1st Edition

The Delivery of Regenerative Medicines and Their Impact on Healthcare

Edited By Catherine Prescott, Dame Julia Polak Copyright 2011
    416 Pages 17 B/W Illustrations
    by CRC Press

    416 Pages 17 B/W Illustrations
    by CRC Press

    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.

    Introduction
    What Is Regenerative Medicine? J. Polak

    Finance
    A New Political-Financial Paradigm, R. Klein and A. Trounson
    Investment Models 4. Public Funding in Australia, G. Macdonald
    Capitalising On A 50-Year Legacy, A. Lyall
    Investing in Regenerative Medicine: What Drives the Private Investor? C. Prescott
    Public Investment Models: Coming Out of the Closet And Going Public! R. Benjamin

    Business Models
    Cell-Based Products: Allogenic, P. Kemp
    Autologous Cell Based Products: Fulfilling the Promise of Cell Therapy, E. Bravo and M. Blanco-Molina
    Business Models for Cord Blood, S. Watt
    Changing the Game of Drug Discovery, J. Walker
    Discovery of Small Molecule Regenerative Drugs, Y. Choo
    The Adoption of Therapeutic Stem Cell Technologies by Large Pharmaceutical Companies, A. Vertes
    Role of Tools and Technologies Companies in the Successful Commercialization of Regenerative Medicine, J. Goswami
    Key Considerations in Manufacturing of Cellular Therapies, R. Preti
    State of the Global Regenerative Medicine Industry, L. Buckler, R. Margolin, and S. Haecker

    Intellectual Property
    Regenerating Ip: Europe After Warf, J. Hitchcock and D. Crease
    Protecting Regenerative Medicine Intellectual Propery in the Use: Problems and Strategies, D. Resnick, R. Eisenstein, and J. McWilliams
    Impact of Indian Policies and Laws on Regenerative Medicine Patent Applications, P. Ganguli

    The Regulatory Landscape
    A CATalyst for Change: Regulating Regenerative Medicines in Europe, C. Bravery
    The US Regulatory Reimbursement, Political Environment and Strategies for Reform, M. Werner

    Reimbursement
    The Fourth Hurdle: Reimbursement Strategies for Regenerative Medicine, F. Meurgey and Micheline
    Cellular Therapies and Regenerative Medicine: Preparing for Reimbursement in the United States, E. Faulkner
    The Adoption and Evaluation of Regenerative Medicine and the NHS, M. Parton

    Insurance
    If You Build It Will They Insure It? M. Clark

    Biography

    Catherine Prescott, Dame Julia Polak