The Agile Approach to Adaptive Research
The Agile Approach to Adaptive Research

Author: Michael J. Rosenberg

Publisher: John Wiley & Sons

Published: 2010-02-18

Total Pages: 296

ISBN-13: 0470599677

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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.

Managing Agile Projects
Managing Agile Projects

Author: Sanjiv Augustine

Publisher: Pearson

Published: 2005

Total Pages: 272

ISBN-13:

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Your Hands-On, "In-the-Trenches" Guide to Successfully Leading AgileProjectsAgile methods promise to infuse development with unprecedented flexibility, speed, and valueand these promises are attracting IT organizations worldwide. However, agile methods often fail to clearly define the manager s role, and many managers have been reluctant to buy in. Now, expert project manager Sanjiv Augustine introduces agility "from the manager s point of view, offering a proven management framework that addresses everything from team building to project control. Augustine bridges the disconnect between the assumptions and techniques of traditional and agile management, demonstrating why agility is better aligned with today s project realities, and how to simplify your transition. Using a detailed case study, he shows how agile methods can scale to succeed in even the largest projects: Defining a high-value role for the manager in agile project environmentsRefocusing on "outcomes--not rigid plans, processes, or controlsStructuring and building adaptive, self-organizing "organic teams"Forming a guiding vision that aligns your team behind a common purposeEmpowering your team with the information it needs to succeedManaging the flow of customer value from one creative stage to the nextLeveraging your team members strengths as "whole persons"Implementing full-life-cycle agility: from planning and coding to maintenance and knowledge transfer Customizing agile methods to your unique environmentBecoming an "adaptive leader" who can inspire and energize agile teams Whether you re a technical or business manager, "Managing Agile Projectsgives you all the tools you need to implement agility in "your environmentand reap its full benefits. "Managing Agile Projects is part of the Robert C. Martin series.(c) Copyright Pearson Education. All rights reserved.

Adaptive Software Development
Adaptive Software Development

Author: James A. Highsmith

Publisher: Dorset House Publishing Company, Incorporated

Published: 2000

Total Pages: 0

ISBN-13: 9780932633408

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- support an adaptive culture or mindset, in which change and uncertainty are assumed to be the natural state--not a false expectation of order- introduce frameworks to guide the iterative process of managing change- institute collaboration, the interaction of people on three levels: interpersonal, cultural, and structural- add rigor and discipline to the RAD approach, making it scalable to the uncertainty and complexity of real-life undertakings

Adaptive Space: How GM and Other Companies are Positively Disrupting Themselves and Transforming into Agile Organizations
Adaptive Space: How GM and Other Companies are Positively Disrupting Themselves and Transforming into Agile Organizations

Author: Michael J. Arena

Publisher: McGraw Hill Professional

Published: 2018-06-15

Total Pages: 289

ISBN-13: 1260118037

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Lack of Agility is the kiss of death. Position your company to succeed in world of change.To edge out the competition in today’s disruptive environment, you need to ensure that your company is agile—that it can respond to change instantly and effectively. Because fast and furious change is the only thing you can count on in business today.Network expert Michael Arena helped enable GM’s legendary turnaround. In these pages, he explains how you can transform your own company through the concept of adaptive space. Based on hundreds of interviews and the author’s own groundbreaking study of dozens of organizations spanning a variety of industries, Adaptive Space shows how to position your company for today—and for the future—by enabling creativity, innovation, and novel ideas to flow freely among teams, across departments, and throughout the company. Using GM as the main case study—along with the stories of other highly adaptive organizations, like Apple, Amazon, Disney, and Gore—Arena provides a model you can follow to reinvent your company. It’s about inspiring employees to explore new ideas, empowering the most creative people and teams to spread their ideas across the organization, and operationalizing the entrepreneurial spirit so adaptability is set in stone. Hesitation is a killer in today’s business landscape. With Adaptive Space, you have everything you need to confront disruption with smart, confident actions and seize the valuable opportunities that come with change.

Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio
Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio

Author: Mark Chang

Publisher: John Wiley & Sons

Published: 2010-06-15

Total Pages: 284

ISBN-13: 0470438568

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ExpDesign Studio facilitates more efficient clinical trial design This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio: Covers both classical and adaptive clinical trial designs, monitoring, and analyses Explains various classical and adaptive designs including groupsequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples Emphasizes applications, yet covers key mathematical formulations Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basis Written with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials. ERRATUM Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio By Mark Chang The license for the ExpDesign Studio software on the CD included with this book is good for one-year after installation of the software. Prior to the expiration of this period, the software will generate a reminder about renewal for the license. The user should contact CTriSoft International (the owners of ExpDesign Studio) at www.CTriSoft.net or by email at [email protected], about renewal for the license. This should have been made clear in the first printing of this book. We apologize for this error.

Predictive Approaches in Drug Discovery and Development
Predictive Approaches in Drug Discovery and Development

Author: J. Andrew Williams

Publisher: John Wiley & Sons

Published: 2012-04-10

Total Pages: 420

ISBN-13: 0470170832

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Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

Collaborative Computational Technologies for Biomedical Research
Collaborative Computational Technologies for Biomedical Research

Author: Sean Ekins

Publisher: John Wiley & Sons

Published: 2011-08-04

Total Pages: 462

ISBN-13: 1118026020

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Methods, Processes, and Tools for Collaboration "The time has come to fundamentally rethink how we handle the building of knowledge in biomedical sciences today. This book describes how the computational sciences have transformed into being a key knowledge broker, able to integrate and operate across divergent data types." Bryn Williams-Jones, Associate Research Fellow, Pfizer The pharmaceutical industry utilizes an extended network of partner organizations in order to discover and develop new drugs, however there is currently little guidance for managing information and resources across collaborations. Featuring contributions from the leading experts in a range of industries, Collaborative Computational Technologies for Biomedical Research provides information that will help organizations make critical decisions about managing partnerships, including: Serving as a user manual for collaborations Tackling real problems from both human collaborative and data and informatics perspectives Providing case histories of biomedical collaborations and technology-specific chapters that balance technological depth with accessibility for the non-specialist reader A must-read for anyone working in the pharmaceuticals industry or academia, this book marks a major step towards widespread collaboration facilitated by computational technologies.

Software Engineering Research, Management and Applications 2009
Software Engineering Research, Management and Applications 2009

Author: Roger Lee

Publisher: Springer Science & Business Media

Published: 2009-10-27

Total Pages: 311

ISBN-13: 3642054404

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The 7th ACIS International Conference on Software Engineering Research, Management and Applications (SERA 2009) was held on Hainan Island, China from December 2 – 4. SERA ’09 featured excellent theoretical and practical contributions in the areas of formal methods and tools, requirements engineering, software process models, communication systems and networks, software quality and evaluation, software engineering, networks and mobile computing, parallel/distributed computing, software testing, reuse and metrics, database retrieval, computer security, software architectures and modeling. Our conference officers selected the best 17 papers from those papers accepted for presentation at the conference in order to publish them in this volume. The papers were chosen based on review scores submitted by members or the program committee, and underwent further rigorous rounds of review.

Collaborative Innovation in Drug Discovery
Collaborative Innovation in Drug Discovery

Author: Rathnam Chaguturu

Publisher: John Wiley & Sons

Published: 2014-04-14

Total Pages: 768

ISBN-13: 0470917377

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Can academia save the pharmaceutical industry? The pharmaceutical industry is at a crossroads. The urgent need for novel therapies cannot stem the skyrocketing costs and plummeting productivity plaguing R&D, and many key products are facing patent expiration. Dr. Rathnam Chaguturu presents a case for collaboration between the pharmaceutical industry and academia that could reverse the industry's decline. Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships provides insight into the potential synergy of basing R&D in academia while leaving drug companies to turn hits into marketable products. As Founder and CEO of iDDPartners, focused on pharmaceutical innovation, Founding president of the International Chemical Biology Society, and Senior Director-Discovery Sciences, SRI International, Dr. Chaguturu has assembled a panel of experts from around the world to weigh in on issues that affect the two driving forces in medical advancement. Gain global perspectives on the benefits and potential issues surrounding collaborative innovation Discover how industries can come together to prevent another "Pharma Cliff" Learn how nonprofits are becoming the driving force behind innovation Read case studies of specific academia-pharma partnerships for real-life examples of successful collaboration Explore government initiatives that help foster cooperation between industry and academia Dr. Chaguturu’s thirty-five years of experience in academia and industry, managing new lead discovery projects and forging collaborative partnerships with academia, disease foundations, nonprofits, and government agencies lend him an informative perspective into the issues facing pharmaceutical progress. In Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships, he and his expert team provide insight into the various nuances of the debate.

Computational Toxicology
Computational Toxicology

Author: Sean Ekins

Publisher: John Wiley & Sons

Published: 2018-02-13

Total Pages: 450

ISBN-13: 111928256X

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Dieses Buch ist ein wichtiges Referenzwerk für Toxikologen in vielen Bereichen und bietet eine umfassende Analyse molekular Modellansätze und Strategien der Risikobewertung von pharmazeutischen und Umweltchemikalien. - Zeigt, was mit rechnergestützter Toxikologie aktuell erreicht werden kann, und wirft einen Blick auf zukünftige Entwicklungen. - Gibt Antworten zu Themen wie Datenquellen, Datenpflege, Behandlung, Modellierung und Interpretation kritischer Endpunkte im Hinblick auf Gefahrenbewertungen im 21. Jahrhundert. - Bündelt herausragende Konzepte und das Wissen führender Autoren in einem einzigartigen Referenzwerk. - Untersucht detailliert QSAR-Modelle, Eigenschaften physiochemischer Arzneistoffe, strukturbasiertes Drug Targeting, die Bewertung chemischer Mischungen und Umweltmodelle. - Behandelt zusätzlich die Sicherheitsbewertung von Verbraucherprodukten und den Bereich chemische Abwehr und bietet Kapitel zu Open-Source-Toxikologie und Big Data.