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© 2015

Regulatory Aspects of Gene Therapy and Cell Therapy Products

A Global Perspective

  • Maria Cristina Galli
  • Mercedes Serabian
Book

Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 871)

Also part of the American Society of Gene & Cell Therapy book sub series (ASGCT, volume 871)

Table of contents

  1. Front Matter
    Pages i-xii
  2. Alexander M. Bailey, Judith Arcidiacono, Kimberly A. Benton, Zenobia Taraporewala, Steve Winitsky
    Pages 1-29
  3. Marina O’Reilly, Robert Jambou, Eugene Rosenthal, Maureen Montgomery, Morad Hassani, Linda Gargiulo et al.
    Pages 31-47
  4. Anthony Ridgway, Francisca Agbanyo, Jian Wang, Michael Rosu-Myles
    Pages 49-71
  5. Matthias Renner, Brigitte Anliker, Ralf Sanzenbacher, Silke Schuele
    Pages 87-101
  6. Paula Salmikangas, Martina Schuessler-Lenz, Sol Ruiz, Patrick Celis, Ilona Reischl, Margarida Menezes-Ferreira et al.
    Pages 103-130
  7. Daisuke Maeda, Teruhide Yamaguchi, Takami Ishizuka, Masakazu Hirata, Kazuhiro Takekita, Daisaku Sato
    Pages 147-162
  8. Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim, Won Shin
    Pages 163-179
  9. Yi-Chu Lin, Po-Yu Wang, Shih-Chih Tsai, Chien-Liang Lin, Hsuen-Yung Tai, Chi-Fang Lo et al.
    Pages 181-194
  10. Choon Wee Goh, Srinivasan N. Kellathur, Lee Lee Ong, Xiaofeng Wu
    Pages 195-212
  11. Back Matter
    Pages 221-230

About this book

Introduction

Medical literature for health care practitioners on the evaluation and treatment of breastfeeding issues has been disjointed, conflicting, and difficult to find. The field of breastfeeding medicine itself is nonexistent—there are no "breastfeeding doctors" who are specifically trained to understand this complex and interactive process. While much of the literature about breastfeeding describes how it "should" work, there is currently nothing available to explain why it often fails and how to treat it.

Clinician’s Guide to Breastfeeding: Evidence-based Evaluation and Management is written for health care practitioners who work with breastfeeding mothers; physicians, nurses, nurse practitioners, and lactation consultants. It provides clear information and clinically tested strategies to help professionals guide new mothers to breastfeed successfully. The first of its kind to consider the entirety of the breastfeeding experience, Clinician’s Guide to Breastfeeding is written by Dr. Linda D. Dahl, a leading expert on the subject. It is a comprehensive review of breastfeeding, covering objective analyses of ideal or “normal” nursing, as well as the evaluation and treatment of abnormal nursing, including case studies to illustrate the treatment decision-making process.

Keywords

Cell therapy Cell therapy products Gene therapy Regulatory oversight Regulatory policies

Editors and affiliations

  • Maria Cristina Galli
    • 1
  • Mercedes Serabian
    • 2
  1. 1.Cell Biology and NeurosciencesIstituto Superiore di SanitàRomeItaly
  2. 2.Center for Biologics Evaluation and Research/Office of Cellular, Tissue, and Gene TherapiesPharmacology/Toxicology Branch, US Food and Drug AdministrationSilver SpringUSA

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
  • Series Abbreviated Title Advs Exp. Medicine, Biology
  • DOI https://doi.org/10.1007/978-3-319-18618-4
  • Copyright Information American Society of Gene and Cell Therapy 2015
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences Biomedical and Life Sciences (R0)
  • Hardcover ISBN 978-3-319-18617-7
  • Softcover ISBN 978-3-319-35729-4
  • eBook ISBN 978-3-319-18618-4
  • 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
  • Buy this book on publisher's site
Industry Sectors
Biomedicine
Biotechnology