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  • JIMD Reports, Volume 35

    JIMD Reports, Volume 35

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  • Epigenetics: Development and Disease

    Epigenetics: Development and Disease

    Retail Price: $349.00
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  • Regulatory Networks in Stem Cells

    Regulatory Networks in Stem Cells

    Retail Price: $419.00
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  • Admixture Dynamics, Natural Selection and Diseases in Admixed Populations

    Admixture Dynamics, Natural Selection and Diseases in Admixed Populations

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  • Data Production and Analysis in Population Genomics

    Data Production and Analysis in Population Genomics

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  • Genetic Epidemiology

    Genetic Epidemiology

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  • Epigenetics Protocols

    Epigenetics Protocols

    Retail Price: $169.00
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  • Virus-Induced Gene Silencing

    Virus-Induced Gene Silencing

    Retail Price: $139.00
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  • Evolutionary Genomics

    Evolutionary Genomics

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  • Recombinant and In Vitro RNA Synthesis

    Recombinant and In Vitro RNA Synthesis

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  • Synthetic Messenger RNA and Cell Metabolism Modulation

    Synthetic Messenger RNA and Cell Metabolism Modulation

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  • Strain Engineering

    Strain Engineering

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  • Next-Generation MicroRNA Expression Profiling Technology

    Next-Generation MicroRNA Expression Profiling Technology

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  • Chromatin Remodeling

    Chromatin Remodeling

    Retail Price: $169.00
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  • Quantitative Trait Loci (QTL)

    Quantitative Trait Loci (QTL)

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  • PCR Mutation Detection Protocols

    PCR Mutation Detection Protocols

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  • RT-PCR Protocols

    RT-PCR Protocols

    Retail Price: $189.00
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  • DNA Damage Detection In Situ, Ex Vivo, and In Vivo

    DNA Damage Detection In Situ, Ex Vivo, and In Vivo

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  • DNA Recombination

    DNA Recombination

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  • Antiviral RNAi

    Antiviral RNAi

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  • Ancient DNA

    Ancient DNA

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  • Olfactory Receptors

    Olfactory Receptors

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  • Exon Skipping

    Exon Skipping

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  • Gene Regulatory Networks

    Gene Regulatory Networks

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  • Mammalian Chromosome Engineering

    Mammalian Chromosome Engineering

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  • Heterologous Gene Expression in E.coli

    Heterologous Gene Expression in E.coli

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  • High-Throughput Next Generation Sequencing

    High-Throughput Next Generation Sequencing

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  • Mobile Genetic Elements

    Mobile Genetic Elements

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  • Array Comparative Genomic Hybridization

    Array Comparative Genomic Hybridization

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  • Gene Regulation

    Gene Regulation

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  • Metagenomics

    Metagenomics

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  • Muscle Gene Therapy

    Muscle Gene Therapy

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  • DNA Repair Protocols

    DNA Repair Protocols

    Retail Price: $179.00
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  • Mitochondrial DNA

    Mitochondrial DNA

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  • Statistical Methods for Microarray Data Analysis

    Statistical Methods for Microarray Data Analysis

    Retail Price: $139.00
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  • Whole Genome Amplification

    Whole Genome Amplification

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  • C. elegans

    C. elegans

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  • TALENs

    TALENs

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  • Microarray Technology

    Microarray Technology

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  • Regulatory Aspects of Gene Therapy and Cell Therapy Products

    Regulatory Aspects of Gene Therapy and Cell Therapy Products

    Retail Price: $189.00
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About the Author

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.

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