The Delivery of Regenerative Medicines and Their Impact on Healthcare  book cover
1st Edition

The Delivery of Regenerative Medicines and Their Impact on Healthcare

ISBN 9781138115446
Published June 14, 2017 by CRC Press
400 Pages 17 B/W Illustrations

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Book Description

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.

Table of Contents

What Is Regenerative Medicine? J. Polak

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

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

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

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