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Supply Chain Management in the Drug Industry. Delivering Patient Value for Pharmaceuticals and Biologics
John Wiley and Sons Ltd, February 2011, Pages: 456
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. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.
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.
5.4.3 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).
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.
9.6 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.
10.9 Shipping regulations relating to materials.
10.10 A finishing note.
CHAPTER 11 INFORMATION SYSTEMS (IS) and INFORMATION TECHNOLOGY (IT).
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 Ending with the Beginning.
"A recommended read for all wishing to shift performance to greater levels." (Supply Management, 1 February 2012)
"This book is ideal reading for those entering or currently working in the field of supply chain management, such as clinical supply managers, or those in operations or production and planning ... This book would be an excellent resource for small pharmaceutical companies that may have limited experience of supply chain implementation or outsourcing, giving a thorough overview of the process and plenty of food for thought." (The Pharmaceutical Journal, 16 November 2011)
"This is a solid text that is equally suitable for the newcomer or experienced profesional in the pharmaceutical/biologics industries . . . Overall, I recommend the book for its educational perspective on the industry and the significance of effective SCM for its future success." (Quality World, 1 July 2011)