January 17, 2021

Download Ebook Free A Biotech Manager’s Handbook

A Biotech Manager's Handbook

A Biotech Manager's Handbook
Author : M O'Neill,M M Hopkins
Publisher : Elsevier
Release Date : 2012-05-02
Category : Science
Total pages :414
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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

The Routledge Handbook of the Political Economy of Science

The Routledge Handbook of the Political Economy of Science
Author : David Tyfield,Rebecca Lave,Samuel Randalls,Charles Thorpe
Publisher : Routledge
Release Date : 2017-04-28
Category : Business & Economics
Total pages :464
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The political economy of research and innovation (R&I) is one of the central issues of the early twenty-first century. ‘Science’ and ‘innovation’ are increasingly tasked with driving and reshaping a troubled global economy while also tackling multiple, overlapping global challenges, such as climate change or food security, global pandemics or energy security. But responding to these demands is made more complicated because R&I themselves are changing. Today, new global patterns of R&I are transforming the very structures, institutions and processes of science and innovation, and with it their claims about desirable futures. Our understanding of R&I needs to change accordingly. Responding to this new urgency and uncertainty, this handbook presents a pioneering selection of the growing body of literature that has emerged in recent years at the intersection of science and technology studies and political economy. The central task for this research has been to expose important but consequential misconceptions about the political economy of R&I and to build more insightful approaches. This volume therefore explores the complex interrelations between R&I (both in general and in specific fields) and political economies across a number of key dimensions from health to environment, and universities to the military. The Routledge Handbook of the Political Economy of Science offers a unique collection of texts across a range of issues in this burgeoning and important field from a global selection of top scholars. The handbook is essential reading for students interested in the political economy of science, technology and innovation. It also presents succinct and insightful summaries of the state of the art for more advanced scholars.

CAPA in the Pharmaceutical and Biotech Industries

CAPA in the Pharmaceutical and Biotech Industries
Author : J Rodriguez
Publisher : Elsevier
Release Date : 2015-12-08
Category : Medical
Total pages :248
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CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations. Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately

Matlab® in Bioscience and Biotechnology

Matlab® in Bioscience and Biotechnology
Author : Leonid Burstein
Publisher : Elsevier
Release Date : 2011-06-05
Category : Science
Total pages :268
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MATLAB® in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In the last decade Matlab has been presented to students as the first computer program they learn. Consequently, many non-programmer students, engineers and scientists have come to regard it as user-friendly and highly convenient in solving their specific problems. Numerous books are available on programming in Matlab for engineers in general, irrespective of their specialization, or for those specializing in some specific area, but none have been designed especially for such a wide, interdisciplinary, and topical area as bioengineering. Thus, in this book, Matlab is presented with examples and applications to various school-level and advanced bioengineering problems - from growing populations of microorganisms and population dynamics, reaction kinetics and reagent concentrations, predator-prey models, mass-transfer and flow problems, to sequence analysis and sequence statistics. This is the first book intended as a manual introducing biologists and other biotechnology engineers to work with Matlab It is suitable for beginners and inexperienced users; however, applications of Matlab to advanced problems such as the Monte Carlo method, curve fitting, and reliable machine diagnostics make the book relevant to university teachers as well The book is different in that it assumes a modest mathematical background for the reader and introduces the mathematical or technical concepts with a somewhat traditional approach; Matlab is then used as a tool for subsequent computer solution

Dartnell's Marketing Manager's Handbook

Dartnell's Marketing Manager's Handbook
Author : Sidney J. Levy,George R. Frerichs,Howard L. Gordon
Publisher : Unknown
Release Date : 1997-10
Category : Business & Economics
Total pages :1432
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Regardless of your marketing management experience level, Dartnell's completely revised Marketing Manager's Handbook will guide you to create and executive winning marketing strategies. -- Contribution from 150 marketing experts on virtually every aspect of marketing. This handbook is the most comprehensive and practical guide available today about marketing management and how it's used. -- Organized into nine sections, this handbook is a comprehensive reference tool that offers a wonderful range of information and assistance to anyone who would better use contemporary marketing techniques to build their their business or their organization into all that it can possibly be. Whether you're looking for ways to organize your marketing staff, reward your employees, or determine sales rep's performance and job attitudes -- you will have at hand some of the best advice and ideas from experts in marketing management. If you're trying to: reach customers by market segmentation, determine customer wants and needs, develop an effective customer service strategy, go green, achieve brand dominance through customer learning, or determine strategic pricing -- you will learn to get the most out of each.

Lipid Analysis

Lipid Analysis
Author : W. W. Christie,X Han
Publisher : Elsevier
Release Date : 2010-01-10
Category : Technology & Engineering
Total pages :448
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This well-known and highly successful book was first published in 1973 and has been completely re-written in subsequent editions (published in 1982 and 2003). This new Fourth Edition has become necessary because of the pace of developments in mass spectrometry of intact lipids, which has given recognition of lipid analysis and ‘lipidomics’ as a distinct science. To bring the book up to date with these developments, author William W. Christie is joined by co-author Xianlin Han. Although devoting considerable space to mass spectrometry and lipidomics, Lipid analysis remains a practical guide, in one volume, to the complexities of the analysis of lipids. As in past editions, it is designed to act as a primary source, of value at the laboratory bench rather than residing on a library shelf. Lipid analysis deals with the isolation, separation, identification and structural analysis of glycerolipids, including triacylglycerols, phospholipids, sphingolipids, and the various hydrolysis products of these. The chapters follow a logical sequence from the extraction of lipids to the isolation and characterization of particular lipid classes and of molecular species of each, and to the mass spectrometric analysis of lipids and lipidomics. The new influence of mass spectrometry is due mainly to the development of electrospray ionization (ESI) and matrix-assisted laser desorption/ionization (MALDI). Most emphasis in this book is placed on ESI, which is enabling structural characterization of different lipid classes and the identification of novel lipids and their molecular species.

The Generic Challenge

The Generic Challenge
Author : Martin A. Voet
Publisher : BrownWalker Press
Release Date : 2020-05-01
Category : Law
Total pages :240
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This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

For God's Sake! Work By The Book: Management Explained From Within

For God's Sake! Work By The Book: Management Explained From Within
Author : Zohn Sarah
Publisher : World Scientific
Release Date : 2017-11-29
Category : Business & Economics
Total pages :372
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Most managers today work solely on intuition rather than best practices plus intuition. People keep reinventing what it means to be a manager, instead of learning from others' experience and improving on it. People these days are not less talented; they have access to more information and they are fast learners. The problem is that there aren't enough places to learn from, as organizations — large and small — are so mercurial and unstable. This book summarizes the author's experience from two major sources: a) growing with different companies through all the management ranks up to Vice President in a mega US corporation in the computer industry, and b) from working as a consultant to dozens of companies and hundreds of managers from different backgrounds and industries. New and experienced managers will benefit from principles, approaches, and checklists for current managerial challenges. The book covers a broad range of managerial challenges — from role definition to strategy to communication. Contents: A Manager's CookbookThe Manager's JobSetting and Achieving GoalsGlobal Company StrategyCommunication Technocrat B2B Marketing BasicsSales Organization Basics for B2BOrganizations: Culture, Structure, and PeopleFriend of NumbersTurning the Curve with Sprezzatura Readership: Managers and leaders of small and medium companies and mid-level management of large companies; general public interested in managerial leadership. Keywords: Management; Experience; Leadership; Manager; Leader; Operational Strategy; Strategy; Execution; Work Management; People Management; Business Ecosystem; Setting Goals; Achieving Goals; Achievement; Business in Numbers; Sprezzatura; Organizations; Principles in Management; Marketing Basics; Sales Basics; Critical Mass; Sunk Cost Review:0

Biopharmaceutical Processing

Biopharmaceutical Processing
Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
Publisher : Elsevier
Release Date : 2018-01-18
Category : Technology & Engineering
Total pages :1308
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Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Bioreactor Design Fundamentals

Bioreactor Design Fundamentals
Author : Norton G. McDuffie
Publisher : Butterworth-Heinemann
Release Date : 2013-10-22
Category : Science
Total pages :150
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Bioreactor Design Fundamentals presents the development in the bioreactor field. This book discusses the applications of biological kinetics and thermodynamics. Organized into seven chapters, this book begins with an overview of the design of biological reactors that involves determining operating conditions, sizing the reactor, controlling temperature and sterility, and controlling operating variables. This text then examines the significance of pH considerations in biological reactor and process design. Other chapters consider enzyme kinetics and the equations most commonly used as models for overall enzyme kinetics. This book discusses as well the mass transfer rates in bioreactors, which are significant because of their effects on some chemical reaction rates in transformations by enzymes or by living cells. The final chapter deals with the ideal state of the continuous stirred-tank reactors (CSTRs). This book is a valuable resource for biochemical engineers and industrial microbiologists.

Chemistry and Industry

Chemistry and Industry
Author : Anonim
Publisher : Unknown
Release Date : 1993
Category : Chemistry, Technical
Total pages :129
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Clinical Trials

Clinical Trials
Author : Tom Brody
Publisher : Academic Press
Release Date : 2011-10-25
Category : Medical
Total pages :638
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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "study schema" and related features of study design Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Author : Lisa Plitnick,Danuta Herzyk
Publisher : Academic Press
Release Date : 2013-06-27
Category : Medical
Total pages :432
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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" A multi-authored book with chapters written by qualified experts in their respective fields

The Roman Guide to Slave Management

The Roman Guide to Slave Management
Author : Jerry Toner
Publisher : Abrams
Release Date : 2014-09-04
Category : History
Total pages :192
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Having spent most of his life managing his servants—many of them prisoners from Rome’s military conquests—he decided to write a kind of owner’s manual for his friends and countrymen. The result, The Roman Guide to Slave Management, is a sly, subversive guide to the realities of servitude in ancient Rome. Cambridge scholar Jerry Toner uses Falx, his fictional but true-to-life creation, to describe where and how to Romans bought slaves, how they could tell an obedient worker from a troublemaker, and even how the ruling class reacted to the inevitable slave revolts. Toner also adds commentary throughout, analyzing the callous words and casual brutality of Falx and his compatriots and putting it all in context for the modern reader. Written with a deep knowledge of ancient culture—and the depths of its cruelty—this is the Roman Empire as you’ve never seen it before.

The Business Book

The Business Book
Author : DK
Publisher : Penguin
Release Date : 2014-12-19
Category : Business & Economics
Total pages :352
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The Business Book clearly and simply explains all of the key theories that have shaped the world of business, management, and commerce. Using easy-to-follow graphics and artworks, succinct quotations, and thoroughly accessible text, The Business Book introduces the would-be entrepreneur and general reader alike to the work of great commercial thinkers, leaders, and gurus. The Business Book includes: - Almost 100 quotations from the great business thinkers and gurus - Information on every facet of business management, including alternative business models, with real life examples from the marketplace - A structure that takes the reader through every stage of business strategy, from start-up to delivering the goods The clear and concise summaries, graphics, and quotations in The Business Book will help even the complete novice understand the key ideas behind business success.