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Outsourcing Biopharma R D to India

Outsourcing Biopharma R D to India Book
Author : P R Chowdhury
Publisher : Elsevier
Release : 2011-05-05
ISBN : 1908818018
Language : En, Es, Fr & De

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Book Description :

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

Outsourcing Biopharma R to India

Outsourcing Biopharma R to India Book
Author : P Chowdhury
Publisher : Unknown
Release : 2011
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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.

Plunkett s Biotech Genetics Industry Almanac 2009

Plunkett s Biotech   Genetics Industry Almanac 2009 Book
Author : Jack W. Plunkett
Publisher : Plunkett Research, Ltd.
Release : 2008-09-01
ISBN : 1593921241
Language : En, Es, Fr & De

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Book Description :

A complete market research guide to the business of biotech, genetics, proteomics and related services--a tool for strategic planning, competitive intelligence, employment searches, or financial research. Complete profiles of nearly 400 leading biotech companies, in-depth chapters on trends. Includes glossary thorough indexes, statistics, research and development, emerging technology--as well a addresses, phone numbers, and executive names.

Contract Research and Manufacturing Services CRAMS in India

Contract Research and Manufacturing Services  CRAMS  in India Book
Author : Milind Antani,Gowree Gokhale
Publisher : Elsevier
Release : 2012-10-31
ISBN : 1908818166
Language : En, Es, Fr & De

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Book Description :

The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. Simple and accessible presentation using tables, charts and diagrams Practical tips from leading practitioners Inclusion of relevant case laws and other legal considerations

Global Health Partnerships

Global Health Partnerships Book
Author : Mei-Ling Wang
Publisher : Springer
Release : 2008-11-28
ISBN : 0230582877
Language : En, Es, Fr & De

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Book Description :

An exploration into the current status and future growth of the global pharmaceutical industry and the changing needs of global health. It provides comprehensive coverage of the role of the global pharmaceutical industry in general, and the participation of BRICAs in specific, to address global health needs.

The New Players in Life Science Innovation

The New Players in Life Science Innovation Book
Author : Tomasz Mroczkowski
Publisher : Pearson Education
Release : 2011-07-07
ISBN : 9780132172967
Language : En, Es, Fr & De

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Book Description :

The global center of gravity in life sciences innovation is rapidly shifting to emerging economies. In The New Players in Life Science Innovation, Tomasz Mroczkowski explains how China and other new economic powers are rapidly gaining leadership positions, and thoroughly assesses the implications. Mroczkowski discusses the sophisticated innovation strategies and reforms these nations have implemented: approaches that don't rely on market forces alone, and are achieving remarkable success. Next, he previews the emerging global "bio-economy," in which life science discoveries will be applied pervasively in markets ranging from health to fuels. As R&D in the West becomes increasingly costly, Mroczkowski introduces new options for partnering with new players in the field. He thoroughly covers the globalization of clinical trials, showing how it offers opportunities that go far beyond cost reduction, and assessing the unique challenges it presents. Offering examples from China to Dubai to India, he carefully assesses the business models driving today's newest centers of innovation. Readers will find up-to-date coverage of bioparks, technology zones, and emerging clusters, and realistic assessments of global R&D collaboration strategies such as those of Eli Lilly, Merck, Novartis, and IBM. With innovation-driven industries increasingly dominating the global economy, this book's insights are indispensable for every R&D decision-maker and investor.

The Practice of Outsourcing

The Practice of Outsourcing Book
Author : Mary C. Lacity,Leslie P. Willcocks
Publisher : Springer
Release : 2009-06-25
ISBN : 0230240844
Language : En, Es, Fr & De

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Book Description :

A close look at the main developments in IT, business processes and offshore outsourcing. This book studies these topics in both theory and practice, exploring the rising prominence of outsourcing with a multi-dimensional, contextual perspective.

Practical Leadership for Biopharmaceutical Executives

Practical Leadership for Biopharmaceutical Executives Book
Author : Jane Y Chin
Publisher : Elsevier
Release : 2011-05-05
ISBN : 1908818026
Language : En, Es, Fr & De

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Book Description :

The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity. Focuses on personal leadership, where the executive has an opportunity to manage his/her own effectiveness as a leader and manager, and engage with their own career development and method of contribution within their chosen industry Discusses particularly the unique leadership challenges in biohealthcare: an industry that is at once highly innovative and emotive. Biohealthcare companies are often viewed with suspicion by the consumers who question corporate motives, and product marketing and sales practices. The effective biohealthcare leaders are well aware of these emotive features, and embody ethics through action - not just lip service Includes real life examples, including a series of both phone-based and email-based interviews of executives

The Funding of Biopharmaceutical Research and Development

The Funding of Biopharmaceutical Research and Development Book
Author : David R Williams
Publisher : Elsevier
Release : 2013-10-31
ISBN : 1908818387
Language : En, Es, Fr & De

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Book Description :

The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decrease in the near future. A lack of understanding of the scale, scope, and inner workings of the funding aspects of R&D can, at times, act as a barrier for all involved, and can slow down or even eliminate the R&D process. The book lessens these barriers by describing the theoretical underpinnings, present practice, and trends in R&D funding in this market sector, both in the US and internationally. This includes a review and discussion of public-private partnership activity and their inner-workings, noting the complementary relationship between public and private funding. The book also contains an overview of the inner-workings of strategic alliance activity, including the advantages and disadvantages for each party. It goes on to provide an outline of venture capital activity, detailing the methods by which venture capital firms raise capital and are organized, a description of the venture capital-entrepreneur arrangement, and the effects of this arrangement. The book also presents an overview of the IPO process and the various fates of firms going public. Presents a comprehensive view of the funding issues of R&D in this market sector, adopting a theory-to-practice approach A comprehensive and analytical review of the biopharmaceutical R&D literature and practice An overview of the various and competing/complementary theories of the firm and valuation methods as they apply to biopharmaceutical R&D

The Agile Approach to Adaptive Research

The Agile Approach to Adaptive Research Book
Author : Michael J. Rosenberg
Publisher : John Wiley & Sons
Release : 2010-02-18
ISBN : 9780470599679
Language : En, Es, Fr & De

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Book Description :

Apply adaptive research to improve results in drug development The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently. With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages of adaptive research technology and methods. He explains the concepts, principles, and specific techniques of adaptive research, and demonstrates why it is an essential evolutionary step toward improving drug research and development. Chapters explore such subjects as: The adaptive concept Design and operational adaptations Sample-size reestimation Agile clinical development Safety and dose finding Statistics in adaptive research, including frequentist and Bayesian approaches Data management technologies The future of clinical development By combining centuries-old intellectual foundations, recent technological advances, and modern management techniques, adaptive research preserves the integrity and validity of clinical research but dramatically improves efficiency.

Medical Innovation and Disease Burden

Medical Innovation and Disease Burden Book
Author : Sobin George
Publisher : Cambridge University Press
Release : 2021-02-28
ISBN : 1108968228
Language : En, Es, Fr & De

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Book Description :

Striking the right balance between public health priorities and health innovation is a critical policy challenge for India given their mutually conflicting nature and interests. India has a huge burden of diseases implicated by a gamut of health problems including the uneven distribution of demographic and epidemiological transition, threat of new infectious disease pandemic like COVID 19, increasing privatisation of healthcare, low affordability to life saving medicines and most importantly the escalating healthcare expenditure coupled with poor financial risk protection. The central question that the book addresses is whether health innovation in India is sensitive to the public health needs and priorities. It unearths the overriding issues related to responsiveness and equity in India's health innovation. The book highlights the need for a responsible innovation framework for India that balances the priorities of public health and the industry goals.

A Biotech Manager s Handbook

A Biotech Manager s Handbook Book
Author : M O'Neill,M M Hopkins
Publisher : Elsevier
Release : 2012-05-02
ISBN : 1908818158
Language : En, Es, Fr & De

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Book Description :

A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development

Open Source Software in Life Science Research

Open Source Software in Life Science Research Book
Author : Lee Harland,Mark Forster
Publisher : Elsevier
Release : 2012-10-31
ISBN : 1908818247
Language : En, Es, Fr & De

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Book Description :

The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. The book is divided into four parts. Part one looks at laboratory data management and chemical informatics, covering software such as Bioclipse, OpenTox, ImageJ and KNIME. In part two, the focus turns to genomics and bioinformatics tools, with chapters examining GenomicsTools and EBI Atlas software, as well as the practicalities of setting up an ‘omics’ platform and managing large volumes of data. Chapters in part three examine information and knowledge management, covering a range of topics including software for web-based collaboration, open source search and visualisation technologies for scientific business applications, and specific software such as DesignTracker and Utopia Documents. Part four looks at semantic technologies such as Semantic MediaWiki, TripleMap and Chem2Bio2RDF, before part five examines clinical analytics, and validation and regulatory compliance of free/open source software. Finally, the book concludes by looking at future perspectives and the economics and free/open source software in industry. Discusses a broad range of applications from a variety of sectors Provides a unique perspective on work normally performed behind closed doors Highlights the criteria used to compare and assess different approaches to solving problems

NMR Metabolomics in Cancer Research

NMR Metabolomics in Cancer Research Book
Author : Miroslava Čuperlović-Culf
Publisher : Elsevier
Release : 2012-12-17
ISBN : 1908818263
Language : En, Es, Fr & De

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Book Description :

The application of nuclear magnetic resonance (NMR) metabolomics in cancer research requires an understanding of the many possibilities that NMR metabolomics can offer, as well as of the specific characteristics of the cancer metabolic phenotype and the open questions in cancer research. NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. Following an overview of the potential use of NMR metabolomics in cancer research, the book begins with an examination of the cancer metabolic phenotype and experimental methodology, before moving on to cover data pre-processing and data analysis. Chapters in the latter part of the book look at dynamic metabolic profiling, biomarker discovery, and the application of NMR metabolomics for different types of cancer, before a concluding chapter discusses future perspectives in the field. Focused description of NMR spectroscopy needed by cancer biologists who are starting to use metabolomics Current overview of knowledge related to the cancer metabolic phenotype from the perspective of metabolomics applications Information about the best practices in NMR metabolomics experimentation and data preprocessing as applied to different sample types

Lean Biomanufacturing

Lean Biomanufacturing Book
Author : Nigel J Smart
Publisher : Elsevier
Release : 2013-10-31
ISBN : 1908818409
Language : En, Es, Fr & De

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Book Description :

With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful. Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. A focus on the issues associated with the application of lean principles to biomanufacturing Practical examples of factors which can affect biopharmaceutical processes Coverage of key factors which require integration to run an efficient biopharmaceutical process

The Politics of the Pharmaceutical Industry and Access to Medicines

The Politics of the Pharmaceutical Industry and Access to Medicines Book
Author : Hans Löfgren
Publisher : Routledge
Release : 2017-07-06
ISBN : 1351470590
Language : En, Es, Fr & De

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Book Description :

The book studies the pharmaceutical industry of India. It is one of the most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals.

Growth Strategies Of Indian Pharma Companies

Growth Strategies Of Indian Pharma Companies Book
Author : B Rajesh Kumars M Satish
Publisher : ICFAI Books
Release : 2007-09-04
ISBN : 8131407578
Language : En, Es, Fr & De

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Book Description :

The pharmaceutical industry in India is one of the largest and most advanced among the developing countries. During the last three decades, Indian pharmaceutical industry achieved spectacular progress by any standard. India s pharmaceutical industry has b

Computer Aided Applications in Pharmaceutical Technology

Computer Aided Applications in Pharmaceutical Technology Book
Author : Jelena Djuris
Publisher : Elsevier
Release : 2013-04-10
ISBN : 1908818328
Language : En, Es, Fr & De

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Book Description :

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development Book
Author : J E Aguilar
Publisher : Elsevier
Release : 2013-09-30
ISBN : 1908818506
Language : En, Es, Fr & De

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Book Description :

A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools. Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software. Coverage of artificial intelligence tools, new expert systems, understanding of pharmaceutical processes, robust development of medicines, and new ways to develop medicines Development of drugs and medicines using mathematical tools Compilation of expert system developed around the world

An Introduction to Pharmaceutical Sciences

An Introduction to Pharmaceutical Sciences Book
Author : Jiben Roy
Publisher : Elsevier
Release : 2011-07-25
ISBN : 1908818042
Language : En, Es, Fr & De

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Book Description :

This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences. This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry. A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries