Licensing, Selling and Finance in the Pharmaceutical and Healthcare Industries is an assessment of the turbulent state of pharmaceutical and biotechnology markets as we enter the second decade of the 21st Century. At the same time, the book offers a cautionary evaluation of the future financing of innovation in terms of what's gone wrong and how to succeed in the future. Martin Austin explores the challenge that the pharmaceutical (and related) industries face in terms of balancing short term, cost containment and expenditure control in areas such as internal research and development; whilst embracing in-licensing and the acquisition of innovative therapies to counteract their impending portfolio weaknesses in the mid to longer term. The first part of the book provides an engaging and convincing perspective on the context in which the industry currently finds itself; the second part is a pragmatic guide to commercialising your intellectual property; including how to recognise and value what you have as well as the new ways of working that you will need to adopt when negotiating, collaborating and contracting in partnership and alliance with others. Commentators have described in great detail the cocktail of commercial, clinical and social issues that threaten to overwhelm the pharmaceutical industry; Martin Austin's book offers a very distinctive perspective on these issues and their solution.

Licensing, Selling and Finance in the Pharmaceutical and Healthcare Industries is an assessment of the turbulent state of pharmaceutical and biotechnology markets as we enter the second decade of the 21st Century. At the same time, the book offers a cautionary evaluation of the future financing of innovation in terms of what's gone wrong and how to succeed in the future. Martin Austin explores the challenge that the pharmaceutical (and related) industries face in terms of balancing short term, cost containment and expenditure control in areas such as internal research and development; whilst embracing in-licensing and the acquisition of innovative therapies to counteract their impending portfolio weaknesses in the mid to longer term. The first part of the book provides an engaging and convincing perspective on the context in which the industry currently finds itself; the second part is a pragmatic guide to commercialising your intellectual property; including how to recognise and value what you have as well as the new ways of working that you will need to adopt when negotiating, collaborating and contracting in partnership and alliance with others. Commentators have described in great detail the cocktail of commercial, clinical and social issues that threaten to overwhelm the pharmaceutical industry; Martin Austin's book offers a very distinctive perspective on these issues and their solution.

This fifth edition of “Product Lifecycle Management” updates and adds to the successful fourth edition, the most frequently cited PLM publication. It gives the reader a thorough explanation of Product Lifecycle Management (PLM) and provides them with a full understanding and the skills to implement PLM within their own business environment. This new and expanded edition is fully updated to reflect the many technological and management advances made in PLM since the release of the fourth edition. “Product Lifecycle Management” will broaden the reader’s understanding of PLM, nurturing the skills needed to implement PLM successfully and to achieve world-class product performance across the lifecycle. Among the components of PLM described are product-related business processes, product data, product data management (PDM) systems, other PLM applications, best practices, company objectives and organisation. This book also describes the relationships of PLM with the Internet of Things, Industry 4.0, Digital Twins and Digital Threads. “Product Lifecycle Management” (5th edition) explains what PLM is, and why it is needed. It describes the environment in which products are ideated, developed, manufactured, supported and retired, before addressing the main components of PLM and PLM Initiatives. Key activities in PLM Initiatives described include organisational change management (OCM) and project management. The final part of the book addresses the PLM Initiative, showing the typical steps and activities of a PLM project or initiative.

Incorporating HC 1030-i to iii.

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Post pandemic, the world is not the same place. There has been an increasing focus on healthcare and well-being, which has created a once-in-a-lifetime opportunity for healthcare innovations and startups. From adoption of a range of medical apps and telemedicine technologies to heightened public interest in smart wearables and medical devices, the demand for efficient healthcare delivery has been skyrocketing. This book aims to serve as a first-of-its-kind guide for skill development in conception to commercialisation of healthcare products and services. It covers the gamut from the study of healthcare challenges, such as understanding customer requirements, market needs, and competition, to the various steps of the healthcare product development process, such as defining value propositions and specifications, the creation of minimum viable product (MVP) to prototyping, and manufacturing. The authors also discuss key commercialisation and management strategies, including the development of a robust business plan, fund raising, intellectual property, creating barriers to entry, and launching healthcare startups. Medical product pricing, positioning, sales and distribution, and customer acquisition are also presented with real-life examples. This book serves as a key reference not only for biomedical engineers who are looking to launch their products or services in the market but also for budding entrepreneurs willing to explore opportunities in the healthcare domain. For example, engineers and managers working on the development of medical devices require knowledge of ethical guidelines, regulations, and approvals to effectively launch their products in the medtech industry. On the other hand, entrepreneurs looking to benefit from the booming healthcare industry will find this book helpful in understanding the fundamentals of medical product development and commercialisation to launch their ideas successfully.

Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

This book investigates pharmaceutical regulation and the public health issue of fake or illicit medicines in developing countries. The book analyses the evolution of pharmaceutical capitalism, showing how the entanglement of market and health interests has come to shape global regulation. Drawing on extensive fieldwork in India, Kenya, and Europe, it demonstrates how large pharmaceutical companies have used the fight against fake medicines to serve their strategic interests and protect their monopolies, sometimes to the detriment of access to medicines in developing countries. The book investigates how the contemporary dynamics of pharmaceutical power in global markets have gone on to shape societies locally, resulting in more security-oriented policies. These processes highlight the key consequences of contemporary "logistical regimes" for access to health. Providing important insights on how the flows of commodities, persons, and knowledge shape contemporary access to medicines in the developing countries, this book will be of considerable interest to policy makers and regulators, and to scholars and students across sociology, science and technology studies, global health, and development studies.

The Price of Global Health is a unique, much-needed and invaluable resource for anybody interested or involved in, or affected by, the development, funding and use of prescription drugs. The second edition includes new chapters on payer value story development, oncology, orphan drugs and payer negotiations. Country chapters have also been updated to reflect changes in healthcare systems, including the Affordable Care Act in the US, AMNOG in Germany, and medico-economic requirements in France. Almost every chapter has been updated with new examples and illustrations.