EXECUTIVE BIOTECHNOLOGY LESSONS BIG PHARMA LESSONS CROS—THE PITFALLS OF BUSINESS AS USUAL IN DRUG DEVELOPMENT UNDERSTANDING AND NAVIGATING THE FDA THE TRACON PRODUCT DEVELOPMENT PLATFORM HARNESSING GLOBAL INNOVATION FOR US PATIENTS INTEGRATING TECHNOLOGY AS PART OF THE TRACON PDP THE FINER POINTS OF COMMERCIALIZING AN ONCOLOGY DRUG SUMMARY ACKNOWLEDGMENTS GLOSSARY ABOUT THE LEAD AUTHOR OUR SERVICES