Item Details

Supply Chain Management in the Drug Industry [electronic resource]: Delivering Patient Value for Pharmaceuticals and Biologics

Hedley Rees
Format
EBook; Book; Online
Published
Hoboken, N.J. : Wiley, c2011.
Language
English
ISBN
9780470555170 (cloth), 0470555173 (cloth)
Summary
"This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials"--Provided by publisher.
Contents
  • Machine generated contents note: PART I: SURVEYING AND MAPPING THE TERRITORY.
  • CHAPTER 1 SETTING A TRANSFORMATIONAL AGENDA.
  • 1.1 Aims and aspirations of the book.
  • 1.2 Book Format.
  • 1.3 Intended readership.
  • 1.4 A book about two worlds in contrast.
  • 1.5 The pharmaceutical lottery.
  • 1.6 Supply Chain Management (SCM) in context.
  • 1.7 The History of Supply and Value Generation.
  • 1.8 The Development of Processes to Manage the Supply Chain.
  • 1.9 Life in SCM.
  • 1.10 Moving forward.
  • CHAPTER 2 PLOTTING A COURSE TO PATIENT VALUE.
  • 2.1 Why focus on Patient Value?
  • 2.2 Where does the patient currently fit?
  • 2.3 Why is it necessary to plot a course?
  • 2.4 Understanding how the course is presently set.
  • 2.5 Capturing value for patients.
  • CHAPTER 3 PHARMACEUTICAL DRUG DEVELOPMENT.
  • 3.1 Drug development's role in the supply chain.
  • 3.2 Introduction to drug development.
  • 3.3 The Medicinal Product.
  • 3.4 Clinical Trials.
  • 3.5 Related Development Programmes.
  • 3.6 Managing Clinical Programs.
  • 3.7 Regulatory Affairs and Authorities.
  • 3.8 Supply Chain Management in Development Programmes.
  • 3.9 Manufacture and Supply of Commercial Product.
  • 3.10 Supply Chain Management for Commercial Product.
  • CHAPTER 4 END-TO-END PHARMACEUTICAL SUPPLY CHAINS.
  • 4.1 Where does responsibility for the supply chain lay?
  • 4.2 Sponsor companies, license holders and their supply chains.
  • 4.3 Supply chains for small molecule products.
  • 4.4 Starting at the final destination.
  • 4.5 How do drugs enter the body?
  • 4.6 Design of drug delivery systems.
  • 4.7 What does this mean for the supply chain?
  • 4.8 Key aspects of GMP/GDP in relation to SCM.
  • 4.9 An overview of the stages on route to patient delivery.
  • 4.10 Manufacture and supply of biological entities.
  • CHAPTER 5: WHY PHARMA SUPPLY CHAINS DON'T PERFORM.
  • 5.1 Supply chain underperformance.
  • 5.2 Is there a case to answer?
  • 5.3 Birth to infancy - the supply chain critical stage.
  • 5.4 Commercial supply under the patent protection umbrella.
  • 5.4.1 Limited competitive alternatives.
  • 5.4.2 Fragmentation.
  • 5.4.3 Supplier power.
  • 5.4.4 The position of those buying pharmaceutical products.
  • 5.5 What does this mean for the pharmaceutical supply chain?
  • -- PART II: BUILDING A KNOWLEDGE FOUNDATION IN SCM.
  • CHAPTER 6 SUPPLY CHAIN MANAGEMENT AS A COMPETETIVE WEAPON.
  • 6.1 Competition and business strategy.
  • 6.2 The marketing mix.
  • 6.3 Porter's Five Forces.
  • 6.4 Porter's Generic Competitive Strategies.
  • 6.5 Porters Value Chain.
  • 6.6 Competitive strategy and customers.
  • 6.7 The Japanese Experience.
  • 6.8 Total Quality Management.
  • 6.9 Lean Thinking.
  • 6.10 Focusing on value for money.
  • 6.11 SCM processes in competitive strategy.
  • 6.12 SCM in biotech/virtual companies.
  • 6.13 Competition in pharmaceuticals.
  • CHAPTER 7 SUPPLY CHAIN MANAGEMENT (SCM) HOLISTIC.
  • 7.1 The relevance of SCM to Pharmaceuticals.
  • 7.2 Production systems and the holistic of SCM.
  • 7.3 The Core of SCM.
  • 7.4 First principle of SCM.
  • 7.5 Supply chains as a series of interconnected systems.
  • 7.6 Processes to manage the supply chain.
  • 7.7 A word about processes.
  • 7.8 How the SCM processes should mesh together.
  • 7.9 Production & Inventory Control (P & IC).
  • 7.10 Strategic Procurement.
  • 7.11 Transportation, storage and distribution.
  • 7.12 Information Systems and Technology (IS/IT).
  • 7.13 Improvement.
  • CHAPTER 8 PRODUCTION & INVENTORY CONTROL (P & IC).
  • 8.1 Core mission.
  • 8.2 First principles of production and inventory control (P & I C).
  • 8.3 The Wholesome Trinity (TWT) in P & IC.
  • 8.4 The Wholesome Trinity (TWT) and customer expectations.
  • 8.5 Leveraging 'The Wholesome Trinity' (TWT).
  • 8.6 The impact of variety on supply chains.
  • 8.7 Designing appropriate production systems.
  • CHAPTER 9 STRATEGIC PROCUREMENT.
  • 9.1 Core mission.
  • 9.2 The Purchasing Portfolio.
  • 9.3 The Process of Procurement.
  • 9.4 Strategic sourcing and planning.
  • 9.5 Outsourcing.
  • 9.6 Basic principles in contracting for supply.
  • 9.7 Finally, a typical organisational tension over procurement.
  • CHAPTER 10 TRANSPORTATION, STORAGE AND DISTRIBUTION.
  • 10.1 Defining the core mission.
  • 10.2 International trade and commerce.
  • 10.3 The World Trade Organization (WTO).
  • 10.4 Intermediary arrangements.
  • 10.5 Terms of Trade - Incoterms 2000.
  • 10.6 Ownership of goods (Title).
  • 10.7 Third Party Logistics (3PL) Providers.
  • 10.8 Customs.
  • 10.9 Shipping regulations relating to materials.
  • 10.10 A finishing note.
  • CHAPTER 11 INFORMATION SYSTEMS (IS) and INFORMATION TECHNOLOGY (IT).
  • 11.1 Overview.
  • 11.2 A brief (layman's - and very brief!) history of computer systems development.
  • 11.3 IS/IT and Business Process Management (BPM) - Dee Carrie.
  • 11.4 IS/IT and Supply Chain Management.
  • 11.5 IS/IT and patient safety - Adrian Hampshire.
  • 11.6 IS/IT and the regulations.
  • 11.7 IS/IT and SOPs.
  • CHAPTER 12 IMPROVEMENT.
  • 12.1 Why improve?
  • 12.2 Improvement and Production Systems.
  • 12.3 The improvement journey.
  • CHAPTER 13 BRINGING THE HOLISTIC TOGETHER.
  • 13.1 Setting the scene.
  • 13.2 The process explained.
  • 13.3 Developing an action agenda.
  • 13.4 An illustrative case study.
  • -- PART III: PLANNING AND EXECUTING SUPPLY CHAIN CHANGE.
  • CHAPTER 14 IMPROVEMENT IN PHARMACEUTICALS.
  • 14.1 Where are we now?
  • 14.2 Subsequent developments since inception.
  • 14.3 A Blueprint for Quality by Design (QbD).
  • CHAPTER 15 EXEMPLAR THINKING IN ORGANISATIONAL IMPROVEMENT.
  • 15.1 Where are we now?
  • 15.2 What is meant by 'Exemplar'?
  • 15.3 A dialogue on exemplar improvement.
  • CHAPTER 16 BUILDING A FOUNDATION FOR SUSTAINABLE CHANGE.
  • 16.1 Focus on the individual.
  • 16.2 Individuals as leaders.
  • 16.3 Individuals as motivators and the motivated.
  • 16.4 Individuals as group members.
  • 16.5 Individuals as participants in cultural change.
  • 16.6 CASE STUDY MILES LTD., BRIDGEND, GLAMORGAN.
  • CHAPTER 17 A CURE FOR THE PHARMACETICAL SUPPLY CHAIN.
  • 17.1 What is the disease state?
  • 17.2 What is the label claim for the Medicine?
  • 17.3 What will life hold without the medicine?
  • 17.4 What is this 'better way' to develop drugs?
  • 17.5 Full scale production of drugs.
  • 17.6 What are the barriers to change?
  • 17.7 What are the potential benefits of change?
  • 17.8 Defining the art of the possible.
  • 17.9 Concluding message.
Description
Mode of access: World wide Web.
Notes
Includes bibliographical references and index.
Logo for Copyright Not EvaluatedCopyright Not Evaluated
Technical Details

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    a| Supply chain management in the drug industry h| [electronic resource] : b| delivering patient value for pharmaceuticals and biologics / c| Hedley Rees.
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    a| Machine generated contents note: PART I: SURVEYING AND MAPPING THE TERRITORY. -- CHAPTER 1 SETTING A TRANSFORMATIONAL AGENDA. -- 1.1 Aims and aspirations of the book. -- 1.2 Book Format. -- 1.3 Intended readership. -- 1.4 A book about two worlds in contrast. -- 1.5 The pharmaceutical lottery. -- 1.6 Supply Chain Management (SCM) in context. -- 1.7 The History of Supply and Value Generation. -- 1.8 The Development of Processes to Manage the Supply Chain. -- 1.9 Life in SCM. -- 1.10 Moving forward. -- CHAPTER 2 PLOTTING A COURSE TO PATIENT VALUE. -- 2.1 Why focus on Patient Value? -- 2.2 Where does the patient currently fit? -- 2.3 Why is it necessary to plot a course? -- 2.4 Understanding how the course is presently set. -- 2.5 Capturing value for patients. -- CHAPTER 3 PHARMACEUTICAL DRUG DEVELOPMENT. -- 3.1 Drug development's role in the supply chain. -- 3.2 Introduction to drug development. -- 3.3 The Medicinal Product. -- 3.4 Clinical Trials. -- 3.5 Related Development Programmes. -- 3.6 Managing Clinical Programs. -- 3.7 Regulatory Affairs and Authorities. -- 3.8 Supply Chain Management in Development Programmes. -- 3.9 Manufacture and Supply of Commercial Product. -- 3.10 Supply Chain Management for Commercial Product. -- CHAPTER 4 END-TO-END PHARMACEUTICAL SUPPLY CHAINS. -- 4.1 Where does responsibility for the supply chain lay? -- 4.2 Sponsor companies, license holders and their supply chains. -- 4.3 Supply chains for small molecule products. -- 4.4 Starting at the final destination. -- 4.5 How do drugs enter the body? -- 4.6 Design of drug delivery systems. -- 4.7 What does this mean for the supply chain? -- 4.8 Key aspects of GMP/GDP in relation to SCM. -- 4.9 An overview of the stages on route to patient delivery. -- 4.10 Manufacture and supply of biological entities. -- CHAPTER 5: WHY PHARMA SUPPLY CHAINS DON'T PERFORM. -- 5.1 Supply chain underperformance. -- 5.2 Is there a case to answer? -- 5.3 Birth to infancy - the supply chain critical stage. -- 5.4 Commercial supply under the patent protection umbrella. -- 5.4.1 Limited competitive alternatives. -- 5.4.2 Fragmentation. -- 5.4.3 Supplier power. -- 5.4.4 The position of those buying pharmaceutical products. -- 5.5 What does this mean for the pharmaceutical supply chain? --
    505
    8
      
    a| PART II: BUILDING A KNOWLEDGE FOUNDATION IN SCM. -- CHAPTER 6 SUPPLY CHAIN MANAGEMENT AS A COMPETETIVE WEAPON. -- 6.1 Competition and business strategy. -- 6.2 The marketing mix. -- 6.3 Porter's Five Forces. -- 6.4 Porter's Generic Competitive Strategies. -- 6.5 Porters Value Chain. -- 6.6 Competitive strategy and customers. -- 6.7 The Japanese Experience. -- 6.8 Total Quality Management. -- 6.9 Lean Thinking. -- 6.10 Focusing on value for money. -- 6.11 SCM processes in competitive strategy. -- 6.12 SCM in biotech/virtual companies. -- 6.13 Competition in pharmaceuticals. -- CHAPTER 7 SUPPLY CHAIN MANAGEMENT (SCM) HOLISTIC. -- 7.1 The relevance of SCM to Pharmaceuticals. -- 7.2 Production systems and the holistic of SCM. -- 7.3 The Core of SCM. -- 7.4 First principle of SCM. -- 7.5 Supply chains as a series of interconnected systems. -- 7.6 Processes to manage the supply chain. -- 7.7 A word about processes. -- 7.8 How the SCM processes should mesh together. -- 7.9 Production & Inventory Control (P & IC). -- 7.10 Strategic Procurement. -- 7.11 Transportation, storage and distribution. -- 7.12 Information Systems and Technology (IS/IT). -- 7.13 Improvement. -- CHAPTER 8 PRODUCTION & INVENTORY CONTROL (P & IC). -- 8.1 Core mission. -- 8.2 First principles of production and inventory control (P & I C). -- 8.3 The Wholesome Trinity (TWT) in P & IC. -- 8.4 The Wholesome Trinity (TWT) and customer expectations. -- 8.5 Leveraging 'The Wholesome Trinity' (TWT). -- 8.6 The impact of variety on supply chains. -- 8.7 Designing appropriate production systems. -- CHAPTER 9 STRATEGIC PROCUREMENT. -- 9.1 Core mission. -- 9.2 The Purchasing Portfolio. -- 9.3 The Process of Procurement. -- 9.4 Strategic sourcing and planning. -- 9.5 Outsourcing. -- 9.6 Basic principles in contracting for supply. -- 9.7 Finally, a typical organisational tension over procurement. -- CHAPTER 10 TRANSPORTATION, STORAGE AND DISTRIBUTION. -- 10.1 Defining the core mission. -- 10.2 International trade and commerce. -- 10.3 The World Trade Organization (WTO). -- 10.4 Intermediary arrangements. -- 10.5 Terms of Trade - Incoterms 2000. -- 10.6 Ownership of goods (Title). -- 10.7 Third Party Logistics (3PL) Providers. -- 10.8 Customs. -- 10.9 Shipping regulations relating to materials. -- 10.10 A finishing note. -- CHAPTER 11 INFORMATION SYSTEMS (IS) and INFORMATION TECHNOLOGY (IT). -- 11.1 Overview. -- 11.2 A brief (layman's - and very brief!) history of computer systems development. -- 11.3 IS/IT and Business Process Management (BPM) - Dee Carrie. -- 11.4 IS/IT and Supply Chain Management. -- 11.5 IS/IT and patient safety - Adrian Hampshire. -- 11.6 IS/IT and the regulations. -- 11.7 IS/IT and SOPs. -- CHAPTER 12 IMPROVEMENT. -- 12.1 Why improve? -- 12.2 Improvement and Production Systems. -- 12.3 The improvement journey. -- CHAPTER 13 BRINGING THE HOLISTIC TOGETHER. -- 13.1 Setting the scene. -- 13.2 The process explained. -- 13.3 Developing an action agenda. -- 13.4 An illustrative case study. --
    505
    8
      
    a| PART III: PLANNING AND EXECUTING SUPPLY CHAIN CHANGE. -- CHAPTER 14 IMPROVEMENT IN PHARMACEUTICALS. -- 14.1 Where are we now? -- 14.2 Subsequent developments since inception. -- 14.3 A Blueprint for Quality by Design (QbD). -- CHAPTER 15 EXEMPLAR THINKING IN ORGANISATIONAL IMPROVEMENT. -- 15.1 Where are we now? -- 15.2 What is meant by 'Exemplar'? -- 15.3 A dialogue on exemplar improvement. -- CHAPTER 16 BUILDING A FOUNDATION FOR SUSTAINABLE CHANGE. -- 16.1 Focus on the individual. -- 16.2 Individuals as leaders. -- 16.3 Individuals as motivators and the motivated. -- 16.4 Individuals as group members. -- 16.5 Individuals as participants in cultural change. -- 16.6 CASE STUDY MILES LTD., BRIDGEND, GLAMORGAN. -- CHAPTER 17 A CURE FOR THE PHARMACETICAL SUPPLY CHAIN. -- 17.1 What is the disease state? -- 17.2 What is the label claim for the Medicine? -- 17.3 What will life hold without the medicine? -- 17.4 What is this 'better way' to develop drugs? -- 17.5 Full scale production of drugs. -- 17.6 What are the barriers to change? -- 17.7 What are the potential benefits of change? -- 17.8 Defining the art of the possible. -- 17.9 Concluding message.
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