Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics

"...[This] interesting exploration of SCM issues includes business, control, regulatory and technical aspects. . . .a must–read for those entering into the SCM fields as well as all those who intersect with SCM." — Bob Coleman, former FDA Investigator and current Senior Compliance Expert, IHL Consulting Group, Inc.
A timely guide for improving productivity, driving out cost, aising quality
In response to the global pressure to contain healthcare budgets while improving compliance, the pharmaceutical industry is moving supply chain center stage, in an attempt to build supply chains comparable with the aerospace, semi–conductor, electronics, and automotive industries. This book bridges the gap between practitioners of supply chain management and pharmaceutical industry experts. It shows them how to jointly contribute to meaningful improvements in supply chains within the pharmaceutical sector.
Supply Chain Management in the Drug Industry suggests that CMC (chemistry, manufacturing, and 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. In addition, the book:
Provides a practical guide to the application of supply chain management (SCM) processes and practices in the pharmaceutical setting
Stresses the importance of integrated SCM throughout a pharmaceutical organization
Encourages the critical need for cultural shift and fosters collaborations between SCM practitioners and pharmaceutical scientists
With a thorough exploration of SCM from beginning to end of the pharmaceutical process, this book helps secure responsive, cost effective, and risk mitigated supply chains to compete on a world stage.

Spis treści:
PART I: SURVEYING AND MAPPING THE TERRITORY.
CHAPTER 1 SETTING A TRANSFORMATIONAL AGENDA.
1.1 Aims and aspirations of the book.
1.2 Bo ok 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 Fragment ation.
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 I ndividuals 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

Nota biograficzna:

Hedley Rees runs the independent consulting company Biotech PharmaFlow, which specializes in pharmaceutical supply chain management. He has been actively building, managing, and continuously improving supply chains in biotech for the last fifteen years.

Okładka tylna:

"...[This] interesting exploration of SCM issues includes business, control, regulatory and technical aspects. . . .a must–read for those entering into the SCM fields as well as all those who intersect with SCM." — Bob Coleman, former FDA Investigator and current Senior Compliance Expert, IHL Consulting Group, Inc.
A timely guide for improving productivity, driving out cost, aising quality
In response to the global pressure to contain healthcare budgets while improving compliance, the pharmaceutical industry is moving supply chain center stage, in an attempt to build supply chains comparable with the aerospace, semi–conductor, electronics, and automotive industries. This book bridges the gap between practitioners of supply chain management and pharmaceutical industry experts. It shows them how to jointly contribute to meaningful improvements in supply chains within the pharmaceutical sector.
Supply Chain Management in the Drug Industry suggests that CMC (chemistry, manufacturing, and 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. In addition, the book:
Provides a practical guide to the application of supply chain management (SCM) processes and practices in the pharmaceutical setting
Stresses the importance of integrated SCM throughout a pharmaceutical organization
Encourages the critical need for cultural shift and fosters collaborations between SCM practitioners and pharmaceutical scientists
With a thorough exploration of SCM from beginning to end of the pharmaceutical process, this book helps secure responsive, cost effective, and risk mitigated supply chains to compete on a world stage.