This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.
This book provides a powerful insight into strategic portfolio management and its central role in the delivery of organisational strategy, maximisation of value creation, and efficient allocation of resources and capabilities to achieve organisational strategic objectives. The book makes a valuable contribution to the development of thinking on the translation of strategy into actionable work. Whether you are a senior manager building a high-performing strategic portfolio for your organisation or an academic searching for new perspectives on strategy execution through portfolio management, you will find great significance in this book. Twenty-eight chapters in four sections provide multiple perspectives on the topic, with in-depth guidance on organisational design for strategic portfolio management and covering all process, capability, and leadership aspects of strategic portfolio management. The book includes several detailed case studies for the effective deployment of strategic portfolios, bringing together theory and practice for strategic portfolio management. This book is particularly valuable for advanced undergraduate and postgraduate students of project and portfolio management, strategic management, and leadership who are looking to expand their knowledge within the multi-project environment. Highly practical and logical in its structure, it also shows project management professionals how to effectively manage their business portfolios and align this with their business strategy.
Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.
THE #1 GUIDE FOR STUDENTS AND PROFESSIONALS, NOW UPDATED FOR THE LATEST TRENDS AND EMERGING ISSUES Project Management, or the "Project Management bible" as it's widely known, provides practical guidance on all aspects of project management. It features a streamlined approach to PM functions without stinting on detailed coverage of the tools and methods used at all stages of a project. This 12th Edition has been updated to reflect industry changes and features in-depth coverage of emerging topics, including global stakeholder management, causes of failure, agile project management, project governance failure, customer approval milestones, classifying project metrics, and more. Also, supplementary materials are available for students, professionals, and instructors. Understand organizational structures and project management functions Learn how to control costs, manage risk, and analyze trade-offs Examine different methods used for planning, scheduling, QA, and more Work effectively with customers and stakeholders from around the globe As projects increase in scope and complexity, managing them across time zones, language barriers, and technology platforms requires a systematic approach that accounts for every detail. All the more reason to keep Project Management, 12th Edition within arm's reach throughout all stages of the projects you manage.
This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.
This unique guide and professional reference presents a structured framework for practitioners and students of project, program, and portfolio management to enhance their strategic and analytic capabilities in the evolving discipline of project portfolio management (PPM). It provides a practical, step-by-step approach to building competencies in categorizing, evaluating, optimizing, prioritizing, and managing an IT, pharmaceutical, biotech or other complex R&D-oriented portfolio of investments.
Because of rapid developments in the biotechnology industry—and the wide range of disciplines that contribute to its collective growth—there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.
Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.
The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.
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
