Pharmaceutical Outsourcing: Discovery and Preclinical Services

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Author :
Publisher : Lulu.com
ISBN 13 : 0984904905
Total Pages : 277 pages
Book Rating : 4.9/5 (849 download)

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Book Synopsis Pharmaceutical Outsourcing: Discovery and Preclinical Services by : William C. Stevens Jr.

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!

Outsourcing in the Pharmaceutical Industry

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Author :
Publisher :
ISBN 13 : 9781853346132
Total Pages : 116 pages
Book Rating : 4.3/5 (461 download)

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Book Synopsis Outsourcing in the Pharmaceutical Industry by : Patrick Taaffe

Download or read book Outsourcing in the Pharmaceutical Industry written by Patrick Taaffe and published by . This book was released on 1996 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Outsourcing of R&D in the Pharmaceutical Industry

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Author :
Publisher : Springer
ISBN 13 : 0230512631
Total Pages : 205 pages
Book Rating : 4.2/5 (35 download)

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Book Synopsis Outsourcing of R&D in the Pharmaceutical Industry by : Bianca Piachaud

Download or read book Outsourcing of R&D in the Pharmaceutical Industry written by Bianca Piachaud and published by Springer. This book was released on 2004-09-30 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the strategic aspects of outsourcing in relation to the firm. It provides a holistic view of the outsourcing process, starting with conceptualisation, through to implementation and management of the process. Although the book is based on a case study of the pharmaceutical industry, the general principles derived from the Strategic Sourcing Model are generic in nature and the model can be applied to instances of outsourcing in other industries.

Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide

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Author :
Publisher : Pharmalicensing
ISBN 13 : 1905310110
Total Pages : 130 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide by :

Download or read book Legal aspects of outsourcing contracts in the pharmaceutical industry: A practical guide written by and published by Pharmalicensing. This book was released on with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Outsourcing Clinical Development

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Author :
Publisher : CRC Press
ISBN 13 : 1317084586
Total Pages : 193 pages
Book Rating : 4.3/5 (17 download)

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Book Synopsis Outsourcing Clinical Development by : Jane Baguley

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 193 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.

Outsourcing Research in the Pharmaceutical Industry

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Author :
Publisher :
ISBN 13 :
Total Pages : 222 pages
Book Rating : 4.:/5 (337 download)

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Book Synopsis Outsourcing Research in the Pharmaceutical Industry by : Francois Thomas

Download or read book Outsourcing Research in the Pharmaceutical Industry written by Francois Thomas and published by . This book was released on 1995 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Outsourcing Biopharma R&D to India

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Author :
Publisher : Elsevier
ISBN 13 : 1908818018
Total Pages : 133 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Outsourcing Biopharma R&D to India by : P R Chowdhury

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

The Role of Organisational Change Management in Offshore Outsourcing of Information Technology Services

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Author :
Publisher : Universal-Publishers
ISBN 13 : 1599427095
Total Pages : 187 pages
Book Rating : 4.5/5 (994 download)

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Book Synopsis The Role of Organisational Change Management in Offshore Outsourcing of Information Technology Services by : T. R. Ramanathan

Download or read book The Role of Organisational Change Management in Offshore Outsourcing of Information Technology Services written by T. R. Ramanathan and published by Universal-Publishers. This book was released on 2009-03 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: This research study seeks to understand the nature of organisational change with respect to offshore outsourcing of information technology services in a multinational pharmaceutical company, and to examine the effectiveness of approaches used to manage this change so that lessons may be drawn from these experiences. Despite the abundant literature on effective organisational change management, the key factors that need to be managed properly at different stages of the offshore outsourcing process are not well understood. The research adopts a processual view to paint a broad picture of the issues involved in these different stages. A generic process model of change, based on the review of the change literature, was first developed to represent how change was intended to occur. This model focuses on the following four stages in the change process: context, diagnosis and planning, implementation, and institutionalisation. The research employs an interpretive case study approach and draws on fieldwork from three independent information systems departments (cases) of the company, where offshore outsourcing programmes were implemented. Qualitative data from semi-structured interviews, direct observation and document analysis are analysed by applying the generic process model to produce a detailed account of the way in which change was managed in the case organisations. The findings reveal that a combination of contextual factors, both external and internal to the company, influenced the adoption and use of offshore outsourcing in the case organisations. Externally, the economic forces were found to be the main catalyst for the change, while internally the role of the executive leadership and the lack of internal resources further explain the motivations behind the adoption of offshore outsourcing. The study illustrates that achieving successful outcomes from offshore outsourcing activities critically depends on the organisation adequately addressing a number of factors, such as conveying a sense of urgency, developing and communicating the vision, identifying the benefits of change and how they will be delivered, generating short-term wins, providing education and training, developing a fit between the change and organisational culture, etc., throughout the change process. The findings also highlight the effects of offshore outsourcing on the case organisations, including change in job roles and responsibilities and organisational learning activities that enable corrective actions to improve change management efforts. An important contribution of this research is the development of a model providing a more comprehensive understanding of the change process associated with the implementation of offshore IT outsourcing. Recommendations for policy makers and change managers to improve change management practice based on the research findings, as well as recommendations for further research, form a significant part of the conclusions.

China Rx

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Publisher : Prometheus Books
ISBN 13 : 1633883817
Total Pages : 306 pages
Book Rating : 4.6/5 (338 download)

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Book Synopsis China Rx by : Rosemary Gibson

Download or read book China Rx written by Rosemary Gibson and published by Prometheus Books. This book was released on 2018 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Millions of Americans are taking prescription drugs made in China and don't know it-- and pharmaceutical companies are not eager to tell them. This probing book examines the implications for the quality and availability of vital medicines for consumers. Several decades ago, penicillin, vitamin C, and many other prescription and over-the-counter products were manufactured in the United States. But with the rise of globalization, antibiotics, antidepressants, birth control pills, blood pressure medicines, cancer drugs, among many others are made in China and sold in the United States. China's biggest impact on the US drug supply is making essential ingredients for thousands of medicines found in American homes and used in hospital intensive care units and operating rooms. The authors convincingly argue that there are at least two major problems with this scenario. First, it is inherently risky for the United States to become dependent on any one country as a source for vital medicines, especially given the uncertainties of geopolitics. For example, if an altercation in the South China Sea causes military personnel to be wounded, doctors may rely upon medicines with essential ingredients made by the adversary. Second, lapses in safety standards and quality control in Chinese manufacturing are a risk. Citing the concerns of FDA officials and insiders within the pharmaceutical industry, the authors document incidents of illness and death caused by contaminated medications that prompted reform. This is a disturbing, well-researched book and a wake-up call for improving the current system of drug supply and manufacturing.

Global Pharmaceutical Outsourcing Strategy Report for Small Pharmaceutical Companies

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Author :
Publisher :
ISBN 13 :
Total Pages : 109 pages
Book Rating : 4.:/5 (97 download)

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Book Synopsis Global Pharmaceutical Outsourcing Strategy Report for Small Pharmaceutical Companies by : Muyang Hu

Download or read book Global Pharmaceutical Outsourcing Strategy Report for Small Pharmaceutical Companies written by Muyang Hu and published by . This book was released on 2015 with total page 109 pages. Available in PDF, EPUB and Kindle. Book excerpt: Diabetes is a global health issue that threatens millions of lives. Thermalin Diabetes, LLC is striving to commercialize new types of insulins that fulfil unmet market needs for both Type I and Type II diabetes patients. However, as a small pharmaceutical company, Thermalin Diabetes faces obstacles operationally and financially due to its size and limited funding sources. As Thermalin is exploring the option of outsourcing its production activities, it is challenging to allocate the right amount of capital while still trying to mitigate the risks at a minimum level. In this thesis, I will analyze different risks associated with outsourcing in the pharmaceutical industry as well as an internal and external cost analysis to evaluate the cost efficiency for Thermalin. Ultimately, a structured framework will be provided for Thermalin to make strategic decisions on outsourcing.

Value Creation in the Pharmaceutical Industry

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Publisher : John Wiley & Sons
ISBN 13 : 3527339132
Total Pages : 511 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Value Creation in the Pharmaceutical Industry by : Alexander Schuhmacher

Download or read book Value Creation in the Pharmaceutical Industry written by Alexander Schuhmacher and published by John Wiley & Sons. This book was released on 2016-04-11 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

Offshoring Outsourcing in the Pharmaceutical Industry

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Author :
Publisher :
ISBN 13 :
Total Pages : 108 pages
Book Rating : 4.:/5 (634 download)

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Book Synopsis Offshoring Outsourcing in the Pharmaceutical Industry by : Pascal Stiefenhofer

Download or read book Offshoring Outsourcing in the Pharmaceutical Industry written by Pascal Stiefenhofer and published by . This book was released on 2004 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Outsourcing in Clinical Drug Development

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Author :
Publisher : CRC Press
ISBN 13 : 9781574911121
Total Pages : 268 pages
Book Rating : 4.9/5 (111 download)

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Book Synopsis Outsourcing in Clinical Drug Development by : Roy Drucker

Download or read book Outsourcing in Clinical Drug Development written by Roy Drucker and published by CRC Press. This book was released on 2002-08-15 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this invaluable resource is a complete guide to the drug development outsourcing relationship.

Contract Manufacturing of Medicines

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Publisher : Kluwer Law International B.V.
ISBN 13 : 9041126422
Total Pages : 462 pages
Book Rating : 4.0/5 (411 download)

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Book Synopsis Contract Manufacturing of Medicines by : Magdalena Krekora

Download or read book Contract Manufacturing of Medicines written by Magdalena Krekora and published by Kluwer Law International B.V.. This book was released on 2008-01-01 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and• definition of and‘medicineand’ in different jurisdictions; and• categories of medicines; and• manufacturing and importation regulation in numerous jurisdictions worldwide; and• inspection regimes; and• good manufacturing practice (GMP); and• marketing authorization; and• manufacturing documentation; and• complaints and product recall; and• liability insurance; and• protection of trade secrets; and• data exclusivity and data protection; and• deficiencies and delays; and and• recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.

Outsourcing Clinical Research Projects

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Author :
Publisher : Inst of Clinical Research
ISBN 13 : 1905238053
Total Pages : 40 pages
Book Rating : 4.9/5 (52 download)

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Book Synopsis Outsourcing Clinical Research Projects by : David Bryde

Download or read book Outsourcing Clinical Research Projects written by David Bryde and published by Inst of Clinical Research. This book was released on 2007 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the decision-making process of out-sourcing and provides a model of the process. It covers topics associated with finding an appropriate Clinical Research Organisation, including: the feasibility process, types of contracts, legal documentation and the working relationship between client and sub-contractor.

Outsourcing Resources for the Pharmaceutical Industry

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Author :
Publisher :
ISBN 13 :
Total Pages : 114 pages
Book Rating : 4.:/5 (497 download)

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Book Synopsis Outsourcing Resources for the Pharmaceutical Industry by :

Download or read book Outsourcing Resources for the Pharmaceutical Industry written by and published by . This book was released on 2001 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Future of Outsourcing in Pharmaceutical R&D

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Author :
Publisher :
ISBN 13 : 9781859784679
Total Pages : 150 pages
Book Rating : 4.7/5 (846 download)

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Book Synopsis Future of Outsourcing in Pharmaceutical R&D by : Helen Abbott

Download or read book Future of Outsourcing in Pharmaceutical R&D written by Helen Abbott and published by . This book was released on 2000-12-30 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text investigates the scope for strategic outsourcing in the pharmaceutical industry. It also offers a practical guide on how to best implement strategic outsourcing and reviews best practices across the industry.