Download or read book Pharmaceutical Outsourcing Discovery and Preclinical Services written by William C. Stevens Jr. and published by Lulu.com. This book was released on 2011 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Outsourcing: Discovery and Preclinical Services is the first in a series on pharmaceutical outsourcing. This first book is written for all practitioners in the pharmaceutical and biotech world and is about managing projects in drug discovery and preclinical development. The purpose envisioned by the authors and editors is to provide an understanding of how outsourcing works from the perspective of sponsor, internal customer, service provider, outsourcing service marketplace, principal investigator, project leader, and consultant. The authors of this book and the companies they represent hail from the Americas, Europe, Asia, and Australia, underscoring the fact that drug discovery is an international effort. The scope of the businesses covered include the one-person consulting company through to a sponsor among the largest in the industry. Written in the styles unique to each author, the reader will enjoy getting into the minds of the writer. Our intention is to provide a story for each aspect of the process as you move from target validation, genomic profiling, screening, medicinal chemistry, modeling and informatics, safety evaluation, therapeutic target confirmation, through to protecting the results of the research, the intellectual property. Emerging trends in drug discovery support a rapidly growing business model in outsourcing, the virtual pharma company. In recognition of this important element are several success stories and learnings on arbitraging risks in discovery. Outsourcing provides the ultimate flexibility in managing projects that may quickly grow, progress in directions unanticipated, or fail early. Last but not least, this book provides insights in working with companies outside your region, with business cultures unfamiliar or unknown. Relationship building is about understanding your sponsor or customer in their cultural space and being able to establish the rapport for clear and open communications. Priceless!

Download or read book Modern Strategy for Preclinical Pharmaceutical R D written by David Cavalla and published by John Wiley & Sons. This book was released on 1997-10-07 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: The twentieth century has been a great success for modern medicine, and has resulted in the generation of a plethora of drugs to treat most common illnesses. However, in the light of increasing regulatory demands, spiralling costs and diminishing commercial returns, the question of how, when, where and whether to conduct pharmaceutical R&D has profound implications, and not just for those within the pharmaceutical industry. In response to these and other dilemmas, the authors define the processes involved in drug research, and examine the advantages and disadvantages of collaborative methods of drug research, and examine the roles that academia, CROs, small "biotechnology" companies and "research boutiques," and possibly even the "virtual research company" might play as contractors and collaborators.

Download or read book Outsourcing Clinical Development written by Jane Baguley and published by CRC Press. This book was released on 2016-05-13 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: The challenges facing large pharmaceutical companies are stark: sales are slowing, and research and development costs are rising. There is an overwhelming need to reduce development costs by as much as 30-40%, while at the same time significantly shortening development cycle times. Pharmaceutical spend on outsourcing faces double-digit growth for the next three to five years and yet, if outsourcing is to meet these challenges, new models of collaborative and cooperative working are needed now. Outsourcing Clinical Development offers a guide to these new models and to future clinical outsourcing strategy. There is advice on the basis for an outsourcing strategy and guidance on how to work most productively with CROs (contract research organisations); geographical issues, including working in low-cost environments, are also covered. There is a detailed guide to selecting candidates, and managing the proposal, negotiation and contract process successfully; as well as reviewing outsourcing performance and developing fruitful long-term strategic relationships. The pharmaceutical outsourcing process is as complex and as influential as the clinical trials it supports. Outsourcing Clinical Development, with a powerful mix of perceptive insight from leading lights in the industry, advice on long-term strategic direction and tools for immediate help is a must-have read for pharmaceutical companies and their CRO partners.

Download or read book The Offshoring of Engineering written by National Academy of Engineering and published by National Academies Press. This book was released on 2008-08-14 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The engineering enterprise is a pillar of U.S. national and homeland security, economic vitality, and innovation. But many engineering tasks can now be performed anywhere in the world. The emergence of "offshoring"- the transfer of work from the United States to affiliated and unaffiliated entities abroad - has raised concerns about the impacts of globalization. The Offshoring of Engineering helps to answer many questions about the scope, composition, and motivation for offshoring and considers the implications for the future of U.S. engineering practice, labor markets, education, and research. This book examines trends and impacts from a broad perspective and in six specific industries - software, semiconductors, personal computer manufacturing, construction engineering and services, automobiles, and pharmaceuticals. The Offshoring of Engineering will be of great interest to engineers, engineering professors and deans, and policy makers, as well as people outside the engineering community who are concerned with sustaining and strengthening U.S. engineering capabilities in support of homeland security, economic vitality, and innovation.

Download or read book Oral Formulation Roadmap from Early Drug Discovery to Development written by Elizabeth Kwong and published by John Wiley & Sons. This book was released on 2017-01-03 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing

Download or read book Women Entrepreneurs written by Mauro F. Guillén and published by Routledge. This book was released on 2013-06-19 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Women Entrepreneurs offers a collection of almost two dozen cases that explore the process by which women become entrepreneurs, as well as the opportunities and challenges they face in growing their businesses. With a particular focus on the intersection between entrepreneurship and economic development, the cases are drawn from across a range of industries and countries. They offer insights into a number of issues women entrepreneurs face, such as launching a business, diversification and internationalization, as well as covering a number of business functions, including finance, marketing and human resource management. Each case is presented with a summary highlighting the themes it covers, and ends with a set of questions to guide classroom discussion. The book also includes a summary of existing literature on entrepreneurship to help contextualize the cases. This casebook would be the ideal companion in an entrepreneurship class, particularly for students with an interest in female entrepreneurship or economic development. With data from a Goldman Sachs/Lauder Institute study.

Download or read book Preclinical Drug Development written by Mark Rogge and published by CRC Press. This book was released on 2016-04-19 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: PharmacokineticsModeling and simula

Download or read book Handbook of LC MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2013-09-03 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.

Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Download or read book Die Trying written by Bo Parfet and published by AMACOM/American Management Association. This book was released on 2009 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: In four years, Parfet accomplished what very few people had done before--he climbed the highest mountain on every continent. Here, he chronicles all of the exhilarating, often terrifying, climbs firsthand.

Download or read book Research and Development in the Pharmaceutical Industry A CBO Study written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

Download or read book Translational Medicine written by Joy A. Cavagnaro and published by CRC Press. This book was released on 2021-11-26 with total page 952 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Collaboration in Government written by David E. McNabb and published by Routledge. This book was released on 2021-11-29 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book comprehensively explores the many different forms of collaboration in government, both formal and informal, including strategic alliances, intergovernmental networks, and public-private partnerships. Contemporary US governmental and public organizations are changing to better cope after several decades of pressures to downsize, as well as to deliver new services with declining resources and, in many cases, decaying infrastructure. To meet these challenges, public managers are developing new networks, partnerships, collaborations, alliances and coalitions to deliver government services. Collaboration in Government is designed to help public organizations parse the new and emerging forms of public partnerships and to develop the skills needed to manage them. Each chapter offers examples of how each type has been used in real public organizations, providing the reader with an understanding of how these partnerships may be applied in a variety of contexts, as well as lessons that may be gleaned from the successes (and failures) of these collaborative models. This book will be of interest to public servants who collaborate in their daily work, as well as students of public administration and public policy.

Download or read book The Future of Drug Discovery written by Tamas Bartfai and published by Academic Press. This book was released on 2013-05-18 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer’s disease, untreatable pain, antibiotics and more. This book carefully exposes the gap between the medicines and therapies we need and the current business path. By analyzing the situation and discussing prospects for the next decade, the The Future of Drug Discovery is a timely book for all those who care about the development needs for drugs for disease. Provides an in-depth, broad perspective on the crisis in drug industry Exposes the disconnect between what society needs and what the drug companies are working on Analyses and projects over 10 years into the future Explains what it means for scientists and society Determines what is needed to be done to make sure that the industry responds to society's needs, remains commercially attractive and answers the question as to who decides which diseases to treat

Download or read book Outsourcing Biopharma R D to India written by P R Chowdhury and published by Elsevier. This book was released on 2011-05-05 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. Constitutes the first ever comprehensive insight on the Indian biopharma sector Provides a perspective based on practical hands-on legal experience Simply structured, clearly presented and free from excessive legal jargon

Download or read book Early Drug Development written by Fabrizio Giordanetto and published by John Wiley & Sons. This book was released on 2018-06-15 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

Download or read book Cancer Drug Design and Discovery written by Stephen Neidle and published by Elsevier. This book was released on 2011-04-28 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ultimate source of information on the design of new anticancer agents, emphasizing small molecules, this newest work covers recent notable successes resulting from the human genome and cancer genomics projects. These advances have provided information on targets involved in specific cancers that are leading to effective medicines for at least some of the common solid tumors. Unique sections explain the basic underlying principles of cancer drug development and provide a practical introduction to modern methods of drug design. Appealing to a broad audience, this is an excellent reference for translational researchers interested in cancer biology and medicine as well as students in pharmacy, pharmacology, or medicinal and biological chemistry and clinicians taking oncology options. * Covers both currently available drugs as well as those under development * Provides a clinical perspective on trials of new anticancer agents * Presents drug discovery examples through the use of case histories