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

ISBN: 978-0-470-92284-2
448 pages
April 2011
Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics (0470922842) cover image
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.
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CONTRIBUTORS.

PREFACE.

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 Ending with the Beginning.

END NOTES.

INDEX.

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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.
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"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)

"In a series of well researched and documented chapters about the pitfalls of inappropriate practice in the end-to-end supply chains for pharmaceuticals and drugs this volume demonstrates the key problems faced by the industry in managing supply chains holistically and for customer value. It also provides useful insights into the major positioning methodologies that the industry should use to make appropriate make/buy and strategic sourcing decisions with suppliers."
Professor Andrew Cox , Chairman, Advisory Board, International Institute for Advanced Purchasing & Supply (IIAPS)

"Using charts, graphic imagery and guest writers' insightful comments, this text delivers an excellent message for the corporate executive, the investor in pharma stocks, the regulatory professional and (last and least) the lawyers who advise the company.... Every reviewer has a list of wished-for items, but I pleased to say that Rees's book met all of my needs and then some.... Rees has a keen eye for what could go wrong in the drug maker's supply chain."
Professor James O'Reilly, University of Cincinnati

"I found it to be a knowledgeable and insightful overview of the role of Supply Chain Management in the Pharmaceutical Industry. I found that it touches knowledgeably on both the small and large molecule products, which most texts fail to do. Hedley has done the industry a significant favor by laying out, in a single volume, a road map for how Supply Chain should function in today's Pharmaceutical Industry."
James Donlevie, Former VP - Worldwide Logistics, Global Biologics Supply Chain, Johnson and Johnson; Currently GPPS, Inc.

"Through his passion to make a difference in the Pharma industry, Hedley has masterfully addressed the complexities of total supply chain management from product development through commercialization.  Building on his years of experience within Pharma and with other regulated industries, Hedley offers solutions that are insightful, proven, holistic and impactful. This easy-to-read book offers a refreshing style that keeps the reader engaged."
Marla A. Phillips, Ph.D., Director, Med-XU, Xavier University

"Hedley's interesting exploration of SCM issues includes business, control, regulatory and technical aspects. The book is salted with many personal experiences which keep the reader entertained as well as informed. This book is a must read for those entering into the SCM fields as well as all those who intersect with SCM."
Bob Coleman former FDA National Expert Drug Investigator and currently Senior Compliance Expert - Pharmaceuticals, IHL Consulting Group, Inc., Atlanta, GA

"This book provides guidance to help modernize the way drugs are developed, made and sold, and presents the argument that counterfeiting and poor SC [supply chain] visibility have their roots in the early stage of drug development.... The author does a great job of demonstrating the need for development of Supply Chain practices in the Pharmaceutical world. With input from various expert sources, the text reads as a 3-part case introducing those in Supply Chain to the world of Pharmaceuticals, those in Science to the world of Supply Chain, and finally a roadmap for a solution.... It may take a while longer to convince those in the Pharma world that involving SC with their R&D teams can [be a] benefit, but the change will come. Those who follow the advice of this author may well lead the way."
Rick Cleveland, P.Log., President, Altered Perspectives

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