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Author: Joy A. Cavagnaro Publisher: CRC Press ISBN: 1000471853 Category : Medical Languages : en Pages : 952
Book Description
Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Author: Joy A. Cavagnaro Publisher: CRC Press ISBN: 1000471853 Category : Medical Languages : en Pages : 952
Book Description
Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Author: Martin Fowler Publisher: Addison-Wesley Professional ISBN: 0201485672 Category : Computers Languages : en Pages : 461
Book Description
Refactoring is gaining momentum amongst the object oriented programming community. It can transform the internal dynamics of applications and has the capacity to transform bad code into good code. This book offers an introduction to refactoring.
Author: Elaine Pofeldt Publisher: Lorena Jones Books ISBN: 0399578978 Category : Business & Economics Languages : en Pages : 274
Book Description
The self-employment revolution is here. Learn the latest pioneering tactics from real people who are bringing in $1 million a year on their own terms. Join the record number of people who have ended their dependence on traditional employment and embraced entrepreneurship as the ultimate way to control their futures. Determine when, where, and how much you work, and by what values. With up-to-date advice and more real-life success stories, this revised edition of The Million-Dollar, One-Person Business shows the latest strategies you can apply from everyday people who--on their own--are bringing in $1 million a year to live exactly how they want.
Author: Kevin Maney Publisher: Currency ISBN: 0385525958 Category : Business & Economics Languages : en Pages : 242
Book Description
A Fresh and Important New Way to Understand Why We Buy Why did the RAZR ultimately ruin Motorola? Why does Wal-Mart dominate rural and suburban areas but falter in large cities? Why did Starbucks stumble just when it seemed unstoppable? The answer lies in the ever-present tension between fidelity (the quality of a consumer’s experience) and convenience (the ease of getting and paying for a product). In Trade-Off, Kevin Maney shows how these conflicting forces determine the success, or failure, of new products and services in the marketplace. He shows that almost every decision we make as consumers involves a trade-off between fidelity and convenience–between the products we love and the products we need. Rock stars sell out concerts because the experience is high in fidelity-–it can’t be replicated in any other way, and because of that, we are willing to suffer inconvenience for the experience. In contrast, a downloaded MP3 of a song is low in fidelity, but consumers buy music online because it’s superconvenient. Products that are at one extreme or the other–those that are high in fidelity or high in convenience–-tend to be successful. The things that fall into the middle-–products or services that have moderate fidelity and convenience-–fail to win an enthusiastic audience. Using examples from Amazon and Disney to People Express and the invention of the ATM, Maney demonstrates that the most successful companies skew their offerings to either one extreme or the other-–fidelity or convenience-–in shaping products and building brands.
Author: Pat Shaughnessy Publisher: No Starch Press ISBN: 1593275277 Category : Computers Languages : en Pages : 362
Book Description
"An under-the-hood look at how the Ruby programming language runs code. Extensively illustrated with complete explanations and hands-on experiments. Covers Ruby 2.x"--
Author: Naomi Oreskes Publisher: A&C Black ISBN: 1408828774 Category : Technology & Engineering Languages : en Pages : 368
Book Description
The U.S. scientific community has long led the world in research on such areas as public health, environmental science, and issues affecting quality of life. These scientists have produced landmark studies on the dangers of DDT, tobacco smoke, acid rain, and global warming. But at the same time, a small yet potent subset of this community leads the world in vehement denial of these dangers. Merchants of Doubt tells the story of how a loose-knit group of high-level scientists and scientific advisers, with deep connections in politics and industry, ran effective campaigns to mislead the public and deny well-established scientific knowledge over four decades. Remarkably, the same individuals surface repeatedly-some of the same figures who have claimed that the science of global warming is "not settled" denied the truth of studies linking smoking to lung cancer, coal smoke to acid rain, and CFCs to the ozone hole. "Doubt is our product," wrote one tobacco executive. These "experts" supplied it. Naomi Oreskes and Erik M. Conway, historians of science, roll back the rug on this dark corner of the American scientific community, showing how ideology and corporate interests, aided by a too-compliant media, have skewed public understanding of some of the most pressing issues of our era.
Author: Timothy Ferriss Publisher: Random House ISBN: 0091929113 Category : Business & Economics Languages : en Pages : 418
Book Description
How to reconstruct your life? Whether your dream is experiencing high-end world travel, earning a monthly five-figure income with zero management, or just living more and working less, this book teaches you how to double your income, and how to outsource your life to overseas virtual assistants for $5 per hour and do whatever you want.
Author: Geshe Michael Roach Publisher: Harmony ISBN: 0385528744 Category : Business & Economics Languages : en Pages : 162
Book Description
Readable in fifty-eight minutes: Traditional Eastern wisdom and real-life business experience come together in this brief and practical guide, which offers a step-by-step plan that will help readers adopt a more successful way of working and living. KARMIC MANAGEMENT is a little book with a revolutionary message. It turns traditional business mentality on its head by stating simply that helping others become successful—suppliers, customers, even competitors—is the real key to success in life as well as in business. Drawing from their own entrepreneurial experiences, the authors explain how, in eight basics steps that take less than one hour in total, readers can learn to apply KARMIC MANAGEMENT to meet goals, both personal and professional. Each lesson opens with a quotation from a Buddhist text and explains how it applies to life and work in the twenty-first century. The authors show readers how to identify the things that aren’t working for them, discover their most valuable assets, and use their new insights to improve the lives of others. To-do lists throughout the book provide practical tools and exercises, and real-life examples highlight the power of KARMIC MANAGEMENT to make dreams come true.
Author: Edward F. Edinger Publisher: Shambhala Publications ISBN: 0834823896 Category : Psychology Languages : en Pages : 445
Book Description
A medical psychiatrist and founding member of the Jung Foundation explores a pivotal part of analytical psychology: encountering the self through individuation This book is about the individual’s journey to psychological wholeness, known in analytical psychology as the process of individuation. Edward Edinger traces the stages in this process and relates them to the search for meaning through encounters with symbolism in religion, myth, dreams, and art. For contemporary men and women, Edinger believes, the encounter with the self is equivalent to the discovery of God. The result of the dialogue between the ego and the archetypal image of God is an experience that dramatically changes the individual’s worldview and makes possible a new and more meaningful way of life.
Author: Joy A. Cavagnaro
Author: Joy A. Cavagnaro
Author: Martin Fowler
Author: 
Author: Elaine Pofeldt
Author: Kevin Maney
Author: Pat Shaughnessy
Author: Naomi Oreskes
Author: Timothy Ferriss
Author: Geshe Michael Roach
Author: Edward F. Edinger