The pharmaceutical and healthcare industry is hugely complex because it involves so many markets, products, processes and intermediaries. It is also heavily regulated, global, and used by everyone at some stage in their life. No wonder the supply chain for delivery of healthcare services is often fragmented and understood only in discrete sections. Changes in one area impact upon the others, and environmental factors such as pricing, regulatory change or actions by competitors impact the whole supply chain in ways that are not easily understood or managed. Accelerating technology, the commoditization of healthcare, increasing demands from ageing populations all influence the approach that suppliers of pharmaceutical products and services worldwide need to take if they are to design and manage an effective supply chain that will be capable of: exploiting their intellectual property in a sustainable way; providing safe and continuous provision of drugs or devices; and sustaining with resilience, yet still be flexible and cost efficient. Supply Chain in the Pharmaceutical Industry offers the basis for organizations to develop their own blueprint for managing the opportunities and threats to the pharmaceutical supply chain. Using examples from companies and markets across the world Rob Whewell offers a very vivid picture of the developing trends for pharmaceutical companies; the customers and markets they serve and points to some of the elements that underpin sustainable pharmaceutical strategies. The current global banking and financial crisis illustrates the important role played by regulation. The healthcare industry is similar in scope, and complexity, yet the implications of error are worse - life threatening. This review of key industry parameters will provide senior executives in the industry and policy makers in healthcare with a broad perspective of the issues and illustrates an understanding of the task at hand.

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.

This book provides an insight of relevant case studies and updated practices in “PharmaceuticalSupply Chains” (PharmSC) while addressing the most relevant topics within the COST Action “Medicines Shortages” (CA15105).The volume focuses on the most recent developments in the design, planning and scheduling ofPharmSC, broadening from the suppliers’ selection to the impact on patients and healthcaresystems, addressing uncertainty and risk mitigation, and computational issues. It is directed at MSc/PhD students and young researchers (Post-Docs) in Pharmaceutics/Pharmaceutical sciences, Engineering fields, Economics/Management, as well as pharmaceutical decision makers, managers, and practitioners, and advanced readers demanding a fresh approach to decision making for PharmSC. The contributed chapters are associated with the homonymous COST Training Schools (TS), and the book creates a better understanding of the Action “Medicines Shortages” challenges and opportunities.

In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.

Error-proofing in the production process of pharmaceuticals isn‘t just a matter of good business, it has life-and-death implications for consumers. The 2013 Drug Quality and Security Act introduces more stringent compliance factors towards this common goal, in large part requiring new mandates on tracking and tracing chain of custody in the supply chain. This book comprehensively overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain. Based on interviews with industry professionals, the book presents an overview of the key challenges and discusses how leading biopharmaceutical companies handle these challenges. It exposes the underlying structures that support the biopharmaceutical supply chain, focusing specifically on distribution—the point at which manufacturers release a finished product to the time that it is administered, and the complicated set of channels that exist between these two points. This overarching view of the supply chain provides an important piece of intelligence that can inform business strategy for life sciences manufacturers and distributors and help them achieve success in this industry.