Unnecessary Expense: An Antidote for the Billion Dollar Drug Problem

by Charles Theuer, Bonne Adams, Mark Wiggins, Scott Brown

Overview

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.

Product Details

ISBN-13:	9781950863570
Publisher:	Advantage Media Group, Inc.
Publication date:	09/21/2021
Pages:	192
Product dimensions:	6.00(w) x 9.10(h) x 0.90(d)

About the Author

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 Universityof 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.

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 Universityof 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.

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 Universityof 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.

Table of Contents

Foreword ix

Introduction 1

Chapter 1 The Billion-Dollar Drug Problem 7

Chapter 2 Journey from Oncology Surgeon to Biotechnology Executive 21

Chapter 3 Biotechnology Lessons 35

Chapter 4 Big Pharma Lessons 51

Chapter 5 Cros-The Pitfalls of Business as Usual in Drug Development 69

Chapter 6 Understanding and Navigating the FDA 87

Chapter 7 The Tracon Product Development Platform 97

Chapter 8 Harnessing Global Innovation for Us Patients 117

Chapter 9 Integrating Technology as Part of the Tracon PDP 137

Chapter 10 The Finer Points of Commercializing an Oncology Drug 151

Summary 157

Acknowledgments 161

Glossary 163

About the Lead Author 175

Our Services 177

Editorial Reviews

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

“High quality drug candidates are increasingly being discovered abroad that have adequate patent protection and can serve as a foundation for accelerated drug development. As foreign sources become more sophisticated and aligned with FDA preclinical requirements, this approach will only become more attractive. Dr. Theuer and his colleagues at TRACON present a cost-efficient drug development platform that solves the problem of accessing the US pharmaceutical market for foreign firms by providing a return on investment even on drugs intended for rare diseases, while simultaneously benefitting US patients.” — BILL RASTETTER, PHD Chairman, Neurocrine Biosciences, Fate Therapeutics, Daré Bioscience, and San Diego Squared; past Chairman, Biogen Idec and Illumina

From the Publisher