Beginning with the untimely death of a young mother, this book unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. This case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug. This book is ideal for professionals in biomedical and drug development. …mehr
Beginning with the untimely death of a young mother, this book unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. This case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug. This book is ideal for professionals in biomedical and drug development.
MICHAEL A. BROWN, PhD, PE, is a Visiting Professor at the University of Illinois at Chicago. Dr. Brown has twenty-five years' experience in the biomedical industry in a product and process design capacity with responsibilities for worldwide engineering and management. He has served as a lead engineer on numerous products, process, and equipment projects including design, implementation, and qualifications. He is a registered Professional Engineer and a certified Six Sigma Black Belt with considerable experience in team leadership. The material presented in this case, including the FDA regulations and Six Sigma concepts, was tested in an engineering senior design course taught by Dr. Brown over a three-year period. Student feedback noted that the difficult design principles were explained in an easy-to-read story that introduced them to the Six Sigma methodologies in an engaging manner.
Inhaltsangabe
Preface xi Part One The Event 1 1 Francesca 3 Part Two Drug Discovery: Five Years Earlier 9 2 Katlin Bioscience: Transgenic Mouse Study 11 3 Oxy-Fox Inhaler 21 3.1 Kinnen Laboratories 21 3.2 Kinnen Laboratories: Oxy-Fox Transfer 22 3.3 Due-Diligence Team and Katlin Data Acceptance 23 Part Three Kinnen Oxy-Fox Inhaler Market Launch Program 25 4 Agency IND and NDA Requirements, Six Sigma Charter, and Device Master Record 27 4.1 Launch Team Meeting Number 1 27 4.2 Meeting with Medical Affairs: Toxicity Studies 46 5 Meeting Minutes Guidelines 49 5.1 Launch Team Meeting Number 2 49 6 Project Timing, Marketing Plan, and Offshore Molding 55 6.1 Launch Team Meeting Number 3 55 6.2 Project Financial Review 61 6.3 Progress Meeting: Who Takes Credit for What? 64 6.4 Morning Meeting: Just-in-Time Manufacturing 65 7 cGMP Process Validation Requirements 69 7.1 Launch Team Meeting Number 4 69 8 Failure Mode Effects Analysis 81 8.1 Launch Team Meeting Number 5 81 9 Design for Manufacturability, Design for Six Sigma, Concurrent Design 93 9.1 Product Development Meeting Number 1 93 9.2 Update Meeting with Ed Chase and Gordon Taylor 102 10 Design Fishbone Diagram 105 10.1 Launch Team Meeting Number 6 105 11 Product Specifications 111 11.1 Product Development Meeting Number 2 111 12 Design Control 115 12.1 Design Team Meeting Number 7 115 12.2 Product Development Staff Meeting 118 12.3 Engineering One-on-One 119 12.4 Program Update 120 13 Design of Experiments (DOE) 123 13.1 Molding Team Meeting 123 14 Start-Up Issues 129 14.1 Oxy-Fox Inhaler Wrap-Up and Equipment Start-Up 129 14.2 The Final Management Review 135 Part Four Present Day: Funeral 139 15 Grief 141 16 The Autopsy Results 145 17 The Agency 151 Part Five Agency Medical Event Letter 155 18 Kinnen Notification 157 18.1 Another Agency Letter 157 18.2 Medical Event Review Meeting 158 19 Investigation Team Management 161 19.1. Morning Meeting with Gail Strom, Marcia Hines, and Dan Garvey 161 20 DMAIC Investigation Process 163 21 Internal Quality Review 171 21.1 Meeting with Gail Strom and Marcia Hines 171 21.2 Executive Management Review 174 22 The Agency Audit Letter 179 23 Agency Arrival 183 24 The Audit 187 24.1 Agency Meeting to Review Qualification Documents and the Quality Acceptance Records of First Lot to Stock 187 24.2 Agency Meeting to Review the Oxy-Fox Inhaler Lot Used in the NDA Clinical Studies 189 24.3 Agency Meeting to Review the Design and Program Team Meeting Minutes 190 24.4 Agency Meeting to Review the Due-Diligence Report Katlin Studies, and Oxy-Fox Design History File, 192 25 End-of-Day Agency Wrap-Up Meeting 197 26 Kinnen Management Review 201 Part Six Reckoning 207 27 Blame and Responsibility 209 27.1 The Investigation Is a Public Record 209 27.2 Kinnen Wrap-Up 210 28 Closure 213 Bibliography 215 Index 217
Preface xi Part One The Event 1 1 Francesca 3 Part Two Drug Discovery: Five Years Earlier 9 2 Katlin Bioscience: Transgenic Mouse Study 11 3 Oxy-Fox Inhaler 21 3.1 Kinnen Laboratories 21 3.2 Kinnen Laboratories: Oxy-Fox Transfer 22 3.3 Due-Diligence Team and Katlin Data Acceptance 23 Part Three Kinnen Oxy-Fox Inhaler Market Launch Program 25 4 Agency IND and NDA Requirements, Six Sigma Charter, and Device Master Record 27 4.1 Launch Team Meeting Number 1 27 4.2 Meeting with Medical Affairs: Toxicity Studies 46 5 Meeting Minutes Guidelines 49 5.1 Launch Team Meeting Number 2 49 6 Project Timing, Marketing Plan, and Offshore Molding 55 6.1 Launch Team Meeting Number 3 55 6.2 Project Financial Review 61 6.3 Progress Meeting: Who Takes Credit for What? 64 6.4 Morning Meeting: Just-in-Time Manufacturing 65 7 cGMP Process Validation Requirements 69 7.1 Launch Team Meeting Number 4 69 8 Failure Mode Effects Analysis 81 8.1 Launch Team Meeting Number 5 81 9 Design for Manufacturability, Design for Six Sigma, Concurrent Design 93 9.1 Product Development Meeting Number 1 93 9.2 Update Meeting with Ed Chase and Gordon Taylor 102 10 Design Fishbone Diagram 105 10.1 Launch Team Meeting Number 6 105 11 Product Specifications 111 11.1 Product Development Meeting Number 2 111 12 Design Control 115 12.1 Design Team Meeting Number 7 115 12.2 Product Development Staff Meeting 118 12.3 Engineering One-on-One 119 12.4 Program Update 120 13 Design of Experiments (DOE) 123 13.1 Molding Team Meeting 123 14 Start-Up Issues 129 14.1 Oxy-Fox Inhaler Wrap-Up and Equipment Start-Up 129 14.2 The Final Management Review 135 Part Four Present Day: Funeral 139 15 Grief 141 16 The Autopsy Results 145 17 The Agency 151 Part Five Agency Medical Event Letter 155 18 Kinnen Notification 157 18.1 Another Agency Letter 157 18.2 Medical Event Review Meeting 158 19 Investigation Team Management 161 19.1. Morning Meeting with Gail Strom, Marcia Hines, and Dan Garvey 161 20 DMAIC Investigation Process 163 21 Internal Quality Review 171 21.1 Meeting with Gail Strom and Marcia Hines 171 21.2 Executive Management Review 174 22 The Agency Audit Letter 179 23 Agency Arrival 183 24 The Audit 187 24.1 Agency Meeting to Review Qualification Documents and the Quality Acceptance Records of First Lot to Stock 187 24.2 Agency Meeting to Review the Oxy-Fox Inhaler Lot Used in the NDA Clinical Studies 189 24.3 Agency Meeting to Review the Design and Program Team Meeting Minutes 190 24.4 Agency Meeting to Review the Due-Diligence Report Katlin Studies, and Oxy-Fox Design History File, 192 25 End-of-Day Agency Wrap-Up Meeting 197 26 Kinnen Management Review 201 Part Six Reckoning 207 27 Blame and Responsibility 209 27.1 The Investigation Is a Public Record 209 27.2 Kinnen Wrap-Up 210 28 Closure 213 Bibliography 215 Index 217
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