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. 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 nave 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 (Publisher-supplied data) WHAT IS REGENERATIVE MEDICINE / Julia Polak A NEW POLITICAL-FINANCIAL PARADIGM FOR MEDICAL RESEARCH: THE CALIFORNIA USA MODEL / Robert Klein/Alan Trounson INVESTMENT MODELS 4. PUBLIC FUNDING IN AUSTRALIA / Graham Macdonald CANADA: CAPITALISING ON A 50-YEAR LEGACY / Andrew Lyall INVESTING IN REGENERATIVE MEDICINE: WHAT DRIVES THE PRIVATE INVESTOR? / Cathy Prescott PUBLIC INVESTMENT MODELS: COMING OUT OF THE CLOSET AND GOING PUBLIC! / Reni Benjamin CELL-BASED PRODUCTS: ALLOGENIC / Paul Kemp AUTOLOGOUS CELL BASED PRODUCTS: FULFILLING THE PROMISE OF CELL THERAPY / Eduardo Bravo, Magdalena Blanco-Molina BUSINESS MODELS FOR CORD BLOOD / Suzanne Watt CHANGING THE GAME OF DRUG DISCOVERY / John Walker DISCOVERY OF SMALL MOLECULE REGENERATIVE DRUGS / Yen Choo THE ADOPTION OF THERAPEUTIC STEM CELL TECHNOLOGIES BY LARGE PHARMACEUTICAL COMPANIES / Alain Vertes ROLE OF TOOLS AND TECHNOLOGIES COMPANIES IN THE SUCCESSFUL COMMERCIALIZATION OF REGENERATIVE MEDICINE / Joydeep Goswami KEY CONSIDERATIONS IN MANUFACTURING OF CELLULAR THERAPIES / Robert Preti STATE OF THE GLOBAL REGENERATIVE MEDICINE INDUSTRY / Lee Buckler, R. Margolin, S. Haecker REGENERATING IP: EUROPE AFTER WARF Julian Hitchcock and Devanand Crease PROTECTING REGENERATIVE MEDICINE INTELLECTUAL PROPERTY IN THE USE: PROBLEMS AND STRATEGIES / David Resnick, Ronald Eisenstein, Joseph McWilliams IMPACT OF INDIAN POLICIES AND LAWS ON REGENERATIVE MEDICINE PATENT APPLICATIONS / Prabuddha Ganguli A CATalyst FOR CHANGE: REGULATING REGENERATIVE MEDICINES IN EUROPE / Christopher Bravery THE US REGULATORY REIMBURSEMENT POLITICAL ENVIRONMENT AND STRATEGIES FOR REFORM / Michael Werner. "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. This book will become a pivotal reference to anyone within the healthcare sector interested in understanding and investing in the delivery of regenerative medicines to the benefit of patients"--Provided by publisher. 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 naive 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 deve 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 is suitable for those within the healthcare sector interested in investing in the delivery of regenerative medicines to the benefit of patients.