Regulation of Regenerative Medicines: A Global Perspective
iii
Table of Contents
Foreword. .................................................................................................................................................vii
Preface. ......................................................................................................................................................ix
Author Acknowledgments........................................................................................................................ xi
Chapter 1 Introduction. .........................................................................................................................1
By Jocelyn Jennings, MS, RAC (US, Drugs, Devices)
Chapter 2 History of Regenerative Medicine. .......................................................................................3
By Karen M. Hauda, MS, JD, Stephen Westover, RAC, and Grant S. Griffin, DRSc, RAC
Chapter 3 Unique Properties of Regenerative Medicines: Key Differences From Small Molecules
and Non-Regenerative Biologics.........................................................................................23
By David Litwack, PhD
Chapter 4 Combination Products and Regenerative Medicine............................................................29
By Jocelyn Jennings, MS, RAC (US, Drugs, Devices)
Chapter 5 Special Considerations for Gene Therapy. ..........................................................................39
By Kristin Van Goor, PhD, Snehal Naik, PhD, and Dylan Bechtle, MS
Chapter 6 Gene Therapy and Viral Vectors: An Overview on Current Trends....................................49
By Marites T. Woon, PhD and Rajesh L. Thangapazham, PhD, RAC
Chapter 7 Special Considerations for Cell-Based Advanced Therapies. ..............................................57
By Bridget Bulwer, Mo Heidaran, PhD, and Darin J. Weber, PhD
Chapter 8 Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy
Industry...............................................................................................................................71
By Mo Heidaran, PhD
Chapter 9 Distribution of Regenerative Medicines. ............................................................................85
By Andrea Zobel, PhD
iii
Table of Contents
Foreword. .................................................................................................................................................vii
Preface. ......................................................................................................................................................ix
Author Acknowledgments........................................................................................................................ xi
Chapter 1 Introduction. .........................................................................................................................1
By Jocelyn Jennings, MS, RAC (US, Drugs, Devices)
Chapter 2 History of Regenerative Medicine. .......................................................................................3
By Karen M. Hauda, MS, JD, Stephen Westover, RAC, and Grant S. Griffin, DRSc, RAC
Chapter 3 Unique Properties of Regenerative Medicines: Key Differences From Small Molecules
and Non-Regenerative Biologics.........................................................................................23
By David Litwack, PhD
Chapter 4 Combination Products and Regenerative Medicine............................................................29
By Jocelyn Jennings, MS, RAC (US, Drugs, Devices)
Chapter 5 Special Considerations for Gene Therapy. ..........................................................................39
By Kristin Van Goor, PhD, Snehal Naik, PhD, and Dylan Bechtle, MS
Chapter 6 Gene Therapy and Viral Vectors: An Overview on Current Trends....................................49
By Marites T. Woon, PhD and Rajesh L. Thangapazham, PhD, RAC
Chapter 7 Special Considerations for Cell-Based Advanced Therapies. ..............................................57
By Bridget Bulwer, Mo Heidaran, PhD, and Darin J. Weber, PhD
Chapter 8 Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy
Industry...............................................................................................................................71
By Mo Heidaran, PhD
Chapter 9 Distribution of Regenerative Medicines. ............................................................................85
By Andrea Zobel, PhD