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Supply Chain Planning for Clinical Trials

A Practical Guide
1. Aufl.

von: Ryan Mills
129,99 €
Verlag:	Wiley
Format:	EPUB
Veröffentl.:	03.07.2024
ISBN/EAN:	9781394179572
Sprache:	englisch
Anzahl Seiten:	496

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Titelbeschreibung

Ensure your clinical trial supply chain is running smoothly with this practical guide Clinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development. Supply Chain Planning for Clinical Trials offers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of clinical trial supply chain management, it proceeds step by step through all aspects of demand and supply planning for clinical trials. The result is a thorough overview that also offers practical examples of how to plan supply for clinical trials. Supply Chain Planning for Clinical Trials readers will also find: <ul><li>Tools for minimizing risk and expense by optimizing the relationship between supply and demand </li><li>Detailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management </li><li>Spreadsheet-based models to illustrate key concepts, adaptable to the readers’ specific scenarios</li></ul> Supply Chain Planning for Clinical Trails is ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics.

Inhaltsverzeichnis

Preface xiii Acknowledgments xvii 1 Supply Chain Management 1 1.1 Supply Chain Management 1 1.2 Plan 3 1.3 Source 6 1.4 Make 8 1.5 Deliver/Return 11 1.6 Data, Analytics, and Metrics 12 1.7 The People–Process–Technology Framework 16 1.8 Key Takeaways 16 Notes 17 2 Introduction to Clinical Trials 19 2.1 Introduction to Clinical Trials 19 2.2 A Conversation About Clinical Trials 19 2.3 Intrinsic Elements of a Clinical Trial 23 2.4 Extrinsic Elements of a Clinical Trial 26 2.5 Preclinical Drug Development 27 2.6 The Clinical Development Plan 28 2.7 Phase I Clinical Trials 29 2.8 Clinical Pharmacology Trials 30 2.9 Phase II and III Clinical Trials 31 2.10 Adaptive Trials 32 2.11 Master Protocol Designs – Platform, Basket, and Umbrella Trials 32 2.12 Decentralized Clinical Trials 33 2.13 Post-marketing Clinical Trials 34 2.14 Clinical Trial Stakeholder Summary 34 2.15 Trends in Clinical Trial Design and Conduct 36 2.16 Key Takeaways 37 Notes 38 3 Introduction to the Clinical Trial Supply Chain 39 3.1 Introduction to the Clinical Trial Supply Chain 39 3.2 Drug Modalities 40 3.3 Starting Materials and Drug Substance 43 3.4 Drug Product 44 3.5 Analytical Development and Characterization 45 3.6 Manufacturing Process Development 48 3.7 Packaging 49 3.8 Labeling 51 3.9 Distribution 53 3.10 Clinical Trial Supply Chain Summary 54 3.11 CMC Development and Manufacturing Strategy 55 3.12 CMC Stakeholder Summary 57 3.13 Trends in Clinical Manufacturing and Supply Chain Management 61 3.14 Key Takeaways 62 Notes 63 4 Quality Considerations 65 4.1 What Is Quality? 65 4.2 Good Manufacturing Practice: An Overview 67 4.3 Source: Supplier Identification and Qualification 70 4.4 Make: Batch Records, Sampling, Batch Release, Deviations, and Disposition 71 4.5 Deliver: Good Distribution Practice, Temperature Excursions, Returns, and Recalls 73 4.6 Plan: Planning Inputs and Change Management 75 4.7 Preapproval Inspection 77 4.8 The Qualified Person 78 4.9 Key Takeaways 80 Notes 81 5 Regulatory Considerations 83 5.1 Introduction to Regulatory Applications 83 5.2 Regulatory Application Content and the CTD 84 5.3 Health Authority Interactions 87 5.4 The Clinical Trial Regulation in the European Union 87 5.5 Application Authoring, Submission, and Approval 88 5.6 Amendments 90 5.7 Commitments and Restrictions 92 5.8 Regulatory Status Tracking 93 5.9 Batch and IMP Lifecycle Management 94 5.10 Process Version Management 97 5.11 Key Takeaways 100 Notes 101 6 RTSM and Its Role in the Clinical Supply Chain 103 6.1 Randomization and Trial Supply Management 103 6.2 RTSM Scope and Functionality 104 6.3 The Kit Identifier 106 6.4 IMP Supply Strategies 107 6.5 IMP Expiry Management Settings 114 6.6 Transactions, Alerts, and Drug Accountability 115 6.7 Reports and Their Link to Demand and Supply Planning 118 6.8 Additional IMP Management Considerations 119 6.9 RTSM Supplier Selection 120 6.10 RTSM Trends and Future Capabilities 121 6.11 Key Takeaways 122 Notes 123 7 Supply Chain Planning for Clinical Trials 125 7.1 Framing the Road Ahead 125 7.2 Clinical Planning Objectives 126 7.3 Clinical Planning Activities 127 7.4 Mathematical Approaches to Clinical Planning 130 7.5 The Elements of Demand and Supply Planning for Clinical Trials 130 7.6 Clinical Demand and Supply Planning Business Processes 133 7.7 Alternative Clinical Supply Chain Scenarios 134 7.8 The Role of the Clinical Supply Chain Function 134 7.9 Getting Started 137 7.10 Key Takeaways 137 8 Finished Product Demand Planning: Basic Concepts 139 8.1 Introduction to Demand Planning for Clinical Trials 139 8.2 The What of Demand Forecasting: The Stockkeeping Unit 140 8.3 The Where of Demand Forecasting: Depot Versus Site 143 8.4 The Demand Forecast Period: Weeks Versus Months of Supply 144 8.5 The Demand Forecast Table 146 8.6 Forecasting Individual Subject Demand 146 8.7 Forecasting Enrollment 152 8.8 Overage 160 8.9 Site Stocking Demand 162 8.10 Total Demand and Next Steps 163 8.11 The Challenge of Accuracy in Clinical Trial Demand Planning 163 8.12 Key Takeaways 164 Notes 165 9 Finished Product Supply Planning: The Production Plan 167 9.1 Introduction to Supply Planning 167 9.2 Min–Max Inventory Management 168 9.3 Weeks-of-Supply 174 9.4 The Production Plan Table 175 9.5 The Impact of Future Demand on Production Order Requirements 176 9.6 Selecting Supply Planning Parameters and Their Impact on Production Order Requirements 178 9.7 From Requirements to Orders 181 9.8 The Production Plan Summary 184 9.9 Production Order Readiness 185 9.10 Key Takeaways 186 10 Finished Product Expiry Planning 189 10.1 Expiry Management and the Planning Process 189 10.2 First In First Out and Last In First Out Inventory Management 190 10.3 The Importance of Batch Visibility 191 10.4 Incorporating Expiry into the Finished Product Plan 192 10.5 Forecasting Expiry Events 196 10.6 Shelf-Life Extensions Versus Replacement Inventory 199 10.7 Strategies for Managing Expiry Limitations 201 10.8 Key Takeaways 203 11 Finished Product Supply Planning: The Distribution Plan 205 11.1 Introduction to Distribution Planning 205 11.2 Mapping the Clinical Packaging and Distribution Network 206 11.3 Connecting Regional Depots to the Central Depot 209 11.4 Demand and Supply Planning Parameters Revisited 212 11.5 Distribution Planning Strategies 213 11.6 Aggregate Finished Product Weeks-of-Supply 218 11.7 The Weeks-of-Supply Summary 220 11.8 The Distribution Plan Summary 220 11.9 Distribution Order Readiness 222 11.10 Key Takeaways 223 12 Upstream Supply Planning: Primary Packaging, Drug Product, and Drug Substance 225 12.1 Planning for Upstream Materials 225 12.2 General Approach to Demand Planning for Upstream Materials 226 12.3 General Approach to Supply Planning for Upstream Materials 230 12.4 Upstream Supply Planning Strategies 234 12.5 Small-Molecule Primary Packaging Planning 237 12.6 Small-Molecule Drug Product Planning 238 12.7 Small-Molecule Drug Substance Planning 239 12.8 Large-Molecule Drug Product Planning 241 12.9 Large-Molecule Drug Substance Planning 242 12.10 The Upstream Production Plan Summary 245 12.11 Upstream Production Order Readiness 246 12.12 Key Takeaways 247 13 Advanced Concepts in Demand and Supply Planning 249 13.1 Advanced Concepts in Demand and Supply Planning 249 13.2 Accuracy or Conservatism in Demand Planning 250 13.3 Aggregate Forecasting 252 13.4 Forecasting Subject Attrition and Subject Replacement 253 13.5 End-to-End Supply Planning Strategy 255 13.6 Demand and Supply Planning for Variable Durations of Treatment 258 13.7 Demand and Supply Planning for Dose Titrations, Reductions, and SKU Switches 259 13.8 Demand and Supply Planning for Extensions 261 13.9 Segregating Site Inventory from Depot Inventory 263 13.10 Inventory Pooling 264 13.11 Low-Case–High-Case Demand and Supply Planning 264 13.12 Deterministic Versus Stochastic Demand and Supply Planning 268 13.13 Key Takeaways 268 Notes 270 14 Clinical Supply Chain Reports, Budgets, and Metrics 271 14.1 The Importance of Communication in Supply Chain Management 271 14.2 Inventory Reporting 272 14.3 Visualizing the Production Plan 273 14.4 Visualizing the Supply Plan and Inventory Management Strategy 275 14.5 Portfolio Reports 277 14.6 Translating the Supply Plan into a Budget Forecast 279 14.7 Cost of Goods Analyses 282 14.8 Metrics 283 14.9 Dashboards 285 14.10 Key Takeaways 287 Notes 288 15 Clinical Supply Chain Planning Processes 289 15.1 The Clinical Supply Chain Planning Processes 289 15.2 Demand and Supply Plan Creation 290 15.3 Demand and Supply Planning 293 15.4 Operational Clinical Demand and Operations Planning 299 15.5 Strategic Clinical Demand and Operations Planning 303 15.6 Supply Plan Handover and Order Readiness 305 15.7 Global Supply Execution Readiness 306 15.8 Supply Network Planning 307 15.9 Three Keys to Business Process Success 309 15.10 Key Takeaways 310 16 A Week in the Life of a Clinical Planner 313 16.1 Before the Week Begins 313 16.2 Monday: Scenarios Incoming 314 16.3 Tuesday: Study Design Scenario Planning 315 16.4 Wednesday: A Lower-than-Planned Yield 318 16.5 Thursday Morning: Regulatory Restrictions 321 16.6 Thursday Afternoon and Friday: The Adaptive Trial Design 323 16.7 Friday Afternoon: Excellence in Planning 329 16.8 Key Takeaways 331 17 Comparator and Ancillary Planning 333 17.1 Comparator and Ancillary Definitions 333 17.2 Regulatory Implications for IMP and Non-IMP Comparators 334 17.3 Active IMP Comparator Considerations 336 17.4 Additional Blinded IMP Comparator Considerations 339 17.5 Non-IMP Comparator Medication Considerations 340 17.6 Ancillary Supply Considerations 340 17.7 Key Takeaways 343 Notes 344 18 Make-to-Order and Just-in-Time Supply Chains in Clinical Trials 345 18.1 Make-to-Stock and Make-to-Order Supply Chain Management 345 18.2 MTS, MTO, Lean, and JIT Supply Chain Principles 347 18.3 Inventory Pooling and Just-in-Time Manufacturing 349 18.4 Allogenic Cell Therapy Supply Chain Considerations 352 18.5 Autologous Cell Therapy Supply Chain Considerations 354 18.6 Key Takeaways 358 Notes 358 19 Direct-to-Patient Supply Chain Management 361 19.1 Introduction to Decentralized Clinical Trials 361 19.2 Direct-to-Patient Supply Chain Models 362 19.3 Direct-to-Patient Supply Chain Stakeholders and Costs 364 19.4 Direct-to-Patient Supply Chain Planning Considerations 366 19.5 The Direct-to-Patient Supply Chain Execution Process 368 19.6 Other Direct-to-Patient Supply Chain Execution Considerations 370 19.7 Parting Thoughts on the Direct-to-Patient Supply Chain 373 19.8 Key Takeaways 373 Notes 374 20 Contract Organization Management and Oversight 375 20.1 Strategic Supplier Management Within the Biopharmaceutical Industry 375 20.2 Insourcing, Make-Versus-Buy, and Outsourcing 376 20.3 Supplier Identification and Selection 378 20.4 Supplier Qualification and Contracting 381 20.5 Strategic Supplier Management 382 20.6 Clinical Supply Chain Sourcing Strategies 385 20.7 Contract Research Organization Engagement 386 20.8 Key Takeaways 388 Notes 389 21 International Logistics for Clinical Biopharmaceutical Products 391 21.1 International Logistics for Clinical Biopharmaceutical Products 391 21.2 Duties, Taxes, Valuation, and Registration 392 21.3 Logistics Stakeholders and IncoTerms 394 21.4 The International Shipping Business Process 396 21.5 Import for Export, Free Trade Zones, and Special Economic Zones 400 21.6 Key Takeaways 401 Notes 402 22 Clinical Supply Chain Planning Tools and Technology 403 22.1 Data, Technology, and Clinical Supply Chain Planning 403 22.2 Demand and Supply Planning in Spreadsheets 405 22.3 Data Governance 408 22.4 Training 410 22.5 Business Process Integration 411 22.6 Beyond Spreadsheets: Selection and Implementation Strategies for Advanced Planning Systems 412 22.7 The Future of Technology in Clinical Supply Chain Management 414 22.8 Key Takeaways 416 23 Integrating the Clinical Supply Chain into a Commercial Launch 419 23.1 Transitioning from Clinical Supply Chain Management to Global Supply Chain Management 419 23.2 Commercial Supply Chain Strategy 420 23.3 Integrating Clinical and Commercial Demand and Supply Planning 423 23.4 Sales and Operations Planning as an Integrator of Clinical and Commercial Supply Chain Management 425 23.5 Commercial Supply Chain Execution 427 23.6 The Commercial Quality Management System and Regulatory Considerations 428 23.7 The Evolution of the Global Supply Chain Organization 430 23.8 Key Takeaways 431 Notes 432 Appendix: Clinical Supply Chain Planning Data Elements and Formulas 433 Glossary 439 Index 449

Autorenportrait

Ryan Mills, MBA, is Senior Director and Head of Supply Chain for Denali Therapeutics, South San Francisco, CA. He has over 15 years of experience in pharmaceutical and biotechnology production, and his background in supply chain planning has involved some of the highest-performing companies in the world.