New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients

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9781419699610: New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients
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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.

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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.

Review:

"This is an excellent primer on the drug development process that importantly stresses the inter-relationship of studies in each part of the process. I will not only use this book in my course on drug discovery but will also recommend it to faculty interested in translational research." --Anthony Giordano, PhD Assistant Dean of Research and Business Development, Office of Research and Director, Experimental Therapeutics, Feist-Weiller Cancer Center Louisiana State University, Shreveport, LA

"Dr. Friedhoff has been a very effective consultant to our firm, and we have profited greatly from his insights. His book, New Drugs, is an eye-opening, inside look at an enormous and very complex sector of the economy, presented in a concise, well-written, and accessible manner. Highly recommended." --Oscar Schafer, Member of "Barron's Roundtable" and Managing Partner of OSS Capital Management, NYC

"As the author makes clear, he has learned from many years of drug development. NEW DRUGS really does reveal insider insights that cannot be found in other volumes. This book has been selected for The First Clinical Research Bookshelf." -- Norman M. Goldfarb Managing Director of First Clinical Research LLC

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Book Description Booksurge Publishing, United States, 2009. Paperback. Condition: New. Language: English . Brand New Book ***** Print on Demand *****. 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. Seller Inventory # APC9781419699610

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Book Description Booksurge Publishing, United States, 2009. Paperback. Condition: New. Language: English . Brand New Book ***** Print on Demand *****.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. Seller Inventory # APC9781419699610

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Book Description Booksurge Publishing. Paperback. Condition: New. 258 pages. 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 youre 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 compounds development. If youre 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. Friedhoffs first-hand knowledge of pharmaceutical R and 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 and 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. Friedhoffs 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. This item ships from multiple locations. Your book may arrive from Roseburg,OR, La Vergne,TN. Paperback. Seller Inventory # 9781419699610

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Book Description Booksurge Publishing, United States, 2009. Paperback. Condition: New. Language: English . This book usually ship within 10-15 business days and we will endeavor to dispatch orders quicker than this where possible. Brand New Book. 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. Seller Inventory # BZV9781419699610

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