The Delivery of Regenerative Medicines and Their Impact on Healthcare PDF

Preface

Regenerative medicines pose a whole new set of challenges to an industry sector otherwise geared to the development and delivery of traditional pharmaceuticals. However, significant strides have already been achieved regarding the many aspects of this nascent field.

This book is unique both in its focus and geographical perspective on these issues. The book covers a broad range of topics from how this new industry is being financed, the business models developed, the impact of a complex patent landscape, and an evolving regulatory environment, through to how these expensive products are viewed by the health insurance industry. Experts from all over the world, including leaders of public and private organizations, share their first-hand experience of the challenges and opportunities facing all aspects that underpin the delivery of regenerative medicines. This book aims to inform a wide audience, including members of the pharmaceutical and biotechnology industry, regional and central governments, investors, health insurers, and academics.

This book is very timely: in 2009, U.S. President Barack Obama relaxed federal funding restrictions for human embryonic stem cell research. The U.S. Food and Drug Administration approved the first clinical trial for an embryonic stem cell-derived therapy, and several large corporations have, for the first time, moved into the sector. The Regenerative Medicines Industry Group was launched in the U.K., and the Alliance for Regenerative Medicine was established in the United States.

To date, all other publications have focused on the science, technology, and ethicsdrawing predominantly on academic expertise. By contrast, this book addresses those issues that are important to the success of the business of regenerative medicines. In doing so, the editors have been rewarded with an enthusiastic response by top industry leaders from across the globe, affirming the importance and timeliness of this book. It is our understanding that this is the very first publication of its kind.