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.
You're already living it.
Was diabetes evolution's response to the last Ice Age? Did a deadly genetic disease help our ancestors survive the bubonic plagues of Europe? Will a visit to the tanning salon help lower your cholesterol? Why do we age? Why are some people immune to HIV? Can your genes be turned on -- or off?
Joining the ranks of modern myth busters, Dr. Sharon Moalem turns our current understanding of illness on its head and challenges us to fundamentally change the way we think about our bodies, our health, and our relationship to just about every other living thing on earth, from plants and animals to insects and bacteria.
Through a fresh and engaging examination of our evolutionary history, Dr. Moalem reveals how many of the conditions that are diseases today actually gave our ancestors a leg up in the survival sweepstakes. When the option is a long life with a disease or a short one without it, evolution opts for disease almost every time.
Everything from the climate our ancestors lived in to the crops they planted and ate to their beverage of choice can be seen in our genetic inheritance. But Survival of the Sickest doesn't stop there. It goes on to demonstrate just how little modern medicine really understands about human health, and offers a new way of thinking that can help all of us live longer, healthier lives.
Survival of the Sickest is filled with fascinating insights and cutting-edge research, presented in a way that is both accessible and utterly absorbing. This is a book about the interconnectedness of all life on earth -- and, especially, what that means for us.