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From Alchemy To Ipo: The Business Of Biotechnology

"A tour-de-force for anyone who is interested in the biotech industry. I applaud the enormous achievement of Cynthia Robbins-Roth."-Frederick Frank, Senior Managing Director & Vice Chair, Lehman Brothers"From Alchemy to IPO tells the dramatic story of this revolutionary industry as only an insider can."-George Rathmann, President and CEO, ICOS Corporation, Chairman Emeritus, AmgenWritten by a well-known industry insider, From Alchemy to IPO addresses the coming-of-age of biotech products and companies and traces the history of biotechnology from its early inception in the seventies to today's heyday of new solutions and breakthrough treatments. It describes the amazing entrepreneurial trail of product development, novel business models, and critical trials that eventually pave the way to market. This is the first book to accurately record the inner workings of an industry-biotechnology-that's on the verge of living up to its monumental promise to change the world as we know it.

Price : $17.50

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New Drugs: An Insider's Guide to the FDA's New Drug Approval P

Drug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and tactical considerations play out in an environment where a balance must be struck between the often-competing interests of the corporation, its investors, government regulators, and the safety and well being of intended patients. All the while, dwindling patent protections impose an ever-contracting timeframe for success.Written to be accessible to a wide audience, NEW DRUGS provides a thorough, succinct, and practical understanding of these drug-development processes. If you're involved in the pharmaceutical industry, NEW DRUGS will provide scientific and management tools to increase the likelihood of regulatory approval at each phase of your compound's development. If you're a patient or consumer, NEW DRUGS will enable you to intelligently discuss medications with your health-care provider and empower you to make informed decisions at the pharmacy. If your portfolio, rather than your health, makes you an interested observer of the fortunes of this critical sector of the US economy, NEW DRUGS will help you to decode press releases and annual reports, so that you can recognize and invest in well-run companies with promising products.About the Author:During his 30-year career in pharmaceutical research and development, author Lawrence T. Friedhoff, MD, PhD, FACP has amassed an extraordinary record of industry accomplishments, most notably as the head of the teams that chose, developed, and brought two chemical compounds through regulatory approvals around the world. These new drugs are market "blockbusters," each used by millions of patients and each generating well over $1 billion annual revenue worldwide. Dr. Friedhoff's first-hand knowledge of pharmaceutical R&D is extensive and comprehensive: he has held management positions at multi-national corporations developing novel drug compounds, small publicly-traded companies manufacturing generic drugs, start-up ventures, and academic-based research teams writing business plans to obtain venture capital. As an R&D head, he held primary responsibility for choosing drug candidates and preparing comprehensive plans for, as well as managing all phases of, their development, always with an eye towards fulfilling FDA (and often, European and Asian) drug requirements. He has also managed post-FDA-approval activities including collecting and analyzing adverse-event information from consumers, fielding inquiries from patients and healthcare providers, and marketing-related scientific studies. Although the press contains numerous reports of disastrous failed clinical trials, during Dr. Friedhoff's career none of the completed pivotal clinical trials for which he was fully responsible ever failed and all of his new drug applications (NDAs) submitted to the FDA were approved. Few industry professionals have been able match his achievements. Dr. Friedhoff has obtained several patents and has been a frequent and off-cited contributor to the scientific literature. He is also the founder of Pharmaceutical Special Projects Group, LLC, a consortium of independent consultants at whose core are the handful of professionals who have worked together on a variety of successful new drugs under his supervision for nearly twenty years; the team provides various drug-development services to clients and is preparing to bring its own products to market.

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Quality Systems and Controls for Pharmaceuticals

Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.

Price : $48.76

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Science Business: The Promise, the Reality, and the Future of Biotech

Why has the biotechnology industry failed to perform up to expectations - despite all its promise? In "Science Business", Gary P. Pisano answers this question by providing an incisive critique of the industry. Pisano not only reveals the underlying causes of biotech's problems; he offers the most sophisticated analysis yet on how the industry works. And he provides clear prescriptions for companies, investors, and policy makers seeking ways to improve the industry's performance. According to Pisano, the biotech industry's problems stem from its special character as a science-based business. This character poses three unique business challenges: how to finance highly risky investments under profound uncertainty and long time horizons for R&D, how to learn rapidly enough to keep pace with advances in drug science knowledge, and how to integrate capabilities across a broad spectrum of scientific and technological knowledge bases.The key to fixing the industry? Business models, organisational structures, and financing arrangements that place greater emphasis on integration and long-term learning over shorter - term 'monetisation' of intellectual property. Pisano maintains that all industry players - biotech firms, investors, universities, pharmaceutical companies, government regulators - can play a role in righting the industry. The payoff? Valuable improvements in health care, and a shinier future for human well-being.

Price : $21.36

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Medical Professionalism in the New Information Age (Critical Issues in H

With computerized health information receiving unprecedented government support, a group of health policy scholars analyze the intricate legal, social, and professional implications of the new technology. These essays explore how Health Information Technology (HIT) may alter relationships between physicians and patients, physicians and other providers, and physicians and their home institutions. Patient use of web-based information may undermine the traditional information monopoly that physicians have long enjoyed. New IT systems may increase physicians' legal liability and heighten expectations about transparency. Case studies on kidney transplants and maternity practices reveal the unanticipated effects, positive and negative, of patient uses of the new technology. An independent HIT profession may emerge, bringing another organized interest into the medical arena. Taken together, these investigations cast new light on the challenges and opportunities presented by HIT.

Price : $24.95

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Molecular Biology made simple and fun, 4th edition

The molecular revolution is upon us! For those who expect to be part of what's happening in the 21st century, the impact of molecular genetics research should not be underestimated. The authors present a simple and fun approach to the topic of molecular biology.Written primarily for the science student, but suitable for the non-scientist, this book will give the reader a solid understanding of the fundamentals and tools of molecular biology. The book also details how this rapidly advancing field has and will continue to have an impact on health, law, agriculture, biotechnology and our understanding of the origin of the species.

Price : $42.30

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The World According to Monsanto: Pollution, Corruption, and the Control

Sends chills down the spine. . . . After reading this, we can no longer afford to turn a blind eye.--Le PointThe result of a remarkable three-year-long investigation that took award-winning journalist and documentary filmmaker Marie-Monique Robin across four continents (North and South America, Europe, and Asia), The World According to Monsanto tells the little-known yet shocking story of this agribusiness giant--the world's leading producer of GMOs (genetically modified organisms)--and how its new "green" face is no less malign than its PCB- and Agent Orange-soaked past.Robin reports that, following its long history of manufacturing hazardous chemicals and lethal herbicides, Monsanto is now marketing itself as a "life sciences" company, seemingly convinced about the virtues of sustainable development. However, Monsanto now controls the majority of the yield of the world's genetically modified corn and soy--ingredients found in more than 95 percent of American households--and its alarming legal and political tactics to maintain this monopoly are the subject of worldwide concern.Released to great acclaim and controversy in France, throughout Europe, and in Latin America alongside the documentary film of the same name, The World According to Monsanto is sure to change the way we think about food safety and the corporate control of our food supply.

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Tissue Engineering

This book—the first in its field—lays the foundation for individuals studying tissue engineering. It provides a conceptual framework that includes exposure to all the necessary background material in all areas. A four-part presentation covers quantitative cell and tissue biology, cell and tissue characterization, engineering methods and design, and clinical implementation. For cell culture scientists and engineers.

Price : $97.65

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World Wide Mind: The Coming Integration of Humanity, Machines, and the I

What if digital communication felt as real as being touched?   This question led Michael Chorost to explore profound new ideas triggered by lab research around the world, and the result is the book you now hold. Marvelous and momentous, World Wide Mind takes mind-to-mind communication out of the realm of science fiction and reveals how we are on the verge of a radical new understanding of human interaction.   Chorost himself has computers in his head that enable him to hear: two cochlear implants. Drawing on that experience, he proposes that our Paleolithic bodies and our Pentium chips could be physically merged, and he explores the technologies that could do it.    He visits engineers building wearable computers that allow people to be online every waking moment, and scientists working on implanted chips that would let paralysis victims communicate. Entirely new neural interfaces are being developed that let computers read and alter neural activity in unprecedented detail.     But we all know how addictive the Internet is. Chorost explains the addiction: he details the biochemistry of what makes you hunger to touch your iPhone and check your email. He proposes how we could design a mind-to-mind technology that would let us reconnect with our bodies and enhance our relationships. With such technologies, we could achieve a collective consciousness - a World Wide Mind. And it would be humankind's next evolutionary step. With daring and sensitivity, Chorost writes about how he learned how to enhance his relationships by attending workshops teaching the power of touch. He learned how to bring technology and communication together to find true love, and his story shows how we can master technology to make ourselves more human rather than less.   World Wide Mind offers a new understanding of how we communicate, what we need to connect fully with one another, and how our addiction to email and texting can be countered with technologies that put us - literally - in each other's minds.

Price : $10.40

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Valuation in Life Sciences: A Practical Guide

This book is the first complete guide to valuation in life sciences for industry professionals, investors, and academics. Boris Bogdan and Ralph Villiger introduce the characteristics of drug and medical device development, explain how to translate these into the valuation, and provide valuable industry data. After guiding the reader through the theory of valuation, including DCF, decision trees, and real options, the authors demonstrate how to value projects, patents, licences, firms, and stocks on real-life examples, even treating complex licence and company structures. Special emphasis is put on the practicability of the proposed methods by including many hands-on examples, without compromising on realistic results. The 3rd edition of the successful work includes new studies about success rates and about drug development in the biotech industry and their influence on valuation.

Price : $64.25

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