Regulation of Regenerative Medicines: A Global Perspective
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Author Acknowledgments
RAPS and the lead editors, Jocelyn Jennings and Bill Sietsema, thank the following subject matter experts
for sharing their experience and knowledge by volunteering their time to contribute to this first edition of
Regulation of Regenerative Medicines: A Global Perspective.
Dylan Bechtle, MS
Regulatory Policy Manager
Genentech
US
Chapters 5 and 17
Bridget Bulwer
Head of Regulatory
Glycostem Therapeutics
Netherlands
Chapter 7
Orin Chisholm, PhD, SFHEA, FRAPS
Academic Lead, Pharmaceutical and Medical
Device Development Programs
Sydney Pharmacy School
The University of Sydney
Australia
Chapter 15
Stefanie Fasshauer, MBA
Regional Regulatory Lead APAC
PharmaLex
Hong Kong
Chapter 16
Grant S. Griffin, DRSc, RAC
Director of Regulatory Affairs
TRACT Therapeutics, Inc.
US
Chapter 2
Karen M. Hauda, MS, JD
Senior Director
Novo Nordisk
US
Chapter 2
Mo Heidaran, PhD
Head of Regulatory and Translational Strategy
GC Therapeutics
US
Chapters 7 and 8
Anette Hjelmsmark, MSc
Senior Regulatory Intelligence Manager
Novo Nordisk
Denmark
Chapter 14
Rasika Kalameghan, PhD
Executive Director and Head, US Regulatory
Policy
Genentech
US
Chapter 17
Janet Lynch Lambert
Chief Executive Officer
Alliance for Regenerative Medicine
Foreword
David Litwack, PhD
Senior Director, Scientific Strategy and
Communications
Prevail Therapeutics (a wholly-owned subsidiary of
Eli Lilly and Company)
Chapter 3