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.
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.
The New York Times bestselling author of The Hormone Cure and The Hormone Reset Diet shows every woman how to create a lifestyle that will help her look great, feel energized, and slow down the effects of aging.
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The body is magnificent but it doesn't come with a lifetime warranty, or an operating manual. You're the result of millions of years of evolution, but many of the adaptations that helped your ancestors survive are now working overtime to accelerate the aging process. The assumption here is that we are our genes and therefore trapped by the past. The good news is that your genetic code—the DNA sequence that is the biochemical basis of heredity—can play a minor role in the way you age.
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Dr. Gottfried identifies and builds this book around the five-key factors that lead to accelerated aging -the muscle factor, the brain factor, the hormone factor, the gut factor, and the toxic fat factor. The 7-week program addresses these factors and treats them in an accessible and highly practical protocol and is as follows:Feed—Week 1Sleep—Week 2Move—Week 3Release—Week 4Expose—Week 5Soothe—Week 6Think—Week 7
Younger increases not only your lifespan, but also your healthspan. Dr. Gottfried's program makes it possible to change the way you age, stay younger longer, and remain healthy and vibrant for all of your days.