Editors:
- Discusses the basic background, regulatory policies, and requirements applied in different global regions for the development of gene therapy (GT) and cell therapy (CT) medicinal products
- Offers the perspective of regulators across the globe with varying levels of hands-on experience in the regulation of GT and CT products
- Includes chapters authored by experts from various regulatory bodies throughout the international community
Part of the book series: Advances in Experimental Medicine and Biology (AEMB, volume 871)
Part of the book sub series: American Society of Gene & Cell Therapy (ASGCT)
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Table of contents (12 chapters)
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Front Matter
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Back Matter
About this book
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations.
Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Editors and Affiliations
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Cell Biology and Neurosciences, Istituto Superiore di Sanità , Rome, Italy
Maria Cristina Galli
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Center for Biologics Evaluation and Research/Office of Cellular, Tissue, and Gene Therapies, Pharmacology/Toxicology Branch, US Food and Drug Administration, Silver Spring, USA
Mercedes Serabian
About the editors
Maria Cristina Galli holds a University degree in Biological Sciences and a PhD in Molecular Medicine; currently she is in-staff senior researcher, Cell Biology and Neurosciences Department, Istituto Superiore di Sanità , Roma, Italy. Her main expertise is in regulatory sciences for translational medicine supported by scientific education and research experience in experimental oncology, cellular biology, and molecular immunology. Dr. Galli spent more than twenty years as a basic researcher in experimental oncology, cellular biology, and molecular immunology, and wrote or co-wrote sixty publications in international journals. Over the past two decades, she has been active in the field of translational medicine as quality assessor for gene therapy and biotechnology medicines in national as well as European procedures; she has also been active for most of this time as GMP and GLP inspector. Dr. Galli was a member of CAT-EMA for three years and for four years served as vice-chair/chair of CAT-EMA Gene Therapy Working Party, in which she has participated since its first meeting. She is currently co-chair of the ATMP platform in the European infrastructure for translational medicine EATRIS-ERIC.
Mercedes Serabian holds an MS degree in Toxicology from American University and is a Diplomat of the American Board of Toxicology (DABT). She currently serves as Chief of the Pharmacology/Toxicology Branch in the Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER) at the USFDA. She is responsible for overseeing the pharmacology/toxicology review, regulation, and policy development for cellular and gene therapy products submitted to FDA. She provided expert pharmacology/toxicology advice on FDA guidance documents such as cancer vaccines, cellular therapies for cardiac disease, cartilage repair/replacement products, long-term follow-up of subjects administered gene therapy products, and viral shedding. Ms. Serabian championed the Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, outlining FDA recommendations on preclinical data to support clinical studies of cellular and gene therapy products. She has participated in several expert working groups under the International Conference for Harmonisation and has presented to outside parties on preclinical regulatory considerations for cellular and gene therapy products intended for administration in clinical trials.
Bibliographic Information
Book Title: Regulatory Aspects of Gene Therapy and Cell Therapy Products
Book Subtitle: A Global Perspective
Editors: Maria Cristina Galli, Mercedes Serabian
Series Title: Advances in Experimental Medicine and Biology
DOI: https://doi.org/10.1007/978-3-319-18618-4
Publisher: Springer Cham
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: American Society of Gene and Cell Therapy 2015
Softcover ISBN: 978-3-319-35729-4Published: 22 October 2016
eBook ISBN: 978-3-319-18618-4Published: 15 September 2015
Series ISSN: 0065-2598
Series E-ISSN: 2214-8019
Edition Number: 1
Number of Pages: XII, 230
Number of Illustrations: 6 b/w illustrations, 17 illustrations in colour
Topics: Gene Therapy