{"product_id":"transforming-the-pharmaceutical-supply-chain-hardback-9781394244126","title":"Transforming the Pharmaceutical Supply Chain (Hardback) 9781394244126","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eTransforming the Pharmaceutical Supply Chain\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cfont size=\"4\"\u003eHedley Rees (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9781394244126, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 29 August 2025\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e368 pages\u003cbr\u003e23.1 x 15.8 x 2.3 cm, 0.68 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003cb\u003eEffective and insightful solutions to the most pressing supply chain challenges facing pharmaceutical companies today\u003c\/b\u003e \u003c\/p\u003e\n\u003cp\u003eIn \u003ci\u003eTransforming the Pharmaceutical Supply Chain,\u003c\/i\u003e veteran biotech supply chain strategist, Hedley Rees, delivers a reasoned and systematic solution to the most widespread and relevant challenges in the pharmaceutical supply chain. The book explains the deeply rooted issues within pharma supply chains and the modus operandi of the industry while also discussing effective solutions to the underlying causes that led to widespread system breakdown. \u003c\/p\u003e\n\u003cp\u003eThe author applies modern methods of product development and commercial supply successfully used by leaders in the field. He provides real-world examples of ways to make the delivery of medicines to patients efficient and effective. \u003c\/p\u003e\n\u003cp\u003eReaders will also find: \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eA clear explanation of the development, manufacture, and delivery of drugs to patients\u003c\/li\u003e\n\u003cli\u003eComprehensive explorations of the issues and challenges to the current supply chain system paired with effective solutions\u003c\/li\u003e\n\u003cli\u003eExpert witness accounts, anecdotes, case studies and examples of pharmaceutical supply chain difficulties and solutions\u003c\/li\u003e\n\u003cli\u003eComplete treatments of how to adapt supply chain techniques to a pharmaceutical era dominated by biologics and advanced therapies\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003ePerfect for pharmaceutical and biopharmaceutical professionals working in drug development, \u003ci\u003eTransforming the Pharmaceutical Supply Chain\u003c\/i\u003e will also benefit industry professionals with a responsibility for the logistics, commercial supply, manufacturing, regulation, quality management, finance, and marketing of pharmaceuticals.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003eForeword xi\u003c\/p\u003e \u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003eAcknowledgments xvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIntroduction 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eSetting a Transformative Agenda 1\u003c\/p\u003e \u003cp\u003eWhat Should You Expect to Take Away from This Book? 2\u003c\/p\u003e \u003cp\u003eBook Format 3\u003c\/p\u003e \u003cp\u003eWho Should Benefit from Reading This Book? 5\u003c\/p\u003e \u003cp\u003eResearch Methodology 6\u003c\/p\u003e \u003cp\u003eA Positive View of the Future 6\u003c\/p\u003e \u003cp\u003eMore Than a Generation of Change Will Be Required 7\u003c\/p\u003e \u003cp\u003eReferences 7\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection I The Pharmaceutical Industry and Its Supply Chain 9\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Industry Basics 11\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003ePharmaceutical Products 11\u003c\/p\u003e \u003cp\u003eIndustry Business Models and the Supply Chain 12\u003c\/p\u003e \u003cp\u003eReferences 20\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 The Pharmaceutical Supply Chain 21\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe End-to-end (E2E) Supply Chain in Perspective 21\u003c\/p\u003e \u003cp\u003eProduction Supply Chain: Small Molecule Products (Originator and Generic) 21\u003c\/p\u003e \u003cp\u003eProduction Supply Chain: Biologic Products (Originator and Biosimilar) 24\u003c\/p\u003e \u003cp\u003eProduction Supply Chain: Advanced Therapies—Autologous 30\u003c\/p\u003e \u003cp\u003eReferences 36\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Regulation of Pharmaceutical Products 39\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eRegulatory Authorities 39\u003c\/p\u003e \u003cp\u003eLicensing Medicinal Products for Sale 40\u003c\/p\u003e \u003cp\u003eElectronic Common Technical Document 41\u003c\/p\u003e \u003cp\u003eDrug Development Programs 42\u003c\/p\u003e \u003cp\u003eRegulatory Good Practices (GxP) 43\u003c\/p\u003e \u003cp\u003eExpert Witness Statement: Alan Kennedy 48\u003c\/p\u003e \u003cp\u003eRegulatory Modernization Initiatives 52\u003c\/p\u003e \u003cp\u003eReferences 62\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Evidence of Serious Supply Chain Problems Emerge 65\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eU.S. Government Accountability Office Sounds an Important Warning Bell 65\u003c\/p\u003e \u003cp\u003eThe Heparin Tragedy 67\u003c\/p\u003e \u003cp\u003eFDA\/Xavier University Co-sponsored Global Outsourcing Conference (GOC) 68\u003c\/p\u003e \u003cp\u003eGovernments and Regulatory Authorities Respond 71\u003c\/p\u003e \u003cp\u003eReferences 78\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Investigating Worrying Supply Chain Symptoms 81\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eLarge Pharmaceutical Companies Outsource Their Assets 81\u003c\/p\u003e \u003cp\u003eThe Valley of Death Creates the Patent Cliff 85\u003c\/p\u003e \u003cp\u003eMerger and Acquisition Becomes the Next Strategic Realignment 85\u003c\/p\u003e \u003cp\u003eThe Emergence of Biologics (eg Monoclonal Antibodies) 87\u003c\/p\u003e \u003cp\u003eCommercial Potential of Recombinant DNA 88\u003c\/p\u003e \u003cp\u003eWhat Is the Purpose of the Orphan Drug Act? 91\u003c\/p\u003e \u003cp\u003eValue-based Pricing and HEOR Groups Emerge 92\u003c\/p\u003e \u003cp\u003eSymptoms Transition to Deep Concerns 98\u003c\/p\u003e \u003cp\u003eReferences 104\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Impact of the Systems Dynamic on Supply Chain Performance 107\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eCircling Back to Professor Andrew Cox's Assessment 107\u003c\/p\u003e \u003cp\u003eSupply Chain Underperformance Through the Development Process 108\u003c\/p\u003e \u003cp\u003eDifferences Between the Commercial and Clinical Supply Chain Challenges 112\u003c\/p\u003e \u003cp\u003eCommercial Launch and Supply (and Phase IV—Clinical Trials After Launch) 115\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 The Outcome 119\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003ePoliticians Have Been Calling Out the Spiraling Price of Drugs 119\u003c\/p\u003e \u003cp\u003eWildly Varying Estimates of Drug Development Costs and Clinical Trial Failures 119\u003c\/p\u003e \u003cp\u003eGeneric Drugs Are Not Always the Same as the Originator’s 120\u003c\/p\u003e \u003cp\u003eAnimal Testing Is Still the Only Way 121\u003c\/p\u003e \u003cp\u003eMe-too Drugs 122\u003c\/p\u003e \u003cp\u003ePatient-centricity Is About Brands Not Cures 122\u003c\/p\u003e \u003cp\u003eCounterfeit Drugs 123\u003c\/p\u003e \u003cp\u003ePrice Gouging 123\u003c\/p\u003e \u003cp\u003eIs Big Pharma Becoming More Focused on the Patient These Days? 124\u003c\/p\u003e \u003cp\u003eDoes the Industry Overlook Side Effects? 124\u003c\/p\u003e \u003cp\u003eExpert Witness Statement: Dr Ray Perkins 125\u003c\/p\u003e \u003cp\u003eDo Genes Define Our Biological and Medical Destiny? 129\u003c\/p\u003e \u003cp\u003eOf Missing Methods, Moldy Models, Mutated Mindsets, and Muddled Medications 131\u003c\/p\u003e \u003cp\u003eTo Ship or Not to Ship? That Is the Question 133\u003c\/p\u003e \u003cp\u003eBasic Assumptions in the Pharmaceutical Industry 135\u003c\/p\u003e \u003cp\u003eImpact of Basic Assumptions 138\u003c\/p\u003e \u003cp\u003eAn Expert Witness Statement: Professor Daniel Steenstra 138\u003c\/p\u003e \u003cp\u003eWhat Is a Paradigm Shift? 139\u003c\/p\u003e \u003cp\u003eReferences 141\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection II Managing the Supply Chain Strategically 143\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Introduction to Socio-technical Systems 145\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhat is a System? 145\u003c\/p\u003e \u003cp\u003eClosed and Open Systems 145\u003c\/p\u003e \u003cp\u003eThe Socio-technical System 147\u003c\/p\u003e \u003cp\u003eSystems Complexity in the Supply Chain: Bullwhip Effect 153\u003c\/p\u003e \u003cp\u003eExample of a High-performing Socio-technical (Production) System 154\u003c\/p\u003e \u003cp\u003eReferences 155\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Fundamentals of the Supply Chain 157\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhat Is a Supply Chain? 157\u003c\/p\u003e \u003cp\u003eThe Supply Chain in Modern Times 158\u003c\/p\u003e \u003cp\u003eThree States in the Supply Chain 159\u003c\/p\u003e \u003cp\u003eReference 160\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 The Supply Chain and Competitive Edge 161\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eSupply Chains, Not Products, Compete 161\u003c\/p\u003e \u003cp\u003eLinking Porter’s Value Chain Model to the Supply Chain System 164\u003c\/p\u003e \u003cp\u003eExpert Witness Statement: Nick Rich, PhD, Professor in Operations Management, Business, at Swansea University 167\u003c\/p\u003e \u003cp\u003eReferences 169\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Core Disciplines of Supply Chain Management 171\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003ePlanning and Inventory Management 171\u003c\/p\u003e \u003cp\u003eStrategic Procurement 189\u003c\/p\u003e \u003cp\u003eTransport Logistics 197\u003c\/p\u003e \u003cp\u003eReferences 209\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Support Disciplines of Supply Chain Management 211\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eInformation Systems (IS) and Information Technology (IT) 211\u003c\/p\u003e \u003cp\u003eIndustrial Improvement 219\u003c\/p\u003e \u003cp\u003eExpert Witness—Javid Cheema 226\u003c\/p\u003e \u003cp\u003eLeadership and Culture in the Supply Chain 239\u003c\/p\u003e \u003cp\u003eReferences 255\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection III Transforming the Pharmaceutical Supply Chain 257\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Shifting the Paradigm Gear 259\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhy Change? 259\u003c\/p\u003e \u003cp\u003eUnderpinning Principles of the New Paradigm 261\u003c\/p\u003e \u003cp\u003eTime to Switch on Your Imagination 263\u003c\/p\u003e \u003cp\u003eAviation as a Comparator with Pharmaceuticals 265\u003c\/p\u003e \u003cp\u003eRedefining Basic Assumptions for the New Paradigm 266\u003c\/p\u003e \u003cp\u003eReferences 268\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Heuristic Methodology to Define the Transformation 269\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003ePrimary Analysis 270\u003c\/p\u003e \u003cp\u003eSupporting Evidence 270\u003c\/p\u003e \u003cp\u003eSmall Molecule Product Supply Chain 270\u003c\/p\u003e \u003cp\u003ePrimary Analysis 270\u003c\/p\u003e \u003cp\u003eSupporting Evidence 271\u003c\/p\u003e \u003cp\u003eConfirmatory Supporting Evidence 273\u003c\/p\u003e \u003cp\u003eCimetidine—More Confirmatory Supporting Evidence 275\u003c\/p\u003e \u003cp\u003eBiologic Product Supply Chain (Including Allogeneic Products) 279\u003c\/p\u003e \u003cp\u003eOverview 283\u003c\/p\u003e \u003cp\u003eManufacturing Capability 283\u003c\/p\u003e \u003cp\u003eReferences 284\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Introducing the Pharmaceutical Production System 285\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDrugs Are Physical Products 285\u003c\/p\u003e \u003cp\u003eA New Model for Product Development 287\u003c\/p\u003e \u003cp\u003eAdopting Production Systems Principles in Hospitals 291\u003c\/p\u003e \u003cp\u003eReferences 293\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Catalyst of Radical Change 295\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe First Step 295\u003c\/p\u003e \u003cp\u003eCriteria for Patentability: New and Useful Process 296\u003c\/p\u003e \u003cp\u003eThe Patent Came After the Process 296\u003c\/p\u003e \u003cp\u003eWhat Is Compound Claims Patent Law? [2] 297\u003c\/p\u003e \u003cp\u003eWhat Is the Purpose of Patent? 298\u003c\/p\u003e \u003cp\u003eCompound Claims for New Molecules 299\u003c\/p\u003e \u003cp\u003ePatent Law Moves Center Stage 300\u003c\/p\u003e \u003cp\u003ePrevious and Ongoing Patent Change Initiatives 300\u003c\/p\u003e \u003cp\u003eReferences 304\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Delivering the Transformation with Stakeholders Onboard 305\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eReturning to Purpose 305\u003c\/p\u003e \u003cp\u003eWhat Can Key Stakeholders Do to Help? 310\u003c\/p\u003e \u003cp\u003eGovernments 310\u003c\/p\u003e \u003cp\u003eRegulatory Authorities 313\u003c\/p\u003e \u003cp\u003eClinicians in the Healthcare System 314\u003c\/p\u003e \u003cp\u003eInvestors in Drug Development 315\u003c\/p\u003e \u003cp\u003eUniversities and Colleges 315\u003c\/p\u003e \u003cp\u003ePatients 317\u003c\/p\u003e \u003cp\u003eKey Stakeholder Groups Inside the Pharmaceutical Supply Chain 317\u003c\/p\u003e \u003cp\u003eEngaging Pharmaceuticals in Supply Chain Management (SCM) 320\u003c\/p\u003e \u003cp\u003eMore than a Generation of Change Is Required 320\u003c\/p\u003e \u003cp\u003eReferences 321\u003c\/p\u003e \u003cp\u003eAppendices 323\u003c\/p\u003e \u003cp\u003eIndex 341\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52501092827416,"sku":"9781394244126","price":73.76,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9781394244126.jpg?v=1786209671","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/transforming-the-pharmaceutical-supply-chain-hardback-9781394244126","provider":"Freshly Printed Books","version":"1.0","type":"link"}