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How quickly and effectively a company can develop and implement novel process technologies increasingly shapes the overall cost, timeliness, and results of new product introductions, and the overall competitive success of the company. This chapter examines the strategic role of process development c... More

This chapter discusses how process development fits into a firm's larger competitive, technological, organizational, and operational environments and develops a framework focusing on the learning that takes place during process development and the role of knowledge in shaping strategies for learning... More

This chapter examines changes in the institutional and technological arenas in which pharmaceutical companies operate to highlight the competitive challenges that both incumbent and new entrants face, as well as the implications of these challenges for development capabilities.... More

This chapter discusses how process development capabilities influence cost, development speed, and product innovation in pharmaceuticals.... More

This chapter looks at the evolution of product and process development in the pharmaceutical industry and describes different learning strategies that are required in different knowledge environments.... More

A challenge facing many companies is to create a development process that is fast, efficient, and capable of generating high-quality process designs. This chapter explores this important relationship between the development process and design quality.... More

In this chapter, the author presents a conceptual framework for learning across development projects and examines the approaches of four different biotechnology firms to managing projects and promoting learning of the skills and knowledge most critical to the firm's competitive advantage.... More

This chapter presents a series of case studies that examine unique management dilemmas related to process development, illustrating the broad organizational context in which process development issues arise and providing insight into the appropriate course of action.... More

Established pharmaceutical firms and new entrants alike have pursued various strategies for improving their process development capabilities in an arena in which firms have traditionally competed solely on the basis of new product introductions. This chapter outlines important process development le... More

Superior development performance requires different practices in different environments. This chapter explores how two strategies-learning by doing and learning before doing-affect development performance.... More

For more than twenty-five years, the biotechnology industry has been host to a profound and important experiment: the fusion of science and business. The significant challenges of integrating science and business have driven this sector to pursue novel organizational and institutional experiments th... More

Too often discussions in both the popular press and academic studies of the pharmaceutical or biotechnology industry treat the science of drug discovery as if it were a single body of knowledge, obscuring the critical fact that not one, but several scientific revolutions have gripped drug discovery ... More

In order to appreciate the revolutionary changes taking place in the drug sciences, as well as understand the fundamental management and economic challenges of companies in the drug business, we need to understand the drug R&D process and its unique characteristics. These characteristics create uniq... More

If we want to understand how the drug and biotechnology business works and what makes it different, we need to understand which characteristics of the R&D process are unique. While drug R&D is similar in many ways to R&D in other sectors, the challenges of drug R&D are dictated, in part, by the limi... More

What types of firms compete in the biotechnology segment? How have these changed over time? What kind of strategies have they pursued? And what capabilities do they have? This chapter describes the emergence of biotechnology as a new segment of the pharmaceutical industry, analyzing how firm capabil... More

Throughout the history of biotech, expectations have been high. The promise of the industry was that the through different (and superior) technology, the process of drug R&D would be transformed, and this transformation would lead to an avalanche of new drugs, and, of course, fuel profitability. In ... More

What are the underlying forces that shape the way the biotechnology industry has evolved, the way it operates, the way firms behave, and the way various types of players interact? Without understanding these forces, it is impossible to understand the root of performance problems, or determine what m... More

The scientific and commercial promise of biotechnology has been impeded by the way the business is structured and operated. What are the key strategic issues facing younger and more established biotechnology firms, specifically on questions of vertical integration and organizational boundaries? This... More

Scientific revolutions like biotechnology are only partly about science. Inextricably linked to the science are experiments in institutional arrangements, organizational forms, business models, and management practices. This chapter offers some reflection on the experiments that are going on in biot... More

Nucleon is a small biotechnology company whose first potential product is about to enter clinical testing. Before Nucleon can begin clinical trials, however, its management must decide how and where to manufacture the product. Three options are being contemplated: 1) build an in-house pilot plant, 2... More

Explores BMW's decision about how to manufacture prototype vehicles. Historically, BMW's prototypes were handcrafted by highly skilled artisans in the company's shop. A proposal has been made to alter the process so that prototypes are made in a way that can better uncover potential problems that ma... More

Presents a plant manager's proposal to improve operations at American Connector Co. The plan attempts to imitate operations at DJC Corp., a successful Japanese competitor. Requires students to consider how changes in manufacturing impact productivity, flexibility, and overall strategy.... More

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