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This book investigates and highlights the most critical challenges the pharmaceutical industry faces in an increasingly competitive environment of inflationary R&D investments and tightening cost control pressures. The authors present three sources of pharmaceutical innovation: new management methods in the drug development pipeline; new technologies as enablers for cutting-edge R&D; and new forms of cooperation and internationalization, such as open innovation in the early phases of R&D. New models and methods are illustrated with cases from Europe, the US, and Asia. This third fully revised edition was expanded to reflect the latest updates in open and collaborative innovation, the greater strategic importance of venture capital and early-stage investments, and the new range of emerging technologies now being put to use in pharmaceutical innovation.

Inhaltsverzeichnis

Frontmatter

1. Innovation: Key to Success in the Pharmaceutical Industry

Abstract
The traditional model of innovation in the pharmaceutical industry is being challenged by an explosion of costs for R&D, a strengthened voice of the customer and regulatory bodies in the development of new medicines, and the vanishing of easy targets. An overview is given of established and emerging pharma companies, the cost structures for pharma innovation, and the nature of the productivity gap. We describe the blockbuster imperative and the pervasive concerns about risk and safety in pharma R&D, and conclude with a brief outlook on the main themes to be discussed in the remainder of the book.
Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer

2. The Industry Challenge: Who Would Want to Be in This Business?

Abstract
Although the pharma industry is primarily based on a science-driven paradigm, the industry itself is highly complex with multiple stakeholders and actors. We employ Porter’s Five-Forces industry analysis to examine the power of suppliers and buyers, potential competitors, the threat of substitute products, and rivalry among established companies. Regulators are also discussed, as they constitute a key stakeholder in the industry. We present key challenges to the traditional pharma business model, and conclude with an overview of merger & acquisition and diversification trends in the industry.
Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer

3. The Science and Technology Challenge: How to Find New Drugs

Abstract
Already a high-tech industry by virtue of its science underpinnings, pharma innovation is undergoing a major shift in the wake of the adoption of several new discovery and development technologies. The rise of the biotech industry is the most obvious one, but new approaches in target discovery, high-throughput screening, combinatorial chemistry, hit and lead generation, bioinformatics, big data, proteomics and pharmacogenetics are also radically changing how pharma R&D is being done at the lab level.
Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer

4. The Pipeline Challenge: How to Organize Innovation

Abstract
More than in most other industries, the success of pharma R&D hinges on efficient and intelligent pipeline management. All activities and tasks in the research and development phases are highly regulated and defined with precision—a prime example of a stage-gate process. Given the long duration of the development of a new drug, and the increasing R&D costs per drug on average, the industry faces unfavorable innovation economics also known as “the innovation scissors.” The nature of the pipeline permits increasingly sophisticated portfolio analysis of drugs in development, offering pharma companies managerial options in managing individual drug candidates based on accessible competencies, risks, and expected benefits.
Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer

5. The Make-or-Buy Challenge: How to In- and Outsource Innovation

Abstract
The formerly fully integrated pharma value chain is disaggregating given the emergence of highly capable and specialized research and clinical development service providers. The options range from outsourcing, out-licensing, and in-licensing, strategic partnerships and co-development. These concepts are discussed in detail and illustrated with cases from industry. We conclude with an example of how a breakthrough innovation can best be commercialized by a small pharma company using those make-or-buy options.
Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer

6. The Open Innovation Challenge: How to Partner for Innovation

Abstract
The business models of major pharmaceutical companies increasingly include external R&D elements that range from the acquisition of drug projects, traditional collaborations with academic institutions, multi-year research partnerships, crowdsourcing, centers for R&D excellence, open source innovation, virtual R&D and public private partnerships. Commonly known as “open innovation”, these new virtual forms of organizing innovation processes challenge the traditional, established inhouse-only R&D paradigm. An outlook of the rise of corporate venture funds in the pharma industry illustrates how important the management and valuation of intellectual property is in the life science industry.
Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer

7. The Internationalization Challenge: Where to Access Innovation

Abstract
Pharma innovation is becoming increasingly global, partly due to the lure of serving new markets, partly because of the need to access early new technology and talent wherever it emerges. Apart from the established centers of innovation in the United States, Europe and Japan, India, China and Singapore are rising attractors for global life science R&D. China as a pharma market and host of pharma R&D is highlighted as a case study, both from the angle of foreign R&D investors and from the perspective of indigenous Chinese players. Given the significant cost pressures in mature markets, reverse innovation in healthcare has drawn considerable attention by local governments.
Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer

8. Future Directions and Trends

Abstract
This final chapter summarizes the key conclusions from the book, identifies key trends and suggests future directions in leading pharmaceutical innovation on three levels: (1) Increasing R&D efficiency and effectiveness; (2) redefining and rethinking the business model, and (3) leading people for innovation and change. Each of these levels is discussed in detail, breaking out the most important drivers and challenges. We conclude with a brief review of the main competencies that pharma innovators must master to remain at the forefront of their industry.
Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer

Backmatter

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