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Full Description
The drug development process in the United States has become so weighted down by a business-as-usual paradigm that an average of more than $2 billion is spent to secure FDA approval for every new drug. Because the investment required is so extreme, drug development companies are understandably focused on discovering and developing drugs designed for large patient populations: diseases experienced by millions, such as high blood pressure, diabetes, or some of the more common cancers.
In Unnecessary Expense, Dr. Charles Theuer, CEO of TRACON Pharmaceuticals, outlines the problem and offers a solution: an aligned and streamlined model that emphasizes quality and reduces the time and cost of drug development, while also harnessing global innovation to benefit patients with rare diseases in urgent need of new treatments. Here Dr. Theuer shows the value of a pharmaceutical paradigm shift, to enable the development of drugs for patients who need them, at a fraction of the time and cost.
Contents
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
