The Delivery of Regenerative Medicines and Their Impact on Healthcare

Based on input from an international panel of experts, this book provides first-hand experience of the challenges and opportunities facing the delivery of regenerative medicines to patients. It highlights key issues beyond science and clinical translation, such as finance and business models, intellectual property and regulatory landscapes as well as questions of how regenerative medicines will be evaluated for reimbursement. It also covers legal issues relevant to regulators, insurers, and investors as well as pharmaceutical and biotech researchers.

Now that prohibitions against stem cell research are relaxing, it is time for the field to move forward with the advances that promise to eliminate so much human suffering. However, it would be naïve to ignore the fact that regenerative medicines pose a whole new set of challenges to an industry sector that for decades has geared itself to the development and delivery of traditional pharmaceuticals.

Still, significant strides are being made. Unique in its focus, The Delivery of Regenerative Medicines and Their Impact on Healthcare delves into material not included in other books. Edited by Dr. Catherine Prescott and Professor Dame Julia Polak, two of the most respected authorities in stem cell research and the business of regenerative medicine, this text presents original firsthand accounts of experts from around the globe. Professor Polak starts by summarizing the progress made and the challenges currently facing the field both as a science and an emerging industry. This is followed by topics relevant to regulators, insurers, and investors as well as pharmaceutical and biotech researchers. Offering innovative insight on topics rarely covered, this volume:

• Details various innovative investment models
• Offers a detailed overview of cell-based products and therapeutic stem cell technologies
• Examines concerns over safeguarding intellectual property
• Looks at evolving regulations in the U.S. and Europe
• Discusses insurance and risk management and the establishment of reimbursement parameters

This book reaches out to inform a wide audience across government, industry, and academia. It goes beyond the usual discussions to help invigorate the dialogue and present solutions that must occur at the crossroads of technology and commerce for regenerative medicines to realize their promise.